Q2 2024 Nano-X Imaging Ltd Earnings Call

August 20, 2024

Good day, and thank you for standing by.

2nd Quarter 2024 Earnings Conference Call

Operator: 2nd quarter, 2024 earnings conference call. At this time, all participants are in a listening mode. After the speaker's presentation, there will be a question-and-answer session.

This is a second quarter 2024 earnings conference call. At this time all participants are on a listen-only mode.

Speaker Change: welton an nnoxs second quter two thousand and twenty-four earnings conference call at the time all participants on a listeningally mode

At this time, all participants are on a listen-only mode.

Welcome to the Nano-X second quarter 2024 earnings conference call.

After the speaker's presentation there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.

Speaker Change: After the speaker's presentation, there will be a question and answer session.

Operator: To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again.

Speaker Change: To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded.

Speaker Change: To withdraw your question, please press star 1 1 again, please be advised that today's conference is being recorded.

Operator: Please be advised that today's conference is being recorded.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor, Relations.

Speaker Change: At this time, all participants are on a listen-only mode.

Operator: I would now like to hand the conference over to your speaker today.

Speaker Change: I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor Relations.

Mike Cavanaugh: Mike Cavanaugh, Investor Relations, please go ahead. Good morning, and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the quarter ended June 30, 2024. The release is currently available on the Investor section of the company's website.

Speaker Change: I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor Relations. Please go ahead.

Speaker Change: Please go ahead.

Speaker Change: Go ahead.

Speaker Change: Good morning and thank you for joining us today.

Speaker Change: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

Speaker Change: Good morning and thank you for joining us today.

Speaker Change: Earlier today, Nano-X Imaging Limited released financial results for the quarter ended June 30, 2024. The release is currently available on the investor section of the company's website.

Speaker Change: Earlier today Nanox Imaging Limited released financial results for the quarter ended June, 30, 2024. The release is currently available on the investor section of the company's website.

Speaker Change: To withdraw your question, please press star 11 again.

Mike Kavanaugh: Good morning and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the quarter ended June 30, 2024.

Speaker Change: The release is currently available on the investors section of the company's website.

Mike Cavanaugh: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Speaker Change: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Speaker Change: With me today are Ares Meltzer, Chief Executive Officer and Acting Chairman, and Ron Daniel, Chief Financial Officer.

Speaker Change: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Mike Cavanaugh: Before we get started, I would like to remind everyone that management will be making statements during this call that include polar-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters. These statements are subject to risks and certain fees and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission.

Speaker Change: Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters. These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date.

Speaker Change: Before we get started, I would like to remind everyone that management will be making statements, during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters. These statements are subject to risks, uncertainties, and assumptions that are based on management's, current expectations as of today and may not be updated in the future.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: Therefore, these statements should not be relied upon as representing the company's, views as of any subsequent date.

Speaker Change: I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor Relations.

Speaker Change: Please go ahead.

Speaker Change: Good morning, and thank you for joining us today.

Speaker Change: Earlier today, Nano-X Imaging Limited released financial results for the quarter ended June 30, 2024. The release is currently available on the Investor section of the company's website.

Speaker Change: These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations as of today and may not be updated in the future.

Speaker Change: therefore these statements should not be relied upon as representing the company's views as of any subsequent date

Speaker Change: Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission.

Speaker Change: Factors that may cause such a difference include, but are not limited to, those described in, the company's filings with the Securities and Exchange Commission.

Speaker Change: factors that may cause such a difference include but are not limited to those described in the company's filings with the securities and exchange commission

Speaker Change: We will also refer to certain non-GAAP financial measures to provide additional information, to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release with the, primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Mike Cavanaugh: We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Speaker Change: We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP-to-GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares.

Speaker Change: We will also refer to certain non-GAAP financial measures to provide additional information to investors.

Speaker Change: A reconciliation of the non-GAAP-to-GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares.

Speaker Change: Non-Gap Cost of Revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Speaker Change: Non-Gap Cost of Revenue

Speaker Change: Non-Gap Gross Profit

Speaker Change: non-gaap gross profit margin non-gaap research and development expenses

Speaker Change: non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Erez Meltzer: With that, I'd now like to turn the call over to Eras Meltzer. Thank you for joining us today, and as always, we appreciate your continued support of Nanox and our mission. 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts. As we continue to expand our deployment in the US and the rest of the world, we're not only accelerating deployment of the Nanox Rx system, but also expanding the footprint of the other value-added elements of the full Nanox solution, including Nanox AI. As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Speaker Change: With that, I'd now like to turn the call over to Erez Meltzer.

Speaker Change: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

era's millter: With that, I'd now like to turn the call over to Erez Meltzer.

era's millter: Thank you for joining us today, and as always, we appreciate your continued support of Nano-X and our mission.

era's millter: Thank you for joining us today, and as always, we appreciate your continued support of Nanox, and our mission.

era's millter: Before we get started, I would like to remind everyone that management will be making statements during this call, that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters.

era's millter: Thank you for joining us today, and as always, we appreciate your continued support of Nano-X and our mission.

era's millter: 2024 has been a period of strong commercial progress while also advancing the value of, our products through our clinical efforts as we continue to expand our deployment in the U.S. and the rest of the world.

era's millter: 2024 has been a period of strong commercial progress, while also advancing the value of our products through our clinical efforts, as we continue to expand our deployment in the U.S. and the rest of the world.

era's millter: 2024 has been a period of strong commercial progress, while also advancing the value of our products through our clinical efforts.

Speaker Change: as we continue to expand our deployment in the U.S. and the rest of the world.

Speaker Change: We're not only accelerating deployment of the Nano-X Arc system, but also expanding the footprint of the other value-added elements of the full Nano-X solution, including Nano-X AI.

Speaker Change: We're not only accelerating deployment of the Nanox Arc system, but also expanding the, footprint of the other value-added elements of the full Nanox solution, including Nanox, AI.

Speaker Change: We are not only accelerating deployment of the Nano-X Arc system, but also expanding the footprint of the other value-added elements of the full Nano-X solution, including Nano-X AI.

Speaker Change: As mentioned in previous calls, I'm committed to providing further insights and detailed, updates on our ongoing advancements in the coming periods.

Speaker Change: These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations, as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date.

Speaker Change: As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancement in the coming period.

Speaker Change: As mentioned in previous calls, I am committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Erez Meltzer: I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advancements, commercial deployments, Nanox AI updates, and any production to our new Nanox Rx system, which we'll call Nanox Rx. After my prepared comments, I'll turn the call over to our CSO, Ran, who will review our Q2 financial results. I will then share a few closing thoughts before turning the call over to the Q&A session. We have a lot to discuss, so let's get started.

Speaker Change: I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advances, commercial deployments, Nano-X AI updates, and an introduction to our new Nano-X Arc system, which we'll call Nano-X ArcX.

Speaker Change: I will begin with a discussion of our recent achievements, which will cover regulatory, updates, clinical advancements, commercial deployments, Nanox AI updates, and an introduction to our new Nanox Arc system, which we'll call Nanox ArcX.

Speaker Change: Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission.

Speaker Change: I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advancements, commercial deployments, Nano-X AI updates, and an introduction to our new Nano-X Arc system, which we'll call Nano-X ArcX.

Speaker Change: After my prepared comments, I'll turn the call over to our CFO, Ran, who will review our Q2 financial results.

Renan: After my prepared comments, I'll turn the call over to our CFO , Ran, who will review our Q2 financial results. I will then share a few closing thoughts before turning the call over to the Q&A session.

Renan: I will then share a few closing thoughts before turning the call over to the Q&A session.

Renan: We have a lot to discuss, so let's get started.

Renan: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510k submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general tomosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest.

Renan: We will also refer to certain non-GAAP financial measures to provide additional, information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Erez Meltzer: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510(k) submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general thermosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest. As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indications and was intended to support the submission.

Speaker Change: We have a lot to discuss, so let's get started.

Speaker Change: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts.

Renan: With that, I'd now like to turn the call over to Erez Meltzer.

Renan: I'm happy to share that just last week, Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general tomosynthesis imaging.

Renan: what's clear the submission will significantly expand the system indication for used from the current demiscape for general use including chest

Renan: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indications, and was intended to support this submission. The submission will include some software updates and is accompanied by new clinical data for various study anatomies with and without pathologies.

Renan: Thank you for joining us today, and as always, we appreciate your continued support of Nano-X, and our mission.

Renan: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indication, and was intended to support the submission. The submission will include some software updates, and is accompanied by new clinical data for various study anatomies, with and without pathology. To be clear, It is worth noting that all CARD-installed Nano-X Arc systems are hardware ready and have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approval. This means that post-SDA clearance is a simple software upgrade that can be done remotely, is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standard.

Renan: as you know much of the clinical work we have been performing recently has centered around the suitability of the nanicsx are for chess indications and was intended to support the submission

Erez Meltzer: The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies. To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post-SDA clearance is a simple software upgrade that can be done remotely, is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards. Additionally, after completing the technical stages, including obtaining the ISO 13485 certifications from BSI and successfully passing the MBR audit, we are now in advanced stages with our notified body to secure the CE mark for the E-origin.

Renan: The submission will include some software updates and is accompanied by new clinical data for various study anatomies.

Renan: To be clear, it is worth noting that all current installed Nano-X Arc systems are hardware-ready, and have the required capabilities to scan MSK chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post-FDA clearance, a simple software upgrade that can be done remotely, is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards.

Renan: with and without pathologies.

Speaker Change: To be clear, it is worth noting that all CARD-installed Nanox Arc systems are hardware-ready and have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approvals.

Speaker Change: This means that post-SDA clearance, a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards.

Renan: Additionally, after completing the technical stages, including obtaining the ISO 13485 certifications from BSI and successfully passing the MDR audit, we are now in advanced stages with our notified body to secure the CE mark for the EU region. Rest assured, we will provide updates as soon as they are available.

Speaker Change: Additionally, after completing the technical stages, including obtaining, the ISO 13485 certifications from BSI and successfully passing the MDR audit. We are now in advanced stages with our notified body to secure the CE mark for the EU region.

Speaker Change: Additionally, after completing the technical stages, including obtaining

Speaker Change: The ISO 13485, Certifications from BSI, and successfully passing the MDR audits.

Speaker Change: We are now in advanced stages with our notified body to secure the CE mark for the EU region.

Speaker Change: Rest assured, we will provide updates as soon as they are available.

Erez Meltzer: Rest assured, we will provide updates as soon as they are available. Turning now to our global deployment and commercial efforts, which continued in the next second quarter, our team is diligently working with imaging centers, physicians, and regulators to increase the footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployments. The deployments in the U.S. are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan.

Speaker Change: Rest assured, we will provide updates as soon as they are available.

Speaker Change: Turning now to our global deployment and commercial efforts, which continued in the second quarter, our team is diligently working with imaging centers, physicians, and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployment.

Speaker Change: 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts as we continue to expand our deployment in the U.S, and the rest of the world.

Speaker Change: Turning now to our global deployment and commercial efforts, which continued in the second quarter.

Speaker Change: Turning now to our Global Deployment and Commercial Efforts, which continued in the second quarter.

Speaker Change: Our team is diligently working with imaging centers, physicians, and regulators to increase footprint of our Nano-X R technology. As of today's call, there are now dozens of units, in various stages of shipment and deployment. The deployments in the U.S. are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To give more color on our U.S. deployment, I would like to add that during the second quarter, we have installed Nano-X Arc system in three prominent healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry.

Speaker Change: Our team is diligently working with imaging centers, physicians, and regulators to increase footprint of our Nano-XR technology.

Operator: 2nd quarter, 2024 earnings conference call.

Operator: 2nd quarter, 2024 earnings conference call. At this time, all participants are in a listening mode. After the speaker's presentation, there will be a question answer session. To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded.

Speaker Change: As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Operator: At this time, all participants are in a listening mode.

Operator: After the speaker's presentation, there will be a question answer session.

Speaker Change: As of today's call, there are now dozens of units in various stages of shipment and deployment.

Operator: To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised.

Speaker Change: The deployments in the U.S. are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To keep more color on our U.S. deployment, I would like to add that during the second quarter, we have installed Nano-X Arc systems in three prominent healthcare chain operating imaging facilities across the U.S., including one of the largest in the industry. Additionally, in the U.S., some of the deployed sites have received certification from the, corresponding state's regulatory body and have begun to scan patients.

Speaker Change: I will begin with a discussion of our recent achievements, which will cover regulatory, updates, clinical advancements, commercial deployments, Nano-X AI updates, and an introduction to our new Nano-X Arc system, which we'll call Nano-X ArcX.

Speaker Change: After my prepared comments, I'll turn the call over to our CFO, Ran, who will review our Q2 financial results.

Speaker Change: I will then share a few closing thoughts before turning the call over to the Q&A session.

Operator: I would now like to hand the conference over to your speaker today.

Mike Cavanaugh: Mike Cavanaugh, investor relations, please go ahead. Good morning and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the quarter-ended June 30, 2024. The release is currently available on the investor section of the company's website. With me today are Erez Meltzer, Chief Executive Officer, and Acting Chairman, and Ran Daniel, Chief Financial Officer. Before we get started, I would like to remind everyone that management will be making statements during this call that include polar-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters.

Erez Meltzer: To keep more color on our U.S. deployment, I would like to add that during the second quarter, we have installed Nano-X Arc systems in its three prominence, healthcare chains operating imaging facilities across the U.S., including one of the largest and the indifference. In addition to the US, some of the deployed sites have received certification from the corresponding state's regulatory body and have begun to scan patients. Others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites has shown up to 14 scans per day.

Speaker Change: We have a lot to discuss, so let's get started.

Operator: To withdraw your question, please press star one one again.

Speaker Change: to keep more color on our u s deployment i would like to add that during the second quarter we have installed nanos are system in three prominent healthcare chains operating imaging facilities across the u s including one of the largest in the industry

Speaker Change: Before I provide an overview of our commercial, progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510k submission to the FDA, which is intended to expand the indications, for our current Nano-X Arc system in general tomosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest.

Speaker Change: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indications and was intended to support the submission. The submission will include some software updates and is accompanied by new clinical, data for various study anatomies with and without pathologies.

Speaker Change: To be clear, it is worth noting that all CARB-installed Nano-X Arc systems are hardware-ready and, have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post-FDA clearance, a simple software upgrade that can be done remotely, is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards.

Speaker Change: Additionally in the U.S.

Speaker Change: Some of the deployed sites have received certification from the corresponding state's regulatory body and have begun to scan patients, others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

Speaker Change: Additionally, in the U.S., some of the deployed sites have received certification from the corresponding state's regulatory body and have begun to scan patients. Others are in the process of obtaining approval.

Operator: Please be advised that today's conference is being recorded.

Speaker Change: Others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

Speaker Change: This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

Mike Cavanaugh: These statements are subject to risks and certain fees and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors.

Erez Meltzer: We recently received good indications for validation of the US CPT and reimbursement process as we received management care ELB. Since March 2024, we have been ramping up in the US with a current targeted backlog of 50 federal prop prospects and an additional 44 leads in the pipeline. With the main segments being outpatient imaging centers, medical imaging chains, and orthopedic centers, we understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period, and we are very confident that this will continue to grow over time.

Speaker Change: We recently received good indication, for validation of the U.S. CPT and reimbursement process as we received management care EOB.

Speaker Change: We recently received good indications for validation of the U.S. CPT and reimbursement, process as we received management care EOB.

Speaker Change: We recently received good indications

Speaker Change: for validation of the U.S. CPT and reimbursement process as we received management care EOB.

Speaker Change: Since March 2024, we have been ramping up in the U.S. with current targeted backlogs, of 50 fair growth prospects and additional 44 leads in the pipeline, with the main segments being outpatient imaging centers.

Speaker Change: Since March 2024, we have been ramping up in the U.S. with current targeted backlog, of 50 favorable prospects and additional 44 leads in the pipeline. With the main segments being outpatient imaging centers, medical imaging chains, and orthopedic, centers.

Speaker Change: Since March 2024, we have been ramping up in the U.S. with current targeted backlog

Speaker Change: of 50 favorable prospects and additional 44 leads in the pipeline.

Mike Cavanaugh: A reconciliation of the non-GAAP to GAAP measures is provided with our press release with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, in non-GAAP gross loss per share.

Speaker Change: with the main segments being outpatient imaging centers, medical imaging chains, and orthopedic centers.

Speaker Change: Medical Imaging Chains, and Orthopedic Centers.

Speaker Change: We understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress, in such a short period of time, and we are very confident that this will continue to grow over time.

Speaker Change: We understand that not all of these 94 leads will convert, but I'm very pleased with our, commercial team's progress in such a short period, and we are very confident that this will continue to grow over time.

Speaker Change: We understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period. And we are very confident that this will continue to grow over time.

Erez Meltzer: We're also awaiting the import license to deploy the first Nano-X Arc in Mexico, with the systems ready for shipment. Additionally, there are two units fully deployed in Israel and another deployment is expected in the upcoming month for both clinical and commercial use. We're able to pursue this opportunity as we obtained a March approval several months ago. Importantly, the number of daily scans is accelerating, and in that July, we experienced an average of 6.67 scans globally for all deployed Nano-X Arc systems, accomplishing both clinical work and commercial patient scans. I think it is interesting to learn that the global commercial and clinical scans by body part are distributed as follows.

Speaker Change: We're also awaiting the import license to deploy the first Nano-X ARC in Mexico with the systems ready for shipment.

Speaker Change: We are also awaiting the import license to deploy the first Nano-X ART in Mexico with, the systems ready for shipment.

Speaker Change: We are also awaiting the import license to deploy the first Nano-X Arc in Mexico with the systems ready for shipment.

Speaker Change: Additionally, there are two units fully deployed in Israel, and another deployment is expected, in the upcoming month for both clinical and commercial use.

Speaker Change: Additionally, after completing the technical stages, including obtaining the ISO 13485, permissions from BSI and successfully passing the MDR audit, we are now in advanced stages with our notified body to secure the CE mark for the EU region. Rest assured, we will provide updates as soon as they are available.

Speaker Change: Additionally, there are two units fully deployed in Israel, and another deployment is expected in the upcoming months for both clinical and commercial use, were able to pursue this opportunity as we obtained a MAR approval several months.

Speaker Change: Additionally, there are two units fully deployed in Israel, and another deployment is expected in the upcoming months for both clinical and commercial use.

Operator: I would now like to hand the conference over to your speaker today.

Erez Meltzer: With that, I'd now like to turn the call over to Eras Meltzer. Thank you for joining us today, and as always, we appreciate your continued support of Nanox and our mission. 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts. As we continue to expand our deployment in the US and the rest of the world, we're not only accelerating deployment of the Nanox Rx system, but also expanding the footprint of the other value-edded elements of the full Nanox solution, including Nanox AI. As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Mike Cavanaugh: Mike Cavanaugh, investor relations, please go ahead.

Speaker Change: We're able to pursue this opportunity as we obtained AMAR approval several months ago.

Speaker Change: We are able to pursue this opportunity as we obtained AMAR approval several months ago.

Speaker Change: Importantly, the number of daily scans is accelerating, and in last July, we experienced an average of 6.67 scans globally for all deployed Nano-X Arc systems, encompassing both clinical, work, and commercial patient scans.

Speaker Change: Importantly, the number of daily scans is accelerating, and in last July, we experienced, an average of 6.67 scans globally for all deployed Nano-X ART systems, encompassing both clinical, work, and commercial patient scans.

Speaker Change: Importantly, the number of daily scans is accelerating, and in last July , we experienced an average of 6.67 scans globally for all deployed Nano-X Arc systems.

Speaker Change: encompassing both clinical, work, and commercial patient scans.

Speaker Change: I think it is interesting to learn that the global commercial and clinical scans by bodypart are distributed as follows.

Speaker Change: I think it is interesting to learn that the global commercial and clinical scans by body, part are distributed as follows.

Speaker Change: I think it is interesting to learn that the global commercial and clinical scans by BodyPart are distributed as follows.

Erez Meltzer: 31% chest, 25% hand, 14% leg, and 14% spine, but of course these indications may vary from overtime.

Speaker Change: 31% chess.

Speaker Change: Thirty-one percent chest, 25 percent hand, 14 percent leg, and 14 percent spine.

Speaker Change: 25% 10.

Speaker Change: 31% chest, 25% hand, 14% leg, and 14% spine, but of course, these indications may vary from over time.

Speaker Change: 14% lag.

Speaker Change: 14% spine.

Speaker Change: But of course, these indications may vary from over time.

Erez Meltzer: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology. To support our accelerating deployments effort, we continued to strengthen our team and infrastructure during their quarter, adding to our US sales and technical teams. Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaboration in the country. Our mission is to provide healthcare practices with a transformative imaging advantage, with Nano-X Arc an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic work.

Speaker Change: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

Erez Meltzer: Good morning and thank you for joining us today.

Speaker Change: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

Speaker Change: To support our accelerating deployments effort, we continue to strengthen our team and infrastructure, during the quarter, adding to our U.S. sales and technical teams.

Speaker Change: Turning now to our global deployment and commercial efforts, which continued in the next second, quarter, our team is diligently working with imaging centers, physicians, and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployment.

Speaker Change: To support our accelerating deployments effort, we continued to strengthen our team and infrastructure during the quarter, adding to our U.S. sales and technical teams.

Speaker Change: The deployments in the U.S. are spread across seven states, the newest being Delaware and, California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To give more color on our U.S. deployment, I would like to add that during the second, quarter, we have installed Nano-X Arc system in three prominent healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry. Additionally in the U.S., some of the deployed sites have received certification from the, corresponding state's regulatory body and have begun to scan patients.

Speaker Change: But of course, these indications may vary from over time.

Speaker Change: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country.

Speaker Change: Others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

Erez Meltzer: After my prepared comments, I'll turn the call over to our CSO, Ran, who will review our Q2 financial results.

Speaker Change: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country.

Erez Meltzer: I will then share a few closing thoughts before turning the call over to the Q&A session. We have a lot to discuss, so let's get started.

Speaker Change: Our mission is to provide healthcare practices with a transformative imaging advantage with, a Nano-X ART, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change: We recently received good indications for validation of the U.S. CPT and reimbursement, process as we received management care EOB.

Speaker Change: Our mission is to provide healthcare practices with a transformative imaging advantage.

Erez Meltzer: Earlier today, Nano-X Imaging Limited released financial results for the quarter-ended June 30, 2024. The release is currently available on the investor section of the company's website.

Speaker Change: Since March 2024, we have been ramping up in the U.S. with current targeted backlog, of 50 fair role prospects and additional 44 leads in the pipeline, with the main segments being outpatient imaging centers, medical imaging chains, and orthopedic centers.

Erez Meltzer: With me today are Erez Meltzer, Chief Executive Officer, and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Erez Meltzer: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share the just last week, Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general thermosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest.

Speaker Change: with Nano-X Arc, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change: We are working to accelerate a steady flow of referrals from healthcare providers for, Nano-X ART digital tomography imaging as part of their diagnostic work.

Speaker Change: We are also awaiting the import license to deploy the first Nano-X ART in Mexico with, the systems ready for shipment.

Speaker Change: we are working to accelerate a steady flow of referrals from health care providers for anunox are digital autography imaging as part of their diagnostic workflow

Erez Meltzer: Before we get started, I would like to remind everyone that management will be making statements during this call that include polar-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters.

Speaker Change: Additionally, there are two units fully deployed in Israel and another deployment is expected, in the upcoming months for both clinical and commercial use.

Speaker Change: Flow.

Speaker Change: We are able to pursue this opportunity as we obtained a MAR approval several months, ago.

Erez Meltzer: We also continue to advance our other clinical efforts in multiple countries and locations. Generating data, demonstrating the utility of the Nano-X Rx for a fuller, wider range of indications, is a key initiative for Nano-X. The reason is simple: if we can show large volumes of data demonstrating the evaluated utility of the Nano-X Rx, it will significantly boost our all-important commercial efforts. For example, the Bayley-N-Sun Hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data. There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies.

Speaker Change: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

Speaker Change: I think it is interesting to learn that the global commercial and clinical scans by BodyPART, are distributed as follows, 31% chest, 25% hand, 14% leg, and 14% spine.

Speaker Change: To support our accelerating deployments effort, we continue to strengthen our team and infrastructure during the quarter, adding to our reviewer sales and technical team.

Speaker Change: We also continue to advance our other clinical efforts in multiple countries and locations.

Erez Meltzer: These statements are subject to risks and certain fees and assumptions that are based on management's current expectations as of today and may not be updated in the future.

Speaker Change: generating data demonstrating the utility of the Nano-X arcs for a fuller, wider range of indications.

Speaker Change: But of course, these indications may vary from over time.

Speaker Change: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country.

Speaker Change: Our mission is to provide healthcare practices with a transformative imaging advantage, with Nano-X Arc, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change: is a key initiative for Nano-X.

Speaker Change: We are working to accelerate a steady flow of referrals from health care providers for Nano-X Arc digital tomography imaging as part of their diagnostic work.

Erez Meltzer: Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date.

Erez Meltzer: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indications and was intended to support the submission. The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies. To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and has the required capabilities to scan MSK, chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals.

Speaker Change: We also continue to advance our other clinical efforts, in multiple countries and locations, generating data demonstrating the utility of the Nano-X arcs for a fuller, wider range of indications, is a key initiative for Nano.

Speaker Change: We also continue to advance our other clinical efforts in multiple countries and, locations.

Speaker Change: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

Speaker Change: To support our accelerating deployments effort, we continue to strengthen our team and infrastructure, during the quarter, adding to our U.S. sales and technical teams.

Speaker Change: For example.

Speaker Change: Generating data demonstrating the utility of the Nano-X Arc for a fuller, wider range of indications is a key initiative for Nano-X.

Speaker Change: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial infrastructure, and future strategic collaboration in the country.

Erez Meltzer: Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission.

Speaker Change: The Beilin Sun Hospital in Israel has been scanning patients for exactly this reason.

Speaker Change: The Beilin Summer Hospital in Israel has been scanning patients for exactly this reason. And this trial has begun to generate data. There have been a few dozens of patients recruited at our clinical sites as part of this and the multi-site study. The previously announced multi-site trial is now operational and we are accelerating patient, Scanning Activity.

Speaker Change: The reason is simple. If we can show large volumes of data demonstrating the value-added utility of the Nano-X Arc, it will significantly boost our all-important commercial efforts. For example, the Bailin Center Hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate, data. There have been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies. The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity.

Speaker Change: We are working to accelerate a steady flow of referrals from healthcare providers for, Nano-X ART digital tomography imaging as part of their diagnostic workflow.

Speaker Change: And this trial has begun to generate data.

Erez Meltzer: We will also refer to certain non-GAAP financial measures to provide additional information to investors.

Speaker Change: There have been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies.

Speaker Change: We also continue to advance our other clinical efforts in multiple countries and locations.

Speaker Change: Generating data demonstrating the utility of the Nano-X ART for a fuller, wider range, of indications is a key initiative for Nano-X. The reason is simple. If we can show large volumes of data demonstrating the value-added utility of the Nano-X ART, it will significantly boost our all-important commercial efforts.

Erez Meltzer: The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating site while already gaining clinical experience with the amount of AHRQ installed in scanning patients. The MSKL trial held at Shamir Hospital has been completed and accompanied white paper publishers recently. The study concluded that the Nano-X AHRQ was a value-added tool in the hospital's clinical workflow, enabling quicker diagnosis when used as a supplemented tool to the standard X-ray system, achieving faster diagnosis time compared to the standard CT-based workflow.

Speaker Change: The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity.

Speaker Change: The UGMC is in the final preparation to join the multi-site trial as the second participating site, while already gaining clinical experience with the Nano-X Arc installed in scanning patients.

Speaker Change: The UGMC is in the final preparation to join the multi-site trial as the second participating site, while already gaining clinical experience with a Nano-X arc installed in scanning patients. The MS-SCALE trial held at Shamir Hospital has been completed and accompanying white paper published recently. The study concluded that the Nano-X arc was a value-added tool in the hospital's clinical workflow.

Erez Meltzer: A reconciliation of the non-GAAP to GAAP measures is provided with our press release with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, in non-GAAP gross loss per share.

Erez Meltzer: This means that post-SDA clearance is a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards. Additionally, after completing the technical stages, including obtaining the ISO 13485 certifications from BSI and successfully passing the MBR audit, we are now in advanced stages with our notified body to secure the CE mark for the E-origin.

Speaker Change: The UGMC is in the final preparation to join the multi-site trial as the second participating site, while already gaining clinical experience with a Nano-X Arc installed in scanning patients.

Speaker Change: The MS-Scale trial held at Shamir Hospital has been completed and accompanied white paper published recently. The study, concluded that the Nano-X Arc was a value-added tool in the hospital's clinical workflow, enabling quicker diagnosis when used as a supplemental tool to the standard X-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow. Furthermore, all Nano-X Arc images were determined to be of high diagnostic quality, enabling optimal depiction of findings.

Speaker Change: For example, the Bailey Insomnia Hospital in Israel has been scanning patients for exactly, this reason, and this trial has begun to generate data.

Speaker Change: There have been a few dozens of patients recruited at our clinical sites as part of, this and the multi-site studies. The previously announced multi-site trial is now operational, and we are accelerating, patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating, site, while already gaining clinical experience with the Nano-X ART installed in scanning patients.

Erez Meltzer: With that, I'd now like to turn the call over to Eras Meltzer.

Speaker Change: The MS-SCALE trial held at Shamir Hospital has been completed and accompanying white paper published recently.

Speaker Change: The MS-SCALE trial held at Shamir Hospital has been completed, and an accompanying white, paper published recently. The study concluded that the Nano-X Arc was a value-added tool in the hospital's clinical, workflow, enabling quicker diagnosis when used as a supplemental tool to the standard X-ray system, achieving faster diagnosis time as compared to the standard CT-based, workflow. Furthermore, all Nano-X Arc images were determined to be of high diagnostic quality, enabling, optimal depiction of findings.

Speaker Change: the study concluded the dynamics arc was evaluaddateded tool in the hospital's clinical workflow

Speaker Change: Enabling quicker diagnosis when used, is the supplemental tool to the standard x-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow. Furthermore, all Nano-X Arc images were determined to be of high diagnostic quality, enabling optimal depiction of findings.

Speaker Change: enabling quaker diagnosis when used as a supplemented tool to the standard xray system achieving fanter diagnosis time and compferred to the standard cp basase workflow

Erez Meltzer: Rest assured, we will provide updates as soon as they are available. Turning now to our global deployment and commercial efforts which continued in the next second quarter, our team is diligently working with imaging centers, physicians and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployments. The deployments in the U.S, are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan.

Erez Meltzer: Furthermore, all Nano-X AHRQ images were determined to be of high diagnostic quality, enabling optimal depiction of findings. Our technology can increase the depiction of the Colchester's lesions, localized characterize and result questionable lesions, even without prior a geologist experience. Colt cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose, cost, and images per study should be further investigated.

Speaker Change: Furthermore, all Nano-X Arc images were determined to be of high diagnostic quality enabling optimal depiction of findings.

Speaker Change: Our technology can increase depiction of occult chest lesions, localize, characterize, and resolve questionable lesions even without prior audiologist experience.

Speaker Change: Our technology can increase depiction of occult chest lesions, localize, characterize, and, resolve questionable lesions even without prior audiologist experience.

Speaker Change: Our technology can increase depiction of occult chest lesions, localize, characterize, and resolve questionable lesions even without prior audiologist experience, called cathode PTS may have an improved diagnostic accuracy compared to CXR, its capability to eliminate the need for CP at a fraction of the radiation dose.

Speaker Change: Our technology can increase depiction of occult chest lesions, localize, characterize, and resolve questionable lesions, even without prior audiologist experience.

Speaker Change: The MS-Scale cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability, to eliminate the need for CT at a fraction of the radiation dose, cost, and images per study should be further investigated.

Speaker Change: Cold cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose, cost, and images per study should be further investigated.

Speaker Change: cold cathode PTS may have an improved diagnostic accuracy compared to CXR.

Speaker Change: Its capability to eliminate the need for CP at a fraction of the radiation dose.

Speaker Change: Costs and images per study should be further investigated.

Speaker Change: For more information, see more our white paper section on our website.

Speaker Change: For more information, see more of our white paper section on our website.

Speaker Change: Costs and images per study should be further investigated. For more information, see more our white paper section on our website.

Erez Meltzer: For more information, see more our white paper section on our website.

Speaker Change: For more information, see more, our white paper section on our website.

Erez Meltzer: To keep more color on our U.S, deployment, I would like to add that during the second quarter, we have installed Nano-X Arc systems in its three prominence, healthcare chains operating imaging facilities across the U.S., including one of the largest and the indifference. In addition to the US, some of the deployed sites have received certification from the corresponding states regulatory body and have begun to scan patients. Others are in the process of obtaining approval.

Speaker Change: Turning to our AI business.

Speaker Change: Turning to our AI business, just last month, we announced that our Nano-X AI cardiac solution, called Health CCNG was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT, annual meeting. We are encouraged by the implementation of our AI cardiac solution at esteemed healthcare, systems along with a continued validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases.

Erez Meltzer: Turning to our AI business. Just last month, we announced that our Nano-X AHRQ solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI cardiovascular solution at a steamed healthcare system, along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases. Clawwell Health has previously reported that in the first full year of implemented health CC&G in its electronic medical record system, there was a 13-fold increase of the patients reported in the previous two years.

Speaker Change: Turning to our AI business.

Speaker Change: Just last month, we announced that our Nano-X AI cardiac solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT, annual meeting.

Speaker Change: Turning to our AI business.

Speaker Change: Just last month, we announced that our Nano-X AI cardiac solution called Health CCNG was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT, annual meeting. We are encouraged by the implementation of our AI cardiac solution at esteemed health, care systems, along with a continued validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases.

Speaker Change: Just last month.

Speaker Change: We announced that our Nano-X AI cardiac solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography.

Speaker Change: We are encouraged by the implementation of our AI Cardiac Solution and esteemed health care systems, along with the continued validation, through real-world studies of its potential to promote, Early Detection and Preventive Care of Cardiovascular Diseases.

Speaker Change: SCCP Annual Meeting

Speaker Change: We are encouraged by the implementation of our AI cardiac solution at esteemed healthcare systems, along with the continued validation

Erez Meltzer: This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day. We recently received good indications for validation of the US CPT and reimbursement process as we received management care ELB. Since March 2024, we have been ramping up in the US with current targeted backlog of 50 federal prop prospects and additional 44 leads in the pipeline. With the main segments being outpatient imaging centers, medical imaging chains and orthopedic centers, we understand that not all of these 94 leads will convert but I'm very pleased with our commercial team's progress in such a short period and we are very confident that this will continue to grow over time.

Speaker Change: through real-world studies of its potential to promote

Speaker Change: CoreWell Health has previously reported that in the first full year of implemented health, CCNG in its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years.

Speaker Change: National Health has previously reported that in the first full year of implemented Health, CCNG in its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years.

Speaker Change: Early Detection and Preventive Care of Cardiovascular Diseases

Speaker Change: ChloroWell Health has previously reported, that in the first full year of implemented health CCNG.

Speaker Change: Corwell Health has previously reported that in the first full year of implemented health CCNG

Speaker Change: In its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years, at Billingson Hospital in Israel, incidental.

Speaker Change: In its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years.

Erez Meltzer: At Bellinson Hospital in Israel, incidental coronary artery calcification on the CT scans of immune mediated inflammatory disease patients identified and quantified by our AI cardiovascular solution was found in over 50-50 percent of scan patients and associated with all-cause mortality and adverse cardiovascular outcome. Traditional cardiovascular risk scoring is difficult in these patients, and I don't say I can be a valuable new tool in quantifying these risks. After being installed and implemented the Jefferson-Imsson hospital, Health, CC&G helped identify 757 patients, age, study or above, with CAC levels higher than 100 AgStone units. In a study conducted by Mass Gen Hospital and Brigham Women Hospital, Health, CC&G was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipopropane A as part of clinical care.

Speaker Change: At Beilinson Hospital in Israel, incidental coronary artery calcification on the CT scans, of immune-mediated inflammatory disease patients identified and quantified by our AI cardiac solution was found in over 50, 50% of scanned patients and associated with all-cause mortality and adverse cardiovascular outcomes. Traditional cardiovascular risk scoring is difficult in these patients, and Nano-X AI, can be a valuable new tool in quantifying these risks.

Speaker Change: Coronary artery calcification on the CT scans of immune-mediated inflammatory disease patients, identified and quantified by our AI Cardio solution, was found in over 50, 50% of scan patients and associated with all-cause mortality and adverse cardiovascular outcomes.

Speaker Change: at Berlingson Hospital in Israel, incidental...

Speaker Change: Coronary artery calcification

Speaker Change: on the CT scans of immune-mediated inflammatory disease patients, identified and quantified by our AI Cardio solution.

Speaker Change: was found in over 50-50% of scan patients and associated with all-cause mortality and adverse cardiovascular outcomes.

Speaker Change: Traditional cardiovascular risk scoring is difficult in these patients, and Nano-X AI can be a valuable new tool in quantifying these risks.

Erez Meltzer: We're also awaiting the import license to deploy the first Nano-X Arc in Mexico with the systems ready for shipment. Additionally, there are two units fully deployed in Israel and another deployment is expected in the upcoming month for both clinical and commercial use. We're able to pursue this opportunity as we obtained a March approval several months ago. Importantly, the number of daily scans is accelerating and in that July, we experienced an average of 6.67 scans globally for all deployed Nano-X Arc systems, accomplishing both clinical work and commercial patient scans.

Speaker Change: traditional carter alelascar risks scoring is difficult in these patients and ano say i can be a valuable new tool in quantifying these risks

Speaker Change: After being installed and implemented the Jefferson-Einstein Hospital, Health CCNG helped identify 757 patients, age 30 or above, with CAC levels higher than 100 Agstone units.

Speaker Change: After being installed and implemented at Jefferson-Einstein Hospital, Health CCNG helped identify 757 patients, aged 30 or above with CAC levels higher than 100 angstone units.

Speaker Change: After being installed and implemented at the Jefferson-Einstein Hospital, Health CCNG helped identify 757 patients aged 30 or above

Speaker Change: with c a c levels higher than one hundred ustone units

Speaker Change: In a study conducted by MassGen Hospital and Brigham and Women's Hospital, Health CCNG was used to analyze, non-contrast chest CT scans of 260 patients, who had measurement, of lipoprotein A as part of a clinical care.

Speaker Change: In a study conducted by MassGen Hospital and Brigham Women's Hospital, Health CCNG was, used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein-A as part of a clinical care. A statistically significant correlation was found between level of CAC and this lipoprotein-A, a risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients.

Speaker Change: In a study conducted by MassGen Hospital and Brigham Women's Hospital, Health CCNG was, used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein, A as part of a clinical care. A statistically significant correlation was founded between level of CAC and this lipoprotein A, a risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients.

Speaker Change: In a study conducted by MassGen Hospital and Brigham and Women Hospital, Health CCNG was used to analyze

Speaker Change: non-contrast chest CT scans of 260 patients who had measurements

Erez Meltzer: I think it is interesting to learn that the global commercial and clinical scans by body part are distributed as follows. 31% chest, 25% hand, 14% leg and 14% spine but of course these indications may vary from overtime.

Erez Meltzer: A statistically significant correlation was found between level of CAC and this lipopropane A risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at risk patients. As a sign-dote, the lead author of this study, Breaking Weber, was declared as Young Investigator Word winner at the annual meeting as well. Nanox is proud to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nanox AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcomes. Additionally, the previous agreements we signed for Nanox AI with Coveira Health and Coveira Health are off to a great start, and the feedback has been very positive thus far.

Speaker Change: Of lipoprotein A is part of a clinical cure.

Speaker Change: A statistically significant correlation was founded between level of CAC and this lipoprotein A, a risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients, is a signed oath.

Speaker Change: A statistically significant correlation was founded between level of CAC and this lipoprotein A.

Speaker Change: A risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients.

Erez Meltzer: For those of you that are interested, we also have some new clinical samples on our website including chest pathology. To support our accelerating deployments effort, we continued to strengthen our team and infrastructure during their quarter, adding to our US sales and technical teams. Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaboration in the country. Our mission is to provide healthcare practices with a transformative imaging advantage, with Nano-X Arc an accessible cost effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care.

Speaker Change: As a side note, the lead author of this study, Brittany Weber, was declared a Young Investigator, Award winner at the annual meeting as well.

Speaker Change: As a side note, the lead author of this study, Brittany Weber, was declared as Young Investigator Award winner at the annual meeting as well.

Speaker Change: The lead author of this study, Brittany Weber, was declared as Young Investigator Award winner at the annual meeting as well.

Breaing Wether: as a signoutte the lead author of this study breaing wether would declaring as young investigator a word winner at the annual meeting as well

Breaing Wether: Nano-X is proud to be associated with dynamic clinical talent that is doing valuable work, to support the use, of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcomes.

Breaing Wether: Nano-X is proud to be associated with dynamic clinical talent that is doing valuable work, to support the use of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcomes.

Speaker Change: Nano-X is proud to be associated with dynamic clinical talent that is doing valuable work.

Speaker Change: to support the use of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcomes.

Erez Meltzer: Thank you for joining us today, and as always, we appreciate your continued support of Nanox and our mission.

Breaing Wether: Additionally, the previous agreements we signed for Nano-X AI with Covair Health and Dandelion, Health are off to a great start and the feedback has been very positive thus far.

Breaing Wether: Additionally, the previous agreements we signed for Nano-X AI with Covair Health and Dandelion Health, are off to a great start and the feedback has been very positive thus far.

Speaker Change: Additionally, the previous agreements we signed for Nano-X AI with Covair Health and Dandelion Health are off to a great start, and the feedback has been very positive thus far.

Speaker Change: Additionally, the previous agreements we signed for Nano-X AI with Covair Health and Dandelion Health are off to a great start and the feedback has been very positive thus far.

Erez Meltzer: We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution and ensuring they reach and benefit a wider audience.

Speaker Change: We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution, in ensuring they reach and benefit a wider audience.

Erez Meltzer: 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts.

Erez Meltzer: We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic work. We also continue to advance our other clinical efforts in multiple countries and locations. Generating data, demonstrating the utility of the Nano-X Rx for a fuller, wider range of indications is a key initiative for Nano-X. The reason is simple, if we can show large volumes of data demonstrating the evaluated utility of the Nano-X Rx, it will significantly boost our all-important commercial efforts.

Speaker Change: We are continually working to expand our AI footprint and make it accessible to a broader, range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solutions, and ensuring they reach and benefit a wider audience.

Speaker Change: We are continually working to expand our AI footprint and make it accessible to a broader, range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solutions and ensuring they reach and benefit a wider audience.

Speaker Change: We are continually working to expand our AI footprint and make it accessible to a broader range of customers.

Speaker Change: Our ongoing innovation and development efforts are focused on enhancing our AI solutions and ensuring they reach and benefit a wider audience.

Erez Meltzer: As we continue to expand our deployment in the US and the rest of the world, we're not only accelerating deployment of the Nanox Rx system, but also expanding the footprint of the other value-edded elements of the full Nanox solution, including Nanox AI.

Erez Meltzer: I think I can speak of all of us at Nanox when I say there is a lot to be excited about. Looking ahead to the near future of Nanox, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback, changes in technology, and evolving use case. Nano-X is no different, and we are constantly working on product and technology future developments.

Speaker Change: I think I can speak of all of us at Nano-X when I say there is a lot to be excited about.

Erez Meltzer: As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Speaker Change: I think I can speak of all of us at Nano-X when I say there is a lot to be excited about.

Speaker Change: Looking ahead to the near future of Nano.

Speaker Change: Looking ahead to the near future of Nano-X, we are always looking to improve and meet, market needs. In fact, every dynamic company that plans to expand rapidly over the long term with, a new technology needs to constantly refine their offering based on customer feedback, changes in technology, and evolving use case.

Speaker Change: Looking ahead to the near future of Nano-X, we're always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long term with a new, technology needs to constantly refine their offering based on customer feedback, changes in technology, and evolving use case.

Speaker Change: We're always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback.

Speaker Change: looking your ahead for the near future of nuos

Speaker Change: We are always looking to improve and meet market needs.

Speaker Change: In fact, every dynamic company that plans to expand rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback, changes in technology, and evolving use case.

Erez Meltzer: For example, the Bayley-N-Sun hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data. There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies. The previously announced multi-site trial is now operational and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating site while already gaining clinical experience with the amount of AHRQ installed in scanning patients.

Speaker Change: Changes in Technology and Evolving Use, Nano-X is no different, and we are constantly working on product and technology future development.

Speaker Change: Nano-X is no different, and we are constantly working on product and technology future developments. I'm very pleased to share for the first time that we are developing another Nano-X Arc system called Nano-X ArcX, which we intend to submit, among others, for FDA clearance.

Speaker Change: Nano-X is no different and we are constantly working on product and technology future developments.

Speaker Change: Nano-X is no different, and we are constantly working on product and technology future developments.

Erez Meltzer: I'm very pleased to share for the first time that we are developing another Nano-X, our system called Nano-X ArcX, which we intend to submit, among others, for FDA clearance. Once cleared, it will be marketed along the current system, which will expand our current product offering. At the high level, the Nano-X ArcX is designed to meet market needs of our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases. Listening to the clinical needs is an important step in the ongoing extension of Nano-X solution.

Speaker Change: Once cleared, it will be marketed along the current system, which will expand our current product offering.

Speaker Change: I'm very pleased to share for the first time that we are developing another Nano-X Arc system called Nano-X ArcX which we intend to submit among others for FDA clearance.

Speaker Change: I'm very pleased to share, for the first time, that we are developing another Nanox Arc system called Nanox Arc XP, which we intend to submit, among others, for FDA clearance.

Speaker Change: I'm very pleased to share, for the first time, that we are developing another Nanox Arc system called Nanox ArcX.

Speaker Change: which we intend to submit, among others, for FDA clearance. Once cleared, it will be marketed along the current system, which will expand our current product offering.

Speaker Change: Once cleared, it will be marketed along the current system which will expand our current product offering.

Speaker Change: Once cleared, it will be marketed along the current system, which will expand our current product offering.

Speaker Change: At the high level, the Nano-X ArcX is designed to meet market needs of our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Speaker Change: At the high level, the Nano-X ArcX is designed to meet market needs of our customers including hospitals and imaging centers as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Erez Meltzer: The MSKL trial held at Shamir Hospital has been completed and accompanied white paper publishers recently. The study concluded that the Nano-X AHRQ was a value-added tool in the hospital's clinical workflow, enabling quicker diagnosis when used as a supplemented tool to the standard X-ray system, achieving faster diagnosis time compared to the standard CT-based workflow. Furthermore, all Nano-X AHRQ images were determined to be of high diagnostic quality enabling optimal depiction of findings. Our technology can increase the depiction of the Colchester's lesions, localized characterize and result questionable lesions, even without prior a geologist experience. Colt cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose cost and images per study should be further investigated.

Speaker Change: Listening to the clinical needs is an important step in the ongoing expansion of Nano-X solutions.

Speaker Change: Listening to the clinical needs is an important step in the ongoing expansion of Nano-X solution.

Speaker Change: Listening to the clinical needs is an important step in the ongoing expansion of nanobsolution.

Speaker Change: Listening to the clinical needs is an important step in the ongoing expansion of nanops solution.

Erez Meltzer: Amongst the feature, I'm able to share this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X Arc systems, enhancing one of our key differentiators. The new system will also be easy to deploy in use with an anticipated one-day set-up time and plug-and-play functionality. There will also be image enhancement options in the new units, which are currently not available on existing Nano-X Arc systems and future synthetic to these.

Speaker Change: Amongst the features I am able to share at this time, the Nanox ArcX will have an even smaller footprint than existing Nanox Arc systems, and Hensink, one of our key differentiators. The new system will also be easy to deploy and use, with an anticipated one-day setup time and plug-and-play functionality.

Speaker Change: Amongst the features I am able to share at this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X Arc systems, enhancing one of our key differentiators. The new system will also be easy to deploy and use with an anticipated one-day setup time and plug-and-play functionality.

Speaker Change: Amongst the features I'm able to share at this time, the Nano-X ArcX, will have an even smaller footprint than existing Nano-X Arc systems. Systems, enhancing one of our key differentiators. The new system will also be easy to deploy and use with an anticipated one-day setup, time and plug-and-play functionality.

Speaker Change: Amongst the features I am able to share at this time, the Nanox ArcX will have an even smaller footprint than existing Nanox Arc systems, enhancing one of our key differentiators.

Speaker Change: The new system will also be easy to deploy and use.

Speaker Change: with an anticipated one-day setup time and plug-and-play functionality.

Speaker Change: There will also be image enhancement options in the new units which are currently not available on existing Nano-X art systems and future synthetic 2D. Please note that we are planning to share more detail about the future Nano-X art system publicly during our next event, which will also be made available via our website.

Speaker Change: There will also be image enhancement options in the new units, which are currently not available on existing Nano-X Arc systems and future synthetic 2D. Please note that we are planning to share more detail about the future Nano-X Arc system publicly during our next event, which will also be made available via our website.

Speaker Change: There will also be image enhancement options in the new units, which are currently not, available on existing Nano-X Arc systems and future synthetic 2D. Please note that we are planning to share more detail about the future Nano-X Arc system, publicly during our next event, which will also be made available via our website.

Speaker Change: There will also be image enhancement options in the new units, which are currently not available on existing Nano-X art systems and future synthetic 2D.

Erez Meltzer: Please note that we are planning to share more detail about the future Nano-X Arc system publicly during our next event, which will also be made available via our website. Stay tuned for further details.

Speaker Change: Please note that we are planning to share more detail about the future Nano-X art system publicly during our next event, which will also be made available via our website. Stay tuned for further detail.

Speaker Change: Stay tuned for further details.

Speaker Change: Stay tuned for further detail.

Speaker Change: To touch on our OEM efforts, I can report that we are well underway, with the first phase of our development program with the US government entity towards completion of a novel tube design, utilizing our emitter and focused on the entity space. We are optimistic we will move towards prototyping tubes the second half of this year.

Erez Meltzer: To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the US government entity towards completion of the Novel Tube design, utilizing our emitter and focused on the entity space. We are optimistic. We will move towards prototyping tubes the second half of this year.

Speaker Change: To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the U.S. government entity, towards completion of a novel tube design utilizing our emitter and focused on the entity space.

Speaker Change: To touch on our OEM efforts, I can report that we are well underway with the first phase, of our development program with the U.S. government entity towards completion of a novel tube design utilizing our emitter and focused on the entity space.

Speaker Change: To touch on our OEM efforts, I can report that we are well underway

Erez Meltzer: For more information see more our white paper section on our website.

Speaker Change: We're the first phase of our development program with the U.S. government entity towards completion of a novel tube design, utilizing our emitter and focused on the entity space.

Ran Daniel: After my prepared comments, I'll turn the call over to our CSO, Ran, who will review our Q2 financial results.

Erez Meltzer: Turning to our AI business. Just last month, we announced that our Nano-X AHRQ solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI Cardiovascular solution at a steamed healthcare system, along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases. Clawwell Health has previously reported that in the first full year of implemented health CC&G in its electronic medical record system, there was a 13-fold increase of the patients reported in the previous two years.

Erez Meltzer: I will then share a few closing thoughts before turning the call over to the Q&A session.

Speaker Change: We are optimistic we will move towards prototyping tubes the second half of this year.

Speaker Change: we are optimistics we will move towards prototyping tubes the second half of this year

Erez Meltzer: Regarding our tele-rojology services, we are leveraging our USA RedCline based on a network of rojology as a significant part of our US deployment plan. On the mass production front, we have finalized the second phase of our development with CSAM, resulting in a high yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our novel emitters. Varics has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our No-Nano-X Arc.

Speaker Change: Regarding our teleradiology services, we are leveraging our USA RAD client based on a network of radiologies as a significant part of our US deployment plan.

Speaker Change: Regarding our teleradiology services, we are leveraging our USA RAD client based on a network of radiologies as a significant part of our U.S. deployment plan.

Speaker Change: Regarding our teleradiology services, we are leveraging our USA RAD client based on a network, of radiologies as a significant part of our U.S. deployment plan.

Speaker Change: Regarding our teleradiology services, we are leveraging our USA RAD client based on a network of radiologists as a significant part of our US deployment plan.

Speaker Change: On the mass production front, we finalized the second phase of our development with CSEM, resulting in a high-yield wafers with functional M2, we are transitioning to production readiness, and confidence we have secured a second source of supply for our novel amateur.

Speaker Change: On the mass production front, we have finalized the second phase of our development with CSAM, resulting in a high-yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our novel emitters.

Erez Meltzer: We have a lot to discuss, so let's get started.

Speaker Change: On the mass production front, we have finalized the second phase of our development with CSAM, resulting in high-yield wafers with functional emitters.

Speaker Change: We are transitioning to production readiness and confident we have secured a second source of supply for our novel amateurs.

Speaker Change: Varex has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our new Nano-X Arc.

Speaker Change: Varex has completed their initial tubes prototype utilizing our emitter for testing to be integrated, into our new nanoXR.

Speaker Change: Varex has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our new Nano-X Rx.

Speaker Change: Varex has completed their initial tubes prototype utilizing our emitter for testing to be integrated into our new Nano-X Rx.

Erez Meltzer: I have covered a lot of ground today, so with that, I will hand the call over to Rand Daniel to review our financials.

Speaker Change: I've covered a lot of ground today, so with that, I'll hand the call over to Ran Daniel to review our financials.

Speaker Change: I've covered a lot of ground today, so with that, I'll hand the call over to Ran Daniel, to review our financials.

rendaniel: I've covered a lot of ground today, so with that, I'll hand the call over to Ran Daniel to review our financials.

rendaniel: Ran?

Ran Daniel: Rand? Thank you, Aaron. We reported a gap net loss for the second quarter of 2024 of $13.6 million, which we will refer to as the reported period, compared with the net loss of $17.44 million in the second quarter of 2023, which I will refer to as the compare bill period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

rendaniel: Thank you, Erez.

rendaniel: Thank you, Aaron.

rendaniel: Thank you, Erez.

rendaniel: We reported a gap net loss for the second quarter of 2024 of $13.6 million, which we, will refer to as the reported period, compared with a net loss of $17.44 million in the second quarter of 2023, which I will refer to as the comparable period. The decrease was largely due to a decrease of $2.1 million in research and development, expenses and a decrease of $1.7 million in the general and administrative expenses and an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

rendaniel: We reported a gap net loss for the second quarter of 2024 of $13.6 million, which we'll, refer to as the reported period compared with a net loss of $17.44 million in the second quarter of 2023, which I'll refer to as the comparable period. The decrease was largely due to a decrease of $2.1 million in the research and development, expenses and a decrease of $1.7 million in the general and administrative expenses, an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

rendaniel: Ron?

rendaniel: We reported a gap net loss for the second quarter of 2024 of $13.6 million, which I will refer to as the reported period, compared with a net loss of $17.44 million in the second quarter of 2023, which I'll refer to as the comparable period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses, an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross.

rendaniel: Thank you, Erez.

rendaniel: We reported a GAAP net loss for the second quarter of 2024 of $13.6 million, which we'll refer to as the reported period.

rendaniel: compared with a net loss of $17.44 million in the second quarter of 2023, which I'll refer to as the comparable period.

rendaniel: The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and an increase of $0.5 million in the company's financial income.

rendaniel: which was mitigated by an increase of $1.2 million in the company's gross loss.

Ran Daniel: Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a GAAP basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a GAAP basis for the comparable period. Nan gap gross loss for the reported period was $0.9 million as compared to a nan gap gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a nan gap basis for the reported period, as compared to a gross profit margin of 34% on a nan gap basis in the comparable period.

rendaniel: Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

rendaniel: Revenue for the reported period was $2.7 million, and gross loss was $2.9 million on a gap basis, compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

rendaniel: Revenue for the reported period was $2.7 million, and gross loss was $2.9 million on, a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

rendaniel: Revenue for the reported period was $2.7 million, and gross loss was $2.9 million on a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

Erez Meltzer: In a study conducted by Mass Gen Hospital and Brigham Women Hospital, Health, CC&G was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipopropane A as part of clinical care. A statistically significant correlation was found between level of CAC and this lipopropane A risk factor for coronary atherosclerosis suggesting that this approach may be used to identify at risk patients. As a sign-dote, the lead author of this study, Breaking Weber, was declared as young investigator word winner at the annual meeting as well.

rendaniel: Non-GAAP gross loss for the reported period was $0.9 million, as compared to a non-GAAP gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a non-GAAP basis.

rendaniel: Non-gap gross loss for the reported period was $0.9 million as compared to a non-gap, gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a non-gap basis for the reported period as compared to a gross profit margin of 34% on a non-gap basis in the comparable period. Revenue from the teleradiology services for both the reported period and comparable period, was $2.5 million with a gross profit of $0.4 million on a GAAP basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a GAAP basis for the reported and comparable period. Non-GAAP gross profit of the company's teleradiology services for the reported and comparable period, was $0.9 million, which represents a gross profit margin of approximately 36% on a non-GAAP basis.

rendaniel: non-GAAP gross loss for the reported period was $0.9 million as compared to a non-GAAP

rendaniel: God's profit to all.

rendaniel: $0.9 million in the comparable period.

rendaniel: which represents a gross loss margin of approximately 9% on a non-GAAP basis for the reported period, as compared to a gross profit margin of 34% on a non-GAAP basis in the comparable period.

rendaniel: Thank you.

Ran Daniel: Revenue from the teleradiology services for both the reported period and comparable period was $2.5 million, with a gross profit of $0.4 million on a GAAP basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a GAAP basis for the reported and comparable period. Nan gap gross profit of the company's teleradiology services for the reported and comparable periods was $0.9 million, which represents a gross profit margin of approximately 36% on a nan gap basis. During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1.13 million, as compared to revenue of $53,000 in the comparable period.

rendaniel: Revenue from the teleradiology services for both the reported period and comparable period was $2.5 million with a gross profit of $0.4 million on a gap basis, in the reported and comparable period, which represent a gross profit margin of approximately 15% on a gap-based, for the reported and comparable period.

rendaniel: revenue from the teoradology services for both the reportter

rendaniel: Revenue from the teleradiology services for both the reported period and comparable period, was $2.5 million with a gross profit of $0.4 million on a gap basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a gap basis for the reported and comparable period.

rendaniel: period and comparable period was $2.5 million with a gross profit of $0.4 million on a gap basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a gap basis.

Erez Meltzer: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share the just last week, Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general thermosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest. As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indications and was intended to support the submission.

Erez Meltzer: Nanox is proud to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nanox AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcome. Additionally, the previous agreements we signed for Nanox AI with Coveira Health and Coveira Health are off to a great start and the feedback has been very positive thus far. We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution and ensuring they reach and benefit a wider audience.

rendaniel: Non-GAAP gross profit of the company's telebiology services.

rendaniel: Non-gap gross profit of the company's teleradiology services for the reported and comparable period, was $0.9 million, which represents a gross profit margin of approximately 36% on a non-gap basis.

rendaniel: for the reported and comparable periods. non-GAAP gross profit of the company's telebiology services for the reported and comparable periods was $0.9 million, which represents a gross profit margin of approximately $36 million.

rendaniel: For more information, please visit our website at www.sciencemedia.org, Gross Profit Margin of Approximately $36 Billion, During the reported period, the company generated revenues through the sales of its AI solutions in the amount of $113,000, compared to revenue of $53,000 in the comparable period.

rendaniel: During the reported period, the company regenerated revenue through the sales of its AI solutions, in the amount of $113,000 as compared to revenue of $53,000 in the comparable period.

rendaniel: During the reported period, the company regenerated revenues through the sales of its AI solutions, in the amount of $113,000, as compared to revenue of $53,000 in the comparable period. During the reported period, the company generated revenues through the sales and deployment, of its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a GAAP and non-GAAP basis. Gross revenue stems from the sale and deployment of the NanoArc systems in the U.S. and the, sales of our 2D systems in Africa.

rendaniel: to send on a non-GAAP basis.

rendaniel: During the reported period, the company regenerated revenues through the sales of its AI solutions in the amount of $113,000, as compared to revenue of $53,000 in the comparable period.

rendaniel: During the reported period, the company generated revenue through the sales and deployment of, its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a gap and non-gap basis.

rendaniel: during the reported period the company generated revenues to the sales and deployment of eat its imaging systems which amounted to sixty eight thousand dollars with a gross loss of one point three million dollars on a gap a n gaap basis

rendaniel: During the reported period, the company generated revenues through the sales and deployment of its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a gap and non-gap basis. Those revenues stem from the sale and deployment of the Nano-X Arc systems in the U.S. and the sales of our 2D systems in Africa.

Ran Daniel: Those revenues stems from the sale and deployment of the nan of our systems in the US and the sales of our two systems in Africa. Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages, a decrease of $0.2 million in share-based compensation, and a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities. Sales and marketing expenses for the reported in comparable periods were at $0.8 million.

rendaniel: Gross revenue stems from the sale and deployment of the NanoArc systems in the U.S. and the, sales of our 2D systems in Africa.

rendaniel: those revenues stemams from the sale and deployment deployment of the nanicsx systems in the u s and the sze of our two system in africa

Erez Meltzer: I think I can speak of all of us at Nanox when I say there is a lot to be excited about. Looking ahead to the near future of Nanox, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long-term with a new technology needs to constantly refine their offering base on customer feedback, changes in technology and evolving use case. Nano-X is no different and we are constantly working on product and technology future developments.

rendaniel: Research and development expenses for the reported period were $4.8 million, as compared to $6.9 million in the comparable period. The decrease of $2.1 million was larger, due to a decrease of $1.2 million in the salaries and wages.

rendaniel: Research and development expenses for the reported period were $4.8 million as compared, to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries, and wages, decrease of $0.2 million in share-based compensation, and a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities.

rendaniel: Research and development expenses for the reported period were $4.8 million, as compared, to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries, and wages, decrease of $0.2 million in share-based compensation, and a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities.

rendaniel: Research and development expenses for the reported period were $4.8 million, as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages.

rendaniel: Decrease of $0.2 million in share-based compensation And a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities

rendaniel: Sales and marketing expenses for the reported and comparable periods were $0.8 million.

Erez Meltzer: The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies.

Erez Meltzer: I'm very pleased to share for the first time that we are developing another Nano-X, our system called Nano-X ArcX, which we intend to submit among others for FDA clearance. Once cleared, it will be marketed along the current system which will expand our current product offering. At the high level, the Nano-X ArcX is designed to meet market needs of our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

rendaniel: General and administrative expenses for the reported period were, $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million.

Ran Daniel: General and administrative expenses for the reported period were $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million. Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million. As compared to a non-GAAP net loss of $9.9 million in the comparable period, the decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses of $2.2 million and an increase of $0.5 million in our non-GAAP interest income, which was offset by a decrease of $1.1 million in our non-GAAP gross profit.

rendaniel: General and administrative expenses for the reported period were $5.9 million, as compared, to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the, amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million.

rendaniel: General and administrative expenses for the reported period were

rendaniel: $5.9 million, as compared to $7.6 million in the comparable period.

Erez Meltzer: To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and has the required capabilities to scan MSK, chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post-SDA clearance is a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards.

rendaniel: The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million.

rendaniel: largely as a result of the finalization of the SEC investigation and the settlement of the class action and a decrease in the cost of directors' and officers' liability insurance premium in the amount of $0.4 million.

Erez Meltzer: Listening to the clinical needs is an important step in the ongoing extension of Nano-X solution. Amongst the feature, I'm able to share this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X Arc systems, enhancing one of our key differentiators. The new system will also be easy to deploy in use with an anticipated one-day set-up time and plug-and-play functionality. There will also be image enhancement options in the new units which are currently not available on existing Nano-X Arc systems and future synthetic to these.

rendaniel: Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million. As compared to a non-GAAP net loss of $9.9 million in the comparable period, the decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses. 1.2 million dollars and an increase of 0.5 million dollars in our non-GAAP interest income which was offset by a decrease of 1.1 million dollars in our non-GAAP gross profit.

rendaniel: Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million, as compared to a non-GAAP net loss of $9.9 million in the comparable period. The decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses, of $2.2 million, and an increase of $0.5 million in our non-GAAP interest income, which was offset by a decrease of $1.1 million in our non-GAAP gross profit.

rendaniel: Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million.

rendaniel: as compared to a non-gaap nets of nine point nine million dolls in the comparable period

rendaniel: The decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses

rendaniel: of $2.2 million, and an increase of $0.5 million in our non-GAAP interest income, which was offset by a decrease of $1.1 million in our non-GAAP gross profit.

Ran Daniel: Turning to our balance sheet, as of June 30th, 2024, we had cash, cash-equivalence with strictly deposits and marketable securities of approximately $64.2 million, and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million. As of June 30th, 2024, we had approximately 58.5 million shares outstanding.

rendaniel: Turning to our balance, עד יום 30-2024, הייתה לנו קארג, קארג אקדיבלנט, דפוס קריטי, ומחקרות ארגוניות במידה מ-64.2 מיליון דולר and we add a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million.

rendaniel: Turning to our balance sheet. As of June 30, 2024, we had cash, cash equivalents, restricted deposits, and marketable securities, of approximately $64.2 million, and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million.

rendaniel: Turning to our balance sheet, as of June 30, 2024, we had cash, cash equivalents, restricted, deposits, and marketable securities of approximately $64.2 million, and we had a $3.2 million loan from a bank. We entered the second quarter of 2024 with a property and equipment net of $44.5 million.

rendaniel: Turning to our balance sheet. As of June 30, 2024, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $64.2 million, and we had a $3.2 million loan from a bank.

Erez Meltzer: Additionally, after completing the technical stages, including obtaining the ISO 13485 certifications from BSI and successfully passing the MBR audit, we are now in advanced stages with our notified body to secure the CE mark for the E-origin. Rest assured, we will provide updates as soon as they are available.

Erez Meltzer: To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the US Government entity towards completion of the Novel Tube design, utilizing our emitter and focused on the entity space. We are optimistic. We will move towards prototyping tubes the second half of this year. Regarding our tele-rojology services, we are leveraging our USA RedCline based on a network of rojology as a significant part of our US deployment plan.

rendaniel: We ended the second quarter of 2024 with a property and equipment net of $44.5 million.

rendaniel: As of June 30, 2024, we had approximately 58.5 million shares outstanding.

Erez Meltzer: With that, I will end the call. Back over to Eris. Thank you, Ron. As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nanox Rx system, as well as integrating the Nanox Rx solution into medical workflow. Our vision is to extend Nanox technology within and beyond hospitals, targeting underserved segments like urgent care units and orthopedic clinics. We deliver a seamless scantodagnosis solution, leveraging AI for a smarter, more efficient healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcome globally. Nanox is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

rendaniel: With that, I will hand the call back over to Erez.

Speaker Change: With that, I will hand the call back over to Erez.

Speaker Change: Thank you, Ron.

Speaker Change: As we enter the second half of 2024, our team remains focused on executing our growth strategy, by continuing to commercialize the NanoXR system, as well as integrating NanoXR's solution into medical workflow.

Speaker Change: As we enter the second half of 2024, our team remains focused on executing our growth strategy, by continuing to commercialize the Nano-X Rx system, as well as integrating Nano-X I solution into medical workflow.

Erez Meltzer: Turning now to our global deployment and commercial efforts which continued in the next second quarter, our team is diligently working with imaging centers, physicians and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployments.

Speaker Change: Thank you, Ran. As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the NanoXRX system, as well as integrating NanoXRX solution into medical workflow.

Erez Meltzer: The deployments in the U.S, are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To keep more color on our U.S, deployment, I would like to add that during the second quarter, we have installed Nano-X Arc systems in its three prominence, healthcare chains operating imaging facilities across the U.S., including one of the largest and the indifference.

Speaker Change: As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nano-X Rx system, as well as integrating nanoxide solution into medical work.

Speaker Change: Our vision is to extend Nano-X technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics.

Speaker Change: Our vision is to extend NanoX technology within and beyond hospitals targeting underserved, segments like urgent care units and orthopedic clinics.

Speaker Change: Our vision is to extend Nano-X technology within and beyond hospitals targeting underserved, segments like urgent care units and orthopedic clinics.

Erez Meltzer: In addition to the US, some of the deployed sites have received certification from the corresponding states regulatory body and have begun to scan patients. Others are in the process of obtaining approval. This commercial scanning activity is accelerating.

Erez Meltzer: On the mass production front, we have finalized the second phase of our development with CSAM resulting in a high yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our Novel emitters. Varics has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our No-Nano-X Arc.

Speaker Change: Our vision is to extend Nano-X technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics.

Erez Meltzer: For example, as of today, one of those sites have shown up to 14 scans per day.

Speaker Change: We deliver a seamless scan-to-diagnosis solution leveraging AI for smarter, more efficient healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Speaker Change: We deliver a seamless scan-to-diagnosis solution, leveraging AI for smarter, more efficient, healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Speaker Change: We deliver a seamless scan-to-diagnosis solution, leveraging AI for smarter, more efficient, healthcare with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Speaker Change: We deliver a seamless scan-to-diagnosis solution, leveraging AI for smarter, more efficient healthcare.

Erez Meltzer: We recently received good indications for validation of the US CPT and reimbursement process as we received management care ELB.

Speaker Change: with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Speaker Change: NanoX is dedicated to accelerating the execution of our commercial infrastructure and future, strategic collaborations in the U.S. Our mission is to provide healthcare practices with a transformative imaging advantage with, a NanoXR, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change: Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future, strategic collaborations in the U.S. Our mission is to provide healthcare practices with a transformative imaging advantage with, a Nano-X Rx, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change: Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

Erez Meltzer: Since March 2024, we have been ramping up in the US with current targeted backlog of 50 federal prop prospects and additional 44 leads in the pipeline.

Ran Daniel: I have covered a lot of ground today, so with that, I will hand the call over to Rand Daniel to review our financials. Rand? Thank you, Aaron. We reported a gap net loss for the second quarter of 2024 of $13.6 million, which we will refer to as the reported period compared with the net loss of $17.44 million in the second quarter of 2023, which I will refer to as the compare bill period.

Nanox: Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

Erez Meltzer: Our mission is to provide healthcare practices with a transformative imaging advantage with a Nanox Rx and accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Nanox: Our mission is to provide healthcare practices with a transformative imaging advantage, with the Nano-X R, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Nanox: Our mission is to provide health care practices with a transformative imaging advantage with a Nano-X Arc.

Ran Daniel: The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss. Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

Nanox: and accessible cost effective solution that not only provides advced diagnostic imaging capabilities but also elevates overall patient care

Erez Meltzer: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers, and shareholders for their support of Nanox and our mission. As always, I am available to meet with you and look forward to sharing the insights of Nano-X Archecks and the upcoming events.

Nanox: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers, and shareholders for their support of Nano-X and our mission.

Nanox: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers, and shareholders for their support of NanoX and our mission.

Nanox: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers, and shareholders for their support of Nano-X and our mission.

Nanox: As always, I am available to meet with you and look forward to sharing the insights of, Nano-X Rx and the upcoming events.

Nanox: As always, I'm available to meet with you and look forward to sharing the insights of, Nano-X Rx and the upcoming events.

Nanox: As always, I am available to meet with you and look forward to sharing the insights of Nano-X Rx and the upcoming events.

Nanox: With that, operator, let's now open the call for questions.

Operator: With that operator, let's now open the call for questions.

Nanox: With that, Operator, let's now open the call for questions.

Nanox: With that, operator, let's now open the call for questions.

Speaker Change: With that, Operator, let's now open the call for questions.

Nanox: Operator, can you pause for a second?

Erez Meltzer: Operator, can you pause for a second? I'd like to make one more comment. Okay? Yes, sir. Okay.

Speaker Change: Operator, can you pause for a second?

Speaker Change: I'd like to make one more comment.

Speaker Change: Operator, can you pause for a second? I'd like to make one more comment.

Speaker Change: Is that okay?

Speaker Change: Yes, sir.

Speaker Change: Okay.

Erez Meltzer: So, in addition to everything we said, I'm happy to announce that, as just today, we received another FDA clearance for the Health, CCNG version 2.0, which is an upgraded version of Advanced AI Cardio Solution, empowering physicians in the assessment of coronary artery calcium. The Health, CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output. For us, it is very pleasing to receive further regulatory validation from the FDA for our AI Cardio Solution.

Speaker Change: I'd like to make one more comment.

Speaker Change: So, in addition to everything we said, I'm happy to announce that as of just today, we received another FDA clearance, for the Health CCNG version 2.0, which is an upgraded version of advanced AI cardiac solution, empowering physicians in assessment of coronary artery calcium. The Health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium, categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

Speaker Change: Yes, sir.

Speaker Change: Yes, sir. Okay.

Speaker Change: So, in addition to everything we said, I'm happy to announce

Ran Daniel: Nan gap gross loss for the reported period was $0.9 million as compared to a nan gap gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a nan gap basis for the reported period, as compared to a gross profit margin of 34% on a nan gap basis in the comparable period. Revenue from the teleradiology services for both the reported period and comparable period was $2.5 million with a gross profit of $0.4 million on a gap basis in the reported and comparable period, which represents a gross profit margin of approximately 15% on a gap basis for the reported and comparable period.

Speaker Change: that just today we received another FDA clearance.

Speaker Change: for the Health CCNG version 2.0, which is an upgraded version of Advanced AI Cardiac Solution, empowering physicians in assessment of coronary artery calcium.

Speaker Change: The Health CCNG version 2.0, an upgraded version of the Cardiac Solution, introduces additional zero-calcium categorization of coronary calcium, CAC,

Speaker Change: and generates an exact Calcium score with corresponding CAC detection category in output.

Speaker Change: For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution.

Ran Daniel: Nan gap gross profit of the company's teleradiology services for the reported and comparable periods was $0.9 million, which represents a gross profit margin of approximately 36% on a nan gap basis. During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1.13 million as compared to revenue of $53,000 in the comparable period. During the reported period, the company generated revenues through the sales and deployment of its imaging systems which amounted to $68,000 with a gross loss of $1.3 million on a gap basis.

Speaker Change: Is that okay?

Speaker Change: So, thank you.

Operator: So thank you, and with that, now we will turn the open the call for questions. Thank you. As a reminder to ask a question, please press star one of your telephone away for your name to be announced. To withdraw your question, please press star one one again.

Speaker Change: And with that, now we will open the call for questions.

Speaker Change: Okay.

Speaker Change: So, thank you, and with that, now we will open the call for questions.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Speaker Change: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Speaker Change: To withdraw your question, please press star 11 again.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Latin Bird. Your line is now open. Good morning, Arizona. How are you? Good. Good morning.

Speaker Change: OK.

Speaker Change: Our first question comes from the line of Jeffrey Cohen with Lattinburg.

Speaker Change: Our first question comes from the line of Jeffrey Cohen with Lattenberg. Your line is now open.

Speaker Change: Your line is now open.

Speaker Change: So in addition to everything we said, I'm happy to announce, that just today, we received another FDA clearance for the Health CCNG version 2.0, which is an upgraded version of advanced AI cardiac solution.

Speaker Change: Good morning, Iris and Ren.

Speaker Change: Empowering Physicians in Assessment of Coronary Artery Calcium. The Health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero-calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

Speaker Change: How are you?

Speaker Change: For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution.

Speaker Change: Good.

Speaker Change: Good morning.

Jeffrey Cohen: Good morning, Erez and Ran. How are you? Good morning. Good morning. So, um, I wondered firstly, could you expand upon a little bit regarding your

Jeffrey Cohen: So, thank you.

Jeffrey Cohen: And with that, now we will open the call for questions.

Jeffrey Cohen: So, I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke, about 50 on sales and 34 on leads?

Jeffrey Cohen: So, in addition to everything we said, I'm happy to announce that just today, we received, another FDA clearance for the Health CCNG version 2.0, which is an upgraded version of Advanced AI Cardiac Solution, empowering physicians in assessment of coronary artery calcium. The Health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional, zero-calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

Erez Meltzer: So I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke about 50 on sales and 34 on leads? Could you give us a sense of where these units are? Imagine they're mostly domestic U.S. and how that follow looks for actually placements in training over the coming quarters. Okay, so I think that we mentioned last time, the number of 20 right now, the number was growing to more than triple, as you can imagine, in various stages of deployment. We have a few dozens, which are already deployed.

Jeffrey Cohen: Thank you.

Jeffrey Cohen: For us, it is very pleasing to receive further regulatory validation from the FDA for our, AI cardiac solution.

Jeffrey Cohen: As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Jeffrey Cohen: So thank you and with that now we will turn the open the call for questions.

Jeffrey Cohen: Thank, you.

Jeffrey Cohen: As a reminder to ask a question please press star 1 1 on your telephone and wait for your name to be announced.

Jeffrey Cohen: To withdraw your question please press star 1 1 again.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Lattenberg.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with, Flattenburg.

Jeffrey Cohen: your backlog as far as imaging when you spoke about 50 on sales and 34 on leads. Could you give us a sense of

Jeffrey Cohen: Could you give us a sense of where these units are?

Jeffrey Cohen: Your line is now open.

Jeffrey Cohen: Good morning Erez and Ran.

Jeffrey Cohen: How are you?

Jeffrey Cohen: Good.

Jeffrey Cohen: Your line is now open.

Jeffrey Cohen: Good morning.

Jeffrey Cohen: I imagine they're mostly domestic US and how that funnel looks for actually placements and training over the coming quarters.

Jeffrey Cohen: So I wondered firstly could you expand upon a little bit, regarding your your backlog as far as imaging when you spoke about 50 on sales and 34 on leads.

Speaker Change: where these units are. I imagine they're mostly domestic U.S. and how that funnel looks for actually placements and training over the coming quarters.

Jeffrey Cohen: Okay.

Jeffrey Cohen: Could you give us a sense of where these units are?

Jeffrey Cohen: So, I think that we mentioned last time the number of 20.

Jeffrey Cohen: I imagine they're mostly domestic US and how that funnel looks for actually placements and training over the coming quarters.

Speaker Change: Okay, so I think that we mentioned...

Jeffrey Cohen: Right now, the number was growing to more than triple, as you can imagine, in various stages of deployment.

Jeffrey Cohen: Okay so I think that we mentioned last time the number of 20.

Speaker Change: Last time the number of 20, right now the number is...

Speaker Change: was growing to more than triple, as you can imagine, in various stages of deployment.

Jeffrey Cohen: We have a few dozens which are already deployed, a few that are waiting for approval, regulatory, the state approvals, because they are spread over seven states and the last two states are waiting for approvals.

Jeffrey Cohen: Right now the number was growing to more than triple as you can imagine in various stages of deployment.

Erez Meltzer: A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals. And we believe that the indication that we gave, which 50 of them are probably favorable to be installed. And the 44 in the leads in the beginning of the process, we are getting to the target of that we wanted to be by the end of the year.

Speaker Change: We have a few dozens which are already deployed.

Speaker Change: A few that are waiting for approval, regulatory, the state approvals, because they are spread over seven states and the last two states are waiting for

Ran Daniel: Sales and marketing expenses for the reported in comparable periods were at $0.8 million. General and administrative expenses for the reported period were $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million.

Jeffrey Cohen: And we believe that the indication that we gave, which 50 of them are probably favorable to be installed, and 44 in the leads in the beginning of the process, we are getting to the target that we want it to be by the end of the year.

Jeffrey Cohen: We have a few dozens which are already deployed.

Speaker Change: approvals and we believe that the indication that we gave which 50 of them are probably favorable to be installed and 44 in the leads in the beginning of the process

Speaker Change: We are getting to the target that we wanted to be by the end of the year, and that's where we are.

Jeffrey Cohen: And that's where we are.

Erez Meltzer: And that's where we are. Okay, got it.

Jeffrey Cohen: Okay, got it.

Speaker Change: Good morning, Erez and Ran.

Erez Meltzer: And then, graduations on the news today for a calcium score. Could you talk a little bit about these other 510(k) indications and for general term as well, in addition to our general interest? And could you talk about the codes associated with them as far as reimbursement and facilities? Okay. So, with maybe I'll start with the end with the reimbursement right now. What we speak about the reimbursement is based on the Tomo CPT code, which is 76100. And this is the basis for the reimbursement of those that submitted their scans for the reimbursement. We received only already indications from more than two, I think, that insurance insurers.

Speaker Change: okay god it and then graduations on the news today

Speaker Change: for a calcium score. Could you talk a little bit about these?

Speaker Change: other 510k indications, and for General Tomo as well, in addition to General Cheston, could you talk about the codes associated with them as far as reimbursement at facilities?

Ran Daniel: Our non-gap net loss attributable to ordinary shares for the reported period was $8.4 million. As compared to a non-gap net loss of $9.9 million in the comparable period, the decrease of $1.5 million was mainly due to a decrease in non-gap operating expenses of $2.2 million and an increase of $0.5 million in our non-gap interest income, which was offset by a decrease of $1.1 million in our non-gap gross profit. Turning to our balance sheet, as of June 30th, 2024, we had cash, cash-equivalence with strictly deposits and marketable securities of approximately $64.2 million, and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million. As of June 30th, 2024, we had approximately 58.5 million shares outstanding.

Speaker Change: How are you?

Speaker Change: Good morning.

Speaker Change: Okay.

Speaker Change: so with them

Speaker Change: Maybe I'll start with the end. With the reimbursement right now what we speak about the reimbursement is based on the TOMO CPT code which is 76100.

Speaker Change: And this is the basis for the reimbursement of those that submitted their...

Speaker Change: scans for the reimbursement. We have received already indications from two, I think, insurance insurers, and this continues to grow.

Erez Meltzer: And this is continuous to grow. The numbers that we received are in line with the model that we put together. So, basically, right now, it seems that for the clinics and the sites that the system has installed, the model is profitable. With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar. It's in line with what we have indicated in the past that we are going to submit this year the additional clinical indications, especially the chest. We decided that we're going to submit it for whole body, so including the chest, not only, but we are able to scan whole body and basically everything.

Speaker Change: The numbers that were received are in line of the model that we put together. So basically right now it seems that the, for the clinics.

Speaker Change: that and besides that the system is installed the it's the the model is profitable.

Erez Meltzer: With that, I will end the call back over to Eris. Thank you, Ron. As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nanox Rx system, as well as integrating Nanox Rx solution into medical workflow. Our vision is to extend Nanox technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics. We deliver a seamless scantodagnosis solution, leveraging AI for a smarter, more efficient healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Erez Meltzer: With the main segments being outpatient imaging centers, medical imaging chains and orthopedic centers, we understand that not all of these 94 leads will convert but I'm very pleased with our commercial team's progress in such a short period and we are very confident that this will continue to grow over time.

Speaker Change: With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the...

Speaker Change: And then congratulations on the news today for a calcium score.

Speaker Change: Can you, talk a little bit about these other 510K indications and for General Tomo as well, in addition to General Cheston.

Speaker Change: Similar, it's a line of what we have indicated in the past that we are going to submit it to submit.

Speaker Change: Can you talk about the codes associated with them as far as reimbursement and facilities?

Erez Meltzer: We're also awaiting the import license to deploy the first Nano-X Arc in Mexico with the systems ready for shipment.

Speaker Change: This year, the additional clinical indications, especially the chest,

Speaker Change: We decided that we're going to submit it for whole body, so including the chest, not only, but by the time that we get this clearance, then even in the U.S., not only in the rest of the world.

Erez Meltzer: Additionally, there are two units fully deployed in Israel and another deployment is expected in the upcoming month for both clinical and commercial use.

Speaker Change: We are able to scan the whole body and basically everything.

Erez Meltzer: Bear in mind that in the rest of the world and especially part of the others and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body and we are using it to all the clinical indications. Based on this indication, I gave in this call today, I gave indication of the spread between the various body anatomies or body parts that were received, and I gave the percentage that we have on the role on a global basis. And you can see the chest is a major part of them.

Speaker Change: bear in mind that in the rest of the world and especially part of the others and including the submission to of the CE we are using the fact that the hardware is how they're ready for whole body and we are using it to

Erez Meltzer: We're able to pursue this opportunity as we obtained a March approval several months ago.

Erez Meltzer: Nanox is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S. Our mission is to provide healthcare practices with a transformative imaging advantage with a Nanox Rx and accessible cost effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Erez Meltzer: Importantly, the number of daily scans is accelerating and in that July, we experienced an average of 6.67 scans globally for all deployed Nano-X Arc systems, accomplishing both clinical work and commercial patient scans.

Speaker Change: to all the clinical indications. Based on this indication I gave in this call today, I gave indication of the spread between the various...

Speaker Change: Body Anatomies or Body Parts that were received and I gave the percentage that we have on the global basis.

Erez Meltzer: I think it is interesting to learn that the global commercial and clinical scans by body part are distributed as follows.

Erez Meltzer: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers and shareholders for their support of Nanox and our mission. As always, I am available to meet with you and look forward to sharing the insights of Nano-X Archecks and the upcoming events.

Erez Meltzer: Got it.

Speaker Change: and you can see the chest is a major part of them.

Erez Meltzer: And then one more if I may, could you talk a little bit more about the ARCHX platform and perhaps its form factor and differences where should the current platform and the intended commercial presence say you anticipate as compared to the current platform. So first of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter. We are, of course, going to submit it to the FDA. And after the FDA clearance, it will be marketed as a longer, along the current system, which will expand our product offering.

Erez Meltzer: 31% chest, 25% hand, 14% leg and 14% spine but of course these indications may vary from overtime.

Speaker Change: Got it. And then one more if I may, could you talk a little bit more about the ARCX platform and perhaps its form factor and differences versus the current platform and the intended commercial presence that you anticipate as compared to the current platform?

Erez Meltzer: With that operator, let's now open the call for questions. Operator, can you pause for a second? I'd like to make one more comment. Okay? Yes, sir. Okay.

Speaker Change: So, first of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter.

Erez Meltzer: For those of you that are interested, we also have some new clinical samples on our website including chest pathology.

Erez Meltzer: So in addition to everything we said, I'm happy to announce that as just today, we received another FDA clearance for the Health, CCNG version 2.0, which is an upgraded version of Advanced AI Cardio Solution, empowering physicians in assessment of coronary artery calcium. The Health, CCNG version 2.0, an upgraded version of the cardiac solution introduces additional zero calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

Speaker Change: We are, of course, going to submit it to the FDA, and after the FDA clearance, it will be marked as a long recurrent system.

Erez Meltzer: And we mentioned a few times in the past that the ARCH or the first version to point to is not the first product and definitely not the last, and we haven't lined up a real product roadmap for the future. ARCHX is one of them. We will give more indications, but I think that the idea is to make the ARCHX available to more specific locations or sites that are more suitable for the spec of the system. We are talking about footprint. We are talking about, we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features and the beauty of it that whenever we are going to install it, we are going to enable all the features that are coming with the software and the features to be installed remotely.

Speaker Change: which will expand our current product offering, and we mentioned a few times in the past that

Speaker Change: The ARC, or the first version 2.2, is not the first product and definitely not the last and we have in line a real product roadmap for the future. ARC-X is one of them.

Erez Meltzer: To support our accelerating deployments effort, we continued to strengthen our team and infrastructure during their quarter, adding to our US sales and technical teams.

Speaker Change: We will give more indications but I think that the the idea is to to make the ARCICS available to more specific locations or sites.

Speaker Change: that are more suitable for the spec of this system.

Erez Meltzer: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaboration in the country.

Erez Meltzer: For us, it is very pleasing to receive further regulatory validation from the FDA for our AI Cardio Solution.

Speaker Change: We are talking about footprints, we're talking about

Speaker Change: Uh

Speaker Change: We are talking about, first of all, even for us, it's the cost of manufacturing.

Erez Meltzer: Our mission is to provide healthcare practices with a transformative imaging advantage, with Nano-X Arc an accessible cost effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care.

Operator: So thank you and with that, now we will turn the open the call for questions. Thank you. As a reminder to ask a question, please press star one of your telephone away for your name to be announced. To withdraw your question, please press star one one again.

Speaker Change: the return on investment.

Speaker Change: The features and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features.

Erez Meltzer: We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic work.

Erez Meltzer: We also continue to advance our other clinical efforts in multiple countries and locations.

Erez Meltzer: So we don't have to send the technicians to do it. It's downloaded from the network.

Speaker Change: to be installed remotely. So we don't have to send technicians to do it. It's downloaded from the network.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Latin Bird. Your line is now open. Good morning, Arizona. How are you? Good. Good morning.

Erez Meltzer: Thank you, Jeff. Thank you.

Speaker Change: Got it. Okay, super. Erez, thanks for taking our questions.

Erez Meltzer: Generating data, demonstrating the utility of the Nano-X Rx for a fuller, wider range of indications is a key initiative for Nano-X. The reason is simple, if we can show large volumes of data demonstrating the evaluated utility of the Nano-X Rx, it will significantly boost our all-important commercial efforts. For example, the Bayley-N-Sun hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data.

Erez Meltzer: So I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke about 50 on sales and 34 on leads? Could you give us a sense of where these units are? Imagine they're mostly domestic U.S, and how that follow looks for actually placements in training over the coming quarters. Okay, so I think that we mentioned last time, the number of 20 right now, the number was growing to more than triple as you can imagine in various stages of deployment.

Scott Henry: Our next question comes from the line of Scott Henry with the AGP. Your line is now open. Thank you.

Jeff: Thank you, Jeff.

Jeff: Thank you. Our next question comes from the line of Scott Henry with the AGP. Your line is now open.

Jeff: Good morning.

Jeff: Okay, so with, maybe I'll start with the end.

Scott Henry: In the good morning or afternoon, depending on where you are. Just a couple of questions. Congratulations. Again, the 510(k) application in for the general use interest indication. Could you give any thoughts on what you would expect the review timeline to be for that indication? What is it typically in this case just to get a sense of when we may get final approval?

Erez Meltzer: There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site studies. The previously announced multi-site trial is now operational and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating site while already gaining clinical experience with the amount of AHRQ installed in scanning patients.

Scot Henry: Thank you, and good morning or afternoon, depending on where you are. Just a couple questions. Congratulations on getting the 510K application in for the general use in chest indication. Could you give any...

Jeff: With the reimbursement right now, what we speak about the reimbursement is based on the Tomo CPT code, which is 76.100.

Jeff: And this is the basis for the reimbursement of those that submitted their scans to, for, the reimbursement.

Jeff: We received already indications from more than, from two, I think, that insurance insurers.

Scot Henry: Any thoughts on what you would expect the review timeline to be for that indication? What is it typically, in this case, just to get a sense of when we may get final approval?

Erez Meltzer: We have a few dozens which are already deployed. A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals. And we believe that the indication that we gave which 50 of them are probably favorable to be installed. And the 44 in the leads in the beginning of the process, we are getting to the target of that we wanted to be by the end of the year. And that's where we are. Okay, got it.

Scot Henry: So, I wondered firstly, could you expand upon a little bit regarding your, your backlog as far as imaging when you spoke about 50 on sales and 34 on leads.

Erez Meltzer: First of all, I hope that I understand the question, so I'll give the answer. If not, you'll tell me. Bear in mind that I'm up until now all the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK, MSK, spying, hand lag, etc. And not chest. We all know that the chest is the most common use of X-ray, and especially when we talk about the Thomas synthesis. So we expect that once we get the clearance, it will definitely increase the likelihood of sites and the customers to take the arc.

Speaker Change: First of all, I hope that I understand the question, so I'll give the answer and if not, you tell me.

Speaker Change: Could you give us a sense of where these units are.

Speaker Change: Bear in mind that up until now, all the...

Speaker Change: The revenues and the scans that were conducted in the U.S. in the few dozens of systems which are installed

Speaker Change: are mainly MSK. MSK, spine, hand, leg, etc. and not chest. We all know that the chest is the the most common use of x-ray and especially when we talk about the tomosynthesis.

Speaker Change: I imagine they're mostly domestic U.S. and how that funnel looks for actually placements and training over the coming quarters.

Speaker Change: So, we expect that once we get the clearance, it will definitely increase the likelihood of sites and customers to take the ARC.

Erez Meltzer: And then, graduations on the news today for a calcium score. Could you talk a little bit about these other 510K indications and for general term as well, in addition to our general interest? And could you talk about the codes associated with them as far as reimbursement and facilities? Okay. So, with maybe I'll start with the end with the reimbursement right now, what we speak about the reimbursement is based on the Tomo CPT code, which is 76100.

Erez Meltzer: And more than that, that in the sites that the system is going to be installed, it will increase the number of scans per day because it will be used for other indications as stated. Is this what you asked?

Speaker Change: And more than that, in the sites that the system is going to be installed,

Speaker Change: It will increase the number of scans per day because it will be used for other indications as stated.

Erez Meltzer: Well, that's very helpful. Thank you. And I guess the question I initially was hoping to get some sense of is how long do you expect the review period to be for that 510(k)? I wish I could tell you. I do hope that it will be faster than the previous processes that other companies, as well as us, experience since COVID. But I think that the fact that the system itself is already cleared, and it will enhance the process.

Speaker Change: Is this what you asked or? Well, that's very helpful. Thank you. And I guess the question I additionally was hoping to get some sense on is, how long do you expect the review period to be for that 510K?

Speaker Change: hel

Erez Meltzer: And this is the basis for the reimbursement of those that submitted their scans for the reimbursement. We received only already indications from more than two I think that insurance insurers. And this is continuous to grow. The numbers that we received are in line of the model that we put together. So, basically, right now, it seems that for the clinics and the sites that the system has installed, the model is profitable. With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar.

Speaker Change: I wish I could tell you.

Speaker Change: I do hope that it will be faster than the previous processes that other companies as well as us experienced.

Speaker Change: since COVID, but I think that the fact that the system itself is already cleared and it will enhance the process, but I cannot even guesstimate the time.

Speaker Change: okaywell that's how i would say i would say they at a following i'm not happy to guest imate because the last thing i wantedis that i will give an estimate and then it will for some reason to be longer so

Scott Henry: So I will be happy to announce that it's cleared once it's cleared, and everyone can imagine that the period that it will take. Okay, I appreciate that feedback. Second question: you mentioned the installed Nanox ARC systems in the three chain medical imaging. Service providers in the U.S.

Speaker Change: Yep, I will be happy to announce that it's cleared once it's cleared and and everyone can imagine

Erez Meltzer: It's in line of what we have indicated in the past that we are going to submit to submit this year the additional clinical indications, especially the chest. We decided that we're going to submit it for whole body, so including the chest, not only, but we are able to scan whole body and basically everything. Bear in mind that in the rest of the world and especially part of the others and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body and we are using it to all the clinical indications.

Speaker Change: that the paper that it will take

Speaker Change: Okay, I appreciate that feedback. Second question, you mentioned the installed Nano-X Arc systems in the three chain medical imaging

Erez Meltzer: Have you gotten any feedback on it from those three chains and how that's working out, and perhaps, you know, what kind of expands and opportunities there would be? It may be too early, but I just wanted to get a sense of how that was going so far. So, especially for those of the people who are actually on the call, that they hear in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot, or what we call the soft launch of the arc in the U.S.

Speaker Change: service providers in the U.S. Have you gotten any feedback on it from those three chains and how that's working out and perhaps, you know, what kind of expansion opportunities there would be? It may be too early, but I just wanted to get a sense of how that was going so far.

Speaker Change: Okay, so I think that we mentioned last time the number of 20.

Speaker Change: So, and this continues to grow.

Speaker Change: So, especially for those of the people who are actually on the call here, in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the

Speaker Change: The numbers that were received are in line of the model that, that we put together.

Speaker Change: A few that are waiting for approval regulatory the state approvals because they are spread over seven states and the last last two states are waiting for approvals.

Speaker Change: So, basically, right now, it seems that the, for the clinics that, and the sites that the system is installed, it's, the model is profitable.

Speaker Change: And we believe that the indication that we gave which 50 50 of them are probably favorable to be installed and 44 in the leads in the beginning of the process.

Speaker Change: With respect to the 510K, so in addition to the, to the new one of the, of the CCS or, the calcium scoring that we received today, we have submitted the similar, it's in line of what we've indicated in the past that we are going to submit it, to submit this year.

Speaker Change: The additional clinical indications, especially the chest, we decided that we're going to, submit it for whole body.

Speaker Change: So, including the chest, not only, but by the time that we get this clearance, then even in the U.S., not only in the rest of the world, we are able to scan whole body and basically everything.

Speaker Change: Bear in mind that in the rest of the world, and especially part of the others, and including the submission to, of the CE, we are using the fact that the hardware is how they're ready for whole body, and we are using it to, to all, all the clinical indications.

Erez Meltzer: Based on this indication, I gave in this call today, I gave indication of the spread between the various body anatomies or body parts that were received and I gave the percentage that we have on the role on a global basis. And you can see the chest is a major part of them. Got it.

Erez Meltzer: As we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers not only from the chains, but we are getting a lot of feedback from the customers feedback on a clinical basis, click on the maintenance on the usage on the pattern of the body parts which and the anatomies that is being used, the clinical use, so far and this is something that encouraged us to accelerate the installation and the deployment. We receive a very good feedback. And I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system, and they decided to do it.

Speaker Change: the pilot or what we call the soft launch of the ARC in the US, we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains.

Speaker Change: Based on the, this indication I gave in this call today, I gave indication of the spread, between the various body anatomies or body parts that were received, and I gave the percentage that we have on the global basis.

Speaker Change: And you see, you can see the chest is a major part of them.

Speaker Change: Got it.

Speaker Change: But we are getting a lot of feedback from the customers.

Speaker Change: Feedback on a clinical basis, on the maintenance, on the usage, on the pattern of the body parts and the anatomies that is being used, the clinical use.

Speaker Change: And then one more, if I may, could you talk a little bit more about the ARCX platform, and perhaps its form factor and differences versus the current platform and the intended commercial presence that you anticipate as compared to the current platform?

Speaker Change: So far, and this is something that encouraged us to accelerate the installation and the deployment, we received very good feedback. And I think that

Speaker Change: What we see is a lot of examples of...

Erez Meltzer: And after the FDA clearance, it will be marketed as a longer, along the current system, which will expand our product offering. And we mentioned a few times in the past that the ARCH or the first version to point to is not the first product and definitely not the last and we haven't lined up a real product roadmap for the future. ARCHX is one of them. We will give more indications, but I think that the idea is to make the ARCHX available to more specific locations or sites that are more suitable for the spec of the system.

Speaker Change: places that this system is replacing ct places where they didn't have they didn't have in mind to sto to deploy system and they decided to do it

Erez Meltzer: So overall, the feedback is very good.

Speaker Change: So, first of all, we are going to give more details within the next, I would say, end of, this quarter and beginning of the next quarter.

Speaker Change: We are, of course, going to submit it to the, to the FDA, and after the FDA clearance, it will be marketed as a long, along the current system, which will expand our current product offering.

Erez Meltzer: I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, and on the regulatory processes. And we will always, as indicated, even in today's goal, we will always implement them and improve our service and our products accordingly. Okay, great. Thank you for that feedback.

Speaker Change: So, overall, the feedback is very good. I would say...

Speaker Change: And we mentioned a few times in the past that the ARC, or the first version 2.2, is not the first product and definitely not the last.

Speaker Change: that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory.

Speaker Change: And we have in line a real product roadmap for the future.

Speaker Change: processes, and

Speaker Change: and we will always as indicated even in today's go we will always implement them and improve our service and our products accordingly

Erez Meltzer: We are talking about footprint. We are talking about, we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features and the beauty of it that whenever we are going to install it, we are going to enable the all the features that are coming with the software and the features to be installed remotely. So we don't have to send the technicians to do it. It's download from the network.

Erez Meltzer: Final question: when we are thinking about Q3 relative to Q2, should we expect any seasonality in the U.S.? The summer months, do they tend to be a little slower with a pickup in the fourth quarter? Just trying to get a sense of what kind of cadence we should expect through the year. Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base. So we will probably see anyhow a better result, but right now we are not planning or expecting to have any seasonality. Seasonality is a fact.

Speaker Change: she

Speaker Change: OK, great. Thank you for that feedback. Final question. When we're thinking about Q3 relative to Q2, should we expect any seasonality in the U.S.? Is the summer months

Speaker Change: Do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year?

Speaker Change: ah

Speaker Change: Frankly speaking, right now we don't expect any seasonality.

Speaker Change: especially due to the fact that we are ramping up our.

Speaker Change: installed the base so we will probably see anyhow a better result but right now right now we are not planning or or expecting to have any season seasonality effect

Erez Meltzer: Thank you, Jeff. Thank you.

Erez Meltzer: Our technology can increase the depiction of the Colchester's lesions, localized characterize and result questionable lesions, even without prior a geologist experience.

Scott Henry: Our next question comes from the line of Scott Henry with the AGP. Your line is now open. Thank you.

Scott Henry: Okay, great. Thank you for taking the questions. Thank you.

Erez Meltzer: In the good morning or afternoon, depending on where you are. Just a couple of questions. Congratulations. Again, the 510K application in for the general use interest indication. Could you give any thoughts on what you would expect the review timeline to be for that indication? What is it typically in this case just to get a sense of when we may get final approval? First of all, I hope that I understand the question, so I'll give the answer if not you'll tell me.

Speaker Change: Okay, great. Thank you for taking the questions.

Operator: As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Speaker Change: thank you thank you as a reminder to ask a question at this time please forstar one one or you touched toone telephone our next question comes from the line of ross osborne with cancerorfitzgerald your l is open

Erez Meltzer: Colt cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose cost and images per study should be further investigated.

Ross Osborne: Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is open. Hey guys, thanks for sharing the questions. So starting off, seems like you are at the point of inflection in terms of deployments.

Speaker Change: ARCX is one of them.

Speaker Change: We are getting to the targeted that we wanted to be by the end of the year and and that's where we are.

Speaker Change: youguys thanks ing or to questquestion so starting off seems like you are at the point of inflection in terms of deployments with that in mind ke walk through your current manufacturing capabilities and where your various contract initiative stand

Erez Meltzer: With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand? So you're right about what you said. In terms of manufacturing, I would say the following. The two chips; we have no problem. We have available chips right now. We were able, due to the results of the high yield wafers that we get from CSAM. We have two suppliers, and I think that this is not an issue in terms of the cubes. We have already the cubes that are coming from Korea. We have the tubes that are coming from the plant in Europe.

Speaker Change: Okay got it and then congratulations on the news today for a calcium score.

Speaker Change: So you're right about what you said.

Speaker Change: In terms of manufacturing, I would say the following.

Erez Meltzer: Bear in mind that I'm up until now all the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK, MSK, spying, hand lag, etc. And not chest. We all know that the chest is the most common use of X-ray and especially when we talk about the Thomas synthesis. So we expect that once we get the clearance it will definitely increase the likelihood of sites and the customers to take the arc.

Speaker Change: qchips we have no problem we have available chips right now we were able due to the results of the highyield wafers that we get from c we have two supplier and

Speaker Change: and i think that this is not an issue in terms of the tuubes

Speaker Change: We have already the tubes that are coming from Korea. We have the tubes that are coming from the plant in Europe . And last but not least, Varex has completed their initial tube.

Erez Meltzer: And in the last but not least, Varics has completed their initial tube prototype utilizing our emitter, and for this is for testing. So I hope that it will be integrated into our new nanops, our system shortly and it will be part of the available production. In terms of the production of the assembly of the system, we have made the appropriations in the site in Israel that we're moving forward, and we've increased the capacity of the manufacturing to enable what is needed. In the next few quarters, and the local manufacturing arrangements that we have will enable us to ramp up next year even higher than what we are currently doing.

Speaker Change: a prototype utilizing our emitter, and this is for testing.

Speaker Change: So I hope that it will be integrated into our new Nano-X art.

Speaker Change: system shortly, and it will be part of the available production.

Speaker Change: in terms of the in terms of the production of the assembly of the system we have made be apprepriations in the ightes in israel that where we're moving forward and we've increased the capacity of the manufacturing

Erez Meltzer: Well, that's very helpful. Thank you. And I guess the question I initially was hoping to get some sense and how long do you expect the review period to be for that 510K? I wish I could tell you, I do hope that it will be faster than the previous processes that other companies as well as us experience since COVID. But I think that the fact that the system itself is already cleared and it will enhance the process.

Erez Meltzer: For more information see more our white paper section on our website.

Speaker Change: to enable what is needed.

Speaker Change: in the next few quarters. And the low-cost manufacturing arrangement that we have will enable us to ramp up next year even higher than what we are currently doing. So right now,

Erez Meltzer: Turning to our AI business.

Erez Meltzer: So right now, I would say that it seems to be in line of what is needed for the next few quarters. Thank you.

Speaker Change: i would say that it seems to be in line of what is needed for the next few quarters

Erez Meltzer: We are working on the next ramp up for 2025 to be announced. Got it. Later. Perfect. Thank you.

Speaker Change: and how ly we' thank you it

Speaker Change: are working on the next ramp-up for 2025.

Erez Meltzer: But I cannot even guesstimate the time. Well, that's how I would say the following. I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will for some reason be longer. So I will be happy to announce that it's cleared once it's cleared and everyone can imagine that the period that it will take. Okay, I appreciate that feedback. Second question, you mentioned the installed Nanox ARC systems in the three chain medical imaging.

Speaker Change: to be announced. Got it.

Erez Meltzer: Following up on my previous question, would you remind us how large your US sales forces today and then any plans for adding to the team? So right now, right now, we actually work with, I would say, when it's about 10 people all together. And if I had the independent agents, then I think that we are right now at around 15. We are expecting to grow them to the number of 30 in the foreseeable future. Great.

Speaker Change: Later.

Speaker Change: Perfect. Thank you. And then following up on my previous question, would you remind us how large your U.S. sales force is today? And then any plans for adding to the team?

Speaker Change: So...

Speaker Change: right now right now we actually work with

Erez Meltzer: Just last month, we announced that our Nano-X AHRQ solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI Cardiovascular solution at a steamed healthcare system, along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases.

Speaker Change: 10 people all together

Speaker Change: and if i had the

Erez Meltzer: Service Providers in the U.S. Have you gotten any feedback on it from those three chains and how that's working out and perhaps, you know, what kind of expands and opportunities there would be it may be too early, but I just wanted to get a sense of how that was going so far. So, especially for those of the people who are actually on the call that they hear in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S. As we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers not only from the chains, but we are getting a lot of feedback from the customers feedback on a clinical basis, click on the maintenance on the usage on the pattern of the body parts which and the anatomies that is being used, the clinical use, so far and this is something that encouraged us to accelerate the installation and the deployment, we receive a very good feedback.

Speaker Change: if i had the independent agents then i think that we are right now at around ' fifteen

Speaker Change: we are expecting to grow them to the number of thirty in the in the foreseeable future

Erez Meltzer: And then last one for us. This is what I said: is that that's what that's what we anticipate for 2025 to be around 30 to 40. Got it, got it. Thank you.

Erez Meltzer: Clawwell Health has previously reported that in the first full year of implemented health CC&G in its electronic medical record system, there was a 13-fold increase of the patients reported in the previous two years.

Speaker Change: Great, and then last one for us. What I said is that that's what to anticipate for 2025 to be around 30 to 40.

Erez Meltzer: And then lastly, just an anticipation to see Mark Approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting, if you'll build out your own self-sforce or leverage a distributor there, and lastly, what the reimbursement environment looks like? Okay. So, with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past, and we are going to deploy them once the clearance in these countries is expected to be received.

Speaker Change #100: Got it. Got it. Thank you. And then lastly, just an anticipation of CE mark approval.

Speaker Change #101: would you walk us through your commercialization plan in europe and other related geographies in terms of what type of medical syersgy you will be taring if you'll build out your own ceales force or leverage a distributor there and lastly whetherthe reimbursement environment looks like

Speaker Change #102: okay so with respect to the rest of the world first of all there are a few countries that you should remember we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries are

Erez Meltzer: So I mentioned today, one of them, Mexico is really coming very shortly. I will be there next month to visit the places there. They are planning to install the arc. So this is one. We were talking about another one or two countries in Latin America. In terms of Europe, we are waiting for the CE approval, as indicated previously, and we are in the, really in the final process of the, of the CE approval. Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them.

Speaker Change #102: are expected to be received so

Speaker Change #102: I mentioned today, one of them, Mexico, is really coming very shortly. I will be there next month.

Speaker Change #102: who visit the places that they are planning to install the ARC.

Erez Meltzer: Traditional cardiovascular risk scoring is difficult in these patients and I don't say I can be a valuable new tool in quantifying these risks.

Erez Meltzer: And I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it. So overall, the feedback is very good. I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes. And we will always, as indicated, even in today's goal, we will always implement them and improve our service and our products accordingly.

Speaker Change #102: So this is one. We were talking about another one or two countries in Latin America.

Speaker Change #102: In terms of Europe , we are waiting for the CE approval, as indicated previously, and

Speaker Change #102: We are in the really in the final process of the of the CE approval. Once we get the CE, so all the countries that

Erez Meltzer: After being installed and implemented the Jefferson-Imsson hospital, Health, CC&G helped identify 757 patients, age, study or above, with CAC levels higher than 100 AgStone units.

Speaker Change #102: where part of the agreements that we sign like like australia a like new zealand like spain we're going to use mean each one of them it's going to be it's going to be the distributors that are going to do the work

Erez Meltzer: Each one of them, it's going to be the distributors that are going to do the work. If you remember, I mentioned about a year ago that right now only in the US, Israel, and the UK we are planning to have our own people, and in the rest of the world we are planning to have distributors. We are right now already in the last quarter in this quarter in touch with these distributors in order to ensure that we have a plan. Our people visited already few locations in each one or not in each one in most of these countries.

Speaker Change #102: if you remember i mentioned about a year ago that right now only in the u s israel and the uk we're up planning to have our own people

Erez Meltzer: As a sign-dote, the lead author of this study, Breaking Weber, was declared as young investigator word winner at the annual meeting as well.

Speaker Change #102: and in the rest of the world we are planning to have

Speaker Change #102: distributors. We are right now already in the next in the last quarter in this quarter in touch.

Erez Meltzer: Additionally, the previous agreements we signed for Nanox AI with Coveira Health and Coveira Health are off to a great start and the feedback has been very positive thus far.

Erez Meltzer: Okay, great. Thank you for that feedback. Final question, when we are thinking about Q3 relative to Q2, should we expect any seasonality in the U.S.? The summer months, do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year. Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base. So we will probably see anyhow a better result, but right now we are not planning or expecting to have any seasonality, seasonality is a fact.

Speaker Change #102: with these distributors in order to ensure that we have the plan our people visited already fuel locations in each each one not in each what in most of these countries

Operator: Okay, great. Thank you for taking the questions. Thank you. As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Erez Meltzer: Right now, we are talking in Europe and in Mexico. We are talking about a medium to large medical centers. Got it.

Speaker Change #102: Right now we are talking in Europe and in Mexico, we are talking about medium to large medical centers.

Erez Meltzer: Thanks for taking our questions, and congrats again on the quarter. Great. Thank you.

Speaker Change #103: Got it. Thanks for taking our questions and congrats again on the quarter.

Operator: And I'm currently showing no further questions at this time.

Speaker Change #103: Rick.

Operator: This does conclude today's conference call.

Speaker Change #104: Thank you and I'm currently showing no further questions at this time. This does conclude today's conference call. Thank you all for participating and you may now disconnect.

Operator: Thank you all for participating, and you may now disconnect.

Ross Osborne: Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is open. Hey guys, thanks for sharing the questions. So starting off seems like you are at the point of inflection in terms of deployments.

Erez Meltzer: I think I can speak of all of us at Nanox when I say there is a lot to be excited about.

Erez Meltzer: With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand? So you're right about what you said. In terms of manufacturing I would say the following. The two chips, we have no problem, we have available chips right now. We were able, due to the results of the high yield wafers that we get from CSAM. We have two suppliers and I think that this is not an issue in terms of the cubes.

Erez Meltzer: Looking ahead to the near future of Nanox, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long-term with a new technology needs to constantly refine their offering base on customer feedback, changes in technology and evolving use case.

Erez Meltzer: Nano-X is no different and we are constantly working on product and technology future developments.

Erez Meltzer: I'm very pleased to share for the first time that we are developing another Nano-X, our system called Nano-X ArcX, which we intend to submit among others for FDA clearance.

Erez Meltzer: Once cleared, it will be marketed along the current system which will expand our current product offering.

Erez Meltzer: At the high level, the Nano-X ArcX is designed to meet market needs of our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Erez Meltzer: Listening to the clinical needs is an important step in the ongoing extension of Nano-X solution.

Erez Meltzer: We have already the cubes that are coming from Korea. We have the tubes that are coming from the plant in Europe. And in the last but not least, Varics has completed their initial tube prototype utilizing our emitter and for this is for testing. So I hope that it will be integrated into our new nanops, our system shortly and it will be part of the available production. In terms of the production of the assembly of the system, we have made the appropriations in the site in Israel that we're moving forward and we've increased the capacity of the manufacturing to enable what is needed.

Erez Meltzer: There will also be image enhancement options in the new units which are currently not available on existing Nano-X Arc systems and future synthetic to these.

Speaker Change #104: ibe

Erez Meltzer: We are optimistic.

Erez Meltzer: In the next few quarters and the local manufacturing arrangements that we have will enable us to ramp up next year even higher than what we are currently doing. So right now, I would say that it seems to be in line of what is needed for the next few quarters. Thank you. We are working on the next ramp up for 2025 to be announced. Got it. Later. Perfect. Thank you.

Erez Meltzer: We will move towards prototyping tubes the second half of this year.

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Erez Meltzer: Regarding our tele-rojology services, we are leveraging our USA RedCline based on a network of rojology as a significant part of our US deployment plan.

Erez Meltzer: Following up on my previous question, would you remind us how large your US sells forces today and then any plans for adding to the team? So right now, right now, we actually work with, I would say when it's about 10 people all together. And if I had the independent agents, then I think that we are right now at around 15. We are expecting to grow them to the number of 30 in the foreseeable future. Great. And then last one for us. This is what I said is that that's what that's what we anticipate for 2025 to be around 30 to 40. Thank you. Got it. Thank you.

Erez Meltzer: And then lastly, just an anticipation to see Mark Approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting if you'll build out your own self-sourced or leveraged distributor there and lastly, what the reimbursement environment looks like. Okay, so with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries are expected to be received.

Erez Meltzer: So I mentioned today, one of them Mexico is really coming very shortly. I will be there next month to visit the places there. They are planning to install the arc. So this is one we were talking about another one or two countries in Latin America. In terms of Europe, we are waiting for the CE approval as indicated previously and we are in the really in the final process of the of the CE approval.

Erez Meltzer: Once we get the CE, so all the countries that were part of the agreements that we signed like Australia, like New Zealand, like Spain, we're going to use them each one of them. It's going to be the distributors that are going to do the work. If you remember, I mentioned about a year ago that right now only in the US, Israel and the UK, we are planning to have our own people and in the rest of the world, we are planning to have distributors.

Erez Meltzer: We are right now already in the last quarter in this quarter in touch with these distributors in order to ensure that we have a plan. Our people visited already few locations in each one or not in each one in most of these countries. Right now, we are talking in Europe and in Mexico. We are talking about a medium to large medical centers. Thank you for taking our questions and congrats again on the quarter.

Erez Meltzer: Right. Thank you and I'm currently showing no further questions at this time. This does conclude today's conference call. Thank you all for participating and you may now disconnect. [inaudible] us today, thank you all for joining us today, thank you all for joining us today, thank you all[inaudible] Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh,[inaudible] Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, .

Speaker Change: We will give more indications, but I think that the idea is to make the ARCX available to more specific locations or sites that are more suitable for the, for the spec of this system. We are talking about footprint.

Speaker Change: Could you talk a little bit about these other 510k indications and for General Tomo as well in addition to General Cheston.

Speaker Change #104: Right now, the number was growing to more than triple, as you can imagine, in various stages of deployment.

Speaker Change #104: We have a few dozens, which are already deployed.

Speaker Change #104: Can you talk about the codes associated with them as far as reimbursement at facilities?

Speaker Change #105: Good day, and thank you for standing by.

Speaker Change #104: Okay so with maybe I'll start with the end.

Welton NXS: welton nxs second quarter two thousand and twenty four earnings conference call

Welton NXS: at the time o particitionipiness on a isally mode

Speaker Change #107: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

Speaker Change #108: to withdraw your question please for star one one again please be advisor today's conferenice being recorded

Speaker Change #104: We're talking about, we're talking about, first of all, even for us, it's the cost of manufacturing, the return on investment, the features and the beauty of it that whenever we are going to install it, we're going to be to enable the, all the features that are coming with the software and the features to be installed remotely.

Speaker Change #104: With the reimbursement right now what we speak about the reimbursement is based on the Tomo CPT code which is 76100 and this is the basis for the reimbursement of those that submitted the their scans to for the reimbursement.

Speaker Change #108: A few that are waiting for approval, regulatory, the state approvals, because they are spread over seven states, and the last two states are waiting for approvals.

Mike Kavanaugh: i would like to end the conference over to youto speak today mike kcaavanagh investor relations please go ahead

Speaker Change #108: So we don't, we don't have to send the technicians to do it.

Speaker Change #108: We got we received only already indications from more than from from two I think that insurance insurers so and this is continues to to grow.

Mike Kavanaugh: And we believe that the indication that we gave, which 50 of them are probably favorable to be installed, and 44 in the leads in the beginning of the process, we are getting to the target that we want it to be by the end of the year.

Mike Kavanaugh: Good morning and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the quarter ended June 30, 2024.

Mike Kavanaugh: It's download from the, from the, the way, from the, from the network.

Mike Kavanaugh: The numbers that that were received are in line of the model that that we put together so basically right now it seems that the for the clinics that and the sites that the system is installed the it's the the model is profitable.

Mike Kavanaugh: the release is currently available on the investors section of the company's website

Speaker Change #109: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Mike Kavanaugh: Thank you, Jeff.

Mike Kavanaugh: With respect to the 510K, so in addition to the new one, of the CCS or the calcium scoring that we received today, we have submitted the similar, it's in line of what we have indicated in the past that we are going to submit it to submit this year.

Speaker Change #109: And that's where we are.

Speaker Change #109: Okay, got it.

Speaker Change #110: before we get started i would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results research and development manufacturing and commercialization activities regulatory process operations and to other matters

Speaker Change #109: Thank you.

Speaker Change #109: The additional clinical indications, especially the chest, we decided that we're going to submit it for whole body.

Speaker Change #109: Our next question comes from the line of Scott Henry with the AGP.

Speaker Change #109: So including the chest, not only, but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan whole body and basically everything.

Speaker Change #109: Your line is now open.

Speaker Change #109: Bear in mind that in the rest of the world, and especially part of the others and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body.

Speaker Change #110: And then, congratulations on the news today, for a calcium score.

Speaker Change #110: these statements are subject to risks uncertainties and assumptions that are based on management's current expectations as of today and may not be updated in the future

Speaker Change #110: Could you talk a little bit about these?

Speaker Change #110: therefore these statements should not be relied upon as representing the company's views as of any subsequent date

Speaker Change #110: factors that may cause such a difference include but are not limited to those described in the company's filings with the securities and exchange commission

Speaker Change #110: we will also refer to certain non-gaap financial measures to provide additional information to investors

Speaker Change #110: a reconciliation of the non-gaap to gaap measures is provided with our press release with the primary differences being non-gaap net loss attributable to ordinary shares

Speaker Change #110: non-GAAP Cost of Revenue, non-GAAP Gross Profit, non-GAAP Gross Profit Margin, non-GAAP Research and Development Expenses, non-GAAP Sales and Marketing Expenses,

Speaker Change #110: non-gaap general and administrative expenses non-gaap other expenses or income a non-gaap gross loss per share

Erez Meltzer: With that, I'd now like to turn the call over to Erez Meltzer.

Speaker Change #110: other 510k indications, and for General Tomo as well, in addition to General Cheston, could you talk about the codes associated with them as far as reimbursement at facilities?

Erez Meltzer: Thank you for joining us today, and as always, we appreciate your continued support of Nano-X Imaging. 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts as we continue to expand our deployment in the U.S. and the rest of the world. We are not only accelerating deployment of the Nano-X RX system, but also expanding the footprint of the other value-added elements of the full Nano-X solution including Nano-X AI. As mentioned in previous calls, I am committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

erra's memillter: with that i'd now like to turn the call over to erra's memillter

Speaker Change #110: Thank you, and good morning or afternoon, depending where you are.

Speaker Change #110: And we are using it to all the clinical indications.

erra's memillter: Okay.

erra's memillter: thank you for joining us said today and as always we appreciate your continued support of noneox and our mission

erra's memillter: two thousand and twenty-four has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts

Speaker Change #112: as we continue to expand our deployment in the u us and the rest of the world

Speaker Change #112: we'are not only accelerating deployment of the anoics are system but also expanding the footprint of the other value-added elements of the full mano solution including mananoxi

Speaker Change #112: So with, Maybe I'll start with the end.

Speaker Change #112: as mentioned in previous callals i'am committed to providing further insights and detailed updates on our ongoing advestments in the coming periods

Erez Meltzer: I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advancements, commercial deployments, Nano-X AI updates, and any production to our new Nano-X RX system, which will call Nano-X RX.

Speaker Change #112: Just a couple questions, congratulations on getting the 510K application in for the, general use in chest indication.

Speaker Change #112: Based on this indication I gave in this call today, I gave indication of the spread between the various body anatomies or body parts that were received.

Speaker Change #112: With the reimbursement right now, what we speak about the reimbursement is based on the TOMO CPT code, which is 76100.

Speaker Change #112: i will begin with a discussion of our recent achievements which will cover regulatory updates clinical advancements commercial deployments n ' sayi updates and introduction to our new nanox are system which will call noneox archx

Speaker Change #112: Could you give any thoughts on what you would expect the review timeline to be for that, indication?

Speaker Change #112: And I gave the percentage that we have on the world, on a global basis.

Erez Meltzer: After my prepared comments, I'll turn the call over to our CSO, Ren, who will review our Q2 financial results. I will then share a few closing thoughts before turning the call over to the Q&A session. We have a lot to discuss, so let's get started. Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510(k) submission to the FDA, which is intended to expand the indications for our current Nano-X RX system in general thermosynthesis imaging.

Renan: after my preferaredred comments i'll turn the call over to our cfo renan who will review our a q two financial results i will then share a few closing thoughts before turning the call over to the qnaation

Speaker Change #112: What is it typically, in this case, just to get a sense of when we may get final approval?

Speaker Change #112: And you can see the chest is a major part of them.

Renan: And this is the basis for the reimbursement of those that submitted their scans for the reimbursement.

Renan: we have a lot of discuss so let's get started

Renan: First of all, I hope that I understand the question, so I'll give the answer and if not, you tell me.

Renan: Got it.

Renan: before i provide an overview of our commercial progress i will begin with some clinical and regulatory updates which we believe will have a near-ter positive impact on our commercial efforts

Renan: Bear in mind that up until now, all the revenues and the scans that were conducted in the U.S, in the few dozens of systems which are installed are mainly MSK, MSK spine, hand, leg, et cetera, and not chest.

Renan: And then one more, if I may, could you talk a little bit more about the ARCX platform and perhaps its form factor and differences versus the current platform and the intended commercial presence that you anticipate as compared to the current platform?

Renan: We received already indications from two, I think, insurers, and this continues to grow. The numbers that were received are in line of the model that we put together. So basically, right now, it seems that for the clinics and the sites that the system is installed, the model is profitable.

Renan: We all know that the chest is the most common use of x-ray, and especially when we talk, about the tomosynthesis.

Renan: So first of all, we are going to give more details, within the next, I would say end of this quarter and beginning of the next quarter.

Renan: With respect to the 510K, so in addition to the to the new one of the of the CCS or the calcium scoring that we received today, we have submitted the, Similar, it's a line of what we have indicated in the past that we are going to submit it, to submit this year.

Speaker Change #113: i'm happavy to share the just last week none of submitted a new five ten -k submission to the fda which is intended to expand the indications for our recurrent nanics are system in general thomas synthesis imaging

Speaker Change #113: The additional clinical indications, especially the chest, we decided that we're going to submit it for whole body.

Speaker Change #113: So we expect that once we get the clearance, it will definitely increase the likelihood, of sites and the customers to take the ARC, and more than that, that in the sites that the system is going to be installed, it will increase the number of scans per day because it will be used for other indications as stated.

Speaker Change #113: We are of course going to submit it to the FDA.

Erez Meltzer: Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest. As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X RX for chest indications and was intended to support the submission. The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies. To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approvals.

Speaker Change #113: So including the chest, not only, but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan whole body and basically everything.

Speaker Change #113: Bear in mind that in the rest of the world, and especially part of the others, and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body, and we are using it to all the clinical indications.

Speaker Change #113: Is this what you ask or?

Speaker Change #113: And after the FDA clearance, it will be marketed as along the current system, which will expand our current product offering.

Speaker Change #113: what's cleared the submission will significantly expand the system indication for used from the current demisca for general use including chest

Speaker Change #113: Well, that's very helpful.

Speaker Change #113: Based on this indication I gave in this call today, I gave indication of the spread between the various body anatomies or body parts that were received, and I gave the percentage that we have on the global basis.

Speaker Change #113: as you know much of the clinical work we have been performing recently has centered around the suitability of the nanicsx are for chess indications and was intended to support the submission

Speaker Change #113: Thank you.

Speaker Change #113: And we mentioned a few times in the past, that the ARC or the first version 2.2 is not the first product and definitely not the last.

Speaker Change #113: And you can see the chest is a major part of it.

Speaker Change #113: the subicition will include some software updates and is accompanied by a new clinical data for various study anatomies

Speaker Change #113: Got it.

Speaker Change #113: And then one more, if I may, could you talk a little bit more about the ARCX platform and perhaps its form factor and differences versus the current platform and the intended commercial presence that you anticipate as compared to the current platform?

Speaker Change #113: with and without psythchologies

Speaker Change #114: to be clear it is worth noting that all card installed nlooks are systems are hardware ready and have the required capabilities to scan andmscape chest and abdomin subject to the fda clearance and the requisite regulatory approvals

Speaker Change #113: And we have in line a real product roadmap for the future.

Erez Meltzer: This means that post-SBA clearance, a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards. Additionally, after completing the technical stages, including obtaining the ISO 13485 certification from BSI and successfully passing the MDR audit, we are now in advanced stages with our notified body to secure the CE mark for the E-origin.

Speaker Change #115: this means that post as the a clearance a simple software upgrade that can be done remotely is all that will be necessary to bring currently the plooredeconnamics ar units up to the new standards

Speaker Change #115: additionally after completing the technical stages including obtaining

Speaker Change #115: the iso thirteen four eight y five certifications from bsi and successfully passing the ndrr audits

Speaker Change #115: we are now in advanced stages with our notdifified bodyud to secure the ce mark for the eu region

Erez Meltzer: Rest assured, we will provide updates as soon as they are available. Turning now to our global deployment and commercial efforts, which continued in the next second quarter, our team is diligently working with imaging centers, physicians, and regulators to increase the footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployment. The deployments in the U.S. are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan.

Speaker Change #115: rest assurredance we will provide updates as soon as they are available

Speaker Change #115: So, first of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter.

Speaker Change #115: And I guess the question I additionally was hoping to get some sense of, how long do you, expect the review period to be for that 510K?

Speaker Change #115: ARCX is one of them. We will give more indications, but I think that the idea is to make the ARCX available to more specific locations or sites that are more suitable for the spec of the system. We are talking about footprint.

Speaker Change #115: I wish I could tell you.

Speaker Change #115: turning now to our global deployment and commercial efforts which continued in the next second quarter

Speaker Change #115: I do hope that it will be faster than the previous processes that other companies as, well as us experienced since COVID, but I think that the fact that the system itself is already cleared, and it will enhance the process.

Speaker Change #115: We are talking about, first of all, even for us it's the cost of manufacturing, the return on investment, the features and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features to be installed remotely.

Speaker Change #115: But I cannot even guesstimate the time.

Speaker Change #115: We are, of course, going to submit it to the FDA.

Speaker Change #115: And after the FDA clearance, it will be marketed as a long, along the current system, which will expand our product offering.

Speaker Change #115: And we mentioned a few times in the past that the ARC, or the first version 2.2, is not the first product and definitely not the last.

Speaker Change #115: our team is diligently working with imaging centers physiciian and regulators to increase footprint of our annanoics art technology

Speaker Change #115: Okay.

Speaker Change #115: So we don't have to send the technicians to do it.

Speaker Change #115: Well, that's helpful.

Speaker Change #115: It's download from the network.

Speaker Change #115: And we have in line a real product roadmap for the future.

Speaker Change #115: as of today's call there are now dozen of units in various stages of shipment and deployment

Speaker Change #115: I appreciate that.

Speaker Change #115: Thank you, Jeff.

Speaker Change #115: the deployments in the us are spread across seven states the newest being delaware in california which are awaiting state approvals and we expect to grow this number is our commercial team executes our deployment and growth plan

Speaker Change #115: I would say the following.

Speaker Change #115: Thank you.

Speaker Change #115: I'm not happy to guesstimate because the last thing I want is that I will give an estimate, and then it will, for some reason, be longer.

Speaker Change #115: So, I will be happy to announce that it's cleared once it's cleared and everyone can, imagine that the period that it will take.

Speaker Change #115: Okay.

Speaker Change #115: Our next question comes from the line of Scott Henry with the AGP.

Erez Meltzer: To keep more color on our U.S. deployment, I would like to add that during the second quarter, we have installed Nano-X Arc system in three prominence healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry. Additionally, in the U.S., some of the deployed sites have received certification from the corresponding state's regulatory body and have begun to scan patients. Others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites has shown up to 14 scans per day. We recently received good indications for validation of the U.S.

Speaker Change #115: ARC-X is one of them.

Speaker Change #115: I appreciate that feedback.

Speaker Change #115: Your line is now open.

Speaker Change #115: to keep more color on our u s deployment i would like to add that during the second quarter we have installed nos are system in three prominence health care chains operating imaging facilities across the u s including one of the largest and the industry

Speaker Change #115: Second question.

Speaker Change #115: Thank you, and good morning or afternoon, depending where you are.

Speaker Change #115: We will give more indications, but I think that the idea is to make the ARC-X available to more specific locations or sites, that are more suitable for the spec of this system. We are talking about footprint.

Speaker Change #115: Just a couple questions, congratulations on getting the 510K application in for the, general use in chest indication.

Speaker Change #115: We are talking about, first of all, even for us, it's the cost of manufacturing, the return on investment, the features, and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features to be installed remotely.

Speaker Change #115: You mentioned the installed Nanox Arc systems in the three-chain medical imaging, service providers in the US.

Speaker Change #115: Could you give any thoughts on what you would expect the review timeline to be for that, indication?

Speaker Change #115: So we don't have to send technicians to do it.

Speaker Change #115: It's downloaded from the network.

Speaker Change #115: Have you gotten any feedback from those three chains and how that's working out and perhaps what kind of expansion opportunities there would be?

Speaker Change #115: What is it typically in this case, just to get a sense of when we may get final approval?

Speaker Change #115: Got it.

Speaker Change #116: additionally in the u s some of the deployed sites have received certification f ther from the corresponding states regulatory body and has begun to sskin patients others are in the process of paining approof

Speaker Change #116: Okay, super.

Speaker Change #116: First of all, I hope that I understand the question, so I'll give the answer and if not, you tell me.

Speaker Change #116: Erez, thanks for taking our questions.

Speaker Change #116: Thank you, Jeff.

Speaker Change #116: Thank you.

Speaker Change #116: Our next question comes from the line of Scott Henry with the AGP.

Speaker Change #117: this commercial scanning activity is accelerating for example as of today one of those sides have shown up to fourteen ssccanams per dayate

Speaker Change #117: Your line is now open.

Speaker Change #117: we recently received good indications

Erez Meltzer: CPT and reimbursement process as we received management care EOB. Since March 2024, we have been ramping up in the U.S. with current targeted backlog of 50 federal prop prospects and additional 44 leads in the pipeline. With a main segment being outpatient imaging centers, medical imaging chains, and orthopedic centers, we understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period, and we are very confident that this will continue to grow over time. We are also awaiting the import license to deploy the first Nano-X Arc in Mexico, with assistance ready for shipment.

Speaker Change #117: for a validation of the u s cpt and reimbursement process as we received management care e

Speaker Change #117: Thank you, and good morning or afternoon, depending where you are.

Speaker Change #117: It may be too early, but I just wanted to get a sense of how that was going so far.

Speaker Change #117: Bear in mind that up until now, all the revenues and the scans that were conducted in the U.S, in the few dozens of systems which are installed are mainly MSK, MSK spine, hand, leg, et cetera, and not chest.

Speaker Change #117: So, especially for those of the people who are actually on the call that are here, in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot or what we call the soft launch of the arc in the US, we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers.

Speaker Change #117: We all know that the chest is the most common use of x-ray, and especially when we talk, about the tomosynthesis.

Speaker Change #117: since march two thousand and twenty-four we have been renamping up in the u s with current targeted backlogof fifty faorbroone prorop prospects and additional forty-four leads in the pipeline

Erez Meltzer: . [inaudible] . . Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAP financial measures to provide additional information to investors. A reconciliation of the non-GAP to GAP measures is provided with our press release with the primary differences being non-GAP net loss attributable to ordinary shares, non-GAP cost of revenue, non-GAP gross profit, non-GAP gross profit margin, non-GAP research and development expenses, non-GAP sales and marketing expenses, non-GAP general and administrative expenses, non-GAP other expenses or income in non-GAP gross loss per share.

Speaker Change #117: So we expect that once we get the clearance, it will definitely increase the likelihood, of sites and customers to take the ARC, and more than that, that in the sites that the system is going to be installed, it will increase the number of scans per day because it will be used for other indications as stated.

Speaker Change #117: with the main segments being outpatient imaging centers medical imaging changeins and orthothetic centers

Speaker Change #117: Just a couple questions.

Speaker Change #117: we understand that not all of these ninetyfour leads will convert but i'm very pleased with our commercial team progress in such the short period and we are very confident that this will continue to grow over time

Speaker Change #117: Congratulations on getting the 510K application in for the general use in chest indication.

Speaker Change #117: Could you give any thoughts on what you would expect the review timeline to be for that indication?

Speaker Change #117: What is it typically in this case, just to get a sense of when we may get final approval?

Speaker Change #117: we are also waiting the inimport license to deploy the first nox ar in mexico with the systems ready for shipments

Speaker Change #117: First of all, I hope that I understand the question, so I'll give the answer, and if not, you tell me.

Speaker Change #117: Bear in mind that up until now, all the revenues and the scans that were conducted in the U.S. in the few dozens of systems which are installed are mainly MSK, MSK, spine, hand, leg, et cetera, and not chest.

Erez Meltzer: Additionally, there are two units fully deployed in Israel, and another deployment is expected in the upcoming months for both clinical and commercial use. We are able to pursue this opportunity as we obtained a MAR approval several months ago. Importantly, the number of daily scans is accelerating, and in that July, we experience an average of 6.67 scans globally for all deployed Nano-X Arc systems accomplishing both clinical work and commercial patient scans. I think it is interesting to learn that the global commercial and clinical scans by body parts are distributed as follows. 31% chest, 25% hand, 14% leg, and 14% spine.

Speaker Change #117: We all know that the chest is the most common use of x-ray, and especially when we talk about the tomosynthesis.

Speaker Change #117: additionally there are two units willll deployed in israel and another deployment is expected in the upcoming months for both clinical and commercial use

Erez Meltzer: With that, I'd now like to turn the call over to Erez Meltzer. Thank you for joining us today and as always, we appreciate your continued support of Nano-X Imaging. 2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts as we continue to expand our deployment in the U.S, and the rest of the world. We are not only accelerating deployment of the Nano-X RX system, but also expanding the footprint of the other value-edded elements of the full Nano-X solution including Nano-X AI. As mentioned in previous calls, I am committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

Erez Meltzer: Varics has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our No-Nano-X Arc.

Speaker Change #117: So we expect that once we get the clearance, it will definitely increase the likelihood of sites and customers to take the ARC.

Speaker Change #117: And more than more than that, that the in the sites that the system is going to be is going to be installed.

Speaker Change #117: we are able to pursue this opportunity as we obtained a more approval several months ago

Speaker Change #117: It will increase the number of scans per day because it will be used for other indications as stated.

Speaker Change #117: importantly the number of daily sccans is accelerating and in that july we experienced an average of six point sixty seven scans globally for all deployed nicsx are existing

Speaker Change #117: Is this what you ask, or?

Speaker Change #117: accompassing both clinical work and commercial patients scance

Speaker Change #117: Feedback on a clinical basis, on the maintenance, on the usage, on the pattern of the body parts and the anatomy that is being used, the clinical use.

Speaker Change #118: i think it is interesting to learn that the global commercial and clinical scanneds by body part are distributed as follows

Speaker Change #118: thirty one percent chest twenty five percent and fourteen percent leg and fourteen percent spine but of course these indications men vary from over time

Erez Meltzer: But of course, these indications men vary from over time.

Erez Meltzer: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology. To support our accelerating deployment effort, we continue to strengthen our team and infrastructure during the quarter, adding to our US sales and technical teams. Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country. Our mission is to provide healthcare practices with a transformative imaging advantage, with a Nano-X Arc, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic workflow.

Erez Meltzer: I will begin with a discussion of our recent achievements which will cover regulatory updates, clinical advancements, commercial deployments, Nano-X AI updates and any production to our new Nano-X RX system which will call Nano-X RX. After my prepared comments, I'll turn the call over to our CSO Ren who will review our Q2 financial results. I will then share a few closing thoughts before turning the call over to the Q&A session. We have a lot to discuss, so let's get started.

Speaker Change #118: for those of you that are interested we also have some new clinical samples on our website including chest pathology

Speaker Change #117: So far, and this is something that encouraged us to accelerate the installation and the deployment, we received very good feedback.

Speaker Change #118: to support our accelerating deployment effort we continued to strengthen our team and infrastructure during the quarter adding to our u s sales and technical teams

Ran Daniel: I have covered a lot of ground today, so with that, I will hand the call over to Rand Daniel to review our financials.

Speaker Change #118: looking ahead noneops is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaboration in the country

Speaker Change #118: Well, that's very helpful.

Speaker Change #118: And I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.

Speaker Change #118: Is this what you asked or?

Speaker Change #118: our remission is to provide health care practices with a transformative imaging advantage

Ran Daniel: Rand?

Speaker Change #118: Thank you.

Speaker Change #118: So, overall, the feedback is very good.

Speaker Change #118: Well, that's very helpful.

Ran Daniel: Thank you, Aaron.

Erez Meltzer: Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share the just last week Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X RX system in general thermosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest.

Speaker Change #118: And I guess the question I additionally was hoping to get some sense on is, how long do you expect the review period to be for that 510K?

Speaker Change #118: with analoxs arc and accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care

Speaker Change #118: Thank you.

Speaker Change #118: I would say that probably in the next few months, we will, get even better visibility on the usage, on the process, on the installation, on the regulatory processes.

Speaker Change #118: And we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly.

Speaker Change #118: we are working to accelerate a steady flow of referrals from health care providers for unox our digital automography imaging as part of their diagnostic workflow

Speaker Change #118: Okay, great.

Erez Meltzer: We also continue to advance our other clinical efforts in multiple countries and locations. Generating data, demonstrating the utility of the Nano-X Arc for a fuller, wider range of indications is the key initiative for Nano-X. The reason is simple. If we can show large volumes of data demonstrating the evaluated utility of the Nano-X Arc, it will significantly boost our all-important commercial efforts. For example, the Bayley & Sanha Hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data. There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site study.

Speaker Change #118: Thank you for that feedback.

Speaker Change #118: we also convened to advance our other clinical efforts in multiple countries and locations

Speaker Change #118: Final question.

Speaker Change #118: generating data demonstrating the utility of an analpss arts for a fuller wider range of indications

Speaker Change #118: I wish I could tell you.

Speaker Change #118: is a key initiative for noneofx

Speaker Change #118: I do hope that it will be faster than the previous processes that other companies as well as us experienced since COVID.

Erez Meltzer: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X RX for chest indications and was intended to support the submission. The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies. To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and has the required capabilities to scan MSK, chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals.

Speaker Change #118: But I think that the fact that the system itself is already cleared and it will enhance the process, but I cannot even guesstimate the time.

Speaker Change #118: the reason is simple if we can show large volumes of data demonstrating theevaluated utility of the anomics are it will significantly boost our own important commercial efforts for example

Speaker Change #118: Well, that's helpful.

Speaker Change #118: I appreciate it.

Speaker Change #118: I would say the following, I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will, for some reason, be longer.

Speaker Change #118: So, I will be happy to announce that it's cleared once it's cleared.

Speaker Change #118: And everyone can imagine, that the period that it will take.

Speaker Change #118: Okay, I appreciate that feedback.

Speaker Change #118: Second question, you mentioned the installed Nano-X arc systems in the three chain medical imaging, Service Providers in the U.S., have you gotten any feedback from those three chains and how that's working out and perhaps what kind of expansion opportunities there would be?

Speaker Change #118: the babiling some of hospital in israel has been scanning patients for exactly this reason

Speaker Change #118: It may be too early, but I just wanted to get a sense of how that was going so far.

Speaker Change #118: So, especially for those of the people who are actually on the call here, in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S., we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers, feedback on a clinical basis, on the maintenance, on the usage, on the pattern of the body parts and the anatomies that is being used, the clinical uses.

Speaker Change #118: So far, and this is something that encouraged us to accelerate the installation and the deployment, we received very good feedback.

Speaker Change #118: And I think that, What we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system, and they decided to do it.

Speaker Change #118: and this trial has begun to generate data

Speaker Change #119: there has been a few dozens of patients recruited at our clinical sites as part of this and the mululttisite studies

Erez Meltzer: The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating site, while already gaining clinical experience with the Nano-X Arc installed in scanning patients. The MSKL trial held that Shamir Hospital has been completed and accompanied white paper publishers recently. The study concluded that the Nano-X ARC was a value-edited tool in the hospital's clinical workflow, enabling quicker diagnosis when used as a supplemented tool to the standard X-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow.

Speaker Change #119: the previously announced mululttiside trial is now operational and we are accelerating patient

Speaker Change #119: scanning activity

Speaker Change #120: the ugmc is in the final preparation to join the multtiisside trial as the second participating sititees while already gaining clinical experience with an outo ar installed in scananning patients

Speaker Change #121: the emmisscale trial held that chemirre hospital has been completed an an company white paper publishers recently

Speaker Change #121: the study concluded the dynamics aricc was evaluated tool in the hospital's clinical workflow

Speaker Change #121: enabling quicker diagnosis when used as a supplemented tool to the standard xray system achieving fanter diagnosis time and compared to the standard cp base workflow

Erez Meltzer: Furthermore, all Nano-X ARC images were determined to be of high-diagnostic quality, enabling optimal depiction of findings. Our technology can increase the depiction of occult chest lesions, localized characterize and result questionable lesions even without prior radiologist experience. Cold cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose, cost, and images per study should be further investigated.

Ran Daniel: We reported a gap net loss for the second quarter of 2024 of $13.6 million, which we will refer to as the reported period compared with the net loss of $17.44 million in the second quarter of 2023, which I will refer to as the compare bill period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

Erez Meltzer: Turning now to our global deployment and commercial efforts, which continued in the next second quarter, our team is diligently working with imaging centers, physicians and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployment. The deployments in the U.S, are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan.

Speaker Change #121: furthermore all nanos are images were determined to be of high diagnostic quality enabling optimal depiction of findings

Speaker Change #122: our technology can increase depiction of a cultchest lesions localized characterize and resolltve questionable lesions even without prior ologist experience

Ran Daniel: Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

Speaker Change #122: called cather ps may have an improved diagnostic accuracy compared to cxr

Speaker Change #122: its capability to eliminate the need for ct at a fraction of the radiation dose

Speaker Change #122: cost and images per study should be further investigated for more information see more our right paper section on our website

Erez Meltzer: For more information, see more our white paper section on our website.

Erez Meltzer: To keep more color on our U.S, deployment, I would like to add that during the second quarter, we have installed Nano-X Arc system in three prominence healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry. Additionally, in the U.S., some of the deployed sites have received certification from the corresponding states regulatory body and have begun to scan patients. Others are in the process of obtaining approval.

Speaker Change #118: When we are thinking about Q3, relative to Q2, should we expect any seasonality in the U.S.?

Erez Meltzer: Turning to our AI business. Just last month we announced that our Nano-X AI Cardiac solution called Health CCNG was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI Cardiac solution at esteemed healthcare system, along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases. Chloro-Well Health has previously reported that in the first full year of implemented Health CCNG in its electronic medical record system, there was a 13-fold increase of the patients reported in the previous two years.

Speaker Change #122: So overall, the feedback is very good.

Speaker Change #122: I would say, that probably in the next few months, we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes.

Speaker Change #122: And we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly.

Speaker Change #122: turning to our ai business

Speaker Change #122: Okay, great.

Speaker Change #122: jet last month

Speaker Change #122: Thank you for that feedback.

Speaker Change #122: Is it the summer months?

Speaker Change #122: we announced that our nanoxai cardiio solution called health cng was highlighted in multiple scientific presentation at the twou as the two thousand and twenty four society of cardiovascular computed toammography s c annual meeting

Speaker Change #122: Final question.

Speaker Change #122: When we're thinking about Q3 relative to Q2, should we expect any seasonality in the U.S.?

Speaker Change #122: The summer months, do they tend to be a little slower with a pickup in the fourth quarter?

Speaker Change #122: we are encouraged by the implementation of our ai cardiio solution at the steamed health care system along with a continued validation

Erez Meltzer: This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day. We recently received good indications for validation of the U.S. CPT and reimbursement process as we received management care EOB. Since March 2024, we have been ramping up in the U.S, with current targeted backlog of 50 federal prop prospects and additional 44 leads in the pipeline. With a main segment being outpatient imaging centers, medical imaging chains, and orthopedic centers, we understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period, and we are very confident that this will continue to grow over time.

Speaker Change #122: through realword study of its potential to promote

Speaker Change #122: early detection and preventive care of cardiovascular diseases

Speaker Change #122: Just trying to get a sense of what kind of cadence we should expect through the year.

Speaker Change #122: Boop, Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base so we will probably see anyhow a better result but right now right now we are not planning or or expecting to have any season season out season at least, Great.

Speaker Change #122: were well health as previously reported that in the first full year of implemented health fandg

Speaker Change #122: in its electronic medical record system there was a phine fold increase over the patients reported in the previous two years

Erez Meltzer: At Bellinson Hospital in Israel, incidental coronary artery calcification on the CT scans of immune mediated inflammatory disease patients identified and quantified by our AI Cardiac solution was found in over 50 percent of scan patients and associated with all caused mortality and adverse cardiovascular outcome. Traditional cardiovascular risk scoring is difficult in these patients, and Nano-X AI can be a valuable new tool in quantifying these risks. After being installed and implemented, the Jefferson-Einstein Hospital Health CCNG help identify 757 patients, age 30 or above, with CAC levels higher than 100 Agstone units. In a study conducted by Mass Gen Hospital and Brigham Women Hospital, Health CCNG was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein A. It is part of clinical care; a statistically significant correlation was founded between the level of CAC and this lipoprotein A, which is a risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients.

Speaker Change #123: and then some hospital israel in cidental

Speaker Change #124: coronary artery clical culification

Speaker Change #125: on the cp scans of imunemediated inflammatory disease patients

Speaker Change #125: identify and quantify by ai cio of solution

Speaker Change #125: was found in over fifty five zeuro percent of scantpatients and associated with all cause mortality and adverse carardivascularars outcome

Erez Meltzer: We are also awaiting the import license to deploy the first Nano-X Arc in Mexico with assistance ready for shipment. Additionally, there are two units fully deployed in Israel and another deployment is expected in the upcoming months for both clinical and commercial use. We are able to pursue this opportunity as we obtained a mar approval several months ago. Importantly, the number of daily scans is accelerating and in that July, we experience an average of 6.67 scans globally for all deployed Nano-X Arc systems accomplishing both clinical work and commercial patient scans.

Speaker Change #125: traditional carter alasccalar risks scoring is difficult in these patients and i ' sayi can be a valuable new tool in quantifying these risks

Speaker Change #125: after a being installed and implemented the jefferson ims in a hospital health cng help identify seven hundred and fifty- seven patients age thirty or above

Speaker Change #125: with c a c levels higher than one hundred abstone units

Speaker Change #125: in a study conducted by massgen hospital and brriham women hospital health cng was used to analyze

Speaker Change #125: noncontrast ch cityty scans of two hundred and sixty patients

Erez Meltzer: I think it is interesting to learn that the global commercial and clinical scans by body parts are distributed as follows. 31% chest, 25% hand, 14% leg, and 14% spine. But of course, these indications men vary from over time. For those of you that are interested, we also have some new clinical samples on our website, including chest pathology. To support our accelerating deployment effort, we continue to strengthen our team and infrastructure during the quarter, adding to our US sales and technical teams.

Speaker Change #125: who had measurements

Speaker Change #125: of leapon proteine a as part of a clinical cure

Speaker Change #125: statistically significant correlation was fed between level of crc and this leppoworana

Speaker Change #125: a risk factor for coronerary atscholora chores suggesting that this approach may be used to identify attr patients

Erez Meltzer: As a sign-dote, the lead author of this study, Gritting Weber, was declared as young investigator, a word winner at the Sprout to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcome. Additionally, the previous agreements we signed for Nano-X AI with Coveira Health and W Leon Health are off to a great start, and the feedback has been very positive thus far. We are continually working to expand our AI footprint and make it accessible to a broader range of customers.

Wether: as a signoutte the lead author of this study briefing wether was declared as young investigator a winner at the annual meeting as well

Erez Meltzer: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country. Our mission is to provide healthcare practices with a transformative imaging advantage, with a Nano-X Arc an accessible cost effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic workflow.

Speaker Change #128: not x is proud to be asseulated with dynamic clinical talent that is doing valuable work

Speaker Change #129: to support the use of the nnamics ai solutions to identify potential health risks earlier in the care contining and helping to drive better overall patient out

Speaker Change #130: additionally the previous agreements we signed for nanx sei with cover health and won health are off to a great start and the feedback has been very positive thus far

Speaker Change #130: we are continually working to expand our ai footprint and make it accessible to a broader range of customers

Erez Meltzer: Our ongoing innovation and development efforts are focused on enhancing our AI solution and ensuring they reach and benefit a wider audience. I think I can speak of all of us at Nano-X when I say there is a lot to be excited about. Looking ahead to the near future of Nano-X, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to extend rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback, changes in technology, and evolving use case. Nano-X is no different, and we are constantly working on product and technology future developments.

Speaker Change #130: our ongoing innovation and develop an efforts are focused on enhancing our ai solution in ensuring they reach and benefit and wider audience

Erez Meltzer: We also continue to advance our other clinical efforts in multiple countries and locations. Generating data, demonstrating the utility of the Nano-X Arc for a fuller wider range of indications is the key initiative for Nano-X. The reason is simple. If we can show large volumes of data demonstrating the evaluated utility of the Nano-X Arc, it will significantly boost our all-important commercial efforts. For example, the Bayley & Sanha Hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data.

Speaker Change #130: i think i can speak of all of us at nanos when i say there is a lot to be excited about

Speaker Change #131: looking ahead for the near future of nu-os

Speaker Change #132: we're always slookingking to improve and mid market needets

Speaker Change #132: in fact every dynamic company that plans to exptand rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback changes in technology and evolving use case

Speaker Change #122: And I guess the question I additionally was hoping to get some sense on, how long do you, expect the review period to be for that 510K?

Erez Meltzer: There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site study. The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating sites, while already gaining clinical experience with the Nano-X Arc installed in scanning patients. The MSKL trial held that Shamir Hospital has been completed and accompanied white paper publishers recently.

Speaker Change #132: nanox is no different and we are constantly working on product and technology future developments

Erez Meltzer: I am very pleased to share for the first time that we are developing another Nano-X, our system called Nano-X ArcX, which we intend to submit, among others, for FDA clearance. Once cleared, it will be marketed along the current system, which will expand our current product offering. At the high level, the Nano-X ArcX is designed to meet market needs for our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases. Listening to the clinical needs is an important step in the ongoing expansion of Nano-X solution.

Speaker Change #132: Thank you for taking the question.

Speaker Change #132: Thank you.

Speaker Change #132: i'm very pleased to share for the first time that we are developing another nanos are existent called nanox ararchxs

Speaker Change #132: Thank you.

Speaker Change #132: As a reminder, to ask a question at this time, please press star 1-1 on your touchtone telephone.

Speaker Change #132: which is we intend to submit among gaothers for fba cleareance

Speaker Change #132: once cleared it will be marketed along the current system which will exexpend our recurrent product offering

Speaker Change #132: Our next question comes from the line of Ross Osborn with Cantor Fitzgerald.

Speaker Change #132: at the high level theanics architects is designed to meet market mes of our customers including hospitals and imaging centers as well as our clinical partners where are using the nics are to generate data for additional use cases

Speaker Change #132: Your line is now open.

Speaker Change #132: Hey guys, thanks for taking our questions.

Speaker Change #132: So starting off, seems like you are at the point of inflection in terms of deployments.

Erez Meltzer: The study concluded that the Nano-X ARC was a value-edited tool in the Hospital's clinical workflow, enabling quicker diagnosis when used as a supplemented tool to the standard X-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow. Furthermore, all Nano-X ARC images were determined to be of high-diagnostic quality enabling optimal depiction of findings. Our technology can increase the depiction of occult chest lesions, localized characterize and result questionable lesions even without prior adiologist experience. Cold cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose cost and images per study should be further investigated.

Speaker Change #132: listening to the clinical needs is an important step in the ongoing extension of none of solution

Erez Meltzer: Amongst the future, I am able to share this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X ArcX. and Hansink, one of our key differentiators. The new system will also be easy to deploy in use with an anticipated one-day setup time and plug-and-play functionality. There will also be image enhancement options in the new units, which are currently not available on existing Nano-X art systems and future synthetic to be.

Speaker Change #132: With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand?

Speaker Change #132: So, you're right about what you said.

Speaker Change #132: among the feature i am able to share at this time the nanics archkects will have an even smaller footprint than existing nonos art systems

Speaker Change #132: In terms of manufacturing, I would say the following.

Speaker Change #132: The chips, we have no problem. We have available chips right now.

Speaker Change #132: and hence syink one of our key differentiators

Speaker Change #132: the new system will also be easy to deploying use

Speaker Change #132: with an anticipated one day set up time and plug in play functionality

Speaker Change #132: there will also be image enhancement options in the new units which are currently not available on existing nanoxs our system and future synthetic to

Erez Meltzer: Please note that we are planning to share more detail about the future Nano-X art system publicly during our next event, which will also be made available via our website. Stay tuned for further details.

Speaker Change #132: please note that we are planning to share more detail about the future noneox art system publicly d regour next event which will also be made available v ra websitite they tuned for further detail

Erez Meltzer: To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the U.S. government entity towards completion of a no-voltube design, utilizing our emitter and focused on the entity space. We are optimistic. We will move towards prototyping tubes the second half of this year.

Speaker Change #132: to chck to touch on our oem efforts i can report that we are well underway

Erez Meltzer: For more information see more our white paper section on our website.

Speaker Change #132: with the first phase of our development program with the s government entity towards completion of a noltube design utilizing our emitter and focused on the entity space

Erez Meltzer: Turning to our AI business. Just last month we announced that our Nano-X AI Cardiac solution called Health CCNG was highlighted in multiple scientific presentation at the 2024 Society of Cardiovascular Computed Tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI Cardiac solution at esteemed healthcare system along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases. Chloro-Well Health has previously reported that in the first full year of implemented Health CCNG in its electronic medical record system there was a 13 fold increase of the patients reported in the previous two years.

Speaker Change #132: we are optimistics we will move towards prototyping tubes the second half of this year

Erez Meltzer: Regarding our telerogology services, we are leveraging our U.S.A. Radcline based on a network of rogology as a significant part of our U.S. deployment plan. On the mass production front, we have finalized the second phase of our development with CSAM, resulting in a high yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our novel emitters. Varics has completed their initial tubes prototype utilizing our emitter for testing to be integrated into our new Nano-X art.

Speaker Change #132: regarding our teorology services we are leveraging our usa rad cli based on a network of ologies as a significant part of our u s deployment pl

Speaker Change #132: We were able, due to the results of the high-yield wafers that we get from CSAM, we have two suppliers.

Speaker Change #132: on the mass production front we finalizized the second phase of foreignand the development with cason resulting in a high yield wafers when functional emtors

Speaker Change #132: we are transitioning to production readiness and confident we have secured a second source of supply for our novel emittors

Speaker Change #133: varrex has completed their initial tubes pro by utilizing our emitter for testing to be integrated into our renew nnamics s

Ran Daniel: I have covered a lot of ground today, so with that, I will hand the call over to Rand Daniel to review our financials. Run? Thank you, Ares. We reported a gap net loss for the second quarter of 2024 of $13.6 million, which will refer to as the reported period, compared with the net loss of $17.44 million in the second quarter of 2023, which I will refer to as the compare bill period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and an increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

Speaker Change #133: And I think that this is not an issue.

Speaker Change #133: Do they tend to be a little slower with a pickup in the fourth quarter?

Speaker Change #133: I wish I could tell you.

Speaker Change #133: In terms of the tubes, we have already the tubes that are coming from Korea.

Speaker Change #133: We have the tubes that are coming from the plant in Europe. And last but not least, Varex has completed their initial tube prototype utilizing our emitter, and this is for testing.

Speaker Change #133: So, I hope that it will be integrated into our new Nano-X system shortly, and it will be part of the available production.

rentdiel: i've covered a lot of ground today so with that i'll hand the co over to rentdiel to review our financials

rentdiel: In terms of the production of the assembly of the system, we have made the preparations in the site in Israel that we're moving forward, and we've increased the capacity of the manufacturing to enable what is needed in the next few quarters. And the low-cost manufacturing arrangement that we have will enable us to ramp up next year even higher than what we are currently doing.

rentdiel: Just trying to get a sense of what kind of cadence we should expect through the year.

rentdiel: I do hope that it will be faster than the previous processes that other companies as, well as us experienced since COVID, but I think that the fact that the system itself is already cleared, and it will enhance the process.

rentdiel: So, right now, I would say that it seems to be in line with what is needed for the next few quarters.

rentdiel: Frankly speaking, right now, we don't expect any seasonality, especially due to the fact that we, are ramping up our installed base.

rentdiel: Thank you, are working on the next ramp up for 2025, to be announced later.

rentdiel: run

rentdiel: Perfect.

rentdiel: Thank you.

rentdiel: thank you erris

rentdiel: And then following up on my previous question, would you remind us how large your US sales force is today?

rentdiel: And then any plans for adding to the, Um, so, um...

rentdiel: Right now, right now, we actually work with, with, I would say, it's about 10 people altogether, and if I add the independent agents, then I think that we are right now at around 15.

rentdiel: we reported the gover net loss for the second quarter of two thousand and twenty four of thirteen point six million dollars which will refer to as the reported period

rentdiel: We are expecting to grow them to the number of 30 in the foreseeable future.

rentdiel: Great.

Speaker Change #135: compared with the nettals of ' seventeen per four four million dollars in the second quarter of two thousand and twenty-three

Speaker Change #135: And then last one for us.

Speaker Change #135: What I said is that that's what to anticipate for 2025 to be around 30 to 40.

Speaker Change #135: Got it, got it.

Speaker Change #135: Thank you.

Speaker Change #135: And then lastly, just in anticipation of CE mark approval, would you walk us through your commercialization plan in Europe and other related geographies, in terms of what type of medical centers you will be targeting, if you'll build out your own sales force or leverage a distributor there.

Speaker Change #135: We reported a gap net loss for the second quarter of 2024 of $13.6 million, which I will refer to as the reported period, compared with a net loss of $17.4 million in the second quarter of 2023, which I'll refer to as the comparable period. The decrease was largely

Speaker Change #135: And lastly, what the reimbursement environment looks like.

Speaker Change #135: Okay, so with respect to the rest of the world... First of all, there are a few countries that you should remember we have agreements that were signed in the past, and we are going to deploy them once the clearance in these countries are, are expected to be received.

Speaker Change #135: So.

Speaker Change #135: I mentioned today, one of them, Mexico, is really coming very shortly.

Speaker Change #135: I will be there next month, to visit the places that they are planning to install the ARC, so this is one.

Speaker Change #135: We were talking about another one or two countries in Latin America.

Speaker Change #135: In terms of Europe, we are waiting for the CE approval, as indicated previously, and we are in the, really in the final process of the CE approval.

Speaker Change #135: Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them.

Speaker Change #135: In each one of them, it's going to be the distributors that are going to do the work.

Speaker Change #135: If you remember, I mentioned about a year ago that right now only in the U.S., Israel and the U.K. we are planning to have our own people, and in the rest of the world we are planning to have distributors.

Speaker Change #135: We are right now already in the next in the last quarter in this quarter in touch with these distributors in order to ensure that we have a plan.

Speaker Change #135: Our people visited already a few locations in each one or not in each but in most of these countries.

Speaker Change #135: Right now, we are talking in Europe and in Mexico, we are talking about medium to large medical centers.

Speaker Change #135: Got it.

Speaker Change #135: Thanks for taking our questions and congrats again on the quarter.

Speaker Change #135: Great.

Speaker Change #135: Thank you.

Speaker Change #135: And I'm currently showing no further questions at this time.

Speaker Change #135: This does conclude today's conference call.

Speaker Change #135: Thank you all for participating and you may now disconnect.

Speaker Change #135: Good day, and thank you for standing by.

Speaker Change #135: Welcome to the Nano-X Second Quarter 2024 Earnings Conference Call.

Speaker Change #135: At this time, all participants are on a listen-only mode.

Speaker Change #135: After the speaker's presentation, there will be a question and answer session.

Ran Daniel: Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a GAAP basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a GAAP basis for the comparable period. Nan gap gross loss for the reported period was $0.9 million as compared to a nan gap gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a nan gap basis for the reported period. As compared to a gross profit margin of 34% on a nan gap basis in the comparable period.

Speaker Change #135: To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

Speaker Change #135: To withdraw your question, please press star 1 1 again, please be advised that today's conference is being recorded.

Speaker Change #135: I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Investor Relations.

Speaker Change #135: Please go ahead.

Speaker Change #135: Good morning, and thank you for joining us today.

Speaker Change #135: Earlier today, Nano-X Imaging Ltd. released financial results for the quarter ended June 30, 2024. The release is currently available on the investor section of the company's website.

Speaker Change #135: With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ran Daniel, Chief Financial Officer.

Speaker Change #135: Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, and other matters. These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date.

Speaker Change #135: Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission.

Speaker Change #135: We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP-to-GAAP measures is provided with our press release, with the primary differences being non-GAAP net loss attributable to ordinary shares.

Speaker Change #135: Non-Gap Cost of Revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other expenses or income, and non-GAAP gross loss per share.

Speaker Change #135: With that, I'd now like to turn the call over to Erez Meltzer.

Erez Meltzer: In a study conducted by Mass Gen Hospital and Brigham Women Hospital, Health CCNG was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein A is part of clinical care, statistically significant correlation was founded between level of CAC, and this lipoprotein A is a risk factor for coronary atro sclerosis suggesting that this approach may be used to identify at risk patients. As a sign-dote, the lead author of this study, Gritting Weber, was declared as young investigator, a word winner at the Sprout to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcome.

Speaker Change #135: Thank you for joining us today, and as always, we appreciate your continued support of Nano-X and our mission.

Speaker Change #135: 2024 has been a period of strong commercial progress, while also advancing the value of our products through our clinical efforts, as we continue to expand our deployment in the U.S. and the rest of the world.

Speaker Change #135: We're not only accelerating deployment of the Nano-X Arc system, but also expanding the footprint of the other value-added elements of the full Nano-X solution, including Nano-X AI.

Speaker Change #135: As mentioned in previous calls, I'm committed to providing further insights and detailed updates on our ongoing advancement in the coming period.

Speaker Change #135: I will begin with a discussion of our recent achievements, which will cover regulatory updates, clinical advances, commercial deployments, Nano-X AI updates, and an introduction to our new Nano-X Arc system, which we'll call Nano-X ArcX.

Speaker Change #135: After my prepared comments, I'll turn the call over to our CFO, Ran, who will review our Q2 financial results.

Speaker Change #135: I will then share a few closing thoughts before turning the call over to the Q&A session.

Speaker Change #135: We have a lot to discuss, so let's get started, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share that just last week, Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X Arc system in general tomosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest.

Speaker Change #135: As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X Arc for chest indication, and was intended to support the submission. The submission will include some software updates, and is accompanied by new clinical data for various study anatomies, with and without pathology.

Speaker Change #135: To be clear, It is worth noting that all CARD-installed Nanox Arc systems are hardware-ready and have the required capabilities to scan MSK, chest, and abdomen, subject to the FDA clearance and the requisite regulatory approval. This means that post-SDA clearance is a simple software upgrade that can be done remotely, is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standard.

Speaker Change #135: Additionally, after completing the technical stages, including obtaining.., the ISO 13485, certifications from BSI, and successfully passing the MDR audit. We are now in advanced stages with our notified body to secure the CE mark for the E origin. Rest assured, we will provide updates as soon as they are available.

Speaker Change #135: Turning now to our global deployment and commercial efforts, which continued in the next second quarter. Our team is diligently working with imaging centers, physicians, and regulators to increase footprint of our Nano-X R technology. As of today's call, there are now dozens of units, in various stages of shipment and deployment.

Speaker Change #135: The deployments in the U.S. are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To keep more color on our U.S. deployment, I would like to add that during the second quarter, we have installed Nano-X Arc system in three prominent healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry.

Speaker Change #135: Additionally in the U.S.

Speaker Change #135: Some of the deployed sites have received certification from the corresponding state's regulatory body and have begun to scan patients, others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

Speaker Change #135: We recently received good indication, for validation of the U.S. CPT and reimbursement process as we received management care EOB.

Speaker Change #135: Since March 2024, we have been ramping up in the U.S. with current targeted backlogs, of 50 fair role prospects and additional 44 leads in the pipeline, with the main segment being outpatient imaging centers.

Speaker Change #135: Medical Imaging Chains, and Orthopedic Centers.

Speaker Change #135: We understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress, such a short period, and we are very confident that this will continue to grow over time.

Speaker Change #135: We're also awaiting the import license to deploy the first Nano-X ARC in Mexico with the systems ready for shipment.

Speaker Change #135: Additionally, there are two units fully deployed in Israel, and another deployment is expected in the upcoming months for both clinical and commercial, were able to pursue this opportunity as we obtained a MAR approval several months.

Speaker Change #135: Importantly, the number of daily scans is accelerating, and in last July, we experienced an average of 6.67 scans globally for all deployed Nano-X Rx systems, encompassing both clinical, work, and commercial patient scans.

Speaker Change #135: I think it is interesting to learn that the global commercial and clinical scans by BodyPart are distributed as follows.

Speaker Change #135: 31% chess.

Speaker Change #135: 25% 10.

Speaker Change #135: 14% lag.

Speaker Change #135: 14% spine.

Speaker Change #135: But of course, these indications may vary from over time.

Speaker Change #135: For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

Speaker Change #135: To support our accelerating deployments effort, we continue to strengthen our team and infrastructure during the quarter, adding to our US sales and technical team.

Speaker Change #135: Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country.

Ran Daniel: Revenue from the tele-radiology services for both the reported period and comparable period was $2.5 million, with a gross profit of $0.4 million on a GAAP basis in the reported and comparable period, which represent a gross profit margin of approximately 15% on a GAAP basis for the reported and comparable period. Nungap gross profit of the company's tele-radiology services for the reported and comparable period was $0.9 million, which represents a gross profit margin of approximately 36% on a nungap basis. During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1,130,000 as compared to revenue of $53,000 in the comparable period.

Speaker Change #135: Our mission is to provide healthcare practices with a transformative imaging advantage, with Nano-X Arc, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Speaker Change #135: We are working to accelerate a steady flow of referrals from health care providers for Nano-XArc digital tomography imaging as part of their diagnostic work.

Speaker Change #135: We also continue to advance our other clinical efforts, in multiple countries and locations, generating data demonstrating the utility of the Nano-X arcs for a fuller, wider range of indications, is a key initiative for Nano.

Speaker Change #135: The reason is simple. If we can show large volumes of data demonstrating the value-added utility of the Nano-X Arc, it will significantly boost our all-important commercial efforts.

Speaker Change #135: For example.

Speaker Change #135: The Beilinson Hospital in Israel has been scanning patients for exactly this reason. And this trial has begun to generate data. There have been a few dozens of patients recruited at our clinical sites as part of this and the multi-site study. The previously announced multi-site trial is now operational and we are accelerating patient, Scanning Activity.

Speaker Change #135: The UGMC is in the final preparation to join the multi-site trial as the second participating site, while already gaining clinical experience with a NanoX arc installed in scanning patients.

Speaker Change #135: The MS-SCALE trial held at Shamir Hospital has been completed and accompanying white paper published recently. The study concluded that the Nano-X arc was a value-added tool in the hospital's clinical work. Enabling quicker diagnosis when used, is a supplemental tool to the standard x-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow. Furthermore, all Nano-X Arc images were determined to be of high diagnostic quality, enabling optimal depiction of findings.

Speaker Change #135: Our technology can increase depiction of occult chest lesions, localize, characterize, and resolve questionable lesions even without prior audiologist experience, cold cathode PTS may have an improved diagnostic accuracy compared to CXR, its capability to eliminate the need for CP at a fraction of the radiation dose.

Speaker Change #135: Costs and images per study should be further investigated.

Speaker Change #135: For more information, see more, our white paper section on our website.

Speaker Change #135: Turning to our AI business, just last month, we announced that our Nano-X AI cardiac solution, called Health CCNG, was highlighted in multiple scientific presentations at the 2024 Society of Cardiovascular Computed Tomography, SCCT, annual meeting. We are encouraged by the implementation of our AI Cardiac Solution and esteemed health care system, along with the continued validation, through real-world studies of its potential to promote, Early Detection and Preventive Care of Cardiovascular Diseases.

Speaker Change #135: Corwell Health has previously reported, that in the first full year of implemented health CCNG.

Speaker Change #135: In its electronic medical record system, there was a 13-fold increase over the patients reported in the previous two years, at Berlingson Hospital in Israel, incidental.

Speaker Change #135: Coronary artery calcification on the CT scans of immune-mediated inflammatory disease patients, identified and quantified by our AI Cardio solution, was found in over 50, 50% of scan patients and associated with all-cause mortality and adverse cardiovascular outcomes.

Speaker Change #135: Traditional cardiovascular risk scoring is difficult in these patients, and Nano-X AI can be a valuable new tool in quantifying these risks.

Speaker Change #135: After being installed and implemented, the Jefferson-Einstein Hospital, Health CCNG helped identify 757 patients, age 30 or above, with CAC levels higher than 100, Agstone unit.

Speaker Change #135: In a study conducted by MassGen Hospital and Brigham and Women's Hospital, Health CCNG was used to analyze, non-contrast chest CT scans of 260 patients, who had measurement, of lipoprotein A as part of a clinical cure.

Speaker Change #135: A statistically significant correlation was founded between level of CAC and this lipoprotein A, a risk factor for coronary atherosclerosis, suggesting that this approach may be used to identify at-risk patients, is a signed out.

Speaker Change #135: The lead author of this study, Brittany Weber, was declared as Young Investigator Award winner at the annual meeting as well.

Speaker Change #135: Nano-X is proud to be associated with dynamic clinical talent that is doing valuable work, to support the use, of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcomes.

Speaker Change #135: Additionally, the previous agreements we signed for Nano-X AI with Covair Health and Dandelion Health are off to a great start, and the feedback has been very positive thus far.

Speaker Change #135: We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution, in ensuring they reach and benefit a wider audience.

Speaker Change #135: I think I can speak of all of us at Nano-X when I say there is a lot to be excited about.

Speaker Change #135: Looking ahead to the near future of Nano.

Speaker Change #135: We're always looking to improve and meet market needs. In fact, every dynamic company that plans to expand rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback.

Speaker Change #135: Changes in Technology and Evolving Use, Nano-X is no different, and we are constantly working on product and technology future development.

Speaker Change #135: I'm very pleased to share, for the first time, that we are developing another Nanox Arc system called Nanox ArcX, which we intend to submit, among others, for FDA clearance.

Speaker Change #135: Once cleared, it will be marketed along the current system, which will expand our current product offer.

Speaker Change #135: At the high level, the Nano-X ArcX is designed to meet market needs of our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Speaker Change #135: Listening to the clinical needs is an important step in the ongoing expansion of nanobsolution.

Speaker Change #135: Amongst the features I am able to share at this time, the Nanox ArcX will have an even smaller footprint than existing Nanox Arc systems, and Hensink, one of our key differentiators. The new system will also be easy to deploy and use, with an anticipated one-day setup time and plug-and-play functionality.

Speaker Change #135: There will also be image enhancement options in the new units, which are currently not available on existing Nano-X art systems and future synthetic 2D.

Speaker Change #135: Please note that we are planning to share more detail about the future Nano-X R system publicly during our next event, which will also be made available via our website.

Speaker Change #135: Stay tuned for further details.

Speaker Change #135: To touch on our OEM efforts, I can report that we are well underway, with the first phase of our development program with the US government entity towards completion of a novel tube design, utilizing our emitter and focused on the entity space. We are optimistic we will move towards prototyping tubes the second half of this year.

Speaker Change #135: Regarding our teleradiology services, we are leveraging our USA RAD client based on a network of radiologists as a significant part of our US deployment plan.

Speaker Change #135: On the mass production front, we finalized the second phase of our development with CSEM, resulting in a high-yield wafers with functional M2.

Speaker Change #135: We are transitioning to production readiness, and confidence we have secured a second source of supply for our novel amateur. Varix has completed their initial tubes prototype, utilizing our emitter for testing to be integrated into our new Nano-X Rx.

Speaker Change #135: I've covered a lot of ground today, so with that, I'll hand the call over to Ran Daniel to review our financials.

Speaker Change #135: Ran?

Speaker Change #135: Thank you, Erez.

Erez Meltzer: Additionally, the previous agreements we signed for Nano-X AI with Coveira Health and W Leon Health are off to a great start and the feedback has been very positive thus far. We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution and ensuring they reach and benefit a wider audience.

Ran Daniel: During the reported period, the company generated revenues through the sales and deployment of its imaging systems, which amounted to $68,000, with a gross loss of $1.3 million on a GAAP basis. Those revenues stems from the sale and deployment of the Nano-X Arc systems in the US and the sales of R2D systems in Africa. Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages. The decrease of $0.2 million in share-based compensation and a decrease of $0.7 million in expenses that are related to research and development and regulatory activities.

Erez Meltzer: I think I can speak of all of us at Nano-X when I say there is a lot to be excited about. Looking ahead to the near future of Nano-X, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to extend rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback changes in technology and evolving use case. Nano-X is no different and we are constantly working on product and technology future developments.

Ran Daniel: Sales and marketing expenses for the reported and comparable periods were $0.8 million. General and administrative expenses for the reported period were $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million. Our non-GAAP net loss attributable to ordinary shares for the reported period was $8.4 million as compared to a non-GAAP net loss of $9.9 million in the comparable period.

Erez Meltzer: I am very pleased to share for the first time that we are developing another Nano-X our system called Nano-X ArcX, which we intend to submit among others for FDA clearance. Once cleared, it will be marketed along the current system, which will expand our current product offering. At the high level, the Nano-X ArcX is designed to meet market needs for our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Erez Meltzer: Listening to the clinical needs is an important step in the ongoing expansion of Nano-X solution. Amongst the future, I am able to share this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X ArcX, and Hansink, one of our key differentiators. The new system will also be easy to deploy in use with an anticipated one-day setup time and plug-and-play functionality. There will also be image enhancement options in the new units which are currently not available on existing Nano-X art systems and future synthetic to be.

Ran Daniel: The decrease of $1.5 million was mainly due to a decrease in non-GAAP operating expenses of $2.2 million and an increase of $0.5 million in our non-GAAP interest income, which was offset by a decrease of $1.1 million in our non-GAAP gross profit. Turning to our balance sheet, as of June 30, 2024, we had cash, cash equivalent with strictly deposit and marketable securities of approximately $64.2 million, and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million. As of June 30, 2024, we had approximately 58.5 million shares outstanding.

Erez Meltzer: Please note that we are planning to share more detail about the future Nano-X art system publicly during our next event which will also be made available via our website. Stay tuned for further details.

Erez Meltzer: To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the U.S, government entity towards completion of a no-voltube design, utilizing our emitter and focused on the entity space. We are optimistic. We will move towards prototyping tubes the second half of this year. Regarding our telerogology services, we are leveraging our U.S.A. Radcline based on a network of rogology as a significant part of our U.S, deployment plan.

Speaker Change #135: So, we will probably see, anyhow, better results.

Speaker Change #135: But I cannot even guesstimate the time.

Erez Meltzer: With that, I will end the call. Back over to Erez. Thank you, Ran. As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nano-X RX system as well as integrating the Nano-XI solution into medical workflow. Our vision is to extend Nano-X technology within and beyond hospitals, targeting underserved segments like urgent care units and orthopedic clinics. We deliver a seamless scan-to-diagnosis solution, leveraging AI for a smarter, more efficient healthcare with a focus on aligning innovation with clinical needs to enhance patient outcomes globally. Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

Speaker Change #135: Okay.

Speaker Change #135: But right now, we are not planning or expecting to have any seasonality effect.

Speaker Change #135: Well, that's helpful.

Erez Meltzer: On the mass production front, we have finalized the second phase of our development with CSAM resulting in a high yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our novel emitters. Varics has completed their initial tubes prototype utilizing our emitter for testing to be integrated into our new Nano-X art.

Erez Meltzer: Our mission is to provide healthcare practices with a transformative imaging advantage with a Nano-X RX, an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers, and shareholders for their support of Nano-X and our mission.

Speaker Change #135: Okay, great.

Speaker Change #135: I appreciate that.

Speaker Change #135: Thank you for taking the questions.

Speaker Change #135: I would say the following.

Speaker Change #135: Thank you.

Speaker Change #135: I'm not happy to guesstimate because the last thing I want is that I will give an estimate, and then it will, for some reason, be longer.

Erez Meltzer: As always, I am available to meet with you and look forward to sharing the insights of Nano-X RX and the upcoming events. With that operator, let's now open the call for questions. Operator, can you pause for a second? I'd like to make one more comment. Okay? Yes, sir. Okay.

Speaker Change #135: Thank you.

Speaker Change #135: So I will be happy to announce that it's cleared once it's cleared, and everyone can, imagine that the period that it will take.

Erez Meltzer: So, in addition to everything we said, I'm happy to announce that, as just today, we received another FDA clearance for the health CCNG version 2.0, which is an upgraded version of advanced AI cardiac solution, empowering physicians in assessment of coronary artery calcium. The health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output. For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution.

Ran Daniel: Nan gap gross loss for the reported period was $0.9 million as compared to a nan gap gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a nan gap basis for the reported period. As compared to a gross profit margin of 34% on a nan gap basis in the comparable period. Revenue from the tele-radiology services for both the reported period and comparable period was $2.5 million with a gross profit of $0.4 million on a gap basis in the reported and comparable period, which represent a gross profit margin of approximately 15% on a gap basis for the reported and comparable period.

Speaker Change #135: Okay.

Speaker Change #135: I appreciate that feedback.

Speaker Change #135: Second question.

Ran Daniel: Nungap gross profit of the company's tele-radiology services for the reported and comparable period was $0.9 million, which represent a gross profit margin of approximately 36% on a nungap basis. During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1,13,000 as compared to revenue of 53,000 in the comparable period. During the reported period, the company generated revenues through the sales and deployment of its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a gap basis.

Speaker Change #135: You mentioned the installed Nanox arc systems in the three-chain medical imaging, service providers in the U.S. Have you gotten any feedback from those three chains and how that's working out and perhaps what kind of expansion opportunities there would be?

Operator: So thank you, and with that, now we will turn to open the call for questions. Thank you. As a reminder to ask a question, please press star one one of your telephone away for your name to be announced. To withdraw your question, please press star one one again.

Speaker Change #135: As a reminder, to ask a question at this time, please press star, 1-1 on your touchtone telephone.

Speaker Change #135: Our next question comes from the line of Ross Osborne with Cantor Fitzgerald.

Speaker Change #135: It may be too early, but I just wanted to get a sense of how that was going so far.

Speaker Change #135: So, especially for those of the people who are actually on the call that are here, in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S., we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers.

Ran Daniel: During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1.13 million as compared to revenue of $53,000 in the comparable period.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Latin Bird. Your line is now open. Good morning, Erez and Ran. How are you? Good. Good morning. So I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke about 50 on sales and 34 on leads. Could you give us a sense of where those units are, imagine they're most domestic U.S. and how that follow looks for actually placements in training over the coming quarters? Okay, so I think that we mentioned last time the number of 20. Right now, the number was growing to more than triple, as you can imagine, in various stages of deployment.

Speaker Change #135: Your line is now open.

Speaker Change #135: Starting off, it seems like you are at the point of inflection in terms of deployments.

Speaker Change #135: Feedback on a clinical basis, on the maintenance, on the usage, on the pattern of the body parts and the anatomy that is being used, the clinical use.

Ran Daniel: During the reported period, the company generated revenues through the sales and deployment of its imaging systems which amounted to $68,000 with a gross loss of $1.3 million on a gap basis. Those revenues stems from the sale and deployment of the nan of our systems in the US and the sales of our two systems in Africa.

Speaker Change #135: With that in mind, can you walk through your current manufacturing capabilities and where, your various contract initiatives stand?

Speaker Change #135: So far, and this is something that encouraged us to accelerate the installation and the deployment, we received very good feedback.

Speaker Change #135: You are right about what you said.

Speaker Change #135: And I think that what we see is a lot of examples of places that the system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.

Speaker Change #135: So, overall, the feedback is very good.

Speaker Change #135: I would say that probably in the next few months we will, get even better visibility on the usage, on the process, on the installation, on the regulatory processes, and we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly.

Speaker Change #135: In terms of manufacturing, I would say the following.

Speaker Change #135: The chips, we have no problem. We have available chips right now.

Speaker Change #135: We were able, due to the results of the high-yield wafers that we get from CSAM, we have two, suppliers and I think that this is not an issue.

Speaker Change #135: In terms of the tubes, we have already the tubes that are coming from Korea, we have, the tubes that are coming from the plant in Europe, and last but not least, Varex has completed their initial tube prototypes utilizing our emitter and this is for testing.

Speaker Change #135: So I hope that it will be integrated into our new Nano-X system shortly and it will, be part of the available production.

Speaker Change #135: In terms of the production of the assembly of the system, we have made the preparations, in the site in Israel that we're moving forward and we've increased the capacity of the manufacturing to enable what is needed in the next few quarters and the low-cost manufacturing arrangement that we have will enable us to ramp up next year even higher than what we are currently doing.

Ran Daniel: Those revenues stems from the sale and deployment of the Nano-X Arc systems in the US and the sales of R2D systems in Africa. Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages. The decrease of $0.2 million in share-based compensation and a decrease of $0.7 million in expenses that are related to a research and development and regulatory activities.

Speaker Change #135: So right now, I would say that it seems to be in line of what is needed for the next, few quarters.

Speaker Change #135: Okay, great.

Speaker Change #135: By the way, we are working on the next ramp up for 2025 to be announced later.

Ran Daniel: Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages, a decrease of $0.2 million in share-based compensation, and a decrease of $0.7 million in expenses that are related to our research and development and regulatory activities.

Speaker Change #135: Perfect.

Erez Meltzer: We have a few dozens, which are already deployed. A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals. And we believe that the indication that we gave, which 50 50 of them are probably favorable to be installed. And the 44 in the leads in the beginning of the process, we are getting to the targeted that we wanted to be by the end of the year, and that's where we are. Okay, got it.

Ran Daniel: Sales and marketing expenses for the reported in comparable periods were at $0.8 million.

Speaker Change #135: Thank you.

Speaker Change #135: Thank you for that feedback.

Speaker Change #135: Final question.

Erez Meltzer: And then congratulations on the news today for a calcium score. Could you talk a little bit about these other 510(k) indications and for general term as well in addition to general trust? And could you talk about the codes associated with them as far as reimbursement at facilities? Okay, so with maybe I'll start with the end. With the reimbursement right now, what we speak about the reimbursement is based on the Tomo CPT code, which is 76100. And this is the basis for the reimbursement of those that submitted their scans for the reimbursement. We received only already indications from more than from the two I think that insurance insurers, so this is continues to grow.

Ran Daniel: Our non-gap net loss attributable to ordinary shares for the reported period was $8.4 million.

Ran Daniel: Our non-gap net loss attributable to ordinary shares for the reported period was $8.4 million as compared to a non-gap net loss of $9.9 million in the comparable period. The decrease of $1.5 million was mainly due to a decrease in non-gap operating expenses of $2.2 million and an increase of $0.5 million in our non-gap interest income, which was offset by a decrease of $1.1 million in our non-gap gross profit. Turning to our balance sheet, as of June 30, 2024, we had cash, cash equivalent with strictly deposit and marketable securities of approximately $64.2 million and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million.

Ran Daniel: As compared to a non-gap net loss of $9.9 million in the comparable period, the decrease of $1.5 million was mainly due to a decrease in non-gap operating expenses of $2.2 million and an increase of $0.5 million in our non-gap interest income, which was offset by a decrease of $1.1 million in our non-gap gross profit.

Erez Meltzer: So the numbers that we received are in line with the model that we put together. So basically, right now it seems that for the clinics that and the sides that the system is installed. So the model is Profit. With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar, it's in line of what we have indicated in the past that we are going to submit to submit this year, the additional clinical indications, especially the chest. We decided that we're going to submit it for whole body, so including the chest, not only, but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan the whole body and basically everything. Bear in mind that in the rest of the world, and especially part of the others, and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body and we are using it to all the clinical indications.

Ran Daniel: As of June 30th, 2024, we had approximately 58.5 million shares outstanding.

Ran Daniel: As of June 30, 2024, we had approximately 58.5 million shares outstanding.

Erez Meltzer: With that, I will end the call back over to Eris.

Erez Meltzer: With that, I will end the call back over to Erez. Thank you, Ran. As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nano-X RX system as well as integrating Nano-XI solution into medical workflow. Our vision is to extend Nano-X technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics. We deliver a seamless scan-to-diagnosis solution, leveraging AI for a smarter, more efficient healthcare with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Speaker Change #135: And then following up on my previous question, would you remind us how large your U.S. sales, force is today and then any plans for adding to the team?

Speaker Change #135: When we are thinking about Q3 relative to Q2, should we expect any seasonality, in the U.S.?

Speaker Change #135: So, right now, we actually work with, I would say, it's about 10 people altogether. And if I add the independent agents, then I think that we are right now at around 15. We are expecting to grow them to the number of 30 in the foreseeable future.

Speaker Change #135: The summer months, do they tend to be a little slower with a pickup in the fourth quarter?

Speaker Change #135: Great.

Erez Meltzer: Thank you, Ron.

Speaker Change #135: And then last one for us.

Erez Meltzer: As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nanox Rx system, as well as integrating Nanox Rx solution into medical workflow.

Speaker Change #135: What I said is that that's what we anticipate for 2025 to be around 30 to 40.

Speaker Change #135: Lastly, just in anticipation of CE mark approval, would you walk us through your commercialization, plan in Europe and other related geographies in terms of what type of medical centers you will be targeting, if you'll build out your own sales force or leverage a distributor there, and lastly, what the reimbursement environment looks like?

Speaker Change #135: Okay.

Speaker Change #135: Just trying to get a sense of what kind of cadence we should expect through the year.

Speaker Change #135: So, frankly speaking, right now we don't expect any seasonality, especially due to the fact that, we are ramping up our installed base.

Speaker Change #135: So, we will probably see, anyhow, better results.

Speaker Change #135: But right now we are not planning or expecting to have any seasonality's effect.

Speaker Change #135: Okay, great.

Speaker Change #135: Thank you for taking the questions.

Speaker Change #135: Thank you.

Speaker Change #135: As a reminder to ask a, question at this time, please press star 11 on your touchtone telephone.

Erez Meltzer: Our vision is to extend Nanox technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics.

Erez Meltzer: We deliver a seamless scantodagnosis solution, leveraging AI for a smarter, more efficient healthcare, with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Erez Meltzer: Nanox is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

Erez Meltzer: Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S. Our mission is to provide healthcare practices with a transformative imaging advantage with a Nano-X RX, an accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care.

Erez Meltzer: Our mission is to provide healthcare practices with a transformative imaging advantage with a Nanox Rx and accessible cost effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

Erez Meltzer: Based on this indication, I gave in this quote today, I gave indication of the spread between the various body anatomies or body parts that were received, and I gave the percentage that we have on a global basis, and you can see the chest is a major part of them.

Erez Meltzer: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers and shareholders for their support of Nanox and our mission.

Erez Meltzer: Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers and shareholders for their support of Nano-X and our mission. As always, I am available to meet with you and look forward to sharing the insights of Nano-X RX and the upcoming events. With that operator, let's now open the call for questions. Operator, can you pause for a second? I'd like to make one more comment. Okay? Yes, sir. Okay.

Erez Meltzer: Got it, and then one more if I may, could you talk a little bit more about the RCAX platform and perhaps its form factor and differences where should the current platform and the intended commercial presence area anticipate as compared to the current platform. First of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter. We are, of course, going to submit it to the SBA, and after the SBA clearance, it will be marketed as a long, along the current system, which will expand our product offering. We mentioned a few times in the past that the ARC, or the first version, point two, is not the first product, and it's definitely not the last, and we haven't lined up a real product roadmap for the future.

Erez Meltzer: As always, I am available to meet with you and look forward to sharing the insights of Nano-X Archecks and the upcoming events.

Operator: With that operator, let's now open the call for questions.

Speaker Change #135: So, with respect to the rest of the world, first of all, there are a few countries that, you should remember, we have agreements that were signed in the past, and we are going to deploy them once the clearance in these countries are expected to be received.

Erez Meltzer: Operator, can you pause for a second?

Erez Meltzer: I'd like to make one more comment.

Erez Meltzer: Okay?

Erez Meltzer: Yes, sir.

Erez Meltzer: Okay.

Erez Meltzer: So in addition to everything we said, I'm happy to announce that as just today, we received another FDA clearance for the health CCNG version 2.0, which is an upgraded version of advanced AI cardiac solution, empowering physicians in assessment of coronary artery calcium. The health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

Speaker Change #135: So, I mentioned today, one of them, Mexico, is really coming very shortly.

Speaker Change #135: I will be there next month to visit the places that they are planning to install the arc.

Speaker Change #135: So, this is one.

Erez Meltzer: ARC X is one of them. We will give more indications, but I think that the idea is to make the ARC X available to more specific locations or sites that are more suitable for the spec of the system. We are talking about footprint; we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features, and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features to be installed remotely, so we don't have to send the technicians to do it.

Speaker Change #135: We were talking about another one or two countries in Latin America.

Erez Meltzer: For us, it is very pleasing to receive further regulatory validation from the FDA for our AI Cardio Solution.

Erez Meltzer: For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution. So thank you and with that now we will turn the open the call for questions. Thank you. As a reminder to ask a question, please press star one one of your telephone away for your name to be announced. To withdraw your question, please press star one one again.

Operator: So thank you and with that, now we will turn the open the call for questions.

Operator: Thank you.

Operator: As a reminder to ask a question, please press star one of your telephone away for your name to be announced.

Operator: To withdraw your question, please press star one one again.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Latin Bird.

Jeffrey Cohen: Our first question comes from the line of Jeffrey Cohen with Latin Bird. Your line is now open. Good morning, Erez and Ran. How are you? Good. Good morning.

Jeffrey Cohen: It's downloaded from the network. Thank you, Jeff. Thank you.

Jeffrey Cohen: Your line is now open.

Jeffrey Cohen: Good morning, Arizona.

Erez Meltzer: How are you?

Erez Meltzer: Good.

Erez Meltzer: Good morning.

Erez Meltzer: So I wondered, firstly, could you expand upon a little bit regarding your backlog as far as imaging when you spoke about 50 on sales and 34 on leads?

Erez Meltzer: So I wondered firstly, could you expand upon a little bit regarding your your backlog as far as imaging when you spoke about 50 on sales and 34 on leads. Could you give us a sense of where those units are, imagine they're most domestic U.S, and how that follow looks for actually placements in training over the coming quarters? Okay, so I think that we mentioned last time the number of 20 right now the number was growing to more than triple as you can imagine in various stages of deployment.

Scott Henry: Our next question comes from the line of Scott Henry with the AGP. Your line is now open. Thank you and good morning or afternoon, depending on where you are. Just a couple of questions. Congratulations again, the 510K application is in for the general use and chest indication. Could you give any thoughts on what you would expect the review timeline to be for that indication? What is it typically in this case just to get a sense of when we may get final approval? First of all, I hope that I understand the question, so I'll give the answer, and if not, you will tell me.

Speaker Change #135: Our next question comes from the line of Ross Osborne with Canter Fitzgerald.

Speaker Change #135: Your line is now open.

Speaker Change #135: Starting off, it seems like you are at the point of inflection in terms of deployments.

Erez Meltzer: Could you give us a sense of where these units are?

Speaker Change #135: With that in mind, can you walk through your current manufacturing capabilities and where, your various contract initiatives stand?

Erez Meltzer: Imagine they're mostly domestic U.S, and how that follow looks for actually placements in training over the coming quarters.

Erez Meltzer: Okay, so I think that we mentioned last time, the number of 20 right now, the number was growing to more than triple as you can imagine in various stages of deployment.

Erez Meltzer: We have a few dozens which are already deployed.

Erez Meltzer: We have a few dozens which are already deployed. A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals. And we believe that the indication that we gave which 50 50 of them are probably favorable to be installed. And the 44 in the leads in the beginning of the process, we are getting to the targeted that we wanted to be by the end of the year and that's where we are. Okay, got it.

Erez Meltzer: A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals.

Erez Meltzer: Bear in mind that I'm up until now all the the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK. MSK, spine, hand, leg, etc. And not chest. We all know that the chest is the most common use of X-ray, and especially when we talk about the Thomas synthesis. So we expect that once we get the clearance it will definitely increase the likelihood of sites and the customers to take the arc and more than that the in the sites that the system is going to be installed it will increase the number of scans per day because it will be used for other indications as stated.

Erez Meltzer: And we believe that the indication that we gave which 50 of them are probably favorable to be installed.

Erez Meltzer: And the 44 in the leads in the beginning of the process, we are getting to the target of that we wanted to be by the end of the year.

Erez Meltzer: And that's where we are.

Erez Meltzer: Okay, got it.

Erez Meltzer: And then congratulations on the news today for a calcium score. Could you talk a little bit about these other 510K indications and for general term as well in addition to general trust? And could you talk about the codes associated with them as far as reimbursement at facilities? Okay, so with maybe I'll start with the end with the reimbursement right now what we speak about the reimbursement is based on the Tomo CPT code, which is 76100.

Erez Meltzer: Is this what you asked, or? Well, that's very helpful, thank you, and I guess the question I initially was hoping to get some sense of is how long do you expect the review period to be for that 510(k)? I wish I could tell you I do hope that it will be faster than that previous processes that other companies as well as us experience since COVID, but I think that the fact that the system itself is already cleared and it will enhance the process, but I cannot even guesstimate the time. Well, that's helpful. I would say I would say the following: I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will, for some reason, be longer. So I will be happy to announce that it's cleared once it's cleared, and everyone can imagine that the period that it will take.

Erez Meltzer: And this is the basis for the reimbursement of those that submitted their scans for the reimbursement. We received only already indications from more than from from the two I think that insurance insurers, so this is continues to grow. So the numbers that we received are in line of the model that that we put together. So basically right now it seems that the for the clinics that and the sides that the system is installed.

Erez Meltzer: So the model is profit. With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar, it's in line of what we have indicated in the past that we are going to submit to submit this year, the additional clinical indications, especially the chest. We decided that we're going to submit it for whole body, so including the chest, not only, but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan the whole body and basically everything, bear in mind that in the rest of the world, and especially part of the others, and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body and we are using it to all the clinical indications.

Erez Meltzer: And then, graduations on the news today for a calcium score.

Erez Meltzer: Okay, I appreciate that feedback. Second question you mentioned the installed Nanox Arc systems in the three chain medical imaging. Service providers in the U.S. Have you got any feedback on it from those three chains and how that's working out and perhaps what kind of expands and opportunities there would be. It may be too early, but I just wanted to get a sense of how that was going so far. So especially for those of the people who are actually on the call that you hear in the beginning, or I would say at the end of 2023 and at the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S., we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers.

Erez Meltzer: Could you talk a little bit about these other 510K indications and for general term as well, in addition to our general interest?

Speaker Change #135: In terms of Europe, we are waiting for the CE approval, as indicated previously, and, we are really in the final process of the CE approval.

Erez Meltzer: And could you talk about the codes associated with them as far as reimbursement and facilities?

Erez Meltzer: Feedback on a clinical basis on the maintenance, on the usage, on the pattern of the body parts and the anatomies that it's being used, the clinical use, so far, and this is something that encouraged us to accelerate the installation and the deployment. We received a very good feedback, and I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system, and they decided to do it. Overall, the feedback is very good. I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes, and we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly.

Erez Meltzer: Okay.

Erez Meltzer: Got it, and then one more if I may, could you talk a little bit more about the RCAX platform and perhaps its form factor and differences where should the current platform and the intended commercial presence area anticipate as compared to the current platform. First of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter. We are of course going to submit it to the SBA, and after the SBA clearance, it will be marketed as a long, along the current system, which will expand our product offering, and we mentioned a few times in the past that the ARC, or the first version, point two, is not the first product, and it's definitely not the last, and we haven't lined up a real product roadmap for the future.

Erez Meltzer: So, with maybe I'll start with the end with the reimbursement right now, what we speak about the reimbursement is based on the Tomo CPT code, which is 76100.

Erez Meltzer: ARC X is one of them. We will give more indications, but I think that the idea is to make the ARC X available to more specific locations or sites that are more suitable for the spec of the system. We are talking about footprint, we are talking about we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features, and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features to be installed remotely, so we don't have to send the technicians to do it. It's download from the network.

Erez Meltzer: Okay, great. Thank you for that feedback. Final question: when we're thinking about Q3 relative to Q2, should we expect any seasonality in the US? The summer months do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year? Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base, so we will probably see anyhow a better result. But right now we are not planning or expecting to have any seasonality with effect.

Jeffrey Cohen: Thank you, Jeff. Thank you.

Scott Henry: Our next question comes from the line of Scott Henry with the AGP. Your line is now open. Thank you and good morning or afternoon depending where you are. Just a couple of questions.

Scott Henry: Okay, great. Thank you for taking the questions. Thank you. As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Erez Meltzer: Congratulations again the 510K application in for the general use and chest indication. Could you give any thoughts on what you would expect the review timeline to be for that indication? What is it typically in this case just to get a sense of when we may get final approval? First of all I hope that I understand the question so I'll give the answer and if not you will tell me. Bear in mind that I'm up until now all the the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK.

Ross Osborne: Our next question comes from the line of Ross Osborne with Canter Fitzgerald. Your line is open. Hey guys, thanks for sharing the questions. So starting off, seems like you are at the point of inflection in terms of deployments. With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand? So you're right about what you said. In terms of manufacturing, I would say the following. The two chips; we have no problem. We have available chips right now. We were able, due to the results of the high yield wafers that we get from CSAM.

Speaker Change #135: You are right about what you said.

Speaker Change #135: In terms of manufacturing, I would say the following.

Speaker Change #135: The chips, we have no problem. We have available chips right now.

Erez Meltzer: And this is the basis for the reimbursement of those that submitted their scans for the reimbursement.

Speaker Change #135: We were able, due to the results of the high-yield wafers that we get from CSAM, we have two, suppliers and I think that this is not an issue.

Erez Meltzer: We have two suppliers, and I think that this is not an issue in terms of the cubes. We have already the cubes that are coming from Korea. We have the tubes that are coming from the plant in Europe. And in the last but not least, the VARIC has completed their initial tube prototype utilizing our emitter, and for this is for testing. So I hope that it will be integrated into our new Nano-X Arc system shortly, and it will be part of the available production. In terms of the production of the assembly of the system, we have made the appropriations that are in the site in Israel that we're moving forward, and we've increased the capacity of the manufacturing to enable what is needed.

Erez Meltzer: MSK, spine, hand leg, etc. And not chest. We all know that the chest is the most common use of X-ray and especially when we talk about the Thomas synthesis. So we expect that once once we get the clearance it will definitely increase the likelihood of sites and the customers to take the arc and more than that the in the sites that the system is going to be installed it will increase the number of scans per day because it will be used for other indications as stated.

Erez Meltzer: We received only already indications from more than two I think that insurance insurers.

Speaker Change #135: So I hope that it will be integrated into our new Nano-X system shortly and it will, be part of the available production.

Speaker Change #135: In terms of the production of the assembly of the system, we have made the preparations, in the site in Israel that we are moving forward and we have increased the capacity of the manufacturing to enable what is needed in the next few quarters and the low-cost manufacturing arrangement that we have will enable us to ramp up next year even higher than what we are currently doing.

Erez Meltzer: And this is continuous to grow.

Erez Meltzer: Is this what you asked or? Well that's very helpful thank you and I guess the question I initially was hoping to get some sense and how long do you expect the review period to be for that 510K? I wish I could tell you I do hope that it will be faster than that previous processes that other companies as well as us experience since COVID but I think that the fact that the system itself is already cleared and it will enhance the process but I cannot even guesstimate the time.

Erez Meltzer: The numbers that we received are in line of the model that we put together.

Erez Meltzer: In the next few quarters, and the local manufacturing arrangements that we have will enable us to ramp up next year, even higher than what we are currently doing. So right now, I would say that it seems to be in line with what is needed for the next few quarters. Thank you. We are working on the next ramp up for 2025 to be announced. Got it. Later. Perfect. Thank you.

Speaker Change #135: So right now, I would say that it seems to be in line of what is needed for the next, few quarters.

Speaker Change #135: We are working on the next ramp-up for 2025 to be announced later.

Erez Meltzer: Well that's helpful I would say I would say the following I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will for some reason be longer so I will be happy to announce that it's cleared once it's cleared and everyone can imagine that the period that it will take. Okay I appreciate that feedback.

Speaker Change #135: Perfect.

Speaker Change #135: Thank you.

Speaker Change #135: And then following up on my previous question, would you remind us how large your U.S. sales, force is today and then any plans for adding to the team?

Erez Meltzer: Following up on my previous question, would you remind us how large your US sales forces are today and then any plans for adding to the team? So right now, right now, we actually work with, I would say, when it's about 10 people all together. And if I had the independent agents, then I think that we are right now at around 15. We are expecting to grow them to the number of 30 in the foreseeable future. Great. And then last one for us. This is what I said: is that that's what that's what we anticipate for 2025 to be around 30 to 40.

Erez Meltzer: So, basically, right now, it seems that for the clinics and the sites that the system has installed, the model is profitable.

Erez Meltzer: Second question you mentioned the installed Nanox arc systems in the three chain medical imaging. Service Providers in the U.S. Have you got any feedback on it from those three chains and how that's working out and perhaps what kind of expands and opportunities there would be. It may be too early, but I just wanted to get a sense of how that was going so far. So especially for those of the people who are actually on the call that you hear in the beginning, or I would say at the end of 2023 and at the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S., we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers.

Erez Meltzer: With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar.

Speaker Change #135: Great.

Speaker Change #135: And then last one for us.

Speaker Change #135: What I said is that that's what we anticipate for 2025 to be around 30 to 40.

Erez Meltzer: It's in line of what we have indicated in the past that we are going to submit to submit this year the additional clinical indications, especially the chest.

Erez Meltzer: Thank you. Got it, got it. Thank you. And then lastly, just an anticipation to see Mark approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting, if you'll build out your own self-sourced or leveraged distributor there, and lastly what the reimbursement environment looks like? Okay, so with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries is expected to be received.

Speaker Change #135: Okay.

Erez Meltzer: We decided that we're going to submit it for whole body, so including the chest, not only, but we are able to scan whole body and basically everything.

Erez Meltzer: Feedback on a clinical basis on the maintenance, on the usage, on the pattern of the body parts and the anatomies that it's being used, the clinical use, so far and this is something that encouraged us to accelerate the installation and the deployment. We received a very good feedback and I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.

Speaker Change #135: So I mentioned today, one of them, Mexico, is really coming very shortly.

Erez Meltzer: So I mentioned today, one of them, Mexico is really coming very shortly. I will be there next month to visit the places they are planning to install the arc. So this is one. We were talking about another one or two countries in Latin America. In terms of Europe, we are waiting for the CE approval as indicated previously, and we are in the really in the final process of the CE approval. Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them.

Speaker Change #135: I will be there next month to visit the places that they are planning to install the ARC.

Speaker Change #135: So this is one.

Speaker Change #135: We were talking about another one or two countries in Latin America.

Speaker Change #135: In terms of Europe, we are waiting for the CE approval, as indicated previously, and, we are really in the final process of the CE approval.

Speaker Change #135: Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them.

Erez Meltzer: Overall, the feedback is very good. I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes and we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly. Okay, great, thank you for that feedback.

Erez Meltzer: And you can see the chest is a major part of them.

Erez Meltzer: In each one of them, it's going to be the distributors that are going to do the work. If you remember, I mentioned about a year ago that right now, only in the US, Israel, and the UK, we're planning to have our own people, and in the rest of the world, we are planning to have distributors. We are right now already in the last quarter, and this quarter in touch with these distributors in order to ensure that we have a plan. Our people visited already a few locations in each one or not in each one in most of these countries.

Speaker Change #135: Each one of them is going to be – it's going to be the distributors that are going, to do the work.

Speaker Change #135: Each one of them, it's going to be the distributors that are going to do the work.

Speaker Change #135: If you remember, I mentioned about a year ago that right now, only in the U.S., Israel, and the U.K., we are planning to have our own people, and in the rest of the world, we are planning to have distributors.

Speaker Change #135: We are, right now, already, in the last quarter and this quarter, in touch with these distributors, in order to ensure that we have a plan.

Erez Meltzer: Got it.

Erez Meltzer: Final question, when we're thinking about Q3 relative to Q2, should we expect any seasonality in the US? The summer months, do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year? Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base, so we will probably see anyhow a better result, but right now we are not planning or expecting to have any seasonality with effect. Okay, great, thank you for taking the questions. Thank you. As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Speaker Change #135: Our people visited already a few locations in each one – not in each, but in most of, these countries.

Speaker Change #135: Our people visited already a few locations in each one, not in each, but in most of these, countries.

Erez Meltzer: Right now, we are talking in Europe and in Mexico. We are talking about a medium to large medical centers. Got it. Thanks for taking our questions. We can grab the camera on the quarter. Great.

Speaker Change #135: Right now, we are talking in Europe and in Mexico, we are talking about medium to large, remote centers.

Speaker Change #135: Right now, we are talking in Europe and in Mexico, we are talking about medium to large, global centers.

Speaker Change #135: Got it.

Speaker Change #135: Thanks for taking our questions, and congrats again on the quarter.

Speaker Change #135: Great.

Operator: Thank you. And I'm currently showing no further questions at this time.

Speaker Change #135: Thank you, and I'm currently showing no further questions at this time.

Speaker Change #135: Thank you.

Speaker Change #135: I'm currently showing no further questions at this time.

Operator: This does conclude today's conference call.

Speaker Change #135: This does conclude today's conference call.

Operator: Thank you all for participating, and you may now disconnect.

Speaker Change #135: Thank you all for participating, and you may now disconnect.

Speaker Change #135: Jeffrey Cohen, Ran Daniel, Mike Cavanaugh, Erez Meltzer, Mike Cavanaugh, Ran Daniel, Nano-X Imaging, ༼ ༎ຶ ෴ ෴ ༽ ༽ අපි කිරීම් හොඳින්ව යිස්තූතියි ක්‍රීම් හොඳින්ස්තූතියි මිශ්‍ර ඇති අපි කිරීම් බෝල් ලෙමන් අපි පටාරයි කරන්න නැති කිරීම් හොඳින් තොත්තියි හොඳින් කරන්න හොඳින් ක්‍රීම් මිශ්‍ර ස්තූතියි අපි එකතු කිරීම් ගැනීමට කෝස් කිරීම් ස්තූතියි කෙස් හොඳින් සීමට වනු ඇත, මේදා ක්‍රීම් හොඳින් මේදා ස්තූතියි මේදා ක්‍රීම් ස්තූතියි වනු ඇත, ක්‍රීම් ස්තූතියි මම පැලි ස්තූතියි කරන්න, අපි කරන්න, අපි කරන්න, කරන්න, අපි කරන්න, අපි ස්තූතියි අපි කරන්න, ස්තූතියි Scott Henry, Jeffrey Cohen, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Ran Daniel, Nano-X, Good day, and thank you for standing by.

Erez Meltzer: Our next question comes from the line of Ross Osborne with Canter Fitzgerald. Your line is open. Hey guys, thanks for sharing the questions. So starting off seems like you are at the point of inflection in terms of deployments. With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand? So you're right about what you said. In terms of manufacturing, I would say the following.

Erez Meltzer: So first of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter.

Erez Meltzer: We are of course going to submit it to the FDA.

Erez Meltzer: And after the FDA clearance, it will be marketed as a longer, along the current system, which will expand our product offering.

Erez Meltzer: And we mentioned a few times in the past that the ARCH or the first version to point to is not the first product and definitely not the last and we haven't lined up a real product roadmap for the future.

Erez Meltzer: ARCHX is one of them.

Erez Meltzer: The two chips, we have no problem. We have available chips right now. We were able, due to the results of the high yield wafers that we get from CSAM. We have two suppliers and I think that this is not an issue in terms of the cubes. We have already the cubes that are coming from Korea. We have the tubes that are coming from the plant in Europe. And in the last but not least, the VARIC has completed their initial tube prototype utilizing our emitter and for this is for testing.

Erez Meltzer: We will give more indications, but I think that the idea is to make the ARCHX available to more specific locations or sites that are more suitable for the spec of the system. We are talking about footprint.

Erez Meltzer: We are talking about, we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features and the beauty of it that whenever we are going to install it, we are going to enable the all the features that are coming with the software and the features to be installed remotely.

Erez Meltzer: So we don't have to send the technicians to do it.

Erez Meltzer: It's download from the network.

Erez Meltzer: Thank you, Jeff.

Erez Meltzer: Thank you.

Scott Henry: Our next question comes from the line of Scott Henry with the AGP.

Erez Meltzer: So I hope that it will be integrated into our new Nano-X Arc system shortly and it will be part of the available production. In terms of the production of the assembly of the system, we have made the appropriations that are in the site in Israel that we're moving forward and we've increased the capacity of the manufacturing to enable what is needed. In the next few quarters and the local manufacturing arrangements that we have will enable us to ramp up next year, even higher than what we are currently doing. So right now, I would say that it seems to be in line of what is needed for the next few quarters.

Scott Henry: Your line is now open.

Scott Henry: Thank you.

Scott Henry: In the good morning or afternoon, depending on where you are.

Scott Henry: Just a couple of questions.

Scott Henry: Congratulations.

Erez Meltzer: Thank you. We are working on the next ramp up for 2025 to be announced. Got it. Later. Perfect. Thank you.

Scott Henry: Again, the 510K application in for the general use interest indication.

Scott Henry: Could you give any thoughts on what you would expect the review timeline to be for that indication?

Erez Meltzer: And then lastly, just an anticipation to see Mark approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting, if you'll build out your own self-sourced or leveraged distributor there, and lastly what the reimbursement environment looks like? Okay, so with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries are expected to be received.

Scott Henry: What is it typically in this case just to get a sense of when we may get final approval?

Scott Henry: First of all, I hope that I understand the question, so I'll give the answer if not you'll tell me.

Erez Meltzer: So I mentioned today, one of them, Mexico is really coming very shortly. I will be there next month to visit the places they are planning to install the arc. So this is one. We were talking about another one or two countries in Latin America. In terms of Europe, we are waiting for the CE approval as indicated previously and we are in the really in the final process of the of the CE approval.

Scott Henry: Bear in mind that I'm up until now all the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK, MSK, spying, hand lag, etc.

Scott Henry: And not chest.

Scott Henry: We all know that the chest is the most common use of X-ray and especially when we talk about the Thomas synthesis.

Scott Henry: So we expect that once we get the clearance it will definitely increase the likelihood of sites and the customers to take the arc.

Erez Meltzer: Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them. In each one of them, it's going to be the distributors that are going to do the work. If you remember, I mentioned about a year ago that right now, only in the US, Israel and the UK, we're planning to have our own people and in the rest of the world, we are planning to have distributors.

Scott Henry: And more than that, that in the sites that the system is going to be installed, it will increase the number of scans per day because it will be used for other indications as stated.

Scott Henry: Is this what you asked?

Scott Henry: Well, that's very helpful.

Scott Henry: Thank you.

Erez Meltzer: We are right now already in the last quarter and this quarter in touch with these distributors in order to ensure that we have a plan. Our people visited already a few locations in each one or not in each one in most of these countries. Right now, we are talking in Europe and in Mexico. We are talking about a medium to large medical centers. Got it. Thanks for taking our questions. We can grab the camera on the quarter. Great. Thank you. And I'm currently showing no further questions at this time.

Scott Henry: And I guess the question I initially was hoping to get some sense and how long do you expect the review period to be for that 510K?

Scott Henry: I wish I could tell you, I do hope that it will be faster than the previous processes that other companies as well as us experience since COVID.

Scott Henry: But I think that the fact that the system itself is already cleared and it will enhance the process.

Scott Henry: But I cannot even guesstimate the time.

Scott Henry: Well, that's how I would say the following.

Scott Henry: I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will for some reason be longer.

Scott Henry: So I will be happy to announce that it's cleared once it's cleared and everyone can imagine that the period that it will take.

Scott Henry: Okay, I appreciate that feedback.

Scott Henry: Second question, you mentioned the installed Nanox ARC systems in the three chain medical imaging.

Scott Henry: Service Providers in the U.S.

Operator: This does conclude today's conference call. Thank you all for participating and you may now disconnect.

Scott Henry: Have you gotten any feedback on it from those three chains and how that's working out and perhaps, you know, what kind of expands and opportunities there would be it may be too early, but I just wanted to get a sense of how that was going so far.

Scott Henry: So, especially for those of the people who are actually on the call that they hear in the beginning, or I would say at the end of 2023 and the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S.

Scott Henry: As we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers not only from the chains, but we are getting a lot of feedback from the customers feedback on a clinical basis, click on the maintenance on the usage on the pattern of the body parts which and the anatomies that is being used, the clinical use, so far and this is something that encouraged us to accelerate the installation and the deployment, we receive a very good feedback.

Scott Henry: And I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.

Scott Henry: So overall, the feedback is very good.

Scott Henry: I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes.

Scott Henry: And we will always, as indicated, even in today's goal, we will always implement them and improve our service and our products accordingly.

Scott Henry: Okay, great.

Scott Henry: Thank you for that feedback.

Scott Henry: Final question, when we are thinking about Q3 relative to Q2, should we expect any seasonality in the U.S.?

Scott Henry: The summer months, do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year.

Scott Henry: Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base.

Scott Henry: So we will probably see anyhow a better result, but right now we are not planning or expecting to have any seasonality, seasonality is a fact.

Scott Henry: Okay, great.

Scott Henry: Thank you for taking the questions.

Scott Henry: Thank you.

Operator: As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Ross Osborne: Our next question comes from the line of Ross Osborne with Cantor Fitzgerald.

Ross Osborne: Your line is open.

Ross Osborne: Hey guys, thanks for sharing the questions.

Ross Osborne: So starting off seems like you are at the point of inflection in terms of deployments.

Ross Osborne: With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand?

Ross Osborne: So you're right about what you said.

Ross Osborne: In terms of manufacturing I would say the following.

Ross Osborne: The two chips, we have no problem, we have available chips right now.

Ross Osborne: We were able, due to the results of the high yield wafers that we get from CSAM.

Ross Osborne: We have two suppliers and I think that this is not an issue in terms of the cubes.

Ross Osborne: We have already the cubes that are coming from Korea.

Ross Osborne: We have the tubes that are coming from the plant in Europe.

Ross Osborne: And in the last but not least, Varics has completed their initial tube prototype utilizing our emitter and for this is for testing.

Ross Osborne: So I hope that it will be integrated into our new nanops, our system shortly and it will be part of the available production.

Ross Osborne: In terms of the production of the assembly of the system, we have made the appropriations in the site in Israel that we're moving forward and we've increased the capacity of the manufacturing to enable what is needed.

Ross Osborne: In the next few quarters and the local manufacturing arrangements that we have will enable us to ramp up next year even higher than what we are currently doing.

Ross Osborne: So right now, I would say that it seems to be in line of what is needed for the next few quarters.

Ross Osborne: Thank you.

Ross Osborne: We are working on the next ramp up for 2025 to be announced.

Ross Osborne: Got it.

Ross Osborne: Later.

Ross Osborne: Perfect.

Ross Osborne: Thank you.

Ross Osborne: Following up on my previous question, would you remind us how large your US sells forces today and then any plans for adding to the team?

Ross Osborne: So right now, right now, we actually work with, I would say when it's about 10 people all together.

Ross Osborne: And if I had the independent agents, then I think that we are right now at around 15.

Ross Osborne: We are expecting to grow them to the number of 30 in the foreseeable future.

Ross Osborne: Great.

Ross Osborne: And then last one for us.

Ross Osborne: This is what I said is that that's what that's what we anticipate for 2025 to be around 30 to 40.

Ross Osborne: Thank you.

Ross Osborne: Got it.

Ross Osborne: Thank you.

Ross Osborne: And then lastly, just an anticipation to see Mark Approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting if you'll build out your own self-sourced or leveraged distributor there and lastly, what the reimbursement environment looks like.

Ross Osborne: Okay, so with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries are expected to be received.

Ross Osborne: So I mentioned today, one of them Mexico is really coming very shortly.

Ross Osborne: I will be there next month to visit the places there.

Ross Osborne: They are planning to install the arc.

Ross Osborne: So this is one we were talking about another one or two countries in Latin America.

Ross Osborne: In terms of Europe, we are waiting for the CE approval as indicated previously and we are in the really in the final process of the of the CE approval.

Ross Osborne: Once we get the CE, so all the countries that were part of the agreements that we signed like Australia, like New Zealand, like Spain, we're going to use them each one of them.

Ross Osborne: It's going to be the distributors that are going to do the work.

Ross Osborne: If you remember, I mentioned about a year ago that right now only in the US, Israel and the UK, we are planning to have our own people and in the rest of the world, we are planning to have distributors.

Ross Osborne: We are right now already in the last quarter in this quarter in touch with these distributors in order to ensure that we have a plan.

Ross Osborne: Our people visited already few locations in each one or not in each one in most of these countries.

Ross Osborne: Right now, we are talking in Europe and in Mexico.

Ross Osborne: We are talking about a medium to large medical centers.

Ross Osborne: Thank you for taking our questions and congrats again on the quarter.

Ross Osborne: Right.

Operator: Thank you and I'm currently showing no further questions at this time.

Operator: This does conclude today's conference call.

Operator: Thank you all for participating and you may now disconnect.

[inaudible] us today, thank you all for joining us today, thank you all for joining us today, thank you all[inaudible] Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Scott Henry, Ross Osborn, Erez Meltzer, Mike Cavanaugh,[inaudible] Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, Anthony Petrone, Scott Henry, Ross Osborn, Erez Meltzer, .

[inaudible] .

Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission.

We will also refer to certain non-GAP financial measures to provide additional information to investors. A reconciliation of the non-GAP to GAP measures is provided with our press release with the primary differences being non-GAP net loss attributable to ordinary shares, non-GAP cost of revenue, non-GAP gross profit, non-GAP gross profit margin, non-GAP research and development expenses, non-GAP sales and marketing expenses, non-GAP general and administrative expenses, non-GAP other expenses or income in non-GAP gross loss per share.

With that, I'd now like to turn the call over to Erez Meltzer.

Thank you for joining us today and as always, we appreciate your continued support of Nano-X Imaging.

2024 has been a period of strong commercial progress while also advancing the value of our products through our clinical efforts as we continue to expand our deployment in the U.S, and the rest of the world.

We are not only accelerating deployment of the Nano-X RX system, but also expanding the footprint of the other value-edded elements of the full Nano-X solution including Nano-X AI.

As mentioned in previous calls, I am committed to providing further insights and detailed updates on our ongoing advancements in the coming periods.

I will begin with a discussion of our recent achievements which will cover regulatory updates, clinical advancements, commercial deployments, Nano-X AI updates and any production to our new Nano-X RX system which will call Nano-X RX.

After my prepared comments, I'll turn the call over to our CSO Ren who will review our Q2 financial results.

I will then share a few closing thoughts before turning the call over to the Q&A session.

We have a lot to discuss, so let's get started.

Before I provide an overview of our commercial progress, I will begin with some clinical and regulatory updates, which we believe will have a near-term positive impact on our commercial efforts. I'm happy to share the just last week Nano-X submitted a new 510K submission to the FDA, which is intended to expand the indications for our current Nano-X RX system in general thermosynthesis imaging. Once cleared, the submission will significantly expand the system's indication for use from the current MSK for general use, including chest. As you know, much of the clinical work we have been performing recently has centered around the suitability of the Nano-X RX for chest indications and was intended to support the submission.

The submission will include some software updates and is accompanied by a new clinical data for various body anatomies with and without pathologies.

To be clear, it is worth noting that all card-installed Nano-X Arc systems are hardware-ready and has the required capabilities to scan MSK, chest and abdomen, subject to the FDA clearance and the requisite regulatory approvals. This means that post-SBA clearance, a simple software upgrade that can be done remotely is all that will be necessary to bring currently deployed Nano-X Arc units up to the new standards.

Additionally, after completing the technical stages, including obtaining the ISO 13485 certification from BSI and successfully passing the MDR audit, we are now in advanced stages with our notified body to secure the CE mark for the E-origin. Rest assured, we will provide updates as soon as they are available.

Turning now to our global deployment and commercial efforts, which continued in the next second quarter, our team is diligently working with imaging centers, physicians and regulators to increase footprint of our Nano-X Arc technology. As of today's call, there are now dozens of units in various stages of shipment and deployment.

The deployments in the U.S, are spread across seven states, the newest being Delaware and California, which are awaiting state approvals, and we expect to grow this number as our commercial team executes our deployment and growth plan. To keep more color on our U.S, deployment, I would like to add that during the second quarter, we have installed Nano-X Arc system in three prominence healthcare chains operating imaging facilities across the U.S., including one of the largest in the industry. Additionally, in the U.S., some of the deployed sites have received certification from the corresponding states regulatory body and have begun to scan patients.

Others are in the process of obtaining approval. This commercial scanning activity is accelerating. For example, as of today, one of those sites have shown up to 14 scans per day.

We recently received good indications for validation of the U.S.

CPT and reimbursement process as we received management care EOB.

Since March 2024, we have been ramping up in the U.S, with current targeted backlog of 50 federal prop prospects and additional 44 leads in the pipeline.

With a main segment being outpatient imaging centers, medical imaging chains, and orthopedic centers, we understand that not all of these 94 leads will convert, but I'm very pleased with our commercial team's progress in such a short period, and we are very confident that this will continue to grow over time.

We are also awaiting the import license to deploy the first Nano-X Arc in Mexico with assistance ready for shipment. Additionally, there are two units fully deployed in Israel and another deployment is expected in the upcoming months for both clinical and commercial use.

We are able to pursue this opportunity as we obtained a mar approval several months ago.

Importantly, the number of daily scans is accelerating and in that July, we experience an average of 6.67 scans globally for all deployed Nano-X Arc systems accomplishing both clinical work and commercial patient scans.

I think it is interesting to learn that the global commercial and clinical scans by body parts are distributed as follows. 31% chest, 25% hand, 14% leg, and 14% spine.

But of course, these indications men vary from over time.

For those of you that are interested, we also have some new clinical samples on our website, including chest pathology.

To support our accelerating deployment effort, we continue to strengthen our team and infrastructure during the quarter, adding to our US sales and technical teams.

Looking ahead, Nano-X is dedicated to accelerating the execution of our commercial, infrastructure, and future strategic collaboration in the country.

Our mission is to provide healthcare practices with a transformative imaging advantage, with a Nano-X Arc an accessible cost effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care.

We are working to accelerate a steady flow of referrals from healthcare providers for Nano-X Arc digital tomography imaging as part of their diagnostic workflow.

We also continue to advance our other clinical efforts in multiple countries and locations.

Generating data, demonstrating the utility of the Nano-X Arc for a fuller wider range of indications is the key initiative for Nano-X. The reason is simple. If we can show large volumes of data demonstrating the evaluated utility of the Nano-X Arc, it will significantly boost our all-important commercial efforts. For example, the Bayley & Sanha Hospital in Israel has been scanning patients for exactly this reason, and this trial has begun to generate data.

There has been a few dozens of patients recruited at our clinical sites as part of this and the multi-site study. The previously announced multi-site trial is now operational, and we are accelerating patient scanning activity. The UGMC is in the final preparation to join the multi-site trial as the second participating sites, while already gaining clinical experience with the Nano-X Arc installed in scanning patients.

The MSKL trial held that Shamir Hospital has been completed and accompanied white paper publishers recently.

The study concluded that the Nano-X ARC was a value-edited tool in the Hospital's clinical workflow, enabling quicker diagnosis when used as a supplemented tool to the standard X-ray system, achieving faster diagnosis time as compared to the standard CT-based workflow.

Furthermore, all Nano-X ARC images were determined to be of high-diagnostic quality enabling optimal depiction of findings.

Our technology can increase the depiction of occult chest lesions, localized characterize and result questionable lesions even without prior adiologist experience.

Cold cathode PTS may have an improved diagnostic accuracy compared to CXR. Its capability to eliminate the need for CT at a fraction of the radiation dose cost and images per study should be further investigated.

For more information see more our white paper section on our website.

Turning to our AI business.

Just last month we announced that our Nano-X AI Cardiac solution called Health CCNG was highlighted in multiple scientific presentation at the 2024 Society of Cardiovascular Computed Tomography, SCCT Annual Meeting. We are encouraged by the implementation of our AI Cardiac solution at esteemed healthcare system along with a continuous validation through real-world studies of its potential to promote early detection and preventive care of cardiovascular diseases.

Chloro-Well Health has previously reported that in the first full year of implemented Health CCNG in its electronic medical record system there was a 13 fold increase of the patients reported in the previous two years.

At Bellinson Hospital in Israel, incidental coronary artery calcification on the CT scans of immune mediated inflammatory disease patients identified and quantified by our AI Cardiac solution was found in over 50 50 percent of scan patients and associated with all caused mortality and adverse cardiovascular outcome. Traditional cardiovascular risk scoring is difficult in these patients and Nano-X AI can be a valuable new tool in quantifying these risks.

After being installed and implemented the Jefferson-Einstein hospital Health CCNG help identify 757 patients, age 30 or above with CAC levels higher than 100 Agstone units.

In a study conducted by Mass Gen Hospital and Brigham Women Hospital, Health CCNG was used to analyze non-contrast chest CT scans of 260 patients who had measurements of lipoprotein A is part of clinical care, statistically significant correlation was founded between level of CAC, and this lipoprotein A is a risk factor for coronary atro sclerosis suggesting that this approach may be used to identify at risk patients.

As a sign-dote, the lead author of this study, Gritting Weber, was declared as young investigator, a word winner at the Sprout to be associated with dynamic clinical talent that is doing valuable work to support the use of the Nano-X AI solutions to identify potential health risks earlier in the care continuum and helping to drive better overall patient outcome.

Additionally, the previous agreements we signed for Nano-X AI with Coveira Health and W Leon Health are off to a great start and the feedback has been very positive thus far.

We are continually working to expand our AI footprint and make it accessible to a broader range of customers. Our ongoing innovation and development efforts are focused on enhancing our AI solution and ensuring they reach and benefit a wider audience.

I think I can speak of all of us at Nano-X when I say there is a lot to be excited about.

Looking ahead to the near future of Nano-X, we are always looking to improve and meet market needs. In fact, every dynamic company that plans to extend rapidly over the long term with a new technology needs to constantly refine their offering based on customer feedback changes in technology and evolving use case.

Nano-X is no different and we are constantly working on product and technology future developments.

I am very pleased to share for the first time that we are developing another Nano-X our system called Nano-X ArcX, which we intend to submit among others for FDA clearance.

Once cleared, it will be marketed along the current system, which will expand our current product offering.

At the high level, the Nano-X ArcX is designed to meet market needs for our customers, including hospitals and imaging centers, as well as our clinical partners who are using the Nano-X Arc to generate data for additional use cases.

Listening to the clinical needs is an important step in the ongoing expansion of Nano-X solution.

Amongst the future, I am able to share this time, the Nano-X ArcX will have an even smaller footprint than existing Nano-X ArcX, and Hansink, one of our key differentiators. The new system will also be easy to deploy in use with an anticipated one-day setup time and plug-and-play functionality.

There will also be image enhancement options in the new units which are currently not available on existing Nano-X art systems and future synthetic to be. Please note that we are planning to share more detail about the future Nano-X art system publicly during our next event which will also be made available via our website.

Stay tuned for further details.

To touch on our OEM efforts, I can report that we are well underway with the first phase of our development program with the U.S, government entity towards completion of a no-voltube design, utilizing our emitter and focused on the entity space.

We are optimistic.

We will move towards prototyping tubes the second half of this year.

Regarding our telerogology services, we are leveraging our U.S.A.

Radcline based on a network of rogology as a significant part of our U.S, deployment plan.

On the mass production front, we have finalized the second phase of our development with CSAM resulting in a high yield wafer with functional emitters. We are transitioning to production readiness and confident we have secured a second source of supply for our novel emitters.

Varics has completed their initial tubes prototype utilizing our emitter for testing to be integrated into our new Nano-X art.

I have covered a lot of ground today, so with that, I will hand the call over to Rand Daniel to review our financials.

Run?

Thank you, Ares.

We reported a gap net loss for the second quarter of 2024 of $13.6 million, which will refer to as the reported period compared with the net loss of $17.44 million in the second quarter of 2023, which I will refer to as the compare bill period. The decrease was largely due to a decrease of $2.1 million in the research and development expenses and a decrease of $1.7 million in the general and administrative expenses and increase of $0.5 million in the company's financial income, which was mitigated by an increase of $1.2 million in the company's gross loss.

Revenue for the reported period was $2.7 million and gross loss was $2.9 million on a gap basis compared to a revenue of $2.6 million and a gross loss of $1.7 million on a gap basis for the comparable period.

Nan gap gross loss for the reported period was $0.9 million as compared to a nan gap gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a nan gap basis for the reported period.

As compared to a gross profit margin of 34% on a nan gap basis in the comparable period. Revenue from the tele-radiology services for both the reported period and comparable period was $2.5 million with a gross profit of $0.4 million on a gap basis in the reported and comparable period, which represent a gross profit margin of approximately 15% on a gap basis for the reported and comparable period.

Nungap gross profit of the company's tele-radiology services for the reported and comparable period was $0.9 million, which represent a gross profit margin of approximately 36% on a nungap basis.

During the reported period, the company regenerated revenues through the sales of its AA solutions in the amount of $1,13,000 as compared to revenue of 53,000 in the comparable period.

During the reported period, the company generated revenues through the sales and deployment of its imaging systems, which amounted to $68,000 with a gross loss of $1.3 million on a gap basis. Those revenues stems from the sale and deployment of the Nano-X Arc systems in the US and the sales of R2D systems in Africa.

Research and development expenses for the reported period were $4.8 million as compared to $6.9 million in the comparable period. The decrease of $2.1 million was largely due to a decrease of $1.2 million in the salaries and wages. The decrease of $0.2 million in share-based compensation and a decrease of $0.7 million in expenses that are related to a research and development and regulatory activities.

Sales and marketing expenses for the reported and comparable periods were $0.8 million.

General and administrative expenses for the reported period were $5.9 million as compared to $7.6 million in the comparable period. The decrease of $1.7 million was mainly due to a decrease in our legal expenses in the amount of $1.6 million, largely as a result of the finalization of the SEC investigation and the settlement of the class action, and a decrease in the cost of directors and officers' liability insurance premium in the amount of $0.4 million.

Our non-gap net loss attributable to ordinary shares for the reported period was $8.4 million as compared to a non-gap net loss of $9.9 million in the comparable period. The decrease of $1.5 million was mainly due to a decrease in non-gap operating expenses of $2.2 million and an increase of $0.5 million in our non-gap interest income, which was offset by a decrease of $1.1 million in our non-gap gross profit.

Turning to our balance sheet, as of June 30, 2024, we had cash, cash equivalent with strictly deposit and marketable securities of approximately $64.2 million and we had a $3.2 million loan from a bank. We ended the second quarter of 2024 with a property and equipment net of $44.5 million.

As of June 30, 2024, we had approximately 58.5 million shares outstanding.

With that, I will end the call back over to Erez.

Thank you, Ran.

As we enter the second half of 2024, our team remains focused on executing our growth strategy by continuing to commercialize the Nano-X RX system as well as integrating Nano-XI solution into medical workflow.

Our vision is to extend Nano-X technology within and beyond hospitals targeting underserved segments like urgent care units and orthopedic clinics.

We deliver a seamless scan-to-diagnosis solution, leveraging AI for a smarter, more efficient healthcare with a focus on aligning innovation with clinical needs to enhance patient outcome globally.

Nano-X is dedicated to accelerating the execution of our commercial infrastructure and future strategic collaborations in the U.S.

Our mission is to provide healthcare practices with a transformative imaging advantage with a Nano-X RX, an accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care.

Before we conclude our remarks today, I'd like to thank my fellow colleagues, customers and shareholders for their support of Nano-X and our mission.

As always, I am available to meet with you and look forward to sharing the insights of Nano-X RX and the upcoming events.

With that operator, let's now open the call for questions.

Operator, can you pause for a second?

I'd like to make one more comment.

Okay?

Yes, sir.

Okay.

So in addition to everything we said, I'm happy to announce that as just today, we received another FDA clearance for the health CCNG version 2.0, which is an upgraded version of advanced AI cardiac solution, empowering physicians in assessment of coronary artery calcium. The health CCNG version 2.0, an upgraded version of the cardiac solution, introduces additional zero calcium categorization of coronary calcium, CAC, and generates an exact calcium score with corresponding CAC detection category in output.

For us, it is very pleasing to receive further regulatory validation from the FDA for our AI cardiac solution.

So thank you and with that now we will turn the open the call for questions.

Thank you.

As a reminder to ask a question, please press star one one of your telephone away for your name to be announced. To withdraw your question, please press star one one again.

Our first question comes from the line of Jeffrey Cohen with Latin Bird.

Your line is now open.

Good morning, Erez and Ran.

How are you?

Good.

Good morning.

So I wondered firstly, could you expand upon a little bit regarding your your backlog as far as imaging when you spoke about 50 on sales and 34 on leads.

Could you give us a sense of where those units are, imagine they're most domestic U.S, and how that follow looks for actually placements in training over the coming quarters?

Okay, so I think that we mentioned last time the number of 20 right now the number was growing to more than triple as you can imagine in various stages of deployment.

We have a few dozens which are already deployed.

A few that are waiting for approval regulatory, the state approvals because they are spread over seven states and the last two states are waiting for approvals.

And we believe that the indication that we gave which 50 50 of them are probably favorable to be installed.

And the 44 in the leads in the beginning of the process, we are getting to the targeted that we wanted to be by the end of the year and that's where we are.

Okay, got it.

And then congratulations on the news today for a calcium score.

Could you talk a little bit about these other 510K indications and for general term as well in addition to general trust?

And could you talk about the codes associated with them as far as reimbursement at facilities?

Okay, so with maybe I'll start with the end with the reimbursement right now what we speak about the reimbursement is based on the Tomo CPT code, which is 76100.

And this is the basis for the reimbursement of those that submitted their scans for the reimbursement.

We received only already indications from more than from from the two I think that insurance insurers, so this is continues to grow.

So the numbers that we received are in line of the model that that we put together.

So basically right now it seems that the for the clinics that and the sides that the system is installed.

So the model is profit.

With respect to the 510K, so in addition to the new one of the CCS or the calcium scoring that we received today, we have submitted the similar, it's in line of what we have indicated in the past that we are going to submit to submit this year, the additional clinical indications, especially the chest.

We decided that we're going to submit it for whole body, so including the chest, not only, but by the time that we get this clearance, then even in the US, not only in the rest of the world, we are able to scan the whole body and basically everything, bear in mind that in the rest of the world, and especially part of the others, and including the submission of the CE, we are using the fact that the hardware is how they're ready for whole body and we are using it to all the clinical indications.

Based on this indication, I gave in this quote today, I gave indication of the spread between the various body anatomies or body parts that were received, and I gave the percentage that we have on a global basis, and you can see the chest is a major part of them.

Got it, and then one more if I may, could you talk a little bit more about the RCAX platform and perhaps its form factor and differences where should the current platform and the intended commercial presence area anticipate as compared to the current platform.

First of all, we are going to give more details within the next, I would say, end of this quarter and beginning of the next quarter.

We are of course going to submit it to the SBA, and after the SBA clearance, it will be marketed as a long, along the current system, which will expand our product offering, and we mentioned a few times in the past that the ARC, or the first version, point two, is not the first product, and it's definitely not the last, and we haven't lined up a real product roadmap for the future.

ARC X is one of them.

We will give more indications, but I think that the idea is to make the ARC X available to more specific locations or sites that are more suitable for the spec of the system.

We are talking about footprint, we are talking about we are talking about, first of all, even for us, it's the cost of manufacturing, the retirement investment, the features, and the beauty of it that whenever we are going to install it, we're going to enable all the features that are coming with the software and the features to be installed remotely, so we don't have to send the technicians to do it.

It's download from the network.

Thank you, Jeff.

Thank you.

Our next question comes from the line of Scott Henry with the AGP.

Your line is now open.

Thank you and good morning or afternoon depending where you are.

Just a couple of questions.

Congratulations again the 510K application in for the general use and chest indication.

Could you give any thoughts on what you would expect the review timeline to be for that indication?

What is it typically in this case just to get a sense of when we may get final approval?

First of all I hope that I understand the question so I'll give the answer and if not you will tell me.

Bear in mind that I'm up until now all the the revenues and the scans that were conducted in the US in the few dozens of systems which are installed are mainly MSK.

MSK, spine, hand leg, etc.

And not chest.

We all know that the chest is the most common use of X-ray and especially when we talk about the Thomas synthesis.

So we expect that once once we get the clearance it will definitely increase the likelihood of sites and the customers to take the arc and more than that the in the sites that the system is going to be installed it will increase the number of scans per day because it will be used for other indications as stated.

Is this what you asked or?

Well that's very helpful thank you and I guess the question I initially was hoping to get some sense and how long do you expect the review period to be for that 510K?

I wish I could tell you I do hope that it will be faster than that previous processes that other companies as well as us experience since COVID but I think that the fact that the system itself is already cleared and it will enhance the process but I cannot even guesstimate the time.

Well that's helpful I would say I would say the following I'm not happy to guesstimate because the last thing I want is that I will give an estimate and then it will for some reason be longer so I will be happy to announce that it's cleared once it's cleared and everyone can imagine that the period that it will take.

Okay I appreciate that feedback.

Second question you mentioned the installed Nanox arc systems in the three chain medical imaging.

Service Providers in the U.S.

Have you got any feedback on it from those three chains and how that's working out and perhaps what kind of expands and opportunities there would be.

It may be too early, but I just wanted to get a sense of how that was going so far.

So especially for those of the people who are actually on the call that you hear in the beginning, or I would say at the end of 2023 and at the beginning when we started the test or the pilot or what we call the soft launch of the arc in the U.S., we said that we're going in the first quarter or two, we are going to gain feedback from each one of the customers, not only from the chains, but we are getting a lot of feedback from the customers.

Feedback on a clinical basis on the maintenance, on the usage, on the pattern of the body parts and the anatomies that it's being used, the clinical use, so far and this is something that encouraged us to accelerate the installation and the deployment.

We received a very good feedback and I think that what we see is a lot of examples of places that this system is replacing CT, places where they didn't have in mind to install or to deploy a system and they decided to do it.

Overall, the feedback is very good.

I would say that probably in the next few months we will get even better visibility on the usage, on the process, on the installation, on the regulatory processes and we will always, as indicated even in today's call, we will always implement them and improve our service and our products accordingly.

Okay, great, thank you for that feedback.

Final question, when we're thinking about Q3 relative to Q2, should we expect any seasonality in the US?

The summer months, do they tend to be a little slower with a pickup in the fourth quarter, just trying to get a sense of what kind of cadence we should expect through the year?

Frankly speaking, right now we don't expect any seasonality, especially due to the fact that we are ramping up our installed base, so we will probably see anyhow a better result, but right now we are not planning or expecting to have any seasonality with effect.

Okay, great, thank you for taking the questions.

Thank you.

As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Our next question comes from the line of Ross Osborne with Canter Fitzgerald.

Your line is open.

Hey guys, thanks for sharing the questions.

So starting off seems like you are at the point of inflection in terms of deployments.

With that in mind, can you walk through your current manufacturing capabilities and where your various contract initiatives stand?

So you're right about what you said.

In terms of manufacturing, I would say the following.

The two chips, we have no problem.

We have available chips right now.

We were able, due to the results of the high yield wafers that we get from CSAM.

We have two suppliers and I think that this is not an issue in terms of the cubes.

We have already the cubes that are coming from Korea.

We have the tubes that are coming from the plant in Europe.

And in the last but not least, the VARIC has completed their initial tube prototype utilizing our emitter and for this is for testing.

So I hope that it will be integrated into our new Nano-X Arc system shortly and it will be part of the available production.

In terms of the production of the assembly of the system, we have made the appropriations that are in the site in Israel that we're moving forward and we've increased the capacity of the manufacturing to enable what is needed.

In the next few quarters and the local manufacturing arrangements that we have will enable us to ramp up next year, even higher than what we are currently doing.

So right now, I would say that it seems to be in line of what is needed for the next few quarters.

Thank you.

We are working on the next ramp up for 2025 to be announced.

Got it.

Later.

Perfect.

Thank you.

Following up on my previous question, would you remind us how large your US sells forces today and then any plans for adding to the team?

So right now, right now, we actually work with, I would say when it's about 10 people all together.

And if I had the independent agents, then I think that we are right now at around 15.

We are expecting to grow them to the number of 30 in the foreseeable future.

Great.

And then last one for us.

This is what I said is that that's what that's what we anticipate for 2025 to be around 30 to 40.

Thank you.

Got it, got it.

Thank you.

And then lastly, just an anticipation to see Mark approval, would you walk us through your commercialization plan in Europe and other related geographies in terms of what type of medical centers you will be targeting, if you'll build out your own self-sourced or leveraged distributor there, and lastly what the reimbursement environment looks like?

Okay, so with respect to the rest of the world, first of all, there are a few countries that, if you remember, we have agreements that were signed in the past and we are going to deploy them once the clearance in these countries are expected to be received.

So I mentioned today, one of them, Mexico is really coming very shortly.

I will be there next month to visit the places they are planning to install the arc.

So this is one.

We were talking about another one or two countries in Latin America.

In terms of Europe, we are waiting for the CE approval as indicated previously and we are in the really in the final process of the of the CE approval.

Once we get the CE, so all the countries that were part of the agreements that we signed, like Australia, like New Zealand, like Spain, we're going to use them.

In each one of them, it's going to be the distributors that are going to do the work.

If you remember, I mentioned about a year ago that right now, only in the US, Israel and the UK, we're planning to have our own people and in the rest of the world, we are planning to have distributors.

We are right now already in the last quarter and this quarter in touch with these distributors in order to ensure that we have a plan.

Our people visited already a few locations in each one or not in each one in most of these countries.

Right now, we are talking in Europe and in Mexico.

We are talking about a medium to large medical centers.

Got it.

Thanks for taking our questions.

We can grab the camera on the quarter.

Great.

Thank you.

And I'm currently showing no further questions at this time.

This does conclude today's conference call.

Thank you all for participating and you may now disconnect.

Q2 2024 Nano-X Imaging Ltd Earnings Call

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