Q2 2024 Hyperfine Inc Earnings Call
acute care settings, which can be crucial for time-sensitive medical conditions, such as strokes, where time is brain.
Artificial intelligence remains a powerful engine behind our sequence development innovation.
And it has been very rewarding to see how our total number of AI-powered marketing authorizations
places our company in a leading position on the FDA's list of artificial intelligence and machine learning-enabled medical devices recently published.
On the clinical front,
Enrollment began in the CARE PMR study in Alzheimer's program, and it has been progressing well.
We are now scanning for the detection of ARIA complications in patients who are taking amyloid-targeting therapy at three Lechembe infusion programs and are in discussions with several other potential study sites.
As a reminder, CARE PMR compares portable ultra-low-field brain MRI with a high-field commercial MRI to assess the ability of the tube system to detect aria complications in patients taking amyloid targeting therapies.
Speaker Change: And just last week at the Alzheimer's Association International Conference, Washington University and Matt General Brigham presented very promising initial data on aural infection with soup as well as the use of soup
for monitoring the progression of Alzheimer's.
Speaker Change: The first poster was presented by Dr. Okafor from Washington University and included the images of one of the first ARIA cases observed in the study on both a conventional 3-Tesla scanner and the two ultra-low field portable scanners.
Speaker Change: The second poster presented by Dr. Taylor Kimberley from Mass General Brigham.
Speaker Change: focused on the quantitative assessment of ultralow-field MRI images.
Speaker Change: compared to conventional high-field MR images in evaluating brain morphometry in Alzheimer's patients and highlighted a strong agreement in volume between conventional MR images and group images.
Speaker Change: The author concluded, quote, given its portability and low operational cost, low field MRI folks promise as a valuable tool to diagnose Alzheimer's disease and monitor its progression, end of quote.
Speaker Change: There are real workflow benefits to bringing brain imaging closer to patients with Alzheimer's disease, their clinicians, and care partners.
Speaker Change: with a potential to have substantial impact in access, cost and equity in Alzheimer's care.
Speaker Change: We expect to significantly optimize workflow and ultimately open up the opportunity for more patients to be monitored and treated safely and efficiently at different sites of care.
Speaker Change: In stroke, Action CMR is progressing well. This is a multi-sensory evaluation assessing the use of the soup system for the triage of acute ischemic stroke.
Speaker Change: The initial 100 patients have been enrolled to evaluate acute stroke detection with a tube system as compared to CT and conventional MRI.
Speaker Change: Recently, we announced the publication of a subset of data from the study providing early evidence that the soup system is a promising tool for enabling critical stroke treatment choices in urgent care settings.
Speaker Change: The data is published in the August 2024 edition of Annals of Neurology and highlights ophthalopheal MRI's ability to be used as a tissue clock to characterize acute stroke.
Speaker Change: We look forward to having additional data shared later this year. We also plan to launch the workflow phase of our study to assess the efficiency and economic value of accessible brain MRI in ED and spoke settings to triage stroke.
Speaker Change: Now, based on the momentum we have across all of our initiatives, I want to provide more detail on the acceleration we expect to see in our business as early as 2025.
Speaker Change: We have also detailed these catalysts on slide 12 of our most recent investor presentation deck, which can be found on our investor relations site.
Speaker Change: As the field of Alzheimer's care continues to rapidly evolve, we are generating data to support the clinical utility and workflow benefits of the SUCC system for this patient population.
Speaker Change: We anticipate that we will be placing two systems in neurology clinics, infusion centers, and other Alzheimer's care programs commercially in the second half of 2025.
Speaker Change: The Stroke Opportunity will open up the placement of stroke units in EDs and Hub-and-Folk Stroke Networks.
Speaker Change: Cell-free art is creating significant challenges in EDs across the U.S. resulting in considerable clinical and economic burden.
Speaker Change: With the ease that the system can provide a readily available MRI tool to triage a stroke in EDs and both sides, positively impacting stroke care and cost.
Speaker Change: We anticipate EV placements to be incremental to critical care placements in the hospital setting, and we expect revenue contributions from this opportunity starting in the second half of 2025.
Speaker Change: We have also been pursuing opportunities outside of the hospital. I would like to now provide detail on our entrance into the neurology office setting as a new and additional business for subsystem placement.
Speaker Change: Our initial step in our plan to enter neurology offices is obtaining accreditation.
Speaker Change: And we are pursuing expanded out-of-hospital and clinic-setting accreditation through the Inter-Societal Accreditation Commission, IAC.
Speaker Change: which we anticipate being completed by the end of this year.
Speaker Change: Additionally, the American College of Radiology Accreditation recently revised their safety manuals to include new language regarding the safety profile and training requirements of low field point-of-care MRI.
Speaker Change: We are pleased that major accreditation bodies are now formally acknowledging the importance and emergence of low-field, point-of-care MRIs.
Speaker Change: We are mobilizing resources to support this new opportunity for Hyperfine. And we expect to see revenue contributions from the new office business also in the second half of 2025.
Speaker Change: Furthermore, international expansion will be another growth driver in 2025, as we will have a full year of our international distribution network in place, as well as a potential regulatory approval in India in the second half of the year.
Speaker Change: Clinical use internationally is similar to what we have seen and trying to do in the U.S. and we anticipate good system placement in international markets across multiple types of care including adult and pediatric care settings.
Speaker Change: The diverse food system adoption, expansion, and growth opportunities ahead of us are all large and compelling.
Speaker Change: The fundamentals of our business are solid, built on our proprietary technology, our leadership position, our track record of innovation, our healthy gross margin profile, and strong spending discipline.
Speaker Change: We have multiple large and near-term opportunities to grow from a strong foundation and I am confident we will see significant business acceleration in 2025 and beyond.
Speaker Change: I would now like to turn the call over to Brett to review our performance in the quarter.
Brett: Thank you, Maria. Turning to our financial results for the second quarter of 2024.
Brett: Revenue for the quarter ended June 30, 2024 was $3.6 million, up 7% compared to the second quarter of 2023, and up 10% compared to the first quarter of 2024.
Speaker Change: Gross profit for the second quarter of 2024 was $1.8 million, compared to $1.4 million in the second quarter of 2023, resulting in a record gross margin of 50%.
Speaker Change: R&D expenses for the second quarter of 2024 were $5.9 million, compared to $5.3 million in the second quarter of 2023.
Brett: Sales, general, and administrative expenses for the second quarter of 2024 were $6.7 million compared to $7.8 million in the second quarter of 2023. As outlined by Maria, we continue to invest in the areas of innovation and operate lean.
Maria Sainz: Net loss for the second quarter of 2024 was $10.1 million equating to a net loss of $0.14 per share as compared to a net loss of $10.6 million or a net loss of $0.15 per share for the same period of the prior year.
Maria Sainz: The improvement in net loss was a result of our strong revenue, expanding growth margin, and continued spending discipline and cost-saving initiatives implemented across the business over the past year.
Maria Sainz: Our cash burn in the second quarter of 2024 was $9.4 million, and as of June 30, 2024, we have $53.8 million in cash and cash equivalents on our balance sheet.
Maria Sainz: Turning to guidance, we are raising our revenue outlook for the full year 2024 to a range of $13 to $16 million. We expect continued commercial progress in the second half of the year with the expectation of some summer seasonality impact given our increased mix of international revenue.
Maria Sainz: We are driving healthy margins, even at small scale, and we were pleased to drive a record 50% growth margin in the second quarter of 2024.
Maria Sainz: We have a differentiated and attractive profile among medical imaging companies and companies at our scale, and we are optimistic that we will surpass 50% growth margins comfortably and sustainably over time as we realize the commercial acceleration from our growth catalyst.
Maria Sainz: For the full year 2024, we continue to expect gross margins to be in the range of 45 to 50 percent.
Maria Sainz: We continue to anticipate total cash burn of approximately $40 million for the full year 2024. We expect our cash burn to be below 2023 levels and we will execute this plan while sustaining investments in our key growth drivers.
Maria Sainz: We also continue to see a cash runway for the business into early 2026, funding the commercial realization of the growth catalyst Maria mentioned previously.
Maria Sainz: At this point, I'd like to turn the call back to Maria for closing comments.
Maria Sainz: Thank you, Brett. I'm proud of the strong progress the Hyperfine team made in the second quarter and year to date, both advancing our growth initiatives and delivering record revenue.
Maria Sainz: I remain very optimistic in our ability to execute and deliver significant business acceleration in 2025 and beyond.
Speaker Change: Just last week, I was able to witness firsthand the interest and enthusiasm for what portable MRI scans represent in Alzheimer's care.
Speaker Change: The Alzheimer's disease field is an area of huge unmet need, with significant investment from the pharma industry, global policy makers, and advocacy groups.
Speaker Change: It is rapidly evolving and the focus on access, equity, and workflow simplification is often in the center of the debate, which reinforces how we assess the fit and the potential for the subsystem.
Speaker Change: With that, I want to thank you for your time and open up the line for questions.
Maria Sainz: [inaudible]
Speaker Change: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again.
Maria Sainz: If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.
Maria Sainz: We will pause for just a moment to compile the Q&A roster.
Speaker Change: Your first question comes from the line of Yuan Zhi, from B Riley. Please go ahead.
Maria Sainz: Maria, congratulations on a very good quarter and thank you for taking our questions. I've got a couple of questions here.
Long: We'd love to hear the reasons for you to update the guidance here. Was it driven by your U.S. sales force?
Speaker Change: or was it partially contributed by the international sales? And then if you can comment on your confidence reaching the guidance here, that would be great. Then I have another follow-up.
Speaker Change: Sure, thank you Yuan. So clearly the first half has been a strong first half and we're closing the first half with a strong momentum.
Speaker Change: across both our U.S. and our international channels. And that has gotten us to really raise the guidance with confidence that we can deliver a little bit more than we thought before in light of how well the international channel has responded.
Speaker Change: with our support but also the strength of the pipeline in the U.S. both in adult and pediatric hospitals which we have been mentioning for the last few quarters.
Speaker Change: Got it, got it. So, it was great to see the poster presentation at AIC, and I have heard positive feedback on the product demonstration. I'm just curious, have you thought about the timeline to convert some of the leads from AIC into others?
Speaker Change: Great question. And yes, we were very, very pleased with the reception at AAIC of our technology, the image quality, the patient experience.
Speaker Change: We had over 300 of the participants who volunteered and waited in line to get scanned with our device to experience firsthand what that would represent to their patients.
Speaker Change: And we had many of them also check in with Dr. Knopp, our medical officer, in our viewing station and look at the images and the quality of the images.
Speaker Change: It is a little early to know how quickly a lot of these interests will funnel into orders, but we definitely came home with a long list of follow-up items.
Speaker Change: across a lot of interesting opportunities.
Speaker Change: Definitely, we uncover some of the larger LICMB programs that are out there that would be great targets for us to continue to collect.
Speaker Change: Arya Data. Thank you.
Speaker Change: There was interest from some of the other industry players that we're following up.
Speaker Change: There was renewed and continued interest from some of the ADRCs we had already contacted that are willing to go a little bit faster and getting involved with our technology. There was also interest around doing community-based screening using our device to keep filling the funnel of potential likely candidates for the ATT drug therapy.
Speaker Change: So we are anticipating, and we've chosen to add a slide to our investor deck, that really the entry commercially into Alzheimer's is really right around the second half of next year.
Speaker Change: So we are really seeing it as a growth, as a revenue contributor starting about that timeframe.
Speaker Change: Got it. One last question before I jump back to the queue. I'm curious, any updates we should be watch at the CTAS clinical trial in Alzheimer's disease conference in Madrid at the end of October ?
Speaker Change: Yes, great question. And, of course, that is our next very important Alzheimer's meeting, that is the CPAD, so Clinical Trials in Alzheimer's Disease, which, as you said, is the end of October in Madrid. We will have additional data presented from the Washington University group, which is the same one that presented
Speaker Change: on one of the very first ARIA cases on our technology.
Speaker Change: Side by side, really the same case on a 3T technology, which is the encouraging sort of token that starts pointing to the merit of our technology in detecting ARIA.
Speaker Change: So expect to see more data presented by Dr. Okafor again in Madrid late October .
Speaker Change: Got it. Great. Thanks for taking our questions. And again, congrats on a good culture.
Speaker Change: Excellent. Thank you very much.
Speaker Change: There are no more questions at this time. That concludes our Q&A session. I will now turn the call back over to Maria Sainz for closing remarks. Please go ahead.
Maria Sainz: Thanks to all for joining us here today. We look forward to further updates from Hyperfine next quarter.
Speaker Change: i
Speaker Change: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: [inaudible]
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Speaker Change: And the winner is...
Speaker Change: Thanks for watching this video.
Speaker Change: Good afternoon and welcome to Hyperfine's 2nd Quarter 2024 Earnings Conference Call.
Speaker Change: Currently, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
Marissa Bych: I would now like to turn the call over to Marissa Bych from Gilmartin Group for introductory disclosures.
Speaker Change: that
Speaker Change: [inaudible]
Marissa Bych: Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended June 30, 2024. A copy of the press release is available on the company's website, as well as sec.gov.
Speaker Change: Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Speaker Change: Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements.
Speaker Change: All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance.
Speaker Change: Expense Management, Expectations for Hiring, Training and Adoption, Growth in our Organization, Market Opportunity, Commercial and International Expansion, Regulatory Approvals, and Product Development are based upon our current estimates and various assumptions.
Speaker Change: These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.
Speaker Change: Accordingly, you should not place undue reliance on these statements.
Speaker Change: For a list and description of the risks and uncertainties associated with our business, please refer to the risks factors section of our latest periodic filing with the Securities and Exchange Commission.
Speaker Change: This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 8, 2024.
Speaker Change: Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.
Speaker Change: And with that, I will turn the call over to Maria Sainz, President and Chief Executive Officer of Hyperfine.
Maria Sainz: Good afternoon and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale.
Speaker Change: A strong performance in 2024 continued in Q2 with a record quarter at $3.6 million in total revenue and a balanced mix of U.S. and international deals.
Speaker Change: in the U.S.
Speaker Change: We continue adding flagship accounts to our ranks of early and enthusiastic users, and the pipeline is growing strong.
Speaker Change: International contributions to revenue were also very healthy in Q2. We are pleased with the engagement and performance of our distribution network. I would like to share that we conducted our first in-person service and product training session for our global partners early in the quarter.
Speaker Change: Beyond our strong commercial traction, we achieved several important milestones associated with our innovation and clinical program.
Speaker Change: The recently announced clearance by the FDA of our ninth generation AI-powered software marks a critical step forward in the imaging capability of our unique ultra-low field portable brain MRI.
Speaker Change: We are now able to upgrade the image quality and reduce acquisition time, delivering higher overall clinical performance.
Speaker Change: Reducing scan times may help us speed up the diagnostic process in certain clinical circumstances like acute care settings, which can be crucial for time-sensitive mental conditions such as stroke, where time is brain.
Speaker Change: Artificial intelligence remains a powerful engine behind our sequence development innovation.
Speaker Change: And it has been very rewarding to see how our total number of AI-powered marketing authorizations
Speaker Change: places our company in a leading position on the FDA's list of artificial intelligence and machine learning-enabled medical devices recently published.
Speaker Change: On the clinical front,
Speaker Change: Enrollment began in the CARE PMR study in Alzheimer's program, and it has been progressing well.
Speaker Change: We are now scanning for the detection of ARIA complications in patients who are taking amyloid targeting therapy at three Lechembe infusion programs, and are in discussions with several other potential study sites.
Speaker Change: As a reminder, CURE-PMR compares portable ultra-low-field brain MRI with a high-field conventional MRI to assess the ability of the tube system to detect ARIA complications in patients taking amyloid targeting therapies.
Speaker Change: And just last week at the Alzheimer's Association International Conference, Washington University and Matt General Brigham presented very promising initial data on aural infection with soup as well as the use of soup
Speaker Change: or monitoring the progression of Alzheimer's.
Dr. O'Confort: The first poster was presented by Dr. Okafor from Washington University and included the images of one of the first ARIA cases observed in the study on both a conventional 3-Tesla scanner and the Supe Ultra Low-Field Portable Scanner.
Dr. O'Confort: The second poster presented by Dr. Taylor Kimberly from Mass General Brigham.
Speaker Change: Focus on the quantitative assessment of ultralow-field MRI images.
Speaker Change: compared to conventional high-field MR images in evaluating brain morphometry in Alzheimer's patients and highlighted a strong agreement in volume between conventional MR images and sub-images.
Speaker Change: The author concluded, quote, given its portability and low operational cost, low field MRI folks promise as a valuable tool to diagnose Alzheimer's disease and monitor its progression, end of quote.
Speaker Change: There are real workflow benefits to bringing brain imaging closer to patients with Alzheimer's disease, their clinicians, and care partners.
Speaker Change: We have potential to have substantial impact in access, cost, and equity in Alzheimer's care.
Speaker Change: We expect to significantly optimize workflow and ultimately open up the opportunity for more patients to be monitored and treated safely and efficiently at different sites of care.
Speaker Change: In stroke, ACTION-PMR is progressing well. This is a multi-sensory evaluation assessing the use of the soup system for the triage of acute ischemic stroke.
Speaker Change: The initial 100 patients have been enrolled to evaluate acute stroke detection with a tube system as compared to CT and conventional MRI.
Speaker Change: Are you okay?
Speaker Change: We announce the publication of a subset of data from the study, providing early evidence that the soup system is a promising tool for enabling critical treatment choices in urgent care settings.
Speaker Change: The data is published in the August 2024 edition of Annals of Neurology and highlights ophthalopheal MRI's ability to be used as a tissue clock to characterize acute stroke.
Speaker Change: We look forward to having additional data shared later this year. We also plan to launch the workflow phase of our study to assess the efficiency and economic value of accessible brain MRI in ED and spoke settings to triage stroke.
Speaker Change: Now, based on the momentum we have across all of our initiatives, I want to provide more detail on the acceleration we expect to see in our business as early as 2025.
Speaker Change: We have also detailed these catalysts on slide 12 of our most recent investor presentation deck.
Speaker Change: which can be found on our investor relations site.
Speaker Change: As the field of Alzheimer's care continues to rapidly evolve, we are generating data to support the clinical utility and workflow benefits of the SUCC system for this patient population.
Speaker Change: We anticipate that we will be placing subsystems in neurology clinics, infusion centers, and other Alzheimer's care programs commercially in the second half of 2025.
Speaker Change: The Stroke Opportunity will open up the placement of stroke units in EDs and hub-and-spoke stroke networks.
Speaker Change: Cell-free art is creating significant challenges in EDs across the U.S. resulting in considerable clinical and economic burden.
Speaker Change: With the ease that the system can provide a readily available MRI tool to triage a stroke in EDs and stroke sites, positively impacting stroke care and cost.
Speaker Change: We anticipate ED placements to be incremental to critical care placements in the hospital setting, and we expect revenue contributions from this opportunity starting in the second half of 2025.
Speaker Change: We have also been pursuing opportunities outside of the hospital.
Speaker Change: I would like to now provide detail on our entrance into the Neurology Office setting as a new and additional business for subsystem placement.
Speaker Change: Our initial step in our plan to enter neurology offices is obtaining accreditation.
Speaker Change: And we are pursuing expanded out-of-hospital and clinic-setting accreditation through the Inter-Societal Accreditation Commission, IAC.
Speaker Change: which we anticipate being completed by the end of this year.
Speaker Change: Additionally, the American College of Radiology Accreditation recently revised their safety manuals to include new language regarding the safety profile and training requirements of low field point-of-care MRI.
Speaker Change: We are pleased that major accreditation bodies are now formally acknowledging the importance and emergence of low-field, point-of-care MRIs.
Speaker Change: We are mobilizing resources to support this new opportunity for Hyperfine. And we expect to see revenue contributions from the new office business also in the second half of 2025.
Speaker Change: Furthermore, international expansion will be another growth driver in 2025, as we will have a full year of our international distribution network in place, as well as a potential regulatory approval in India in the second half of the year.
Speaker Change: Clinical use internationally is similar to what we have seen and trying to do in the U.S. and we anticipate subsistence placement in international markets across multiple types of care including adult and pediatric care settings.
Speaker Change: The diverse food system, adoption, expansion, and growth opportunities ahead of us are all large and compelling.
Speaker Change: The fundamentals of our business are solid.
Speaker Change: Built on our proprietary technology, our leadership position, our track record of innovation, our healthy gross market profile, and strong spending discipline.
Speaker Change: We have multiple large and near-term opportunities to grow from a strong foundation and I am confident we will see significant business acceleration in 2025 and beyond.
Speaker Change: I would now like to turn the call over to Brett to review our performance in the quarter.
Brett Hale: Thank you, Maria.
Brett Hale: Turning to our financial results for the second quarter of 2024, revenue for the quarter ended June 30, 2024 was $3.6 million, up 7% compared to the second quarter of 2023, and up 10% compared to the first quarter of 2024.
Brett Hale: Gross profit for the second quarter of 2024 was $1.8 million compared to $1.4 million in the second quarter of 2023, resulting in a record growth margin of 50%.
Brett Hale: R&D expenses for the second quarter of 2024 were $5.9 million, compared to $5.3 million in the second quarter of 2023.
Dales: Sales, general, and administrative expenses for the second quarter of 2024 were $6.7 million compared to $7.8 million in the second quarter of 2023. As outlined by Maria, we continue to invest in the areas of innovation and operate lean.
Brett Hale: Net loss for the second quarter of 2024 was $10.1 million equating to a net loss of $0.14 per share as compared to a net loss of $10.6 million or a net loss of $0.15 per share for the same period of the prior year.
Speaker Change: The improvement in net loss was a result of our strong revenue, expanding growth margin, and continued spending discipline and cost saving initiatives implemented across the business over the past year.
Speaker Change: Our cash burn in the second quarter of 2024 was $9.4 million, and as of June 30, 2024, we have $53.8 million in cash and cash equivalents on our balance sheet.
Speaker Change: Turn it to God.
Speaker Change: We are raising our revenue outlook for the full year 2024 to a range of $13 to $16 million. We expect continued commercial progress in the second half of the year with the expectation of some summer seasonality impact given our increased mix of international revenue.
Speaker Change: We are driving healthy margins, even at small scale, and we were pleased to drive a record 50% growth margin in the second quarter of 2024.
Speaker Change: We have a differentiated and attractive profile among medical imaging companies and companies at our scale, and we are optimistic that we will surpass 50% growth margins comfortably and sustainably over time as we realize the commercial acceleration from our growth catalyst.
Speaker Change: For the full year 2024, we continue to expect gross margins to be in the range of 45-50%.
Speaker Change: We continue to anticipate total cash burn of approximately $40 million for the full year 2024. We expect our cash burn to be below 2023 levels, and we will execute this plan while sustaining investments in our key growth drivers.
Speaker Change: We also continue to see a cash runway for the business into early 2026, funding the commercial realization of the growth catalyst Maria mentioned previously.
Speaker Change: At this point, I'd like to turn the call back to Maria for closing comments.
Maria Sainz: Thank you, Brett. I'm proud of the strong progress the Hyperfine team made in the second quarter and year to date, both advancing our growth initiatives and delivering record revenue.
Speaker Change: I remain very optimistic in our ability to execute and deliver significant business acceleration in 2025 and beyond.
Speaker Change: Just last week, I was able to witness firsthand the interest and enthusiasm for what portable MRIs can represent in Alzheimer's care.
Speaker Change: The Alzheimer's disease field is an area of huge unmet need, with significant investment from the pharma industry, global policy makers, and advocacy groups.
Speaker Change: It is rapidly evolving and the focus on access, equity, and workflow simplification is often in the center of the debate, which reinforces how we assess the fit and the potential for the subsystem.
Speaker Change: With that, I want to thank you for your time and open up the line for questions.
Speaker Change: Thank you. The floor is now open for questions.
Speaker Change: If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again.
Speaker Change: If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.
Speaker Change: We will pause for just a moment to compile the Q&A roster.
Speaker Change: Your first question comes from the line of Yuan Zhi, from B Riley, please go ahead.
Yuan Zhi: Maria, congrats on a very good quarter, and thank you for taking our questions. I got a couple of questions here. First, I would love to hear the reasons for you to update the guidance here. Was it driven by your U.S. sales force, or was it partially contributed by the international sales? And then, if you can comment on your confidence reaching the guidance here, that would be great, and I have another follow-up.
Speaker Change: Sure, thank you Yuan. So clearly the first half has been a strong first half and we're closing the first half with a strong momentum.
Speaker Change: across both our U.S. and our international channels.
Speaker Change: And that has gotten us to really raise the guidance with confidence that we can deliver a little bit more than we thought before in light of how well the international channel has responded.
Speaker Change: with our support but also the strength of the pipeline in the U.S. both in adult and pediatric hospitals which we have been mentioning for the last few quarters.
Speaker Change: Got it, got it.
Speaker Change: So, it was great to see the poster presentation at AIC and I have heard positive feedback on the product demonstration. I'm just curious, have you thought about the timeline to convert some of the leads from AIC into others?
Speaker Change: Great question. And yes, we were very, very pleased with the reception at AAIC of our technology, the image quality, the patient experience.
Speaker Change: We had over 300 of the participants who volunteered and waited in line to get scanned with our device to experience first-hand what that would represent to their patients.
Speaker Change: And we had many of them also check in with Dr. Knopp, our medical officer, in our viewing station and look at the images and the quality of the images.
Speaker Change: It is a little early to know how quickly a lot of these interests will funnel into orders, but we definitely came home with a long list of follow-up items.
Speaker Change: across a lot of interesting opportunities.
Speaker Change: Definitely, we uncover some of the larger LICMB programs that are out there that would be great targets for us to continue to collect.
Speaker Change: Aria Data
Speaker Change: There was interest from some of the other industry players that were following up.
Speaker Change: on. There was renewed and continued interest from some of the ADRCs we had already contacted that are willing to go a little bit faster and getting involved with our technology. There was also interest around doing community-based screening using our device to keep filling the funnel of potential likely candidates for the ATT drug therapy.
Speaker Change: So, we are anticipating, and we've chosen to add a slide to our investor deck, that really the entry commercially into Alzheimer's is really right around the second half of next year.
Speaker Change: So we are really seeing it as a growth, as a revenue contributor starting about that timeframe.
Speaker Change: Got it. One last question before I jump back to the queue. I'm curious, any updates we should be watched at the CTAS clinical trial in Alzheimer's disease conference in Madrid at the end of October ?
Speaker Change: Yes, great question. And of course, that is our next very important Alzheimer's meeting. That is the CPAD, so clinical trials in Alzheimer's disease, which, as you said, is the end of October in Madrid.
Speaker Change: We will have additional data presented from the Washington University group, which is the same one that presented
Speaker Change: on one of the very first ARIA cases on our technology.
Speaker Change: Side by side, really the same case on a 3T technology, which is the encouraging sort of token that starts pointing to the merit of our technology in detecting ARIA.
Speaker Change: So expect to see more data presented by Dr. Okafor again in Madrid late October .
Speaker Change: Got it. Great. Thanks for taking our questions. And again, congrats on a good culture.
Speaker Change: Excellent, thank you very much.
Speaker Change: There are no more questions at this time. That concludes our Q&A session. I will now turn the call back over to Maria Sainz for closing remarks. Please go ahead.
Maria Sainz: Thanks to all for joining us here today. We look forward to further updates from Hyperfine next quarter.
Speaker Change: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Maria Sainz: [inaudible]
Speaker Change: https://www.youtube.com.au www.youtube.com.au