Q4 2022 Heartbeam Inc Earnings Call

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Operator: Greetings, welcome to the HeartBeam Q4 and full year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

Speaker 2: Greetings and welcome to the Heartbeam fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation.

Speaker 2: As a reminder, this conference is being recorded.

Speaker 2: Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially.

Speaker 2: You are cautioned not to place undue reliance on these four licking statements, which reflect our opinions only as of the date of this presentation.

Operator: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wires this afternoon at 4:01 PM Eastern Time and is available in the investor relations section of our company's website, heartbeam.com. Your hosts today, Branislav Vajdic, Chief Executive Officer and Founder, Robert Eno, President, and Richard Brounstein, Chief Financial Officer, will present results of operations for the Q4 and year ended 31 December 2022.

Speaker 2: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these four looking statements in light of new information or future events. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these four looking statements in light of new information or future events.

Speaker 2: Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions.

Speaker 2: The press release detailing these results cross the wires this afternoon at 4.01 p.m. Eastern time and is available in the investor relations section of our company's website, heartbeam.com. Your host today, Branislav Vojic, Chief Executive Officer and Founder, Rob Eno, President, and Rick Brownstein, Chief Financial Officer, will present results of operations for the fourth quarter and year ended December 31, 2022. At this time, I will turn the call over to Heartbeam Chief Executive Officer, Branislav Vojic.

Speaker 2: detailing these results across the wires this afternoon at 4.01 p.m. Eastern time and is available in the investor relations section of our company's website, heartbeam.com. Your host today, Branislav Vojic, chief executive officer and founder, Rob Eno, president, and Rick Brownstein, chief financial officer, will present results of operations for the fourth quarter and year ended December 31st, 2022. At this time, I will turn the call over to Heartbeam chief executive officer, Branislav Vojic. You may begin.

Operator: At this time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Vajdic. You may begin.

Branislav Vajdic: Thank you, operator. Good afternoon, everyone. I'm pleased to welcome you to today's Q4 and Full Year 2022 Financial Results Conference Call. I could not be more enthusiastic about the future for HeartBeam, the rapid pace of our product timeline, and our team's ability to trace our commercialization path. For those of you joining us for the first time, or whom I have not had the opportunity to meet, I'd like to take a moment to introduce HeartBeam and our opportunity in a short video introduction. The video explores the HeartBeam AIMIGo technology, needs, market opportunity, and use in the heart attack detection case. HeartBeam AIMIGo is the first and only credit card-sized 12-lead ECG device for remote heart attack detection. While we are playing the video for our dialing participants, unfortunately, it will be about three minutes of silence.

Speaker 3: Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's fourth quarter and full year 2022 financial resolve conference call. I could not be more enthusiastic about the future for Heartbeam, the rapid pace of our product timeline and our team's ability to trace our commercialization path. For those of you joining us for the first time or whom I have not had the opportunity to meet, I'd like to take a moment to introduce Heartbeam and our opportunity in a short video introduction.

Speaker 3: The video explores the hard beam A-MINGO technology, need, market, opportunity, and use in the hard attack detection case.

Speaker 3: Hot beam A-B-Go is the first and only credit card size 12-lead ECD device for remote heart attack detection.

Branislav Vajdic: I'd like to remind you that this video is available on our website, heartbeam.com.

Speaker 3: While we are playing the video for our diving participants, unfortunately, it will be about three minutes of silence. But I'd like to remind you that this video is available on our website, heartbeat.com.

[Company Representative] (HeartBeam): Undiagnosed heart attacks can be lethal for individuals and costly to the healthcare system. Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the healthcare system over $10 billion each year. Because of uncertainty, patients often delay seeking care for an average of 3 hours, causing a 40% increase in mortality rate. Currently available ECG monitoring solutions are indicated only for screening for arrhythmias, but not for heart attacks. HeartBeam's innovative technology, the HeartBeam AIMIGo device, introduces a simple, patient-friendly solution designed specifically for heart attack detection. This credit card-sized device, paired with the smartphone application, puts patients in immediate contact with their care team. The patient places the wireless device on their chest for a 30-second signal recording. The patient's healthcare provider is then notified of the new ECG.

Speaker 4: Undiagnosed heart attacks can be lethal for individuals and costly to the health care system. Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the health care system over $10 billion each year.

Speaker 4: HeartBeam's innovative technology, the HeartBeam Aimee GO device, introduces a simple, patient-friendly solution designed specifically for heart attack detection. This credit card-sized device paired with the smartphone application puts patients in immediate contact with their care team.

[Company Representative] (HeartBeam): To fully characterize the three dimensions of the heart, HeartBeam captures the heart's electrical activity in 3D by recording X, Y, and Z projections into a simple, user-friendly platform. The HeartBeam AIMI system provides a comparison of the patient's baseline ECG, along with a symptomatic ECG, with a marker and a diagnostic suggestion indicating potential heart attack. The results are instantly shared with the patient's care team through the HeartBeam AIMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions, and direct the patient accordingly. Today, clinicians must rely on 12-lead ECG for heart attack detection, performed solely within a hospital or clinic. HeartBeam's AIMI and AIMIGo technology has the potential to become the standard of care for cardiac patients, with the potential to serve over 18 million patients in the US alone.

Speaker 4: by recording X, Y, and Z projections into a simple, user-friendly platform. The Heartbeam AMIE system provides a comparison of the patient's baseline ECG along with a symptomatic ECG with a marker and a diagnostic suggestion indicating potential heart attack.

Speaker 4: Today, clinicians must rely on 12 lead ECG for heart attack detection performed solely within a hospital or clinic. HeartBeam's Amy and Amy Go technology has the potential to become the standard of care for cardiac patients with the potential to serve over 18 million patients in the US alone.

[Company Representative] (HeartBeam): With a simplified 12-lead ECG process in a portable solution, HeartBeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. HeartBeam, putting tomorrow's technology in patients' hands today.

Speaker 4: technology that can be used anytime, anywhere. HeartBeam, putting tomorrow's technology in patients' hands today. HeartBeam.com

Branislav Vajdic: It is really important to understand how our ECG technology is different and vastly more powerful than ECG technologies that are in the marketplace today. Today, there are many ECG technologies offered to consumers and patients outside of a medical facility. What they all have in common is that they do not offer a standard of care 12-lead ECG in a user-friendly, always with the patient, easy-to-apply solution. That means that they are not capable of detecting a heart attack. In the great majority of cases, it is a single lead ECG that may be adequate for some arrhythmias, but is certainly not capable of detecting a heart attack. Shown in this slide is the actual message from Apple Watch warning the user of its inability to detect a heart attack.

Speaker 3: It is really important to understand how our ECD technology is different and vastly more powerful than ECD technologies that are in the marketplace today. Today, there are many ECD technologies offered to...

Speaker 3: to consumers and patients outside of a medical facility.

Speaker 3: What they all have in common is that they do not offer a standard of care family ECG in a user-friendly, always-in-patient, easy-to-apply solution.

Speaker 3: That means that they are not capable of detecting a heart attack.

Speaker 3: In the great majority of cases, it is a single EDCG that may be adequate for some reasons, but is certainly not capable of detecting a heart attack.

Speaker 3: Stown in this slide is the actual message from Apple Watch warning the user of its inability to detect a heart attack. Similarly, AliveCore with their cardiac products prominently features on their website,

Branislav Vajdic: Similarly, AliveCor, with their cardiac products, prominently features on their website the same disclaimer about the inability to detect a heart attack. Our technology, we believe, has solved the problem of heart attack detection outside of a medical institution. The HeartBeam technology is intended to quickly and accurately help clinicians identify a heart attack. This could reduce the critical time to intervention for heart attack patients, saving many lives and reducing healthcare costs by ruling out heart attacks and reducing the number of emergency room visits. Shown on this graph are ECG technologies and their diagnostic capabilities. Today, in the market of ambulatory ECG devices, we see technologies that offer one to two, one, I'm sorry, one to six actual leads. What is common to all these technologies is that their diagnostic value is limited to arrhythmia, such as atrial fibrillation or AFib.

Speaker 3: the same disclaimer about the inability to detect a part of that.

Speaker 3: Our technology, we believe, has solved the problem of heart attack detection outside of our medical institution.

Speaker 3: The hobby technology is intended to quickly and accurately help clinicians identify a heart attack.

Speaker 3: This could reduce the critical time to intervention for heart attack patients.

Speaker 3: saving many lives and reducing healthcare costs by ruling out heart attacks.

Speaker 3: and reducing the number of emergency room visits.

Speaker 3: So on this graph are ECT technologies and their diagnostic capabilities.

Speaker 3: Today, in the market of Ambulosory ECG devices, we see technologies that offer one to six actual leads. When the market has disappeared, we use some technology to willing to invent many products

Speaker 3: What is common to all these technologies is that their diagnostic value is limited to arrhythmia, such as atrial fibrillation or AP.

Branislav Vajdic: There are some well-known players in this space, such as iRhythm, Apple, and AliveCor. If we go beyond six leads, in other words, to 12 leads in this graph, we see the standard of care capabilities are achieved, but there are no players in this space that offer a user-friendly, always with patient, easy-to-apply 12-lead ECG solution. The technology that has diagnostic capability that goes over beyond standard of care 12-lead ECG is vector electrocardiography or VECG. Our HeartBeam AIMIGo technology is capable of recording and processing VECG signals and using powerful 3D vector-based algorithms to detect heart attacks. Perhaps most importantly, for this initial phase of our technology development, HeartBeam AIMIGo technology will bring the power of a standard of care 12-lead ECG to physicians in front of their patients and remotely that are anywhere at any time.

Speaker 3: There are some well-known players in this space such as iRithm, Apple, and the Lifeborne.

Speaker 3: If we go beyond six leads, in other words, to 12 leads in this graph, we see the standards of care capabilities are achieved, but there are no players in this space that offer a user-friendly, always patient.

Speaker 3: easy to apply from this ECD solution.

Speaker 3: the technology that has the agnostic capability.

Speaker 3: that goes over beyond standards of care-filled ECG is vector electrocardiography or VECG.

Speaker 3: Our hard beam A-MIGO technology is capable of recording and processing VECG signals and using powerful 3D vector-based algorithms to detect heart attacks. Perhaps most importantly, for this initial phase of our technology development, hard beam A-MIGO technology,

Speaker 3: will bring the power of a standard of care, 12-EDC gene to physicians in front of their patients and remotely that are anywhere and at anytime. No other user-friendly, easy to use, all-in-the-patient technology is able to use the world-class starter machine.

Branislav Vajdic: No other user-friendly, easy-to-use, always with patient technology is able to offer that. This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the HeartBeam telehealth product, the heart attack detection, 12-lead ECG capability, integration of patient history and symptoms, and the presentation of baseline and symptomatic ECG to the physician, the HeartBeam AIMIGo device is significantly different. It is offering in a very underserved market. We believe HeartBeam AIMI and HeartBeam AIMIGo, by leveraging our patented 3D VECG technology, offers substantial capabilities beyond existing offerings. We continue to engage with potential customers and partners in anticipation of the FDA clearance and commercial launch for our products.

Speaker 5: to offer that.

Speaker 3: This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the Harbin Telehealth product,

Speaker 3: This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the Harbin Telehealth product, there are also factors such as heart attack detection,

Speaker 3: quality ECG capability, integration of patient history and symptoms, and the presentation of baseline and symptomatic ECG to the physician.

Speaker 3: The heartbeat AIMiGO device is significantly different and it is offering in a very underserved market.

Speaker 3: We believe hard in any and hard in any goal by leveraging our patented 3D vector ECG technology offers substantial capabilities beyond existing offerings and we continue to engage with potential customers.

Speaker 3: and partners in anticipation of their clearness and commercial launch for our products. Our fourth quarter was highlighted by formal movement

Branislav Vajdic: Our Q4 was highlighted by forward movement toward production and commercialization of our products, underscored by a series of milestones, including new partnerships, IP protection, and a strengthened management team. As we look forward to FDA clearance for HeartBeam AIMI, we are also making significant progress with our core product, the HeartBeam AIMIGo 3D VECG collection device, as we prepare for FDA submission in the coming weeks. Recently, we announced the acquisition of substantially all assets from LIVMOR, a digital health solution company providing a patient-engaging remote monitoring system of clinical physiological biomarkers. This consisted of LIVMOR intellectual property, including 3 US patents and the LIVMOR technology, including the Halo+ atrial fibrillation AFib detection system. The Halo+ AFib detection system is the world's first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring.

Speaker 3: for production and commercialization of our products.

Speaker 3: underscored by a series of milestones including new partnerships, IP protection, and the strength management team.

Speaker 3: As we look forward, FDA clearance.

Speaker 3: for hardening, we are also making significant progress with our core project.

Speaker 3: the Harbin Amigo 3D VCG collection device as we prepare for FDA submission in the coming weeks.

Speaker 3: Recently, we announced the acquisition of substantially all assets from Limor, a digital health solution company providing a patient engaging remote monitoring system of clinical physiological biomarkers.

Speaker 3: This persisted of Limor's intellectual property, including US patents, and the Limor technology, including the Halo Plus ACF regulation ACF detection system.

Speaker 3: The Halo Plus AFib detection system is developed first at the clear prescription variable for continuous cardiac rhythm monitoring. The Halo Plus system provides continuous monitoring of pulse rhythms for the detection of AFib on demand during the day and automatically overnight.

Branislav Vajdic: The Halo+ system provides continuous monitoring of pulse rhythms for detection of AFib on demand during the day and automatically overnight. The acquisition extends our reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. This acquisition is a natural fit and extension of our successful partnership with LIVMOR and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs. Our newly acquired state-of-the-art FDA-cleared watch-based arrhythmia detection tool, once integrated with HeartBeam AIMIGo telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting. During the quarter, we partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card-sized HeartBeam AIMIGo 3D VECG recording device.

Speaker 3: The acquisition extends our reach in the most monitoring and detection with full ownership of an existing cutting edge MBA clear product.

Speaker 3: This acquisition is a natural fit, an extension of our successful partnership.

Speaker 3: We live more, and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs. Our newly acquired state-of-the-art FDA cleared.

Speaker 3: watch-based arrhythmia detection tool, once integrated with Harbin's A-N-G-O telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting.

Speaker 3: During the quarter, we partnered with evolved manufacturing technologies, a contact with a medical device manufacturing company to build the credit card sites on the Amigo 3D VECD recording device.

Branislav Vajdic: Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers. We can now leverage Evolve's manufacturing and packaging expertise to support commercialization of HeartBeam AIMIGo device following the expected FDA clearance. We further advanced intellectual property protection with two recent new patents. An initial European patent strengthens IP for the HeartBeam AIMIGo technology, offering 12-lead ECG capability as we expand our product applications to reach a variety of regions and global markets. We also received a US patent for a 12-lead ECG smartwatch-based monitor intended for detection of heart attacks and complex arrhythmias. The breakthrough inventions protected by this patent enable our proprietary 3D VECG technology to be built into a smartwatch, eliminating the need for a dedicated ECG device while offering 12-lead ECG capability, enabling heart attack and complex arrhythmia detection.

Speaker 3: Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers. We can now leverage Evolve's manufacturing and packaging expertise.

Speaker 3: Initially, European patent strengthens IP for the higher-hundred naming gold technology, offering 12-leg ECG capability as we expand our product applications to reach a variety of regions and global markets.

Speaker 3: We also received a US patent for a 12-EDCG smartwatch-based monitor intended for detection of heart attacks and complex arrhythmias.

Speaker 3: The breakthrough inventions protected by this patent enable our proprietary 3D VECG technology to be built into a smartwatch.

Speaker 3: eliminating the need for a dedicated ECG device while offering 12 lead ECG capabilities, enabling heart attacks, and conflict therapy and detection.

Branislav Vajdic: We believe this patent may prove to be one of our most valuable patents, and we continue to expand on our granted and pending core patents for remote heart attack detection. We recently welcomed Rob Eno to the new created position of President. Rob, who you will meet in a moment, is a passionate and visionary senior executive with over 28 years experience creating go-to-market strategies for multiple breakthrough products. He's playing a key role in our strategic decisions, commercialization efforts, and day-to-day operations. He joins our other recent appointment, Dr. Peter Fitzgerald, the Chief Medical Officer. Peter is now playing a major role in defining best paths for adoption, clinical strategies, and partnerships to advance our products in the market. I would like to turn the call over to our President, Rob Eno, to further discuss our products and commercialization plans. Rob.

Speaker 3: We believe this patent may prove to be one of our most

Speaker 3: valuable patents and we continue to expand on our granted and pending core patents for remote heart attack detection.

Speaker 3: We recently welcomed Rob Eno.

Speaker 3: to the new creative position of presidents.

Speaker 3: Rob, who you will meet in a moment, is a passionate visionary senior executive with over 28 years experience.

Speaker 3: go-to-market strategies for multiple breakthrough products.

Speaker 3: He is playing a key role in our strategic decisions, commercialization efforts, and day-to-day operations.

Speaker 3: He joins our other recent appointments, Dr. Peter Figero, the Chief Medical Officer.

Speaker 3: Peter is now playing a major role in defining best paths for adoption, clinical strategies, and partnerships.

Speaker 3: to advance our products in the market.

Speaker 3: I would like to turn the call over to our President, Rob Eno, to further discuss our products and commercialization plans. Rob. Thank you, Bronislav. And to everyone joining us today, I'm privileged to join Heartbeam at such an exciting time.

Robert Eno: Thank you, Branislav. To everyone joining us today, I'm privileged to join HeartBeam at such an exciting time as the company prepares to enter a new phase of commercialization. Since joining in January, I've been incredibly impressed with the HeartBeam team, their accomplishments, and diligence in working toward our mission. Turning to our product timelines and updates, we had several key developments related to our HeartBeam AIMI and HeartBeam AIMIGo platforms. As Branislav mentioned, we previously announced the 510(k) submission of our HeartBeam AIMI platform to the FDA. We received questions from FDA within the statutory 30-day review deadline, discussed the questions via teleconference with the FDA review team, and provided written responses addressing the questions to the primary reviewer. The substantive review is in progress, we expect to receive FDA clearance in Q2, followed by a limited market release in early Q3.

Speaker 6: as the company prepares to enter a new phase of commercialization.

Speaker 6: Since joining in January , I've been incredibly impressed with the Heartbeam team, their accomplishments and diligence in working toward our mission.

Speaker 6: Turning to our product timelines and updates, we had several key developments related to our Heartbeam Aimee and Heartbeam Aimee Go platforms.

Speaker 6: As Bronislav mentioned, we previously announced the 510K submission of our Heartbeam AIMI platform to the FDA.

Speaker 6: We received questions from FDA within the statutory 30-day review deadline, discussed the questions via teleconference with the FDA review team, and provided written responses addressing the questions to the primary reviewer.

Speaker 6: The substantive review is in progress, and we expect to receive FDA clearance in the second quarter, followed by a limited market release in early Q3.

Robert Eno: Briefly, the total available market for the HeartBeam AIMI software solution is $500 million, and for AIMIGo, it is $12 billion. These are estimated market numbers for the US only. HeartBeam AIMIGo has a 510(k) regulatory pathway. We've already identified predicate devices and plan to demonstrate substantial equivalence with a validation study. Importantly, the clearance of the V1 device allows HeartBeam to collect 3D vector cardiogram data and use these data for conducting 12-lead equivalent studies for the V2 product. Turning to HeartBeam AIMIGo product updates. In September, we were granted a patent that provides additional intellectual property protection for our HeartBeam AIMIGo technology, offering 12-lead ECG capability in the form of a credit card-sized device with the same footprint as the single-lead products currently in the market today.

Speaker 6: Briefly, the total available market for the Heartbeam AIMI software solution is $500 million and for AIMI Go it is $12 billion. These are estimated market numbers for the U.S. only.

Speaker 6: Heartbeam Amigo has a 510k regulatory pathway.

Speaker 6: We've already identified predicate devices and plan to demonstrate substantial equivalence with a validation study.

Speaker 6: Importantly, the clearance of the V1 device allows HeartBeam to collect 3D vector cardiogram data and use these data for conducting 12 lead equivalent studies for the V2 product. According to HeartBeam Amygo product updates, the V1 device is not capable of generating

Speaker 6: In September , we were granted a patent that provides additional intellectual property protection for our Heartbeam Amigo technology, offering 12-lead ECG capability in the form of a credit card-sized device with the same footprint as the single-lead products currently in the market today.

Robert Eno: We also partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card-size HeartBeam AIMIGo 3D VECG recording device that enables a 12-lead ECG readout for remote heart attack detection. We plan to file an initial 510(k) submission for the V1 version of HeartBeam AIMIGo as an ECG collection device, followed by a second submission for the software that enables 12-lead synthesis from our 3D VECG signals. We expect to file the V1 submission shortly, and the V2 submission is targeted for Q4. Our go-to-market strategy for HeartBeam AIMIGo is a phased approach. We'll initially focus on direct pay market segments in which payment is outside of the reimbursement system. Within the direct pay segments, we will initially focus on those where we will demonstrate HeartBeam AIMIGo as equivalent to 12-lead ECGs.

Speaker 6: We also partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card size heartbeat Amigo 3D VECG recording device that enables a 12-lead ECG readout for remote heart attack detection.

Speaker 6: We plan to file an initial 510k submission for the V1 version of Heartbeam AIMi GO as an ECG collection device.

Speaker 6: followed by a second submission for the software that enables 12 lead synthesis from our 3D VECG signals. We expect to file the V1 submission shortly and the V2 submission is targeted for Q4. Our go-to-market strategy for Heartbeam AIMI Go is the phased approach.

Speaker 6: We'll initially focus on direct pay market segments in which payment is outside of the reimbursement system.

Speaker 6: Within the direct pay segments, we will initially focus on those where we will demonstrate Heartbeam A-ME-GO as equivalent to 12 lead ECGs.

Robert Eno: We will then focus on developing clinical and cost-effectiveness evidence, which will be the basis of expansion into new direct pay segments and ultimately unique reimbursement. We have a deep product pipeline, starting with the HeartBeam AIMIGo system. Other products in the pipeline include a 12-lead ECG extended wear monitor or patch, as well as a system that fully integrates HeartBeam AIMIGo and the heart monitoring smartwatch technology we acquired from LIVMOR. In addition, the product pipeline includes predictive algorithms that result from applying machine learning to our VECG data and a 12-lead ECG smartwatch for heart attack detection, complex arrhythmia monitoring, and other cardiac disorders.

Speaker 6: We will then focus on developing clinical and cost-effectiveness evidence, which will be the basis of expansion into new direct pay segments and ultimately unique reimbursement.

Speaker 6: We have a deep product pipeline starting with the Heartbeam Amigo system.

Speaker 6: Other products in the pipeline include a 12 lead ECG extended wear monitor or patch, as well as a system that fully integrates Heartbeam AIMi GO and the heart monitoring smartwatch technology we acquired from LiveMore. In addition, the product pipeline includes predictive algorithms that result from applying machine learning.

Branislav Vajdic: I'll now turn the call over to Rick Brounstein, Chief Financial Officer, to discuss operational updates and financials.

Richard Brounstein: Thank you, Rob. Turning to our financials, I will now give a succinct preview of our financial results. A full breakdown is available in our regulatory filings and in the press release that just crossed the wire after the close of market today. Let me start with Silicon Valley Bank. They were our checking account and payroll account. On 10 March last week, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver, and as a result, we stood to lose approximately $600,000. On 13 March, the Federal Reserve announced that the account holders would not bear the loss of this event. Nevertheless, before the issues with SVB, we had planned to move to a Big Four bank, and we are currently completing that move. Turning now to the statement of operations.

Speaker 7: Thank you, Rob.

Speaker 6: Turning to our financials, I will now give a succinct review of our financial results. A full breakdown is available in our regulatory filings and in the press release that just crossed the wire after the closing market today.

Speaker 6: Let me start with Silicon Valley Bank.

Speaker 6: They were our checking account and payroll account.

Speaker 6: On March 10th last week, SCD was closed by the California Department of Financial Protection and Innovation

Speaker 6: which appointed the FDIC as receiver. As a result, we stood to lose approximately $600,000.

Speaker 6: On March 13th, the Federal Reserve announced that the account holders would not bear the loss of this event. The Federal Reserve announced that the account holders would not bear the loss of this event.

Speaker 6: Nevertheless, before the issues with SCV, we had planned to move to a big four bank, and we are currently completing that move.

Richard Brounstein: General and administrative expenses for Q4 2022 were $2.1 million, compared to $1.2 million for Q4 2021. For the year ended 31 December 2022, G&A expense increased to $7.4 million compared to $2 million in the same period of 2021. This reflects a growth in our team and other costs in support of our being a public company. Research and development expenses for Q4 2022 were $1.6 million, compared to $96,000 in Q4 2021. For the year ended 31 December 2022, research and development expenses increased to $5.7 million from $255,000 in the prior year. Most of 2021 was pre-IPO. Our 2022 focus on R&D consisted largely of product development costs for HeartBeam AIMI, which is now essentially done, and also HeartBeam AIMIGo.

Speaker 6: Turning now to the statement of operations. General administrative expenses for the 4th quarter of 2022 were 2.1 million. Compared to 1.2 million for the 4th quarter of 2021.

Speaker 6: For the year ended December 31, 2022, G&A expense increased to $7.4 million compared to $2 million in the same period of 2021. This reflects growth in our team and other costs in support of our being a public company. Research and development expenses for the fourth quarter of 2021.

Speaker 6: in the prior year. Most of 2021 was pre-IPO.

Speaker 6: Our 2022 focus on R&D consisted largely of product development costs for Heartbeat Nanny, which is now essentially done, and also Heartbeat Nanny Go.

Richard Brounstein: HeartBeam AIMIGo includes both software and hardware, the latter with our professional services agreement with Triple Ring Technologies. Additionally, there are clinical costs in support of our FDA submissions for both our products this year, as well as research costs in support of the future product pipeline coming from our patented vector 3D ECG platform technology. Other income during the year ended 31 December 2022 of $69,000 primarily related to the cash balances from the IPO. In 2021, we had $2.1 million of expense, largely tied to the 2015 convertible note accounting. These notes were converted and added to common stock at the November 2021 IPO and in equity as of 31 December 2021.

The name EGO includes both software and hardware, the latter with our professional services agreement with Triple Ring Technologies.

Additionally, there are clinical costs in support of our FDA submissions for both our products this year, as well as research costs in support of the future product pipeline coming from our patented Vector3D ECG platform technology.

Other income during the year ended December 31, 2022 of $69,000, primarily related to the cash balances from the IPO.

In 2021, we had $2.1 million of expense, largely tied to the 2015 convertible note accounting. These notes were converted and added to common stock at the November 2021 IPO and in equity as of December 31, 2021. Our loss for the fourth quarter of 2022 was 3.5 million.

Richard Brounstein: Net loss for Q4 2022 was $3.7 million, compared to a net loss of $2.1 million for Q4 2021 and $13 million for the full year of 2022, compared to $4.4 million in the year-ago period. We ended Q4 2022 with $3.6 million in cash and cash equivalents, compared to $13.2 million as of 31 December 2021, having invested the proceeds from the November 2021 IPO to accelerate our product development path. Most of the cash is maintained in short-term investment accounts not tied to potential bank liquidity problems.

$6 million in cash and cash equivalents, compared to $13.2 million as of December 31, 2021, having invested the proceeds from the November 21 IPO to accelerate our product development path.

Richard Brounstein: As you have seen, we are publicly marketing through our S-1 registration statement, and as noted in the IPO registration statement, we plan to finance ourselves to the next inflection point in 2024, FDA clearance of our HeartBeam AIMIGo product with a personalized 12-lead simulation display that a physician is used to seeing with a standard 12-lead ECG today, but using our patented 3D ECG technology. I will now turn the call back over to Branislav for some closing thoughts.

Most of the cash is maintained in short-term investment accounts not tied to potential bank liquidity problems.

As you have seen, we are publicly marketing through our S1 registration statement. As noted in the IPO registration statement, we plan to finance ourselves to the next inflection point in 2024, FDA clearance of our HeartBeam InEgo product with a personalized 12-lead simulation display that a physician is used to seeing the patient's heart rate increase

position is used to see with a standard 12 lead ECG today, but using our patented VECG technology.

Branislav Vajdic: Thank you, Rick. Indeed, ours is a true platform technology. So far, we have developed two products that are either already submitted to the FDA, in the case of HeartBeam AIMI, or soon to be submitted to the FDA for the HeartBeam AIMIGo product. The recent LIVMOR asset purchase has also brought to HeartBeam LIVMOR's intellectual property, including three US patents and the LIVMOR technology, including the Halo+ artificial atrial fibrillation product as well. Halo+ is the world's first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. During Q4, we continued to operate from a position of strength, equipped with strategic partnerships to advance product development and near-term milestones.

I will now turn the call back over to Brandeis Laufer for some closing thoughts.

Thank you, Ike. Indeed, ours is a true platform technology. So far, we have developed two products that are either already submitted to the FDA in the case of Heartbeam AMI or soon to be submitted to the FDA for the Heartbeam AMI Go product.

The recent Limor asset purchase has also brought to Harvey Limor's intellectual property including three U.S. patents.

and the LIMOR technology including the Halo Plus artificial atrial fibrillation product as well.

Hemoplasty is the world's first FDA-cleared prescription variable for continuous cardiac rhythm monitoring.

During the fourth quarter, we continued to operate from a position of strength equipped with strategic partnerships to advance product development and near-term milestones.

Branislav Vajdic: We continue to strengthen our IP with patents granted, most recently with a European patent for signal transformation from vector electrocardiogram to 12-lead ECG, and a new patent for a 12-lead ECG smartwatch-based monitor intended for detection of heart attacks and complex cardiac arrhythmias as well. We also acquired three issued United States patents as part of our LIVMOR asset purchase. All of these enhance our intellectual property and provide protection of our technology in priority global markets. Beyond that, looking at the product pipeline, we think that the application of artificial intelligence will be of great value to us. We will have very unique data set of patients who actually have recorded their ECG on a daily, weekly, or monthly basis. That longitudinal data for our patient population will be of tremendous value.

We continue to strengthen our IP with patents granted, most recently with a European patent for single transformation from Vector electrocardion grant to 12EDCG, and a new patent for a 12EDCG smartwatch-based monitor.

intended for detection of heart attacks and complex cardiac arrhythmias as well. We also acquired three issues United States patent as part of our Limor Asset Purchase.

All of these enhance our intellectual property and provide protection of our technology in priority global markets.

Beyond that, looking at the product pipeline, we think that the application of artificial intelligence will be of great value to us.

We will have very unique data set of patients who actually have recorded their ECG on a daily, weekly, or monthly basis.

Branislav Vajdic: Applying artificial intelligence to this data set that is extremely data-rich, much richer than the standard 12-lead ECG, will yield, we strongly believe, additional insight into cardiovascular disease and further help cardiovascular patients. On the right side of this slide is shown the 12-lead patch. We have recently received a patent for that technology. We are very pleased with that development because it addresses a very large market projected at $4.8 billion by 2030. This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole. Looking ahead, we remain confident in our anticipated upcoming product milestones. Our next milestones on the commercialization path include FDA submission for the initial HeartBeam AIMIGo 3D vector ECG product and FDA clearance for HeartBeam AIMI, both expected in the near future.

That longitudinal data for our patient population will be of tremendous value.

Applying this visual intelligence to this data set.

that is extremely data-rich, much richer than the standard value DCG will need, be strongly believed, additional insight into cardiovascular disease and further help target hospital patients. On the right side of this slide is shown the...

year 2030.

This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole.

Looking ahead, we remain pocketed in our anticipated upcoming project milestones.

Our next milestones on the commercialization path include FDA submission.

for the initial hard beam Amigo 3D vector ECG product.

Branislav Vajdic: We approach these milestones from a position of strength with an experienced team, bolstered by the recent appointment of Peter Fitzgerald as chief medical officer and Rob Eno as president, to support these goals. I'd like to share a final thought. We are all very excited about the prospect of helping millions and millions of cardiovascular patients, initially heart attack patients, but we believe our technology will essentially address all cardiac diseases that are detectable by a 12-lead ECG. That's a very exciting prospect for us and a great motivator to be helping many millions of patients throughout the world. I look forward to providing our shareholders with further updates in the near term as we move toward commercialization. I thank you all for attending, and now the HeartBeam team would like to answer your questions. Operator.

and have the experience for had been aiming both expected in the near future. We approach these milestones from a position of strength with an experienced team both as by the recent appointment of Peter Fidel, a Schmeregal Officer in Robino as president.

to support these goals.

I'd like to share a final thought. We are all very excited about the prospect of helping millions and millions of cardiovascular patients.

Initially, heart attack patients, but we believe our technology will essentially address all cardiac diseases that are detectable by a 12 lead ECG.

So that's a very exciting prospect for us and a great motivator to be helping many millions of patients throughout the world.

I look forward to providing our shareholders with further updates in the near term as we move toward commercialization. Thank you all for attending and now the HAVI team would like to answer your questions.

Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from the line of Jason Kolbert with Dawson James Securities. Please proceed with your question. Jason, is your line on mute?

Thank you. And at this time we will be conducting a question and answer session. If you would like to ask a question please press star 1 on your telephone keypad.

A confirmation tone will indicate your line is in the question queue.

You may press star 2 if you would like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.

using speaker equipment, it may be necessary to pick up your handset before pressing the start key. One moment please while we poll for questions.

DaunttoR

Come from the line of Jason Colbert with Dawson James. Please proceed with your questions.

Jason is your line on mute.

Jason Kolbert: Hi, guys. Can you hear me? Hello?

Operator: Yes, we can hear you now.

Hi, guys. Can you hear me? I got to the destroy ceiling up there and I have to get out and meet a poor guy, so

Branislav Vajdic: Yes.

Operator: Yes.

Jason Kolbert: Oh, okay. Sorry about that. My first question was regarding the recent acquisition. I know you got a lot of IP, but I think you also had a lot of intellectual capital. Can you talk a little bit about how many of those folks have come over to HeartBeam and what it is that they're really bringing to the company?

Hello? Yes, we can hear you now. Yes. Oh, okay. Sorry about that. My first question was regarding the recent acquisition. I know you got a lot of IP, but I think you also had a lot of intellectual capital. Can you talk a little bit about how many of those folks have come over to Heartbeam and what it is that they're really...

Branislav Vajdic: Yes. We covered so far in our presentation, the IP aspects of that acquisition in the form of three patents. They're very significant because they really give us an incredibly fast head start into the AFib detection. The company we wanted to get into with the addition of these three patents, we have an incredibly good entry point into the AFib market. Beyond that, we have acquired the whole technical team that has developed these technologies for LIVMOR. In that sense, we have completed the whole circle in a way because we now have FDA-cleared product. We have three patents. We have the platform, Halo+ platform, and we have all the key people that have developed this platform. We are very excited about this acquisition and what it will mean for the future of HeartBeam.

bringing to the company? Yes, we covered so far in our presentation the IP aspects of death acquisition in the form of three patents. They are very significant because they really give us an incredibly...

fast head start into the A-Fib detection. This is the company we wanted to get into and with the addition of these three patents, we have an incredibly good entry point into the A-Fib market. Beyond that, we have acquired...

the whole technical team that has developed these technologies for lead more.

And in that sense, we have completed the whole circle in a way because we now have FDA-led products, we have three patents, we have the platform, Halo Plus platform, and we have Cara Martin.

all the key people that have developed this platform. So we are very excited about this acquisition and what it will mean for the future of heartbeating.

Jason Kolbert: I'd like to drill down on that. How does that break down in terms of software versus hardware? Is there even a manufacturing component associated with the hardware that you feel helps support HeartBeam in terms of its commercialization efforts and kind of managing that whole process?

And so I'd like to drill down on that. How does that break down in terms of software versus hardware? And is there even a manufacturing component associated with the hardware that you feel helps? How does that break down in terms of software versus hardware versus hardware versus hardware?

support Heartbeam in terms of

Branislav Vajdic: LIVMOR technology is based on so-called PPG sensor, which is integral parts of, in the case of their development, Samsung Watch. The components of the hardware that LIVMOR has used comes from Samsung. What the real value for us is the full ownership of the Halo+ platform that we previously licensed, and now we have a full ownership of it, with all the source code and ability to modify it and extend it, plus the FDA-cleared product. The main value points are centered around software, intellectual property, and the team.

its commercialization efforts and kind of managing that whole process. Limor technology is based on so-called PPG sensor, which is an integral part of in the case of their development Samsung Watch.

And so the component of the hardware that Lee Moore has used comes from Samsung. What the real value for us is, is the full ownership of the Halo Plus.

platform that we previously licensed and now we have a full ownership of it with all the source code and ability to modify and extend it.

plus the FDA-clear product. So the main value points are centers around the software, intellectual property, and the team. Okay, and on the manufacturing side, is that something where you feel you're in a good position with your current?

Jason Kolbert: Okay. On the manufacturing side, is that something where you feel you're in a good position with your current contract manufacturers, that you can make changes, revisions? Clearly there's next generation product on the AIMI side here.

Branislav Vajdic: Yes. For our initial production goals, we have engaged Evolve Manufacturing, and they're clearly capable and willing of producing tens of thousands of our devices. We are working with Triple Ring and Evolve because they form a really incredibly good team on driving the parts down. Initially, these units were not cost-effective. With our current project, we are reducing the cost several times to the tune of four to five times reduction in cost. We plan to go down that curve even further.

have engaged Evolve manufacturing and they're clearly capable and willing of producing tens of thousands of our devices. We are working with Triple Ring and Evolve because they form really an incredibly good team on driving the cars down.

Initially, you know, these units were not cost effective. And with our current project, we have reduced the cost several times, you know, four to five times reduction in cost.

Jason Kolbert: Yeah. That's exactly what I was looking for, Branislav. It's not the type of thing that's a hard point for people to understand who haven't been in the business and haven't. You have a concept, you come up with units, but you know that you have to get the cost down when you get to scale, so. It makes sense that a team that's already done that is going to add a lot of value as you pursue that. My last question has to do with both AIMI and AIMIGo, and it has to do with the time gap between when you complete the submission and when you get FDA clearance. That's a relatively short time gap, about six months, and I guess that's pretty standard in the industry. You have confidence that that review time should work for you as well. Is that right?

and the plan to go down that curve even further. Yeah, that's exactly what I was looking for, Pranat Swav. And it's not the type of thing that, you know, it's a hard point for people to understand who haven't been in the business and haven't, you know, you have a concept, you come up with units, but you know.

you know that you have to get the cost down when you get to scale. So, and it makes sense that, you know, a team that's already done that is going to add a lot of value as you pursue that. My last question has to do with both Amy and Amigo, and it has to do with the time gap between, you know, when you complete the submission and when you get FDA clearance. And, you know, that's a relatively short answer.

Short time gap about 6 months and I. I guess that's pretty standard in the industry. You have confidence that that review time should work for you as well. Is that right? Yes, we have a very close interaction with the FDA. We have just completed another meeting with them and.

Branislav Vajdic: Yes. We have a very close interaction with the FDA. We have just completed another meeting with them. The interaction is very productive, and we remain confident that the results will be positive. That's all I can say. It has been perhaps a process that extended a bit longer than we expected, but it's very much an unpredictable process. In our case, included holiday season and so on and so on. Yeah, we remain very optimistic about the prospect of getting the clearance for AIMI, and again, submitting AIMIGo in Q2 of this year.

The interaction is very productive and we remain confident that the results will be positive. And that's all I can say. It has been perhaps a process that takes a little bit longer than we expected, but it's very much an unpredictable process.

And in our case, included holiday season and so on and so on. So yeah, we remain very optimistic about the prospect of getting the clearance for Amy and again submitting Amy Go in Q2 of this year. And in terms of a successful financing.

Jason Kolbert: In terms of a successful financing, that seems to be critical now as you look, because clearly there's going to be a rise in SG&A spending as you anticipate the beginning of commercialization into H2 of this year and next year, right? That's correct.

Branislav Vajdic: Yes. Rick, maybe you want to comment on this question?

Richard Brounstein: Sure, Jason. Yeah, absolutely. Obviously, not only we have the S-1 registration as it works out, of course, but we have the S-3 in place with the ATM. We have ability to sort of bridge ourself as we need. I think most people saw we did a deal with Maverick that gives us a short-term capability for another $4 million. We're careful. It's clearly challenging in these times, but we can moderate ourselves, and we think we have the capability to get things done.

Yes, Rick, maybe you want to comment on this question.

Jason, absolutely. Obviously, not only do we have the S1 registration, as it works out, of course, but we have the S3 in place. That's ridiculous.

the ATM facility so we have ability to sort of bridge ourselves as we need. I think most people saw we did a deal with Maverick that gives us a short-term capability for another four million, so we're you know, we're careful. I mean, it's clearly challenging in these times, but we can moderate ourselves and we think we have the capability to get things done.

Jason Kolbert: Yeah. That's exactly the comment I was looking for too, is that you don't have a gun pointing out at you. The ATM offers you a bit of a bridge and some breathing room so that you can kind of build a syndicate towards a successful capital raise, right?

Yeah, and that's exactly the comment I was looking forward to is that you don't have a. A gun pointing out at you, the ATM offers you a bit of a bridge and some brief. If you think room so that you can kind of build this and to get towards a successful capital raise. Right? Yeah, absolutely. Okay, good. Thanks guys. Really appreciate the update.

Richard Brounstein: Yeah, absolutely.

Jason Kolbert: Okay, good. Thanks, guys. Really appreciate the update.

Branislav Vajdic: Thank you, Jason.

Operator: Our next question comes from the line of Bill Sutherland with The Benchmark Company. Please proceed with your question.

Thank you, Jason. Our next question comes from the line of Bill Sutherland with the Benchmark Company. Please proceed with your question. Thank you. Hello, Brian Aswad. I was intrigued with the patent on the patch and the patent on the

Bill Sutherland: Thank you. Hello, Branislav. I was intrigued with the patent on the patch and wondering if there's any preliminary ideas at this point about the path for that to get to a commercialized stage.

wondering if there's any preliminary ideas at this point about the, you know, the

the path for that to get to a commercial live stage? Yes, the more we look at the patch, we have two patents actually that protect this invention extremely well.

Branislav Vajdic: Yes. The more we look at the patch, we have two patents actually that protect this invention extremely well. The more we realize the value of this technology and product for the future of HeartBeam. As it stands right now, we realize that this market is projected to be about $4.8 billion by the end of the year 2030. Our ability to develop this product is very real. In terms of time and money needed to arrive at the prototype, we are seeing some estimates that are very attractive. At this point, it's under consideration. Everything we have seen is pointing to the direction of doing the patch sooner rather than later, which does not put any concrete start date for this project.

the more we realize the value of this technology and product for the future of hard being. As it stands right now, we realize that this market is projected to be about $4.8 billion by the end of the year 2030.

And our ability to develop this product is very real. And in terms of time and money needed to arrive at the prototype, we are seeing some estimates that are very attractive.

So, at this point, it's under consideration. But everything we have seen is pointing to the direction of doing the patch sooner rather than later, which does not put any, you know, concrete start date for this project, but we really like what we are seeing in terms of.

Branislav Vajdic: We really like what we are seeing in terms of the value and potential disruptive effect it may have on this well-established market with a $3 billion company market cap being the leader.

Bill Sutherland: Yeah. It's interesting comparison. The other very fascinating development is the AI development, and curious how you might benefit from the data that you're going to be being able to analyze and work with. Is that going to lead to product or monetization of some kind?

very fascinating development is the AI development. I'm curious how you might benefit from the data that you're going to be being able to analyze and work with. Is that going to lead to product or monetization of some kind?

Branislav Vajdic: No, the data component of our technology is very powerful actually, because we have a set of parameters, ECG parameters describing that heart, patient's heart, that go well beyond the 12-lead ECG. Applying AI to this data set, we strongly believe will not only provide an increased value for reacting to an event such as heart attack, but actually offering predictive and preventive value, which will be huge, we strongly believe. All in all, we are focusing right now on reacting to that heart attack symptom. Doing the right thing for the patient, getting the right people to care or keeping them at home, basically saving lives and saving healthcare dollars. We believe strongly that the data component of our data set will be hugely valuable going forward.

The data component of our technology is very powerful actually because we have a set of parameters, ECG parameters describing that heart, patient's heart, that go well beyond the talking rhythm.

and applying AI to this data set, we strongly believe will not only provide an increased value for reacting to an event such as Heart Attack, but actually offering predictive and preventive value, which will be huge, we strongly believe.

So, all in all, we are focusing right now on reacting to that heart attack symptom, right, doing the right thing for the patient, getting the right people to care or keep it at home, you know, basically saving lives and saving healthcare dollars. But we believe strongly that the data component of our data set will be...

Bill Sutherland: Got it. Very good. Thanks again, Branislav.

hugely valuable going forward. Got it. Very good. Thanks again, Brad. Thank you. And our next question comes from the line of Ben Haynor with Alliance Global Partners. Please.

Branislav Vajdic: Thank you, Bill.

Operator: Our next question comes from the line of Ben Haynor with Alliance Global Partners. Please proceed with your question.

Ben Haynor: All right. Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, Rob, nice to meet you over the conference call, but was curious on really what attracted you to HeartBeam and what are you most excited about going forward?

We'll see what your question is. Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, Rob, nice to meet you over the conference call, but was curious on really what attracted you to Heartbeam and what are you most excited about going forward?

Robert Eno: No. Thanks. Happy to talk about that. Just with my background, I have 28 years in medical technology, it's all based around bringing disruptive new technologies through commercialization and scale-up. I joined because I believe in the company and I believe in the technology and think this could be absolutely a chance to bring a game-changing technology to market. Being able to get a 12-lead ECG into patients' hands and with the VECG technology potentially being able to go beyond that and the data aspects that Branislav mentioned. I see it as a way to really influence a tremendous number of patients' lives, address a major healthcare issue that has not yet been adequately addressed, and take part in what I think is gonna be an amazing company going forward.

Thanks, happy to talk about that. Just with my background, I have 28 years in medical technology and it's all based around bringing disruptive new technologies through commercialization and scale up. I joined because I believe in the company and I believe in the technology and think this could be.

absolutely a chance to bring a game-changing technology to market. You know, being able to get a 12-week EKG into patients' hands and with the VECG technology potentially being able to go beyond that and the data aspects that Bronislav mentioned. So I see it as a way to...

really influence tremendous number of patients lives address a major health care issue that has not yet been adequately addressed and, and take part in what I think is going to be an amazing company going forward. Okay, good deal. And, you know, have you had a quite a few discussions with, you know, folks that could serve or could be potential you've talked about the potential uncertainty

Ben Haynor: Okay. Good deal. Have you had quite a few discussions with folks that could serve or could be potential customers down the road of AIMI, AIMIGo, and the other products? Any color on those, if so?

Customer is down a little the Amy, Amy going the other products, any color on those if so. Sorry, can you repeat that just to make sure I understand? Sure, so I'm just curious on what your background, you know,

Robert Eno: Sorry, can you repeat that just to make sure I understood?

Ben Haynor: Sure. I was just curious on with your background, clearly you probably have a Rolodex of folks, and you're out there talking to folks that could be potential customers of HeartBeam AIMI, HeartBeam AIMIGo, the other products. Can you talk about any conversations that you've had and any color on those?

Clearly you probably have a roll of decks of folks and you're out there talking to folks that could be potential customers of Amy, Amy Gold, the other products. You know, can you talk about any conversations that you've had and you know any color on those? No, sure. Sorry. Thanks. Appreciate that.

Robert Eno: No. Sure. Sorry. Thanks. I appreciate that. Yeah. Absolutely talked to a number of cardiologists, and what strikes me is. What I hear constantly is 12-lead ECG itself is limited to hospitals, but it's also 100-year-old technology, and many of them know of the VECG process or the VCG process, vector cardiography. It was taught in medical schools years ago. It really never took off because physicians having to interpret 3D loops in space was very difficult. They understand that studies, even decades ago, show that it had a number of benefits beyond standard ECG. We get a lot of excitement that the company has figured out a way to take VCG, harness it, and bring it to patients.

Yeah, absolutely talk to a number of cardiologists. And what strikes me is what I hear constantly is 12 lead EKG itself is limited to hospitals, but it's also 100-year-old technology. And many of them know of the...

They understand that studies, even decades ago, show that it had a number of benefits beyond standard EKG. So we get a lot of excitement that the company has figured out a way to take VCG, harness it and bring it to patients. Then I hear a lot of this.

Robert Eno: I hear a lot of physicians where we describe the concept of a full VECG or potentially beyond that in the hands of patients, saying game-changing, and they can think of all kinds of different applications for it. I've been very pleased with the excitement of the physicians, the willingness to partner with us and help us, both in terms of potential clinical studies, early sites, and helping us figure out the best strategies to scale the technology.

physicians when we describe the concept of a full WCG or potentially beyond that in the hands of patients, you know, saying game-changing and they can think of all kinds of different applications for it. So I've been very pleased with the excitement of the physicians, the willingness to partner with us and help us and both in terms of potential clinical studies or early sites and helping us figure out the best strategies to scale the technology.

Ben Haynor: It sounds like nice to have the support on your decision to do it from folks that are excited about the technology. Good deal. On LIVMOR, congrats on the acquisition there. Are there any plans to commercialize the Halo+ AF detection system immediately, or what's kind of the commercialization thoughts there?

It sounds like nice to have the support on your decision to join from folks at Park Science about the technology. Good deal. And then on Live More, are there any regrets on the acquisition there?

Are there any plans to commercialize the Halo Plus AF detection system immediately? What's the commercialization thoughts there?

Branislav Vajdic: Yes, let me answer that question. We have acquired this system, and we have established that actually, in terms of a potential product, what makes sense is an integration of Halo+ platform for AFib detection with our AmiGo product. Why does that make sense? Well, as I said before, Halo+ is watch-based, and it can provide a sort of alert for AmiGo to do a 12-lead ECG when there are indications from the watch that there are things that are getting outside of the normal. Right? We believe that getting the AmiGo to the FDA clearance state will enable us to consider offering an integrated product where you have a watch that's working with AmiGo for a full-blown ability to detect a variety of conditions to our 12-lead ECG.

Yes, let me answer that question. We have acquired this system and we have established

that actually in terms of a potential product, what makes sense is an integration of Halo Plus platform for AP detection.

with our Amigo product. Why does that make sense? Well, as I said before, the Halo Plus is watch based.

and it can provide a sort of an alert.

for Amy Go to do a 12-EDC-G where there are indications from the watch that there are things that are getting outside of the normal, right? And so we believe that getting the Amy Go to the FDA clearance stage will enable us to...

consider offering an integrated product where you have a watch that's working with Amy Go for a full blown ability to detect a variety of conditions through our quality TV.

Branislav Vajdic: What's interesting about that is that physicians, under this scenario here, would get something that was alerted by the watch that they have learned is not very reliable, creating very many false positives, false negatives, etc. In this case, it will be validated by AIMIGo device, and that double validation, if you want, would probably mean that they believe in this referral from our system with a much higher degree of credibility. All in all, an integration makes sense, but AIMIGo is very much a front and center of that system, potential integrated system. We are still focused on AIMIGo totally and the potential integration into an integrated offering will come later.

And what's interesting about that is that physicians under this scenario here would get something that was alerted by the watch that they have learned is not very reliable, 80% very many positive, false positives, false negatives.

system with a much higher degree.

of credibility. So all in all, an integration makes sense, but Amygo is very much a front and center of that system, potential integrated system. So we are still focused on Amygo totally and the potential integration into an integrated offering.

Ben Haynor: Okay. That integration definitely makes sense. Lastly for me, just given the optimism on the FDA timelines, on your interactions with the agency, can you maybe characterize the questions that you've received? It doesn't sound like there's any showstoppers in there. Just any areas that common questions were arising or anything you can provide there would be helpful.

the questions that you've received. I mean it doesn't sound like there's any showstoppers in there but you know just you know any...

areas that common questions were arising or anything you can provide that would be helpful. Well, I'm not at liberty to really talk about much detail there. I would just say that at the top level,

Branislav Vajdic: Well, I'm not at liberty to really talk about much detail there. I would just say that at the top level, they are focused on cybersecurity and rightfully so. I think that's as much as I can go into details, but all in all, again, productive interactions with the FDA.

they are focused on cyber security and rightfully so. So I think that's as much as I can go into details, but all in all, again, productive interactions with the FDA.

Ben Haynor: Okay. Fair enough. Thanks for taking the questions, gentlemen, and congrats on the progress.

Okay, fair enough. Thanks for taking the questions gentlemen and congrats on the progress.

Branislav Vajdic: Oh, thank you, Ben.

Okay, fair enough. Thanks for taking the questions gentlemen and congrats on the progress. Oh, thank you Ben. Thanks Ben.

Robert Eno: Thanks, Ben.

Operator: This concludes our dial-in Q&A session, and we will now have questions via the webcast.

And this concludes our dial-in Q&A session. And we will now have questions via the webcast. Our first questioner asks, based on your IP, does the IP address have a password or password for the IP address?

[Company Representative] (HeartBeam): Our first questioner asks, Based on your IP, you can pursue several very interesting opportunities between beyond AIMI and the initial AIMIGo planned releases. They would like to know what is the next product that you will start developing.

You can pursue several very interesting opportunities between Beyond Amy and the initial Amy Go plan releases. They would like to know what is the next product that you will start developing.

Branislav Vajdic: Yeah. Let me reiterate that AIMIGo is front and center of our development efforts and commercialization path. As far as our IP is concerned, the good news is that we have incredibly deep IP portfolio here, and including a watch, which I happen to believe is the ultimate solution here, where you really don't have to have any other device other than your watch to be able to do a 12-lead ECG. That's not in the near-term focus, and perhaps that presents a partnership opportunity, right? There are many well-known players out there with a single-lead ECG watch, and we have extremely well-covered our intellectual property for the 12-lead watch. That's not going to be on our immediate development list. Again, partnership opportunity is probably very significant.

Yes, so let me reiterate that Amigo is front and center of our development efforts and commercialization a path.

As far as our IP is concerned, the good news is that we have incredibly deep IP portfolio here, including a watch.

which I happen to believe is the ultimate solution here, where you really don't have to have any other device other than your watch to be able to do a lovely DCG. But that's not in the near term focus. And perhaps that presents a partnership opportunity.

There are many well-known players out there with a single EDCG, a watch.

And we have extremely well covered our agricultural property for the 12-leaf watch. So that's not going to be our immediate development list, but again, partnership opportunities are probably very significant.

Branislav Vajdic: Secondly, as far as patch is concerned, as I alluded to, we are very seriously considering the opportunity that it presents. Well-established market, changing core factors. Technology-wise, there is very little change that would be required between going from a credit card-sized AIMIGo device, hardly an AIMIGo device, to a patch. That is very much on our radar screen.

Secondly, as far as Tatch is concerned, you know, as I alluded to, we are very seriously considering the opportunities that it presents. Well-established markets changing four factors, but technology-wise, we are very seriously considering the opportunities that it presents.

there is very little change that would be required between going from credit card size Amigo device, or the Amigo device, to a patch. So that is very much on our radar screen.

[Company Representative] (HeartBeam): The next question asks, Direct pay cheap go-to-market is somewhat of a new direction. Can you shed some light on why this is potentially a superior strategy compared to RPM?

The next question asks, direct pay Goto Market is somewhat of a new direction. Can you shed some light on why this is potentially a superior strategy compared to RPM? Sure, I can take that one. What we discussed is the refinement of the Goto Market strategy.

Branislav Vajdic: Arul, please.

Robert Eno: Sure. I can take that one. Yeah, what we discussed is a refinement of the go-to-market strategy. First, for those who don't know, RPM, Remote Physiologic Monitoring, are existing codes paid to physicians who prescribe devices to remotely monitor patients. What we've done is we've identified a number of market segments. RPM certainly could be one of them, but we've identified a number of additional market segments that we think are both big size and also where there's an entity that's willing to pay for the solution outside of the reimbursement system. That's what we're describing as direct pay. Some of these require data that shows that we're equivalent to a standard 12-lead ECG, and we had those listed in the slide. Others that are more value-based will be developing data on clinical and cost-effectiveness.

number of additional market segments that we think are both big size and also where there's an entity that's willing to pay for the solution outside of the reimbursement system. That's what we're describing as direct pay. And some of these require data that shows that we're equivalent to a standard 12 EDCG.

and we had those listed in the slide. And then others that are more value-based will be developing data on clinical and cost effectiveness. And the beauty of that is that we can start right away with the 12-lead ECG, but then the data we gather for the value-based usage is the same data that's going to be useful for our efforts to establish a unique reimbursement code.

Robert Eno: The beauty of that is that we can start right away with the 12-lead ECG, the data we gather for the value-based usage is the same data that's going to be useful for our efforts to establish a unique reimbursement code. We think that these market segments we've identified have the potential to result in more value to HeartBeam potentially than an RPM approach, as well as being in alignment with this long-term strategy of obtaining our own unique reimbursement code.

So we think that these market segments we've identified have the potential to result in more value to heart beam potentially than an RPM approach, as well as being in alignment with this long-term strategy of obtaining our own unique reimbursement code. And that concludes our webcast Q&A.

[Company Representative] (HeartBeam): That concludes our webcast Q&A.

Operator: Thank you. I would now like to turn the call back over to Dr. Vajdic for closing remarks.

I would now like to turn the call back over to Dr. Vyjek for closing remarks. Thank you, operator. I would like to thank each of you for joining our earliest conference call today and look forward to continuing the conversation.

Branislav Vajdic: Thank you, operator. I would like to thank each of you for joining our earnings conference call today and look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again, and all the best.

to update you on our ongoing progress and growth. If you were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again, and all the best.

Operator: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

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