Q2 2024 HeartBeam Inc Earnings Call

August 14, 2024

Speaker Change: . . . . .

Operator: Greetings and welcome to the Heartbeam 2nd quarter, 2024 financial results conference call. At this time, our 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.

Operator: In the next video, we'll see you in the next video. R. R. R. R. R. R. Greetings and welcome to the Heartbeam Second Quarter 2024 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.

Speaker Change: Greetings and welcome to the Heartbeam Second Quarter 2024 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.

Operator: 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 will caution not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. 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.

Operator: I would like to remind everyone that statements made on the call and webcast may include: 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.

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

Speaker Change: 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.

Speaker Change: 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 Change: You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions.

Operator: Only as of the date of this presentation. 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 facts relating to our business that may affect our predictions. You should also review our most recent Form 10K and Form 10Q for a more complete discussion of these factors and other risks, particularly under the heading risk factors.

Speaker Change: Only as of the date of this presentation. 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.

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

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

Operator: 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.

Speaker Change: 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.

Operator: A press release detailing these results across the wire this afternoon and is available in the investor-relations sections of our website, heartbeam.com.

Operator: A press release detailing these results crossed the wire this afternoon and is available in the investor relations sections of our website, heartbeam.com, your host today. Branislav Vajdic, Chief Executive Officer and Founder, Rob Eno, President, and Ravi Malhotra, Senior Director and Corporate Controller, will present results of operations for the second quarter ended June 30, 2024. At this time, I will turn the call over to Heartbeam's Chief Executive Officer, Branislav Vajdic. Please go ahead. Thank you, operator.

Speaker Change: A press release detailing these results crossed the wire this afternoon and is available in the investor relations sections of our website, heartbeam.com.

Operator: Your host today, Brownislaw Yaitich, Chief Executive Officer and Founder, Rob Eno, President, and Robby Mahatro, Senior Director and Corporate Controller, will present results of operations for the second quarter ended during 30th of 2024.

Speaker Change: Your host today, Brounislav Jajdic, Chief Executive Officer and Founder, Rob Eno, President, and Robby Mahalcho, Senior Director and Corporate Controller, will present results of operations for the second quarter and did June 30, 2022.

Branislav Vajdic: At this time, I will turn the call over to your HeartBeam, Chief Executive Officer, Brownislaw Yaitich. Please go ahead.

Speaker Change: At this time, I will turn the call over your heartbeat, chief executive officer, Branislav Geidic, please go ahead.

Branislav Vajdic: Thank you, operator. I'd like to start by reminding you of the vision for Heartbeam's unique technology. Heartbeam is developing Amy Goh, a credit card-side, cable-free cardiac monitoring device that will be capable of producing a 12-lead ECG by leveraging the company's core vector technology, which captures 360-degree signals of the heart's electrical activity. Amy Goh has the potential to create new applications for patients and physicians, specifically heart attack detection across symptoms onset, identification of complex arrhythmias that existing variables cannot detect, and the opportunity to monitor chronic conditions such as heart failure and to be used prevention and screening to the use of AI.

Branislav Vajdic: I'd like to start by reminding you of the vision for Heartbeam's unique technology. Heartbeam is developing Amygo, a credit card-sized, cable-free cardiac monitoring device that will be capable of producing a 12 lead ECG by leveraging the company's core vector technology, which captures 360-degree signals of the heart's electrical activity. Amigo has the potential to create new applications for patients and physicians, specifically heart attack detection upon symptoms onset. Identification of complex arrhythmias that existing variables cannot detect, and the opportunity to monitor chronic conditions such as heartbeater and to be used Proversion and screening to the use of AI

Branislav Geidic: Thank you, operator. I'd like to start by reminding you of the vision for Hardbeam's unique technology.

Speaker Change: Heartbeam is developing Amygo, a credit card-sized, cable-free cardiac monitoring device that will be capable of producing a 12-lead ECG by leveraging the company's core vector technology.

Speaker Change: which captures 360-degree signals of the heart's electrical activity.

Speaker Change: AMIGO has the potential to create new applications for patients and physicians.

Speaker Change: Specifically, heart attack detection upon symptom sunset.

Speaker Change: Identification of complex arrhythmias that exist in variables cannot detect.

Speaker Change: and the opportunity to monitor chronic conditions such as heart failure and to be used.

Branislav Vajdic: In addition, Heartbeams has broad IP protection on its core technology.

Branislav Vajdic: In addition, Heartbeam has broad IP protection on its core technology and on novel forefacts. These include implementing our vector technology on an extended wear cardiac monitor or a mobile cardiac telemetry device, bringing on-demand 12-lead ECG technology to an established market with reimbursement, and novel watch form factor that will combine a continuous monitor and a 12-lead on-demand wrist worn device. As we have mentioned previously, the 12-lead ECG is one of the most commonly performed diagnostic tests and is the standard of care in hospitals and clinics. There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide.

Speaker Change: Prevention and Screening to the Use of AI.

Speaker Change: In addition, Heartbeam has broad IP protection on its core technology.

Branislav Vajdic: on novel form factors. These include implementing our vector technology on extended their cardiac monitor or a mobile cardiac telemetry device, bringing on-demand Web Lead DCG technology to a established market with reimbursement and novel watch form factor that will combine a continuous monitor and a 12-lead on-demand wrist-worn device. As we have mentioned previously, a 12-lead DCG is one of the most commonly performed diagnostic tests and is the standard of care in hospitals and clinics. There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide.

Speaker Change: on novel four-factors.

Speaker Change: These include implementing our vector technology on extended-wear cardiac monitor or a mobile cardiac telemetry device, bringing on-demand WEDCG technology to an established market with reimbursement.

Speaker Change: and NovelWatch form factor that will combine a continuous monitor and a 12-lead on-demand wrist-worn device.

Speaker Change: As we have mentioned previously,

Speaker Change: A 12-lead DCG is one of the most commonly performed diagnostic tests for heart disease.

Speaker Change: and is the standard of care in hospitals and clinics.

Speaker Change: There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide.

Branislav Vajdic: They are not web lead DCGs; instead, they are one lead, three lead, or six lead devices. This is adequate, perhaps, for detecting many arrhythmias, but is not sufficient to detect heart attack or complex arrhythmias. In contrast, Heartbeam Amigo is an easy-to-use, cable-free, telecard-sized system that synthesizes the 12-lead ECG. The key aim of the Heartbeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including a heart attack, outside of a medical institution. Today, patient experience in heart attacks delay seeking care, on an average of three to four hours, which can lead to death and to serious and costly complications such as heart failure.

Branislav Vajdic: They are not 12-lead ECGs. Instead, they are 1-lead, 3-lead, or 6-lead devices. This is adequate perhaps for detecting many arrhythmias but is not sufficient to detect hot attacks or complex arrhythmias. In contrast, Amigo is an easy-to-use, cable-free, 10-card-size system that synthesizes the 12-lead ECG. The key aim of the heartbeat technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including heart attacks, outside of a medical institution. Today, patients experiencing a heart attack. Delay in Seeking Care for an average of 3 to 4 hours, which can lead to death and to serious and costly complications such as heart failure.

Speaker Change: They are not 12-lead ECGs. Instead, they are 1-lead, 3-lead, or 6-lead devices. This is

Speaker Change: Adequate, perhaps, for detecting many arrhythmias, but is not sufficient to detect heart attack or complex arrhythmias. In contrast,

Speaker Change: Amy Goh is an easy-to-use, cable-free, 10-card-size system that synthesizes the 12-lead ECG.

Speaker Change: The key aim of the Heartbeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including the heart attack, outside of a medical institution.

Speaker Change: Today, patients experiencing heart attacks

Speaker Change: delay seeking care on an average of three to four hours, which can lead to death and to serious and costly complications such as heart failure.

Branislav Vajdic: Next, we would like to share a video that demonstrates how easy it will be for patients to use Amigo in the real world. Please note that those of you who are dialed into this call by phone will not hear the audio, so you will be experiencing approximately 50 seconds of silence.

Branislav Vajdic: Next, we would like to share a video that demonstrates how easy it will be for patients to use Amygo in the real world. Please note that those of you who are dialed into this call by phone will not hear the audio. So you will be experiencing approximately 50 seconds of silence.

Speaker Change: Next, we would like to share a video that demonstrates how easy it will be for patients to use Amygo in the real world.

Speaker Change: Please note that those of you who are dialed into this call by phone will not hear the audio, so you will be experiencing approximately 50 seconds of silence.

Speaker Change: [inaudible]

Robert Eno: You now I will turn the call over to Parkbeam President Rob Eno.

Speaker Change: Robert Eno, Robert Eno, Robert Eno,

Rob Eno: Now, I will turn the call over to Heartbeam President Rob Eno. Thank you, Branislav. Heartbeam's technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with Amy Goh, where its 12 lead capabilities and advanced AI could outperform existing ambulatory cardiac monitoring. Expansion into heart attack detection where a 12-lead is needed accesses the 20 million patients with coronary artery disease and is a $12 billion opportunity. Incorporating our proprietary technology into the patch market accesses a market with established reimbursement that's estimated to grow to $4.8 billion in 2030.

Speaker Change: End

Speaker Change: Now I will turn the call over to Heartbeam President Rob Eno.

Robert Eno: Thank you, Brounislav. Heartbeam's technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with Amy Goh, where its 12-lead capabilities and advanced AI could outperform existing ambulatory cardiac ECGs. Expansion into heart attack detection where 12 lead is needed accesses the 20 million patients with coronary artery disease and is a 12 billion dollar opportunity. Incorporating our proprietary technology into the patch market accesses a market with established free embarrassment that's estimated to grow to $4.8 billion in 2030. Over time, Heartbeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease, where 12 lead ECG coupled with deep learning algorithms could provide valuable insights.

Rob Eno: Thank you, Branislav. HeartBeats technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with Amigo, where its 12 lead capabilities and advanced AI could outperform existing ambulatory cardiac ECGs.

Speaker Change: Expansion into heart attack detection where 12-lead is needed accesses the 20 million patients with coronary artery disease and is a 12 billion dollar opportunity.

Speaker Change: Incorporating our proprietary technology into the patch market accesses a market with established reimbursement that's estimated to grow to $4.8 billion in 2030.

Rob Eno: Over time, Heartbeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease, where 12-way DCG coupled with deep learning algorithms could provide valuable insights. And ultimately, a simple, easy-to-use 12-lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease. We're incredibly excited about the long-term potential of the technology. And in addition, we're making steady progress on our near term goals.

Speaker Change: Over time, Heartbeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease, where 12-lead ECG coupled with deep learning algorithms could provide valuable insights.

Robert Eno: And ultimately, a simple, easy-to-use 12-lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease. We're incredibly excited about the long-term potential in the technology, and in addition, we're making steady progress on our near-term milestones.

Speaker Change: And ultimately, a simple, easy-to-use 12-lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease.

Speaker Change: We're incredibly excited about the long-term potential of the technology, and in addition, we're making steady progress on our near-term milestones.

Robert Eno: Our initial clearance for the Amy Goh system will be a major milestone for the company and is important for several reasons. To start, we anticipate this will be the first patient-held device leveraging vector technologies to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for Heartbeam, so it's the cornerstone of our efforts. The vector approach is an excellent platform for AI algorithms. In the longer run, we believe that applying AI algorithms on top of the rich 360-degree signals could result in unsurpassed predictive and diagnostic capabilities. Our 510(k) submission for the Amy Goh system is an active review by the agency.

Rob Eno: Our initial clearance for the Amigo system will be a major milestone for the company, and it is important for several of you. To start, we anticipate this will be the first patient-held device leveraging vector technology to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for heart, so it's the cornerstone of our effort. The vector approach is an excellent platform for AI algorithms.

Speaker Change: Our initial clearance for the Amygo system will be a major milestone for the company and is important for several reasons.

Speaker Change: To start, we anticipate this will be the first patient-held device leveraging vector technology to be cleared by the FDA.

Speaker Change: Also, this clearance will be the basis for further FDA submissions for HeartBeam, so it's the cornerstone of our efforts.

Speaker Change: The Vector approach is an excellent platform for AI algorithms. In the longer run, we believe that applying AI algorithms on top of the rich 360 degree signals could result in unsurpassed predictive and diagnostic capabilities.

Rob Eno: In the longer run, we believe that applying AI algorithms on top of the rich 360-degree signals could result in unsurpassed predictive and diagnostic capabilities. R510K's submission for the Amigo System is an active review by the H... We're in the substantial review phase of answering questions posed by the FDA on this submission. We have successfully resolved the vast majority of the questions the FDA has asked.

Speaker Change: Our 510K submission for the AMIGO system is in active review by the agency.

Robert Eno: We're in a substantial review phase of answering questions posed by the FDA on this submission. We have successfully resolved the vast majority of the questions the FDA has asked. Since our last update, the FDA requested additional information, which we were in the process of providing. The company is working with the FDA to address the small number of remaining questions. We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clearance.

Speaker Change: We're in the substantial review phase of answering questions posed by the FDA on this submission.

Speaker Change: We have successfully resolved the vast majority of the questions the FDA has asked.

Rob Eno: Since our last update, the FDA requested additional information, which we're in the process of providing. The company is working with the FDA to address the small number of remaining questions. We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clarity.

Speaker Change: Since our last update, the FDA requested additional information, which we're in the process of providing. The company is working with the FDA to address the small number of remaining questions.

Speaker Change: We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clearance.

Robert Eno: The company continues to plan for a limited launch of Amy Goh by the end of 2024, which will provide us with valuable feedback on a user experience and functionality of the system in a real-world setting. We continue to make significant progress on other fronts, where preparing materials for our second FDA 510(k) submission on the algorithms that convert the 360-degree signals captured by the Amy Goh system into a synthesized 12-lead ECG. On June 20th, we completed enrollment in Valid ECG, the 198-patient trial comparing simultaneously placed Amy Goh and 12-lead ECGs. We completed enrollment in just three months, which is extremely fast for a study of this.

Rob Eno: The company continues to plan for a limited launch of Amygo by the end of 2024, which will provide us with valuable feedback on the user experience and functionality of the system in a real world. We continue to make significant progress on other We're preparing materials for our second FDA 510K submission on the algorithms that convert the 360-degree signals captured by the Amigo system into a synthesized 12-lead ECG. On June 20th, we completed enrollment in valid ECG, the 198 patient trial comparing Amy Go and 12 lead ECG. We completed enrollment in just three months, which is extremely fast for a study of this.

Speaker Change: The company continues to plan for a limited launch of Amigo by the end of 2024, which will provide us with valuable feedback on the user experience and functionality of the system in a real-world setting.

Speaker Change: We continue to make significant progress on other fronts. We're preparing materials for our second FDA 510K submission on the algorithms that convert the 360-degree signals captured by the Amigo system into a synthesized 12-lead ECG.

Speaker Change: On June 20th, we completed enrollment in VALID ECG, the 198 patient trial comparing simultaneously placed Amy Goh and 12 lead ECGs. We completed enrollment in just three months, which is extremely fast for a study of this size.

Robert Eno: The data are currently being analyzed. Valid C.G. will be the basis of the 12 lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the Amigo system. Prior to enrolling Valid C.G., we conducted an 80-patient pilot study utilizing the same protocol.

Rob Eno: The data are currently being analyzed. Valid ECG will be the basis of the 12-lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the Amigo system. Prior to enrolling Valid CG, we conducted an 80-patient pilot study utilizing the same protocol. That study has been accepted for presentation at the American Heart Association meeting. We've also made great progress on our AI program. In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrated the ability of Heartbeam's AI to detect atrial flutter.

Speaker Change: The data are currently being analyzed. Valid ECG will be the basis of the 12-lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the Amigo system.

Speaker Change: Prior to enrolling Val at ECG, we conducted an 80 patient pilot study utilizing the same protocol. That study has been accepted for presentation at the American Heart Association meeting in November .

Robert Eno: That study has been accepted for presentation at the American Heart Association Meeting in November. We've also made great progress on our AI program. In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrate the ability of Heartbeam's AI to detect atrial flutter. It is important arrhythmia, that's difficult to identify with a single lead ECG. These studies demonstrated that Heartbeam's AI algorithm applied to vector cardiography or VCG greatly outperformed AI on a single-lead ECG. Also, Heartbeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single-lead ECGs and, impressively, an expert panel reviewing 12-lead ECGs, with a statistically significant improvement in the detection of atrial flutter cases.

Speaker Change: We've also made great progress on our AI program.

Speaker Change: In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrate the ability of Heartbeam's AI to detect atrial flutter, an important arrhythmia that's difficult to identify with a single EDCG.

Rob Eno: It's an important arrhythmia that's difficult to identify with a single ECG. These studies demonstrated that Heartbeam's AI algorithm applied to vector cardiography, or VCG, greatly outperformed AI on a single EDC. Also, Heartbeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single-lead ECGs and, impressively, an expert panel reviewing 12-lea The development of AI algorithms has progressed.

Speaker Change: These studies demonstrated that Heartbeam's AI algorithm applied to Vector Cardiography, or VCG, greatly outperformed AI on a single EDCG.

Speaker Change: Also, Heartbeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single-lead ECGs and impressively, an expert panel reviewing 12-lead ECGs, with a statistically significant improvement in the detection of atrial flutter cases.

Robert Eno: The development of the AI algorithm has progressed. We're getting close to freezing our multiple AI models, powering Heartbeam AI, that once cleared by the FDA will provide a comprehensive set of diagnostic suggestions. This powerful AI-based tool combined with a 12-lead ECG provided to the cardiologist will make, we believe, an offering beyond anything that's available in patient-obtained ECGs, both in terms of diagnoses covered and diagnostic accuracy. We've gained significant experience with AMIGO and believe the technology is de-risked. We've conducted multiple clinical studies in rolling more than 500 patients. These include the Valid ECG study described previously, as well as the 80 patient pilot study.

Rob Eno: We're getting close to freezing our multiple AI models, powering Heartbeam AI that, once cleared by the FDA, will provide a comprehensive set of diagnostic suggestions. This powerful AI-based tool, combined with a 12-lead ECG provided to the cardiologist, will make, we believe, an offering beyond anything that's available in patient-obtained ECGs, both in terms of diagnoses covered and diagnostic accuracy. We've gained significant experience with AmyGo and believe that the technology is de-risked. We have conducted multiple clinical studies enrolling more than 500 patients.

Speaker Change: The development of the AI algorithms has progressed. We're getting close to freezing our multiple AI models powering HeartBeam AI that, once cleared by the FDA, will provide a comprehensive set of diagnostic suggestions.

Speaker Change: This powerful AI-based tool combined with a 12-lead ECG provided to the cardiologist will make, we believe, an offering beyond anything that's available in patient-obtained ECGs, both in terms of diagnoses covered and diagnostic accuracy.

Speaker Change: We've gained significant experience with AMIGO and believe that technology is de-risked. We've conducted multiple clinical studies enrolling more than 500 patients. These include the valid ECG study described previously as well as the 80 patient pilot study.

Rob Eno: These include the valid ECG study described previously, as well as the 80 patient pilot. We've previously discussed the study published last year in Jack Advances, demonstrating equivalence to 12-lead ECG in detecting coronary occlusions and also showing a significant improvement in accuracy when comparing the Heartbeam approach with a baseline recording to a single 12-lead ECG, which is often the case in an emergency.

Robert Eno: We've previously discussed the study published last year and also showing a significant improvement in accuracy when comparing the Heartbeam approach with a baseline reporting to a single 12-lead ECG, which is often the case in an emergency room. We've completed another study on the performance of our ECG technology together with symptoms and patient history compared to the standard of care.

Speaker Change: We've previously discussed the study published last year in JAK Advances, demonstrating equivalence to 12-lead ECG in detecting coronary occlusions.

Speaker Change: and also showing a significant improvement in accuracy when comparing the heart beam approach with a baseline recording to a single 12-week ECG, which is often the case in an emergency room.

Rob Eno: We've completed another study on the performance of our ECG technology, together with symptoms and patient history compared to the standard of care. These results will also be presented at the American Heart Association meeting in November, along with the results of the 12-lead synthesis pilot study mentioned earlier. So a total of two presentations at a strategic scientific conference later this year. Beyond the clinical protocols, we have usability experience in a real-world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the system's functioning. I'd now like to hand the call over to our corporate controller, Ravi Malhotra, to present our selected financials.

Speaker Change: We've completed another study on the performance of our ECG technology together with symptoms and patient history compared to the standard of care.

Robert Eno: These results also will be presented in the American Heart Association meeting in November, along with the results of the 12 lead census as pilot study mentioned area, so a total of two presentations at this strategic scientific conference later this year. Beyond the clinical protocols, we have usability experience in a real-world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the system's functionality.

Speaker Change: These results also will be presented at the American Heart Association meeting in November , along with the results of the 12-lead

Speaker Change: Synthesis Pilot Study Mentioned Area, so a total of two presentations at the Strategic Scientific Conference later this year.

Speaker Change: Beyond the clinical protocols, we have usability experience in a real world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the system's functionality.

Ravi Malhotra: I'd now like to hand the call over to our Corporate Controller, Ravi Mahotra, to present selected financials.

Ravi Vajdic: I'd now like to hand the call over to our corporate controller, Ravi Malhotra, to present selected financials.

Ravi Malhotra: Thank you, Rob. I'll now give a brief overview of our financial results.

Ravi Malhotra: I'll now give a brief overview of our financial results. A full breakdown is available in our regulatory filings and in the press release that crossed the wire aftermarket close today. General and administrative expenses for the second quarter of 2024 were 2.2 million compared to 1.8 million for the second quarter of 2023.

Ravi Vajdic: Thank you all.

Ravi Malhotra: A full breakdown is available in our regulatory filings and in the press release that crossed the buyer aftermarket close today. General and administrative expenses for the second quarter of 2024 were $2.2 million compared to $1.8 million for the second quarter of 2023. The increase in GNA expense is primarily related to non-cash stock-based compensation expense associated with additional awards, which the company granted since June 30, 2023, and also higher consulting costs, primarily offset by lower legal cost in the current period. Research and development expenses for the second quarter of 2024 were 2.8 million, compared to 1.5 million for the second quarter of 2023.

Ravi Vajdic: I'll now give a brief overview of our financial results. A full breakdown is available in our regulatory filings and in the press release that crossed the wire after market closed today.

Ravi Malhotra: The increase in GNA expense is primarily related to non-cash stock-based compensation expense associated with additional awards, which the company granted since June 30, 2023, and also higher consulting costs primarily offset by lower legal costs in the current period. Research and development expenses for the second quarter of 2024 were $2.8 million compared to $1.5 million for the second quarter of 2023. The increase in R&D expense is primarily related to an increase in headcount, increase in clinical and AI-related costs, and increase in consulting spend, which is offset by a decrease in product development consulting cost spending, primarily driven by completion of milestone projects in the prior period. The net loss for the second quarter of 2024 was $5 million compared to a net loss of 3.2 million for the second quarter of 2023.

Ravi Vajdic: General and administrative expenses for the second quarter of 2024 were $2.2 million compared to $1.8 million for the second quarter of 2023.

Ravi Vajdic: The increase in G&A expense is primarily related to non-cash stock-based compensation expense associated with additional awards which the company granted since

Ravi Vajdic: June 30th, 2023, and also higher consulting costs primarily offset by lower legal costs in the current period.

Ravi Vajdic: Research and development expenses for the second quarter of 2024 were $2.8 million compared to $1.5 million for the second quarter of 2023.

Ravi Malhotra: The increase in RNA expense is primarily related to an increase in head count, an increase of clinical and AI-related costs, and an increase in consulting spend, which is offset by a decrease in product development's consulting cost spending, primarily driven by the completion of milestone projects in the prior period.

Ravi Vajdic: The increase in R&E expense is primarily related to an increase in headcount.

Ravi Vajdic: increase of clinical and AI related costs and increase in consulting spend, which is offset by a decrease in product development consulting cost spending, primarily driven by completion of milestone projects in the prior period.

Ravi Malhotra: Net loss for the second quarter of 2024 was $5 million compared to a net loss for $3.2 million for the second quarter of 2023.

Ravi Vajdic: Net loss for the second quarter of 2024 was 5 million compared to a net loss for 3.2 million for the second quarter of 2023.

Ravi Malhotra: We ended the quarter with approximately 9.2 million in cash and cash equivalence as we close to carefully manage spending.

Branislav Vajdic: We ended the quarter with approximately 9.2 million in cash and cash equivalents as we continue to carefully manage spending. I will now turn the call back to Branislav for closing. In conclusion, we remain extremely excited about the potential heartbeats and progress. Amy Goh will be the smallest, easiest to use, and first cable-free 12 ADCG device enabled by Heartbeam's unique and IP Protected Vector Technology. It has the potential to disrupt numerous large markets and clinical applications, starting with the ability to detect complex arrhythmias.

Ravi Vajdic: We ended the quarter with approximately $9.2 million in cash and cash equivalents as we close to carefully manage spending.

Branislav Vajdic: I will now turn the call back to Brannislav for closing thoughts.

Ravi Vajdic: I will now turn the call back to Branislav for closing thoughts.

Ravi Vajdic: Robert Eno, Ravi Malhotra,

Speaker Change: Robert Eno, Ravi Malhotra,

Branislav Vajdic: In conclusion, we remain extremely excited about the potential of cardbeam and progress. Amigo will be smallest, easiest to use and first cable-free 12-EDCG device enabled by Cardbeam's unique and IP protected vector technology. It has the potential to disrupt numerous large markets and clinical applications, starting with the ability to detect complex arrhythmias, expanding to heart attack detection, and then to monitoring or complex diseases such as heart failure. Ultimately, we believe that the combination of the small four-factor, powerful 360-degree ECD technology and advanced AI algorithms will have significant applications in prediction and screening of cardiac conditions. We continue to make progress toward key regulatory and clinical milestones.

Branislav Geidic: In conclusion, we remain extremely excited about the potential EcardWin and progress.

Speaker Change: Amygo will be smallest, easiest to use, and first cable-free 12-lead ECG device enabled by HeartBeam's unique IP-protected vector technology.

Speaker Change: It has the potential to disrupt numerous large markets and clinical applications.

Branislav Vajdic: Expanding to Heart Attack Detection, and then to monitoring for complex diseases such as heart failure. Ultimately, we believe that the combination of the small four factor, powerful 360-degree ECG technology, and advanced AI algorithms will have significant applications in prediction and screening of cardiac conditions.

Speaker Change: starting with the ability to detect complex arrhythmias.

Speaker Change: expanding to heart attack detection.

Speaker Change: and then to monitoring for complex diseases such as heart failure.

Speaker Change: Ultimately, we believe that the combination of the small four-factor, powerful 360-degree ECG technology…

Speaker Change: and Advanced AI Algorithms.

Speaker Change: will have significant applications in prediction and screening of cardiac conditions.

Branislav Vajdic: We continue to make progress towards key regulatory and clinical milestones. Our initial 510k application for the AMIGO system is under active FDA review, with productive discussions underway. The company is working with the FDA to address the small number of remaining questions.

Speaker Change: We continue to make progress toward key regulatory and clinical milestones.

Branislav Vajdic: Our initial five-tank application for the Amigo system is under active FDA review, with productive discussions underway. The company is working with the FDA to address the small number of remaining questions. We believe that we are progressing toward clearance. We anticipate a limited launch by the end of the year focused on the Amigo system, which will provide the company with valuable feedback on the user experience and functionality of the system in a real world set. We are preparing materials for our second FDA submission, that will be a 510(k) submission, on the algorithms that convert the vector signals captured by our AMIGO system into a synthesized web lead ECG.

Speaker Change: Our initial 510k application for the AMIGO system is under active FDA review.

Speaker Change: with productive discussions underway.

Speaker Change: The company is working with the FDA to address the small number of remaining questions.

Branislav Vajdic: We believe that we are progressing toward clearance. We anticipate a limited launch by the end of the year focused on the Amigo system, which will provide the company with valuable feedback on the user experience and functionality of the system in a real world setting. We are preparing materials for our second FDA submission, which will be a five-takeage submission on the algorithms that convert the vector signals captured by our AMIGO system into a synthesized. We have completed enrollment in the valid ECG study and anticipate submitting the 510k application soon after the clearance of the gaming system.

Speaker Change: We believe that we are progressing toward clearance.

Speaker Change: We anticipate

Speaker Change: Unlimited launch by the end of the year, focused on the Amigo system, which will provide the company with valuable feedback on the user experience and functionality of the system in a real-world setting.

Speaker Change: We are preparing materials for our second FDA submission, that will be a 510k submission, on the algorithms that convert the vector signals captured by our Amigo system into a synthesized family DCG.

Branislav Vajdic: We have completed enrollment in the valid ECG study, and anticipate submitting the 510(k) application soon after the clearance of the AMIGO system. We presented positive new data on our deep learning algorithm, Heartbeam AI, demonstrating excellent performance in detecting archaea flutter, even outperforming a panel of three electrophysiology reviewing the 12-lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithms. We ended the quarter with approximately 9.2 million in cash and cash equivalent, enabling the company to execute on upcoming clinical and regular televised tools.

Speaker Change: We have completed enrollment in the valid ECG study and anticipate submitting the 510K application soon after the clearance of the gaming system.

Branislav Vajdic: We presented positive new data on our deep learning algorithm, Heartbeam AI, demonstrating excellent performance in detecting atria flutter, even outperforming a panel of three electrophysiologists reviewing 12-lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithm. We ended the quarter with approximately $9.2 million in cash and cash equivalents, enabling the company to execute on upcoming clinical and regulatory milestones.

Speaker Change: We presented positive new data on our deep learning algorithm, HeartBeam AI.

Speaker Change: Demonstrating excellent performance in detecting atria flutter.

Speaker Change: Even outperforming a panel of three electrophysiologists reviewing 12 lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithms.

Speaker Change: We ended the quarter with approximately $9.2 million in cash and cash equivalents, enabling the company to execute on upcoming clinical and regulatory milestones.

Branislav Vajdic: I look forward to providing our shareholders with further updates in the near term. I thank you all for attending, and now the Heartbeam team would like to answer your questions.

Operator: I look forward to providing our shareholders with further updates in the near term. I thank you all for attending. Now, the Heartbeam team would like to answer your question. Operator. We will now begin the question and answer session. For those on the phone, please press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Speaker Change: I look forward to providing our shareholders with further updates in the near term. I thank you all for attending, and now the Heartbeam team would like to answer your questions. Operator.

Operator: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. For those on the webcast, please type your question on the screen. Again, if you're on the phone, please press star one for questions. Currently, I do not see any questions on the phone. Our first webcast question: can you just provide some more detail on the timing of FDA clearance? Yeah, let me comment on that.

Operator: Operator, we will now begin the question and answer session. For those on the phone, please press star, then one on your touchstone phone. If you are using a speaker phone, please pick up your hands up before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two.

Operator: We are under active review with the FDA, and we really can't give any more details than what is said in the call and in our earnings materials. To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked.

Speaker Change: We will now begin the question and answer session. For those on the phone, please press star, then one on your touchtone phone.

Speaker Change: If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.

Operator: For those on the webcast, please type your question on the screen. Again, if you are on the phone, please press star one for questions. Currently, I do not see any questions on the phone.

Speaker Change: For those on the webcast, please type your question on the screen.

Speaker Change: [inaudible]

Speaker Change: Again, if you're on the phone, please press star 1 for questions.

Speaker Change: [inaudible]

Speaker Change: Currently, I do not see any questions on the phone.

Robert Eno: Our first webcast question, can you just provide some more detail on the timing of the FDA clearance? Let me comment on that. We are under active review with the FDA, and we really can't give any more details than what we said in the call and in our earnings materials. To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked. And the last quarter, FDA requested additional information, which we are now in the process of providing. We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance.

Speaker Change: [inaudible]

Speaker Change: Our first webcast question, can you just provide some more detail on the timing of the FDA clearance?

Operator: Greetings and welcome to the Heartbeam 2nd quarter, 2024 Financial Results Conference call. At this time, our 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.

Speaker Change: Yeah, let me comment on that. We are under active review with the FDA and we really can't give any more details than what we said in the call and in our earnings materials.

Operator: You will caution not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. 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 facts relating to our business that may affect our predictions. You should also review our most recent form 10K and form 10Q for a more complete discussion of these factors and other risks, particularly under the heading risk factors.

Speaker Change: To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked.

Operator: Last quarter, FDA requested additional information, which we are now in the process of providing. We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance. We still anticipate a limited launch before the end of the year. Again, this will provide us with valuable feedback on the user experience as well as functionality of the system in the real world setting. Extremely valuable to us.

Speaker Change: And last quarter, FDA requested additional information, which we are now in the process of providing.

Speaker Change: We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance.

Robert Eno: We still anticipate a limited launch before the end of the year.

Speaker Change: We still anticipate a limited launch before end of the year.

Robert Eno: Again, we will provide us with valuable feedback on the user experience as well as functionality of the system in the real-world setting, extremely valuable to us.

Speaker Change: Again, this will provide us with valuable feedback on the user experience as well as functionality of the system in the real world setting. Extremely valuable to us.

Speaker Change: Thank you.

Robert Eno: Let's see, our next question: you showed market sizes for Heartbeam Technology.

Operator: Thank you. Let's see our next question. You showed market sizes for Heartbeam's technology fee. Can you explain just where you're going with those, Rob?

Speaker Change: Let's see. Our next question, you showed market sizes for Heartbeam's technology. Can you explain just where you're going with those?

Operator: A press release detailing these results across the wire this afternoon and is available in the investor-relation sections of our website, heartbeam.com.

Robert Eno: Can you explain just where you're going, but those? Brock? Sure, yeah, thanks. That was a new framework. I can elaborate. The main point there really is to show that Heartbeam Technology, which, again, is a credit card-sized, cable-free device that produces a 12-lead ECG, can have a wide range of applications. So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection. We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on-demand 12-lead capabilities. And with both that form factor and with Amigo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease.

Operator: Your host today, Brownislaw Yaitich, Chief Executive Officer and Founder, Rob Eno, President and Robby Mahatro, Senior Director and Corporate Controller will present results of operations for the second quarter ended during 30th of 2024.

Rob Eno: Sure. Yeah, thanks. That was a new framework.

Speaker Change: Rob.

Speaker Change: Sure, yeah thanks. That was a new framework so I can elaborate. The main point there really is to show that Heartbeam's technology, which again is a credit card sized cable free device that produces a 12 lead ECG, can have a wide range of applications.

Rob Eno: So I can elaborate. The main point there really is to show that Heartbeam's technology, which again is a credit card sized table-free device that produces a 12 lead ECG, can have a wide range of applications. [inaudible] So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection. We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on demand 12 week capabilities.

Branislav Vajdic: At this time, I will turn the call over your heartbeam, Chief Executive Officer, Brownislaw Yaitich, please go ahead. Thank you, operator. I'd like to start by reminding you of the vision for heartbeams unique technology. Heartbeam is developing Amy Goh, a credit card-side cable-free, cardic monitoring device that will be capable of producing a 12-lead ECG by leveraging the company's core vector technology, which captures 360-degree signals of the heart's electrical activity. Amy Goh has the potential to create new applications for patients and physicians, specifically heart attack detection across symptoms onset, identification of complex arrhythmias that existing variables cannot detect, and the opportunity to monitor chronic conditions such as heart failure and to be used prevention and screening to the use of AI.

Speaker Change: So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection.

Rob Eno: And with both that form factor and with Amigo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease. And then, ultimately, beyond that, we think that patients taking frequent 12 lead ECGs over time, especially when combined with AI algorithms, can enable prevention and screening for a very large number of patients. So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention.

Speaker Change: We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on-demand 12-lead capabilities. And with both that form factor and with Amigo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease.

Robert Eno: And then ultimately, beyond that, we think that patients taking frequent 12-lead ECGs over time, especially when combined with AI algorithms, can enable prevention and screening for a very large number of patients.

Speaker Change: And then ultimately, beyond that, we think that patients taking frequent 12-week ECGs over time, especially when combined with AI algorithms, can enable prevention and screening for a very large number of patients.

Robert Eno: So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention and screening.

Speaker Change: So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention and screening.

Robert Eno: Thanks.

Robert Eno: Our next question. You mentioned that the Valid ECG study has completed enrollment. What are the results of the study? Yeah, I'm pleased to have some lives on that. Sure. So first, as a reminder, Valid ECG was a study with simultaneously collected ECGs, so the patient had both the standard 12-lead ECG and Amigo at the same time. And the goal was to demonstrate the similarity between the standard 12-lead signals and our synthesized 12-lead signals. And we've had two pre-submission meetings with FDA that are largely focused on the endpoints of the study. So where we are right now is we've completed enrollment back in June, as I mentioned, but the data is currently being analyzed; so the results are not available.

Rob Eno: Our next question, you mentioned that the valid ECG study has completed enrollment. What are the results of the study? Yeah, Rob, please share some lives on that. Sure. Um, so first, as a reminder, Validate ECG with a study with simultaneously collected ECGs. So the patient had both a standard 12 lead ECG and Amy go at the same time. And the goal was to demonstrate the similarity between the standard 12 lead signals and our synthesized 12 lead signals.

Speaker Change: Thanks.

Speaker Change: Our next question, you mentioned that the valid ECG study has completed enrollment. What are the results of the study?

Branislav Vajdic: In addition, heartbeams has broad IP protection on its core technology, on novel form factors. These include implementing our vector technology on extended their cardic monitor or a mobile cardic telemetry device, bringing on-demand Web Lead DCG technology to a established market with reimbursement and novel watch form factor that will combine a continuous monitor and a 12-lead on-demand wrist-word device. As we have mentioned previously, a 12-lead DCG is one of the most commonly performed diagnostic tests and is the standard of care in hospitals and clinics.

Speaker Change: Yeah, Rob, please shed some light on that.

Robert: Sure. So first, as a reminder, valid ECG was a study with simultaneously collected ECGs. So the patient had both a standard 12-lead ECG and amigo at the same time. And the goal was to demonstrate the similarity between the standard 12-lead signals and our synthesized 12-lead signals.

Rob Eno: And we've had two pre-submission meetings with FDA that are largely focused on the endpoints of the study. So, where we are right now is that we completed enrollment back in June, as I mentioned, but the data is currently being analyzed, so the results are not available. We do anticipate completing that analysis soon, as that'll be the basis for the second FDA submission that we plan to submit. I would note that we did complete this 80 patient pilot study with the same protocol.

Robert: And we've had two pre-submission meetings with FDA that are largely focused on the endpoints of the study.

Rob Eno: We can't say the results of that because it's been accepted for a presentation in November by the American Heart Association, but based on the results of those studies, that study did proceed with faculty. Great, thank you. The next question, if the 12 L ECG is being evaluated by a physician, why do you need AI? Let me answer that question.

Robert: So, where we are right now is we've completed enrollment back in June, as I mentioned, but the data is currently being analyzed, so the results are not available. We do anticipate completing that analysis soon, as that'll be the basis for the second FDA submission that we plan to submit shortly.

Robert Eno: We do anticipate completing that analysis soon, as that'll be the basis for the second FDA submission that we plan to submit shortly. I would note that we did complete this 80-patient pilot study with the same protocol.

Robert: I would note that we did complete this 80 patient pilot study with the same protocol. We can't say the results of that because it's been accepted for a presentation in November at the American Heart Association, but based on the results of those studies, that study we did proceed with thalides CG.

Robert Eno: We can't say the results of that because it's been accepted for a presentation in November of the American Heart Association, but based on the results of those studies, that study we did proceed with Valid ECG.

Branislav Vajdic: There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide. They are not Web Lead DCGs, instead they are one lead, three lead or six lead devices. This is adequate, perhaps, for detecting many arrhythmias but is not sufficient to detect heart attack or complex arrhythmias. In contrast, Heartbeam Amigo is an easy-to-use cable-free telecard-sized system that synthesizes the 12-lead ECG.

Robert Eno: Great. Thank you.

Robert Eno: The next question. The 12-lead ECG is being evaluated by a physician. What do you need to AI? Let me answer that question. Our vision is that with hard beam AI, the user will get an automated arithea classification, and that's going to happen immediately after every use. However, of course, it is important that a physician review a patient's clinical picture, the complete thank-up picture, which includes ECG.

Robert: i

Speaker Change: Great, thank you.

Speaker Change: My next question, if the 12L ECG is being evaluated by a physician, why do you need AI?

Rob Eno: Our vision is that with Heartbeam AI, the user will get an automated, and that's going to happen immediately after every use. However, of course, it is important that a physician review the patient's clinical picture, the complete clinical picture, which includes ECG. We actually anticipate, you know, like having two workflows.

Speaker Change: Let me answer that question. Our vision is that with Hard Beam AI, the user will get an automated arithmetic classification, and that's going to happen immediately after every use.

Speaker Change: However, of course, it is important.

Speaker Change: that a physician review patient's clinical picture, the complete clinical picture, which includes ECG.

Branislav Vajdic: The key aim of the Heartbeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions including a heart attack outside of a medical institution. Today, patient experience in heart attacks delay seeking care on an average of three to four hours which can lead to death and to serious and costly complications such as heart failure.

Robert Eno: We actually anticipate, you know, like having two workflows here. If the user is experienced in symptoms, the ECG will be automatically sent to the user's physician or to a physician reading service for evaluation. On the other hand, if the user is not experienced in symptoms but is taking a routine recording to add to their database of ECGs, the ECG will not automatically go to a physician for interpretation. This is an asymptomatic recording, but the user will have the option to do so. In either case, symptomatic or not symptomatic, AI will play a key role in informing the patient and helping the physician diagnose the patient.

Speaker Change: We actually anticipate, you know, like having two workflows here.

Rob Eno: If the user is experiencing symptoms. The ECG will be automatically sent to the user's physician, or to a physician reading service for evaluation. On the other hand, if the user is not experiencing symptoms, but is taking a routine recording, to add to their database of ECGs. The ECG will not automatically go to a physician for interpretation. This is asymptomatic recording, but the user will have the option to do so. In either case, symptomatic or not symptomatic, AI will play a key role, in informing the patient and helping physician diagnose the patient. Thanks.

Speaker Change: If the user is experiencing symptoms, please call us at 1-866-933-7483 or call 1-866-933-7483.

Speaker Change: The ECG will be automatically sent to the user's physician.

Speaker Change: or to a physician-reading service for evaluation.

Speaker Change: On the other hand, if the user is not experiencing symptoms, but is taking a routine recording,

Operator: Next, we would like to share a video that demonstrates how easy it will be for patients to use Amigo in the real world. Please note that those of you who are dialed into this call by phone will not hear the audio so you will be experiencing approximately 50 seconds of silence.

Speaker Change: to add to their database of ECGs. The ECG will not automatically go to a physician for interpretation. This is asymptomatic recording, but the user will have the option to do so. In either case,

Speaker Change: in informing the patient and helping physician diagnose the patient.

Robert Eno: Thanks.

Rob Eno: Next question, will the initial aim of the product be able to detect heartbeats from the get go, or will there need to be further R&D before that claim can be made? We have actually done a lot of research, and we've done two studies related to heart detection. So in terms of the development, there is still some work to do.

Robert Eno: Next question. Will the initial end-go product be able to detect hearted effects from the get-go, or will there need to be further R&D before that claim to be made? We have actually done a lot of research, and we've done two studies related to heart attack detection. So, in terms of the development, there is still some work to do, but fundamentally, we believe that we have a technology that's going to provide needed insight into the patients with a chest pain. So all in all, at this point, we are focusing on a repair detection, especially complex repairs that other technologies cannot detect.

Speaker Change: Thanks. Next question, will the initial AIM-GO

Speaker Change: Product to be able to detect heart attacks from the get-go or will there need to be further R&D before that claim can be made?

Speaker Change: We have actually done a lot of research and we've done two studies.

Rob Eno: But fundamentally, we believe that we have a technology that's going to provide needed insight into the patient with chest pain. So, all in all, at this point, we are focusing on arrhythmia detection, especially complex arrhythmias that other technologies cannot detect. And our plan is, as soon as that is productized, as soon as that is, you know, in the marketplace, that we will apply all our resources to enable the product to detect heart attacks. Next question, is it possible to speak to pursuing FDA approval for atrial clutter versus atrial fibrillation? Yeah, let me just take that one for us.

Speaker Change: related to heart attack detection.

Speaker Change: So in terms of the development, there is still some work to do. But fundamentally, we believe that we have a technology that's going to provide

Robert Eno: you Now I will turn the call over to Parkbeam President Rob Eno. Thank you, Brounislav. Heartbeam's technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with Amy Goh, where its 12 lead capabilities and advanced AI could outperform existing ambulatory cardiac ECGs. Expansion into heart attack detection where 12 lead is needed accesses the 20 million patients with coronary artery disease and is a 12 billion dollar opportunity.

Speaker Change: need an insight into the patients with chest pain.

Speaker Change: So, all in all, at this point, we are focusing on arrhythmia detection, especially complex arrhythmias that other technologies cannot.

Robert Eno: And our plan is, as soon as that is productized, as soon as that is in the marketplace, that we will apply all our resources to enable the product to detect heart attack.

Speaker Change: detect. And our plan is as soon as that is productized, as soon as that is, you know, in the marketplace, that we will apply all our resources to enable the product to detect heart attack.

Robert Eno: Next question.

Rob Eno: Yeah, go ahead. Yeah, it's just, you know, similar to what Brounstein said before, we're taking a stepwise approach with FDA, and so the initial indications are for arrhythmia, and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation, and we'll have clinical data on that. So yes, pursuing those is within the scope of, Okay, great. That is the final question there.

Branislav Vajdic: I'll now turn the call back over to Dr. Vajdic for his closing remarks. Thank you, operator. I would like to thank each of you for joining our conference today and look forward to continuing to update you on our ongoing progress and growth. If you were not able to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Robert Eno: Is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fig relation? Yeah, I want me to take that one. Yeah, go ahead.

Speaker Change: Thanks.

Speaker Change: Next question, is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fibrillation?

Robert Eno: Incorporating our proprietary technology into the patch market accesses a market with established free embarrassment that's estimated to grow to $4.8 billion in 2030. Over time, Heartbeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease where 12 lead ECG coupled with deep learning algorithms could provide valuable insights. And ultimately, a simple easy to use 12 lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease. We're incredibly excited about the long-term potential in the technology and in addition, we're making steady progress on our near-term milestones.

Robert Eno: Yeah, it's just, you know, similar to what Brenna said before. We're taking a stepwise approach with FDA, and so the initial indications are for arrhythmia, and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation, and we'll have clinical data on that. So, so yes, pursuing those, those are within the scope of the initial clearances.

Speaker Change: Let me just take that one, Branislav.

Branislav Geidic: Yeah, go ahead.

Branislav Geidic: Yeah, it's just um

Speaker Change: Similar to what Branislav said before, we're taking a stepwise approach with FDA, and so the initial indications are for arrhythmia, and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation, and we'll have clinical data on that.

Speaker Change: So yes, pursuing those are within the scope of the initial clearances.

Robert Eno: Okay, great.

Operator: That is the final question there.

Speaker Change: Great. That is the final question there. I'll turn now the call back over to Dr. Vajdic for his closing remarks.

Robert Eno: Our initial clearance for the Amy Goh system will be a major milestone for the company and is important for several reasons. To start, we anticipate this will be the first patient held device leveraging vector technologies to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for Heartbeam, so it's the cornerstone of our efforts. The vector approach is an excellent platform for AI algorithms. In the longer run, we believe that applying AI algorithms on top of the rich 360-degree signals could result in unsurpassed predictive and diagnostic capabilities.

Dr. Vajdic: Thank you, operator.

Dr. Vajdic: I would like to thank each of you for joining our conference today and look forward to continuing to update you on our ongoing progress and growth.

Branislav Vajdic: If you were not able to answer any of your questions today, please reach out to our higher firm, MZ Group, who would be more than happy to assist. Thank you again.

Dr. Vajdic: If you were not able to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again.

Operator: The conference is now concluded. Thank you, Frank, for attending today's presentation.

Operator: You may now disconnect.

Speaker Change: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Robert Eno: Our 510-K submission for the Amy Goh system is an active review by the agency. We're in a substantial review phase of answering questions posed by the FDA on this submission. We have successfully resolved the vast majority of the questions the FDA has asked. Since our last update, the FDA requested additional information, which were in the process of providing. The company is working with the FDA to address the small number of remaining questions. We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clearance.

Robert Eno: On June 20th, we completed enrollment in Valid ECG, the 198-patient trial comparing simultaneously placed Amy Goh and 12-lead ECGs. We completed enrollment in just three months, which is extremely fast for a study of this. The data are currently being analyzed. Valid C.G, will be the basis of the 12 lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the Amigo system.

Robert Eno: Prior to enrolling Valid C.G., we conducted an 80 patient pilot study utilizing the same protocol. That study has been accepted for presentation at the American Heart Association meeting in November. We've also made great progress on our AI program. In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrate the ability of Heartbeam's AI to detect atrial flutter. It important arrhythmia, that's difficult to identify with a single lead ECG. These studies demonstrated that Heartbeam's AI algorithm applied to vector cardiography or VCG greatly outperformed AI on a single lead ECG.

Robert Eno: Also, Heartbeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single lead ECGs and impressively an expert panel reviewing 12 lead ECGs with a statistically significant improvement in the detection of atrial flutter cases. The development of the AI algorithm has progressed. We're getting close to freezing our multiple AI models, powering Heartbeam AI, that once cleared by the FDA will provide a comprehensive set of diagnostic suggestions. This powerful AI based tool combined with a 12 lead ECG provided to the cardiologist will make, we believe, an offering beyond anything that's available in patient obtained ECGs, both in terms of diagnoses covered and diagnostic accuracy.

Robert Eno: We've gained significant experience with AMIGO and believe the technology is de-risked. We've conducted multiple clinical studies in rolling more than 500 patients. These include the Valid ECG study described previously as well as the 80 patient pilot study. We've previously discussed the study published last year and also showing a significant improvement in accuracy when comparing the Heartbeam approach with a baseline reporting to a single 12 lead ECG, which is often the case in an emergency room.

Robert Eno: We've completed another study on the performance of our ECG technology together with symptoms and patient history compared to the standard of care. These results also will be presented in the American Heart Association meeting in November, along with the results of the 12 lead census as pilot study mentioned area, so a total of two presentations at this strategic scientific conference later this year.

Robert Eno: Beyond the clinical protocols, we have usability experience in a real-world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the system's functionality.

Ravi Malhotra: I'd now like to hand the call over to our corporate controller, Ravi Mahotra, to present selected financials. Thank you, Rob. I'll now give a brief overview of our financial results.

Ravi Malhotra: A full breakdown is available in our regulatory filings and in the press release that crossed the buyer aftermarket close today. General and administrative expenses for the second quarter of 2024 were 2.2 million compared to 1.8 million for the second quarter of 2023. The increase in GNA expense is primarily related to non-cash stock-based compensation expense associated with additional awards, which the company granted since June 30, 2023, and also higher consulting costs primarily offset by lower legal cost in the current period.

Ravi Malhotra: Research and development expenses for the second quarter of 2024 were 2.8 million compared to 1.5 million for the second quarter of 2023. The increase in RNA expense is primarily related to an increase in head count, increase of clinical and AI-related costs and increase in consulting spend, which is offset by a decrease in product development's consulting cost spending, primarily driven by completion of milestone projects in the prior period. Net loss for the second quarter of 2024 was 5 million compared to a net loss for 3.2 million for the second quarter of 2023. We ended the quarter with approximately 9.2 million in cash and cash equivalence as we close to carefully manage spending.

Branislav Vajdic: I will now turn the call back to Brannislav for closing thoughts. In conclusion, we remain extremely excited about the potential of cardbeam and progress.

Branislav Vajdic: Amigo will be smallest, easiest to use and first cable-free 12-EDCG device enabled by cardbeams unique and IP protected vector technology. It has the potential to disrupt numerous large markets and clinical applications, starting with the ability to detect complex arrhythmias, expanding to heart attack detection and then to monitoring or complex diseases such as heart failure. Ultimately, we believe that the combination of the small four-factor, powerful 360-degree ECD technology and advanced AI algorithms will have significant applications in prediction and screening of cardiac conditions.

Branislav Vajdic: We continue to make progress toward key regulatory and clinical milestones. Our initial five-tank application for the Amigo system is under active FDA review with productive discussions underway. The company is working with the FDA to address the small number of remaining questions. We believe that we are progressing toward clearance.

Branislav Vajdic: We anticipate a limited launch by the end of the year focused on the Amigo system which will provide the company with valuable feedback on the user experience and functionality of the system in a real world set. We are preparing materials for our second FDA submission, that will be a 510K submission, on the algorithms that convert the vector signals captured by our AMIGO system into a synthesized Web lead ECG. We have completed enrollment in the valid ECG study, and anticipate submitting the 510K application soon after the clearance of the AMIGO system.

Branislav Vajdic: We presented positive new data on our deep learning algorithm, Heartbeam AI, demonstrating excellent performance in detecting archaea flutter, even outperforming a panel of three electrophysiology reviewing the 12 lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithms. We ended the quarter with approximately 9.2 million in cash and cash equivalent, enabling the company to execute on upcoming clinical and regular televised tools.

Branislav Vajdic: I look forward to providing our shareholders with further updates in the near term.

Branislav Vajdic: I thank you all for attending, and now the Heartbeam team would like to answer your questions.

Operator: Operator, we will now begin the question and answer session. For those on the phone, please press star then one on your touchstone phone. If you are using a speaker phone, please pick up your hands up before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two.

Operator: For those on the webcast, please type your question on the screen.

Operator: Again, if you are on the phone, please press star one for questions. Currently, I do not see any questions on the phone.

Branislav Vajdic: Our first webcast question, can you just provide some more detail on the timing of the FDA clearance? Let me comment on that. We are under active review with the FDA, and we really can't give any more details than what we said in the call and in our earnings materials.

Branislav Vajdic: To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked. And the last quarter, FDA requested additional information, which we are now in the process of providing. We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance.

Branislav Vajdic: We still anticipate a limited launch before the end of the year. Again, we will provide us with valuable feedback on the user experience as well as functionality of the system in the real world setting, extremely valuable to us.

Robert Eno: Let's see, our next question, you showed market sizes for Heartbeam Technology. Can you explain just where you're going, but those? Brock? Sure, yeah, thanks. That was a new framework. I can elaborate. The main point there really is to show that Heartbeam Technology, which, again, is a credit card-sized, cable-free device that produces a 12-lead ECG can have a wide range of applications. So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection.

Robert Eno: We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on-demand 12-lead capabilities. And with both that form factor and with Amigo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease. And then ultimately, beyond that, we think that patients taking frequent 12-lead ECGs over time, especially when combined with AI algorithms, can enable prevention and screaming for a very large number of patients.

Robert Eno: So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention and screening. Thanks.

Operator: Our next question.

Operator: You mentioned that the Valid ECG study has completed enrollment.

Robert Eno: What are the results of the study? Yeah, I'm pleased to have some lives on that. Sure. So first, as a reminder, Valid ECG was a study with simultaneously collected ECGs, so the patient had both the standard 12-lead ECG and Amigo at the same time. And the goal was to demonstrate the similarity between the standard 12-lead signals and our synthesized 12-lead signals. And we've had two pre-submission meetings with FDA that are largely focused on the end points of the study.

Robert Eno: So where we are right now is we've completed enrollment back in June, as I mentioned, but the data is currently being analyzed, so the results are not available. We do anticipate completing that analysis soon as that'll be the basis for the second FDA submission that we plan to submit shortly. I would note that we did complete this 80-patient pilot study with the same protocol. We can't say the results of that because it's been accepted for a presentation in November of the American Heart Association, but based on the results of those studies, that study we did proceed with Valid ECG.

Operator: Great. Thank you.

Operator: The next question.

Operator: The 12-lead ECG is being evaluated by a physician.

Robert Eno: What do you need to AI? Let me answer that question. Our vision is that with hard beam AI, the user will get an automated arithea classification, and that's going to happen immediately after every use. However, of course, it is important that a physician, a review patient's clinical picture, the complete thank-up picture, which includes ECG. We actually anticipate, you know, like having two workflows here. If the user is experienced in symptoms, the ECG will be automatically sent to the user's physician or to a physician reading service for evaluation.

Robert Eno: On the other hand, if the user is not experienced in symptoms but is taking a routine recording to add to their database of ECGs, the ECG will not automatically go to a physician for interpretation. This is an asymptomatic recording, but the user will have the option to do so. In either case, symptomatic or not symptomatic, AI will play a key role in informing the patient and helping physician diagnose the patient.

Operator: Thanks.

Operator: Next question.

Robert Eno: Will the initial end-go product be able to detect hearted effects from the get-go or will there need to be further R&D before that claim to be made? We have actually done a lot of research and we've done two studies related to heart attack detection. So in terms of the development, there is still some work to do, but fundamentally, we believe that we have a technology that's going to provide needed insight into the patients with a chest pain. So all in all, at this point, we are focusing on a repair detection, especially complex repairs that other technologies cannot detect.

Robert Eno: And our plan is as soon as that is productized, as soon as that is in the marketplace, that we will apply all our resources to enable the product to detect heart attack.

Operator: Next question.

Robert Eno: Is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fig relation?

Robert Eno: Yeah, I want me to take that one. Yeah, go ahead. Yeah, it's just, you know, similar to what Brenna said before, we're taking a stepwise approach with FDA and so the initial indications are for arrhythmia and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation and we'll have clinical data on that. So, so yes, pursuing those, those are within the scope of the initial clearances.

Operator: Okay, great.

Operator: That is the final question there.

Branislav Vajdic: I'll turn now the pull back over to Dr. Vitech for his closing remarks. Thank you, operator. I would like to thank each of you for joining our needs conference today and look forward to continuing to update you on our ongoing progress and growth. If you were not able to answer any of your questions today, please reach out to our higher firm, MZ Group, who would be more than happy to assist. Thank you again.

Operator: The conference is now concluded. Thank you, Frank, attending today's presentation.

Operator: You may now disconnect.

Q2 2024 HeartBeam Inc Earnings Call

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