Q1 2024 HeartBeam Inc Earnings Call
Operator: Greetings and welcome to the Heartbeam First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode.
Greetings and welcome to the heart being first quarter 2024 financial results Conference call. At this time, all participants are in a listen only mode.
Operator: 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 this 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.
Operator: A question and answer session will follow the formal presentation hazards.
Operator: As a reminder, this conference is being recorded.
Operator: You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of the 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 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.
Operator: Before we begin the formal presentation I would like to remind everyone that statements made on this call and webcast may include predictions estimates or other information that might be considered might be considered forward looking and while these forward looking statements represent our current judgment on what the future holds they are subject to risks and uncertain.
Operator: Ts 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 the presentation.
Operator: Please keep in mind that we are not obligating ourselves to revise or publicly really released the results of any revision to these forward looking statements in light of new information or future events.
Operator: 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 couple of complete.
Operator: For a more complete discussion of these factors and other risks, particularly under the heading risk factors.
Operator: A press release detailing these results crossed the wires this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Branislav Vajdic. Chief Executive Officer and Founder, Rob Eno, President, and Rick Brounstein. The Consulting Chief Financial Officer will present results of operations for the first quarter ended March 31st, 2024. At this time, I will turn the call over to Heartbeam, Chief Executive Officer. Branislav Vajdic, please go ahead.
Operator: A press release detailing these results.
Operator: Crossed the wires. This afternoon and is available in the rest of it in the Investor Relations section of our company's website Heartbeat dotcom.
Speaker Change: Your host today Branislav bite it.
Speaker Change: Chief Executive Officer, and founder Robert You know President and Rick Bond steam.
Rick Brounstein: Consulting Chief Financial Officer will present results of operations for the first quarter ended March 31st 2024.
Speaker Change: At this time I will turn the call over to harping.
Speaker Change: Chief Executive Officer.
Branislav Vajdic: Branislav provided please go ahead.
Branislav Vajdic: Thank you operator I.
Branislav Vajdic: Thank you, operator. I'd like to start by giving a brief overview of Heartbeam and our technology. It is important to understand how our VECG technology is different and that it is more powerful than the most common personal ECG technologies that are on the market today. K12 EDCG is one of the most commonly performed diagnostic tests in hospitals and clinics. There are many easy technologies that can be used by patients, for Consumers at Home. You can see a couple of examples on this slide that I can cite.
Branislav Vajdic: I'd like to start by giving a brief overview.
Branislav Vajdic: Our technology it is important to understand how our <unk> technology is different.
Branislav Vajdic: Would that be more powerful than the most common pearsall ECG pathologies.
Branislav Vajdic: On the market today.
Branislav Vajdic: <unk> is one of the most commonly performed diagnostic steps.
Branislav Vajdic: In the stands.
Branislav Vajdic: Cost results.
Branislav Vajdic: Yes, mainly ECG you at all or is that can be used by patients.
Branislav Vajdic: For consumers.
Speaker Change: Paul if.
Branislav Vajdic: You could see a couple of examples on this slide though that I can't cite.
Branislav Vajdic: They're not valid ECG technologies. Instead, they are one-lead, three-lead, or six-lead ECGs. This is adequate for detecting many arrhythmias but is not sufficient to detect a heart attack or Complex Arrhythmia. In contrast, Heartbeam's Amygo is an easy-to-use credit card-sized system that synthesizes the 12-ADCG. The key aim of heartbeat technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including a heart attack, outside of a medical institution.
Branislav Vajdic: They have knocked about <unk> technologies is that they are wildly really or six leap <unk>.
Branislav Vajdic: It is adequate for the testing many of them, yet, but is not sufficient to detect a heart attack.
Branislav Vajdic: More complex.
Branislav Vajdic: Yes.
Branislav Vajdic: In contrast, a heartbeat Amy go is it easy to use credit card sizes.
Branislav Vajdic: That's just the size is about the BCG.
Branislav Vajdic: The key aim of.
Branislav Vajdic: Obviously urology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including heart attack.
Branislav Vajdic: Outside of our medical institution.
Branislav Vajdic: Yeah.
Branislav Vajdic: The Amygo device, coupled with a smartphone app and cloud-based diagnostic software, facilitates remote evaluation of cardiac symptoms by physicians, and we believe it could reduce the critical time to intervention for heart attack patients, shortening their time from symptoms to the door of a medical facility, which would reduce complications and save many lives. An effective pre-op tool in the hands of patients could also reduce the number of unnecessary emergency room visits and reduce costs to the health care system.
Branislav Vajdic: The Amy go device, coupled with a smartphone app.
Branislav Vajdic: Cloud based diagnostic software to facilitate remote evaluation of cardiac symptoms.
Branislav Vajdic: Musicians.
Branislav Vajdic: And we believe it could reduce the physical time intervention for heart attack patients.
Branislav Vajdic: Shortly the exact time.
Branislav Vajdic: From symptoms to their door or a medical facility.
Branislav Vajdic: Reduce complication and save many lives.
Branislav Vajdic: And the effective pre op.
Branislav Vajdic: In the hands of patients.
Branislav Vajdic: <unk> also reduced the number of <unk>.
Branislav Vajdic: Unnecessary emergency room visits.
Branislav Vajdic: Our reduced cost to the health care.
Branislav Vajdic: Yeah.
Branislav Vajdic: So why do we think that an easy to use throughout Lee BTG with patients is the formation of <unk>.
Branislav Vajdic: So why do we think that an easy-to-use 12-ADCG with patients is transformational? First, having the ability for patients to take frequent ECD readings over time and in a variety of real-life settings potentially has huge diagnostic value. Whenever a patient is feeling symptoms, they can get the 12-lead reading that will be reviewed by a physician; second, trending, or 12 ADCG both symptomatic and asymptomatic over time will allow physicians to gain insight to help guide cardiac care. Pre-convalidated genes create a trending and insightful way of tracking a target condition. Finally, combining deep learning algorithms with a large number of studentally collected BCGs has the potential to create an unsurpassed predictive and diagnostic algorithm.
Branislav Vajdic: First.
Branislav Vajdic: Kevin is the ability for patients to take frequent validly ECB at evenings over time and people realized synthes potentially has huge they cannot be red.
Branislav Vajdic: Whenever the patient is feeling symptoms they can get the lead really.
Branislav Vajdic: The review will best position.
Branislav Vajdic: Secondly.
Branislav Vajdic: So Anthony <unk>, both symptomatic and asymptomatic overtime.
Branislav Vajdic: But we will allow the physicians to gain insight to help guide currently appear.
Branislav Vajdic: <unk>.
Branislav Vajdic: Create a branding.
Branislav Vajdic: And.
Branislav Vajdic: Insightful way of tracking our bad debt provision.
Branislav Vajdic: Finally, combining deep learning algorithms with a large number of studios.
Branislav Vajdic: Collective BCG has the potential to create great.
Branislav Vajdic: Surpassed.
Branislav Vajdic: Steve and agnostic.
Branislav Vajdic: We have the opportunity to address not only the arterial fibrillation market but also the coronary artery disease market, which is six times larger. In the United States, there are approximately 3 million AP patients, representing a $2 billion market. There are approximately 20 million coronary artery disease patients, which is $12 billion. So the overall opportunity in the U.S. is only about $14 billion. I'd like to now turn the call over to our president, Robbie.
Branislav Vajdic: Recap your opportunity to address not only the RTL simulation market, but also the coronary artery disease market.
Robbie: Which is six times larger.
Robbie: United States, there are approximately 3 million of Afib patients.
Robbie: <unk> to be adopt Marquis Prost.
Robbie: Approximately 21 million quarterly active disease patients.
Robbie: I'll give you a ballpark.
Robbie: So the overall opportunity in the U S. Only is about $14 billion.
Robbie: I'd like to now turn the call over to our President Robby.
Robert Eno: Thanks Branislav. We next wanted to give an update on our progress related to Amygo. Our initial clearance for the Amygo system will be a major milestone for the company, and it's important for several reasons.
Robbie: Thanks, Branislav, we next wanted to give an update on our progress related to Amy go.
Robbie: Our initial clearance for the <unk> system will be a major milestone for the company and it is important for several reasons to start we expect this to be the first patient held three D V ECG device to be cleared by the FDA.
Robert Eno: To start, we expect this to be the first patient-held 3D VECG device 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 effort. The 3D VECG approach is an excellent platform for AI algorithms.
Robert Eno: Also this clearance will be the basis for further FDA submissions for heartbeat, So which is the cornerstone of our efforts.
Robert Eno: <unk> approach is an excellent platform for AI algorithms in the longer run we believe that applying AI algorithms on top of the rich the ECG data could result, an unsurpassed predictive and diagnostic capabilities.
Robert Eno: In the longer run, we believe that applying AI algorithms on top of the rich VECG data could result in unsurpassed predictive and diagnostic capability. Our landmark study published in Jack Advances in August of last year showed that the Amigo VECG technology had similar diagnostic ability as a 12 lead ECG in detecting coronary occlusion. Adding a baseline reading for comparison, which is a crucial part of our system, resulted in significantly better accuracy than a single 12-lead ECG.
Robert Eno: Our landmark study published in Jack advances in August of last year showed that the amey Gove ECG technology had similar diagnostic ability as a 12 million ECG in detecting coronary occlusions, adding a baseline reading for comparison, which is accrued a crucial part of our system.
Robert Eno: Resulted in significantly better accuracy than a single 12, we'd ECG.
Robert Eno: We have a 510k application under review with the FDA for our Amigo 3D VECG system. This is the cornerstone submission for Heartbeam and will be the basis of future regulatory efforts. The system includes the Amygo device, a patient application, a physician portal, and wireless communications among the elements. We submitted our 510K application in the second quarter of 2023.
Robert Eno: We have a five 10-K application under review with the FDA for Amy go three D. V. ECG system. This is a cornerstone submission for heartbeat and will be the basis of future regulatory efforts. The system includes the Amy go device, our patient application a physician portal in wireless.
Robert Eno: Communications among the elements.
Robert Eno: We submitted our 500 10-K application in the second quarter of 2023. The review remains active with FDA as we have successfully passed the acceptance of the filing and have completed the initial substantive review phase with questions and requests from FDA.
Robert Eno: The review remains active with FDA as we have successfully passed the acceptance of the filing and have completed the initial substantive review phase with questions and requests from FDA. We have conducted the agreed-upon testing to address FDA's open questions and are in the process of finalizing our official responses. Once these are submitted, the FDA will complete its review. Our timeline remains on track, and we anticipate clearance by the end of Q2 2024, followed by a limited launch of Amigo by the end of 2024.
Robert Eno: We have conducted the agreed upon testing to address Fda's open questions and are in the process of finalizing our official responses. Once these are submitted the FDA will complete their review.
Robert Eno: Our timeline remains on track and we anticipate clearance by the end of Q2 2024, followed by a limited launch of Amy go by the end of 2024.
Robert Eno: Following the clearance of the Amigo 3D VECG system, we will be working to obtain a second FDA clearance focused on the ability to offer to the physician a pair of baseline and symptomatic 12-lead ECGs, both of which are synthesized from the 3D VECG signals. This second 510k application is planned to be submitted to FDA by Q3 2024.
Robert Eno: Following the clearance of the Amy go <unk> system, we will be working to obtain a second FDA clearance focused on the ability to offer to the physician a pair of baseline and symptomatic <unk> both of which are synthesize from the three D. The ECG signals the second.
Robert Eno: 500, 10-K application is planned to be submitted to FDA by Q3 2024, a key part of this submission will be a pivotal study are valid ECG study.
Robert Eno: A key part of this submission will be a pivotal study, our valid ECG study. As we announced in March, we've enrolled the first patients in this pivotal study, which is designed to validate the Amygo 12-lead ECG synthesis software by comparing its results with those of a standard, hospital-based, FDA-cleared 12-lead ECG, using both quantitative and qualitative assessment methodologies. The primary objective is to demonstrate the similarities of ECG waveforms between Amy Goh's synthesized 12-Weed ECG and a standard 12-Weed ECG recorded simultaneously in each subject by assessing intervals and amplitude.
Robert Eno: As we announced in March we've enrolled the first patients in this pivotal study, which is designed to validate the Amy go 12 feet ECG synthesis software by comparing its results with those of our standard hospital based FDA cleared 12, we'd ECG using both quantitative and qualitative.
Robert Eno: <unk> methodologies. The primary objective is to demonstrate the similarities of ECG waveforms between Amy goes synthesize 12, we'd ECG and a standard <unk> recorded simultaneously any sub each subject by assessing intervals and amplitudes in.
Robert Eno: In preparation for this pivotal study, we completed an 80 patient pilot study, which mirrors the pivotal study. And based on these pilot results, we plan to enroll a total of approximately 198 adult patients. Currently, we've enrolled more than 50% of the patients.
Robert Eno: In preparation for this pivotal study we completed an 80 patient pilot study, which mirrors the pivotal study and based on these pilot results. We plan to enroll a total of approximately 198 adult patients.
Robert Eno: Currently we have enrolled more than 50% of the patients. We anticipate completion of enrollment of the valid ECG study in Q2 2024 and submission of the second 500 10-K application by Q3 of 2024.
Robert Eno: We anticipate completion of enrollment in the valid ECG study in Q2, 2024 and submission of the second 510K application by Q3, 2024. As we've discussed on previous conference calls, we have an active AI program underway. We have acquired approximately 1,000,012 read ECGs from various sources, a key element in our fast-paced AI development. We have developed initial deep learning algorithms focused on the ability to detect various cardiac arrhythmias. Heartbeam has had data on its deep learning algorithm accepted for presentation at two prestigious electrophysiology conferences.
Robert Eno: As we've discussed on previous conference calls, we have an active AI program underway. We have acquired approximately 1 million 12 <unk> from various sources are key element in our fast paced AI development efforts.
Robert Eno: Developed initial deep learning algorithms focused on the ability to detect various cardiac arrhythmias. Our team has had data on its deep learning algorithm accepted for presentation at two prestigious electrophysiology conferences.
Robert Eno: We believe that when combined with our credit card-sized Amigo 3D VECG technology, Heartbeam's AI will provide additional value to patients and physicians in a number of ways, including automated classification of cardiac conditions. This could further enhance the user experience and simplify the onboarding process and, in the longer run, could result in unsurpassed predictive and diagnostic capability. The first scientific presentation on the company's deep learning algorithm, Heartbeam AI, was at the European Heart Rhythm Association conference in April.
Robert Eno: We believe that when combined with our credit card size, Amy go <unk> technology, Rpms, AI will provide additional value to patients and physicians in a number of ways, including automated classification of cardiac conditions.
Robert Eno: The potential to further enhance the user experience and simplify the onboarding process and in the longer run could result, an unsurpassed predictive and diagnostic capabilities.
Robert Eno: Results were presented by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Hospital. The study showed that Heartbeam AI combined with VCG delivers equivalent performance to a 12-lead ECG and greatly improves detection of atrial flutter over a single-lead ECG. This presents an opportunity for a VCG-based algorithm that offers arrhythmia detection capabilities beyond what is available today and to fill gaps in health care inequality when obtaining a 12-week ECG is challenging. Additional data on our deep learning algorithm will be presented at the Heart Rhythm Society conference to be held in Boston next year. I'd like to now turn the call over to our consulting CFO, Rick Brounstein.
Robert Eno: The first scientific presentation on the company's deep learning algorithm Heartbeat AI was that the European Heart Rhythm Association Conference in April results were presented by Dr. Vivek Reddy director of cardiac arrhythmia services at the Mount Sinai Hospital.
Rick Brounstein: The study showed that heartbeat AI combined with BCG delivers equivalent performance to a 12 lead ECG and greatly improves detection of atrial flutter over a single ECG.
Rick Brounstein: This presents an opportunity for <unk> based algorithm that offers arrhythmia detection capabilities beyond what is available today and to fill gaps in health care in a quality when obtaining a 12 <unk> is challenging.
Rick Brounstein: Additional data on our deep learning algorithm will be presented at the heart Rhythm Society conference to be held in Boston next week.
Rick Brounstein: I'd like to now turn the call over to our consulting CFO Rick Brownstein.
Robert Eno: Yeah.
Rick Brounstein: Thank you Rob and.
Rick Brounstein: I will now give a brief review of our financial results. A full breakdown is available in our regulatory filings and the press release that crossed the wire after the market closed today.
Rick Brounstein: I will now give a brief review of our financial results.
Rick Brounstein: A full breakdown is available in our regulatory filings and the press release that crossed the wire after market closed today.
Rick Brounstein: General Administrative Expenses for the first quarter of 2024 were $2.4 million compared to $2.5 million for the first quarter of 2025; research and development expenses for the first quarter of 2024 were $2.4 million compared to 1.7 million for the first quarter of 2020. The net loss for the first quarter of 2024 was $4.6 million compared to a net loss of $4.1 million for the first quarter of 2020. Our cash and cash equivalents totaled $12.6 million as of March 31, compared to $16.2 million as of December 31st, 2025.
Rick Brounstein: General and administrative expenses for the first quarter of 2024, or $2 4 million compared to $2 5 million for the first quarter of 2023.
Rick Brounstein: Research and development expenses for the first quarter of 2024, or $2 4 million compared to a $1 7 million for the first quarter.
Rick Brounstein: 2023.
Rick Brounstein: The net loss for the first quarter of 2024 was $4 6 million compared to a net loss of $4 1 million for the first quarter of 2023.
Rick Brounstein: Our cash and cash equivalents totaled $12 6 million as of March 31.
Rick Brounstein: Compared to $16 2 million.
Rick Brounstein: December 31 2023.
Rick Brounstein: PetCast use and operations were $3.5 million for the three months ended March 31, 2024. We remain confident that we have sufficient funds to deliver on our milestones and get prepared to move into the commercialization phase and phase of Heartbeat Navigo. I will now turn the call back over to Branislav for his closing.
Rick Brounstein: Net cash used in operations was $3 5 million for the three months ended March 31 2024.
Branislav Vajdic: We remain confident that we have sufficient funds to deliver on our milestones and get prepared to move into the commercial patients.
Branislav Vajdic: Patients face are parking maybe go.
Branislav Vajdic: I will now turn the call back over to <unk> for his closing thoughts.
Rick Brounstein: Yeah.
Branislav Vajdic: Thanks, Rick.
Branislav Vajdic: So, in conclusion, this is an exciting time for Heartbeam, and 2024 is a pivotal year in our company's evolution. I want to reiterate that our FDA clearance of the Amigo system will be foundational for the company. When cleared, it will be the first patient health 3D ECG device to be cleared by the FDA. It will also serve as a robust and IP protective foundation for many future developments. We have made significant progress on the AMIGO clearance, having successfully passed the acceptance of the filing, and have completed the initial substantive review phase.
Branislav Vajdic: So in conclusion. This is an exciting time for <unk> in 2024 people.
Branislav Vajdic: In our company valuation.
Branislav Vajdic: I want to reiterate our FDA clearance of the Amy go system will be foundational for the compound than clear it will be the first patient the ECG device to be cleared by the FDA. It will be also serving.
Branislav Vajdic: Is there a robust and IP protected foundation for many future developments.
Branislav Vajdic: We have made significant progress on the A&D golf business, having successfully pass.
Branislav Vajdic: <unk> of the filing.
Branislav Vajdic: And have completed the initial substantive review phase.
Branislav Vajdic: We have taken advantage of all available regulatory tools and opportunities to work with the FDA, and we are finalizing our testing and our formal responses to the questions raised by the FDA. Once these responses are submitted in the near future, the FDA will complete its review, and we continue to anticipate clearance by the end of Q2 of this year. This initial clearance is foundational for a number of reasons.
Branislav Vajdic: We have taken advantage of all available of England, three tools and opportunities to work.
Branislav Vajdic: Interactively with the FDA and we are finalizing our destiny and our formal responses to the questions raised by the FDA.
Branislav Vajdic: Once these responses are submitting the.
Branislav Vajdic: The near future the FDA will complete their review.
Branislav Vajdic: Continuous anticipate clearance by the end of Q2 of this year.
Branislav Vajdic: This initial clearance is foundational for a number of reasons.
Branislav Vajdic: First, it will be the basis of our second submission on the algorithm that generates the 12D, Synthesized Vaseline. Currently, we have enrolled more than 50% of the patients in the Valley DCG study. We will submit the results of this pivotal study to the FDA as a key element of this 12-lead synthesis submission. Second, we are developing deep learning algorithms using the 3dBECG signals for input. These will be presented at the European Heart and Ritual Association Conference, making the first scientific presentation on heartbeat AI, and look forward to the second presentation at the Heartbeam Society meeting in Boston next week.
Branislav Vajdic: You will be the basis of our second submission.
Branislav Vajdic: The January.
Branislav Vajdic: Since the site before.
Branislav Vajdic: Currently we have enrolled more than 50%.
Branislav Vajdic: Patients in the <unk> study.
Branislav Vajdic: We will submit the results of this pivotal study to the FDA is a key element of this that lead.
Branislav Vajdic: Synthesis submission.
Branislav Vajdic: Second we are developing deep learning about what it does using <unk> Cmos for coupons.
Branislav Vajdic: We presented at the European Renal association confidence, making the first visit.
Branislav Vajdic: Presentation on AI.
Branislav Vajdic: AI.
Branislav Vajdic: And look forward to the second visitation at the Heartbeat.
Branislav Vajdic: Society.
Branislav Vajdic: Meeting in Boston next week.
Branislav Vajdic: Finally, we will build upon the initial Amygo clearance as a foundation. With both the 12-lead synthesis algorithms and AI efforts, we will continue to advance our robust product pipeline. From AI-enhanced advances to expanding indications to patient-friendly form factors, such as the on-demand 12-lead patch and our 12-lead watch, we believe that our VCG technology has the potential to be the most advanced ambulatory cardiac monitoring solution and is applicable in a number of formats.
Branislav Vajdic: Finally, we will build upon the initial Amy go clearance as a foundation.
Branislav Vajdic: Both the zombie synthesis algorithms and AI efforts, we will continue to advance our robust product pipeline.
Branislav Vajdic: AI advances to expand the indications.
Branislav Vajdic: Patient branded form factor such as the on demand <unk> batch and.
Speaker Change: Sure it's about the watch.
Branislav Vajdic: We believe that our BCD technology.
Branislav Vajdic: So to be the most advanced ambulatory cardiac monitoring solution.
Branislav Vajdic: And is applicable.
Branislav Vajdic: Other form factors.
Branislav Vajdic: In anticipation of FDA clearance, we are refining our go-to-market strategy and are encouraged by our early discussions with industry partners and their interest in our technology. We added the quarter of this year with 2000 million point six million, and Cash and Cash Equivalents. So that is 12.6 million in cash and cash equivalents. We remain confident that we have sufficient funds to deliver on our timeline. I look forward to providing our shareholders with further updates in the near future. 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.
Branislav Vajdic: In anticipation of the FDA clearance, we are refining our go to market strategy and are encouraged by our early discussions with industry partners and the interest in our technology.
Branislav Vajdic: We ended the quarter.
Branislav Vajdic: <unk> this year.
Branislav Vajdic: 2000, 12 million, one 6 million.
Branislav Vajdic: And.
Branislav Vajdic: Cash and cash equivalents, so that viewpoint.
Branislav Vajdic: One 6 million in cash cash equivalents, we remain confident that we have sufficient funds to deliver on our timelines.
Branislav Vajdic: I look forward to providing our shareholders.
Branislav Vajdic: Further updates in the near future.
Speaker Change: Okay. Thank you all for attending and now <unk> would like to answer your questions.
Branislav Vajdic: Operator.
Operator: We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. As a reminder, if you have a question, please press star 1. The first question comes from Leo Tarpio on behalf of Joseph Gunner. Please go ahead.
Branislav Vajdic: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Operator: Are using a speakerphone please pick up your handset before pressing the keys.
Operator: Anytime you. Your question has been addressed and you would like to withdraw your question. Please press Star then two.
Operator: As a reminder, if you have a question please press star one.
Leo Tarpio: The first question comes from Leo Carpio from.
Leo Tarpio: Joseph Gunnar Please go ahead.
Leo Tarpio: Good afternoon, gentlemen. A quick question.
Leo Tarpio: Good afternoon, gentlemen, quick question I'm seeing here on your slides you said your refining the go to market strategy.
Leo Tarpio: I'm seeing here on your slide that you say you're refining the go-to-market strategy. Could you remind us what exactly your strategy was? If I recall, you were trying to target some of the private practice specialists who would have the ability to buy your product and roll it out to their practice and patient base. And so I was wondering if there's been a bit of a change in that, and which industry leaders and players are you speaking with? Thanks.
Leo Tarpio: Would you remind us what exactly was your strategy. If I recall you were trying to targets already.
Leo Tarpio: Sure.
Leo Tarpio: Private practice specialists, who would have the ability to buy your product and roll it altogether.
Leo Tarpio: Practice and patient base and so I was wondering has there been a change in that and which industry leaders and players are you speaking with.
Leo Tarpio: Yes.
Robert Eno: Thank you, Leo Roth. Sure. Yeah.
Speaker Change: Thanks, Rob.
Robert Eno: Sure. Yeah, as far as the go-to-market strategy, yeah, the refinement, you know, as we obviously get closer to the FEA clearance, we're working on that. Yeah, as we described before, the effort that we're undertaking is going after the patient pay segment. So these are where patients are aggregated together, and they have the ability and willingness to pay directly for the product.
Leo Roth: Sure Yes.
Robert Eno: As far as the go to market strategy, Yes, there are five menu as we obviously as we get closer to.
Robert Eno: Two the FDA clearance, we're working on that yes, we described before the effort that we're undertaking is going after.
Robert Eno: The patient pay segment. So these are where patients are aggregated together, an ability and willingness to pay.
Robert Eno: Directly for the product.
Robert Eno: We also are looking at a number of other use cases within value-based care and taking advantage of other market segments that are out there. So it's something that we're going to continue to update you on and get more information as we get closer. But that's what Branislav meant by looking at the various different market segments.
Robert Eno: We also are looking at a number of other use cases within value based care and taking advantage of other <unk>.
Robert Eno: Market segments that are out there. So it's something that we're going to continue to update you on and get more information as we get closer, but but thats what <unk> meant by looking at the various different market segments. We're uncovering a number of things, we think where there is a potential fit for the product and we're continuing to explore those.
Robert Eno: We're uncovering a number of things we think where there's a potential fit for the product, and we're continuing to explore those. But I also want to mention the first effort that we're going to do after the clearance is what we're calling a beta testing phase. So this is really about getting real world experience with the product, understanding the optimal experience for patients and physicians, really testing the end-to-end system, really optimizing everything.
Robert Eno: But I also want to mention the first effort that we're going to do after the clearances, what we're calling <unk>.
Robert Eno: <unk> testing phase.
Robert Eno: So this is really about getting real world experience with the product understanding the optimal experience for patients and physicians really testing the end to end system, we're really optimizing everything so as well that as well as continue to do some clinical work on.
Robert Eno: So as well as that, and continue to do some clinical work on additional clinical studies beyond the valid ECG. So immediately upon clearance, you'll see us going into that phase while we're fine-tuning and finalizing the ultimate launch strategy around the limited launches we've described at the end of the year. And then to touch on the other element, you know, Branislav mentioned we're encouraged by the early discussions we're having with partners.
Robert Eno: Additional clinical studies beyond the valid ECG. So immediately upon the clearance youll see us going into that phase, while we're fine tuning and finalizing the ultimate.
Robert Eno: Our launch strategy around around the limited launch as we've described it at the end of the year.
Robert Eno: And then to touch on the other element.
Robert Eno: Brennan So I've mentioned, we're encouraged by early discussions we're having with partners we're looking at.
Robert Eno: We're looking at going direct, building our own sales force, as well as partnerships with industry partners in a number of different areas. We think that Amygo's technology, the VECG technology, is really the most powerful, has the potential to be the most powerful ambulatory ECG technology, and is applicable in a number of form factors. So we're looking at potential industry partners in a number of different ways. So a little early to talk about, obviously, any details there, but wanted just to underscore that we are working directly on building our go-to-market strategy and talking to potential partners about a fit in general across form factors.
Robert Eno: Boeing direct building our own sales force as well as partnerships with.
Robert Eno: Our industry partners in a number of different areas, we think that.
Robert Eno: That Amy goes technology. The <unk> technology is really the most powerful has the potential of being the most powerful ambulatory.
Robert Eno: <unk> technology and is applicable in a number of form factors. So we're looking at potential industry partners really in a number of different ways. So a little early to talk about and obviously any details there but wanted to just to underscore that working directly on building our go to market strategy and talking to potential partners.
Robert Eno: The fed in general across form factors.
Operator: As a reminder, if you have a question, please press star 1. There are no further questions on the phone. I would like to turn it over to Brooks Hamilton.
Robert Eno: As a reminder, if you have a question please press star one.
Operator: There are no further questions on the phone I would like to turn it over to Brooks Hamilton.
Operator: Okay.
Unknown Attendee: First question from the webcast: can you provide more detail on just the timing of FDA clearance?
Unknown Attendee: Our first question from the webcast can you provide more detail on just the timing of the FDA clearance.
Branislav Vajdic: Well, there is not much to add to what we already discussed here today. Overall, we are pleased with the tenor of our discussions with the agency and the progress. As we mentioned, we are finalizing the materials related to the questions, they have a And we have made progress that will enable very, you know, timely answers to their questions. In that light, we expect [inaudible] to be within the Q2 of this year.
Unknown Attendee: Well there is not much to add to what we already discussed here today.
Branislav Vajdic: Overall, we are pleased with the tone of our discussions with the agency and the progress is.
Branislav Vajdic: As we mentioned we are finalizing the materials related to the questions.
Branislav Vajdic: They have on us.
Branislav Vajdic: And.
Branislav Vajdic: We have made progress will enable.
Branislav Vajdic: Very.
Branislav Vajdic: Yes.
Branislav Vajdic: Timely.
Branislav Vajdic: Answer to the questions.
Branislav Vajdic: In that light we expect.
Branislav Vajdic: The clearance to be.
Branislav Vajdic: I believe the Q2 of this year.
Unknown Attendee: Thank you. Next webcast question. You mentioned that the valid ECG study is enrolling patients. What is the latest on that status?
Speaker Change: Thank you.
Branislav Vajdic: Our next webcast question.
Unknown Attendee: You mentioned that the.
Unknown Attendee: Valid ECG study is enrolling.
Unknown Attendee: The latest on that.
Unknown Attendee: Dennis.
Robert Eno: Rob, please go ahead. Sure. So as we mentioned, we're enrolling.
Speaker Change: Rob. Please go ahead.
Rob: Sure. So as we mentioned were enrolling.
Robert Eno: Sure. So, as we mentioned, we're enrolling up to a total of 198 patients, and we're at five sites. All of the five sites are now up and running and enrolling patients. We're really pleased with that. The sites are Piedmont Heart Institute, Atlanta Heart Specialists, Allegheny Health Network, Mount Sinai, and then Long Island Jewish Hospital, part of Northwell Health.
Robert Eno: <unk> to a total of 198 patients.
Robert Eno: And we're at five sites.
Robert Eno: All of the five sites are now up and running and enrolling patients who are really pleased with that the sites are Piedmont Heart Institute in Atlanta Heart specialists.
Robert Eno: Allegheny Health network, Mount Sinai, and then long Island Jewish Hospital part of the North well system. So all five of those are up and running enrolling patients and we're really pleased with how enrollment is going we're on track relative to our goals and more than 50% of enrolled and we continue to expect that we will finish enrollment.
Robert Eno: So, all five of those are up and running and enrolling patients, and we're really pleased with how enrollment is going. We're on track relative to our goals, and more than 50% are enrolled. And we continue to expect that we'll finish enrollment in Q2. And then just to reiterate, you know, this is an important element of the second submission because we're designing the study to compare the ECG waveforms between our synthesized 12-lead and the standard 12-lead recorded simultaneously. So, progressing very well with all sites up and running and more than half of the enrollment completed. We expect to finish enrollment at this point.
Robert Eno: In Q2.
Robert Eno: And then just just to reiterate this is an important element of the second submission.
Robert Eno: Work, we're designing the study to compare the ECG wave forms between our synthesize 12 leader and the standard 12, we recorded simultaneously so progressing very well with all sites up and running and more than half of the enrollment completed and expect to finish enrollment this quarter.
Robert Eno: Okay.
Unknown Attendee: Next question from the webcast. In your AI update, you're focusing on atrial flutter. Can you explain the significance of that?
Robert Eno: Next question from the webcast and your AI update youre focusing on atrial flutter can you explain the significance of that.
Unknown Attendee: That.
Branislav Vajdic: ACO flutter is an important RAPI and one of the existing variables, and in general, patients facing ECG technologies struggle with it. If undetected and untreated, it can lead to stroke.
Speaker Change: Casey of flattery that important.
Branislav Vajdic: The.
Branislav Vajdic: One is that the existing variables.
Branislav Vajdic: In general patients.
Branislav Vajdic: Based on ECB.
Branislav Vajdic: These struggling.
Branislav Vajdic: If undetected and untreated.
Branislav Vajdic: It can lead to strokes.
Branislav Vajdic: Our clinical data shows that the combination of VECG, our VECG technology, and our Heartbeam AI technology can do an excellent job of actually identifying arterial flutter, in differentiating from arterial fibrillation and normal sinusitis. Beyond this, it is an example of a complex arrhythmia that the VCG and Synthesize 12 Lead can identify. We look forward to further clinical data, of course, on these conditions, but what we have seen so far is extremely encouraging, and Evo.
Branislav Vajdic: Our clinical data shows that the combination of BCG or BCG, neurology, and our heartbeat AI technology.
Branislav Vajdic: Excellent job.
Branislav Vajdic: Actually that you're buying.
Branislav Vajdic: They're in differentiating.
Branislav Vajdic: Emulation and the normal sinus rhythm.
Branislav Vajdic: Beyond this is Susan.
Branislav Vajdic: For example, all of our complex API.
Branislav Vajdic: The BCG.
Branislav Vajdic: And Thats, just as well lead.
Branislav Vajdic: Bill.
Branislav Vajdic: Yeah.
Branislav Vajdic: We look forward to.
Speaker Change: I wanted to really update of course.
Branislav Vajdic: These conditions, but what we have seen so far.
Branislav Vajdic: Is extremely encouraging.
Branislav Vajdic: Yes.
Branislav Vajdic: Looking at the big picture, I'd like to point out one more time, perhaps. This is the existing, and, I would say, demonstrated value of combining the power of VCG with the power of AI. That, combined with the availability of a 12-lead ECG, makes for an offering that will make a difference, first and foremost, for the patient, but also for the physician, who will now be equipped with family synthesized ECGs and a powerful diagnostic suggestion tool that stands from VECG application to the AI algorithm.
Branislav Vajdic: Looking at the Big picture I would like to point out one more time for <unk>.
Branislav Vajdic: Sure.
Branislav Vajdic: This is an existing.
Branislav Vajdic: Yes.
Branislav Vajdic: I would say demonstrate value.
Branislav Vajdic: All combined.
Branislav Vajdic: <unk> of BTG.
Branislav Vajdic: Power with AI.
Branislav Vajdic: That combined with availability.
Branislav Vajdic: ECG.
Branislav Vajdic: Coated offerings that will make the difference first and foremost for the patients but also for the physician.
Branislav Vajdic: We will now be equipped with lead synthesize ECG and powerful diagnostics suggestions to the SaaS model.
Branislav Vajdic: TB.
Branislav Vajdic: The application to the AI algorithms.
Branislav Vajdic: Okay.
Branislav Vajdic: Alright.
Branislav Vajdic: Alright, that looks like it's, that's it for the webcast questions. I'll now turn the call back over to Dr. Vajdic for his closing remarks.
Branislav Vajdic: It looks like it's.
Vajdic: Webcast questions I'll now turn the call back over to Dr. <unk> for closing remarks.
Branislav Vajdic: So.
Branislav Vajdic: [inaudible] At this point, you know, we'd like to conclude this conference. We very much appreciate your attendance and look forward to continuing dialogue with our investors. And if we have not covered all questions today, please do not hesitate to contact our IR firm, MZ Group, for further interaction. Thank you again and have a good day.
Branislav Vajdic: At this point, we'd like to conclude this conference we very much appreciate your attendance and look forward.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Operator: Two continued dialogue.
Operator: With our investors and we have not covered all correct.
Operator: Today, please do not hesitate to contact our.
Operator: IR firm MZ group.
Operator: Further interactions.
Operator: You again and have a good day.
Operator: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.