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spk01: Greetings, and welcome to the HeartBeam fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these four looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks. particularly under the heading Risk Factors. A press release detailing these results crossed the wires this afternoon at 4.01 p.m. Eastern Time and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Branislav Vajic, Chief Executive Officer and Founder, Rob Eno, President, and Rick Brownstein, Chief Financial Officer, will present results of operations for the fourth quarter and year ended December 31st, 2022. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Sajic. You may begin.
spk09: Thank you, operator, and good afternoon, everyone.
spk10: I'm pleased to welcome you to today's fourth quarter and full year 2022 Financial Results Conference call. I could not be more enthusiastic about the future for Harbin, the rapid pace of our product timeline and our team's ability to trace our commercialization path. For those of you joining us for the first time or whom I have not had the opportunity to meet, I'd like to take a moment to introduce Harbin and our opportunity in a short video introduction. The video explores the Heartbeam Amigo technology, need, market, opportunity, and use in the heart attack detection case. Heartbeam Amigo is the first and only credit card-sized 12-lead ECG device for remote heart attack detection. While we are playing the video for our dialing participants, unfortunately, it will be about three minutes of silence. But I'd like to remind you that this video is available on our website, heartbeat.com.
spk03: Undiagnosed heart attacks can be lethal for individuals and costly to the healthcare system. Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the healthcare system over $10 billion each year. Because of uncertainty, patients often delay seeking care for an average of three hours, causing a 40% increase in mortality rate. Currently available ECG monitoring solutions are indicated only for screening for arrhythmias, but not for heart attacks. HeartBeam's innovative technology, the HeartBeam AmyGo device, introduces a simple, patient-friendly solution designed specifically for heart attack detection. This credit card-sized device, paired with the smartphone application, puts patients in immediate contact with their care team, The patient places the wireless device on their chest for a 30-second signal recording. The patient's healthcare provider is then notified of the new ECG. To fully characterize the three dimensions of the heart, HeartBeam captures the heart's electrical activity in 3D by recording X, Y, and Z projections into a simple, user-friendly platform. The HeartBeam AMI system provides a comparison of the patient's baseline ECG along with the symptomatic ECG with a marker and a diagnostic suggestion indicating potential heart attack. The results are instantly shared with the patient's care team through the HeartBeam AMI proprietary cloud-based platform. Physicians are aided by a fully autonomous diagnostic system to view the ECG, review diagnostic suggestions, and direct the patient accordingly. Today, clinicians must rely on 12-lead ECG for heart attack detection, performed solely within a hospital or clinic. HeartBeam's Amy and AmyGo technology has the potential to become the standard of care for cardiac patients, with the potential to serve over 18 million patients in the U.S. alone. With a simplified 12-lead ECG process in a portable solution, HeartBeam is poised to revolutionize the healthcare industry by saving lives, reducing costs, improving the patient experience and provider outcomes, while advancing diagnoses with technology that can be used anytime, anywhere. HeartBeam, putting tomorrow's technology in patients' hands today.
spk10: It is really important to understand how our ECG technology is different and vastly more powerful than ECG technologies that are in the marketplace today. Today, there are many ECG technologies offered to consumers and patients outside of a medical facility. What they all have in common is that they do not offer a standard of care family ECG In a user-friendly, always-in-a-patient, easy-to-apply solution. That means that they are not capable of detecting a heart attack. In the great majority of cases, it is a single EDCG that may be adequate for some arrhythmias, but is certainly not capable of detecting a heart attack. Shown in this slide is the actual message from Apple Watch warning the user of its inability to detect a heart attack. Similarly, AliveCore with their cardiac products prominently features on their website the same disclaimer about the inability to detect a heart attack. Our technology, we believe, has solved the problem of heart attack detection outside of a medical institution. The HeartBeat technology is intended to quickly and accurately help clinicians identify a heart attack. This could reduce the critical time to intervention for heart attack patients, saving many lives, and reducing healthcare costs by ruling out heart attacks
spk09: and reducing the number of emergency room visits. Shown on this graph are ECG technologies and their diagnostic capabilities.
spk10: Today, in the market of ambulatory ECG devices, we see technologies that offer one to two, I'm sorry, one to six actual leads. What is common to all these technologies is that their diagnostic value is limited to arrhythmia, such as atrial fibrillation or AP. There are some well-known players in this space, such as iRhythm, Apple, and the like. If we go beyond six leads, In other words, to 12 leads in this graph, we see that standards of care capabilities are achieved, but there are no players in this space that offer a user-friendly, always patient, easy-to-apply 12-lead ECG solution. The technology that has diagnostic capability that goes over, beyond, standard of KR12-EDCG is vector electrocardiography, or VECG. Our HeartBeam Amygo technology is capable of recording and processing VECG signals and using powerful 3D vector-based algorithms to detect heart attacks. Perhaps most importantly, for this initial phase of our technology development, HeartBeam Amygo technology will bring the power of a standard of care 12 dbcg to physicians from in front of their patients and remotely that are anywhere at any time no other user friendly easy to use always the patient technology is able to offer that this slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the HeartBeam telehealth product, the heart attack detection, the ECG capability, integration of patient history and symptoms, and the presentation of baseline and symptomatic ECG to the physician, The Harbin Amigo device is significantly different and it is offering in a very underserved market. We believe Harbin AMI and Harbin AMI-GO, by leveraging our patented 3D vector ECG technology, offers substantial capabilities beyond existing offerings, and we continue to engage with potential customers and partners in anticipation of their day clearance and commercial launch for our product. Our fourth quarter was highlighted by forward movements toward production and commercialization of our products, underscored by a series of milestones, including new partnerships, IP protection, and a strengthened management team. As we look forward at the clearance For Harvey and Amy, we're also making significant progress with our core product, the Harvey and Amy Gold 3D VECG Collection Device, as we prepare for FDA submission in the coming weeks. Recently, we announced the acquisition of substantially all assets from Limor, a digital health solution company providing a patient-engaging remote monitoring system of clinical physiological biomarkers. This consisted of Limor's intellectual property, including three U.S. patents, and the LiveMore technology, including the Halo Plus atrial fibrillation AFib detection system. The Halo Plus AFib detection system is the world's first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. The Halo Plus system provides continuous monitoring of pulse rhythms for the detection of AFib on demand during the day and automatically overnight. The acquisition extends our reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA CLEAR product. This acquisition is a natural fit, an extension of our successful partnership with Limor and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs. Our newly acquired state-of-the-art FDA clearance Watch-based arrhythmia detection tool, once integrated with HeartBeat Amigo telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting. During the quarter, we partnered with Evolve Manufacturing Technologies, a contract with a medical device manufacturing company, to build the credit card site on the Amigo 3D VCD recording device. Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers. We can now leverage Evolve's manufacturing and packaging expertise to support commercialization of hard beam AMIGO device following expected FDA clearance. We further advance intellectual property protection with two recent new patents. An initial European patent strengthens IP for the hard-to-name GOAT technology, offering 120 DCG capability as we expand our product applications to reach a variety of regions and global markets. We also received a U.S. patent for a 12-VDCG smartwatch-based monitor intended for detection of heart attacks and complex arrhythmias. The breakthrough inventions protected by this patent enable our proprietary 3D VECG technology to be built into a smartwatch, eliminating the need for a dedicated VECG device while offering 12 lead ECG capability, enabling heart attack and complex arrhythmia detection. We believe this patent may prove to be one of our most valuable patents, and we continue to expand on our granted and pending core patents for the most heart attack detection. We recently welcomed Rob Eno, To the new creative position of president, Rob, who you will meet in a moment, is a passionate and visionary senior executive with over 28 years experience creating go-to-market strategies for multiple breakthrough products. He's playing a key role in our strategic decisions, commercialization efforts, and day-to-day operations. He joins our other recent appointment, Dr. Peter Fitzgerald, the chief medical officer. Peter is now playing a major role in defining best paths for adoption, clinical strategies, and partnerships to advance our products in the market. I would like to turn the call over to our president, Rob Eno, to further discuss our products and commercialization plans. Rob.
spk11: Thank you, Bronislav. And to everyone joining us today, I'm privileged to join Heartbeam at such an exciting time as the company prepares to enter a new phase of commercialization. Since joining in January, I've been incredibly impressed with the Heartbeam team, their accomplishments and diligence in working toward our mission. Turning to our product timelines and updates, We had several key developments related to our HeartBeam AMI and HeartBeam AMI Go platforms. As Bronislav mentioned, we previously announced the 510 submission of our HeartBeam AMI platform to the FDA. We received questions from FDA within the statutory 30-day review deadline, discussed the questions via teleconference with the FDA review team, and provided written responses addressing the questions to the primary reviewer. The substantive review is in progress, and we expect to receive FDA clearance in the second quarter, followed by a limited market release in early Q3. Briefly, the total available market for the HeartBeam AMI software solution is $500 million, and for AMI-go, it is $12 billion. These are estimated market numbers for the U.S. only. Heartbeam Amigo has a 510K regulatory pathway. We've already identified predicate devices and plan to demonstrate substantial equivalence with a validation study. Importantly, the clearance of the V1 device allows Heartbeam to collect 3D vector cardiogram data and use these data for conducting 12-lead equivalent studies for the V2 product. Turning to HeartBeam Amygo product updates, in September we were granted a patent that provides additional intellectual property protection for our HeartBeam Amygo technology, offering 12 lead ECG capability in the form of a credit card sized device with the same footprint as the single lead products currently in the market today. We also partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card size HeartBeam Amygo 3D VECG recording device that enables a 12-lead ECG readout for remote heart attack detection. We plan to file an initial 510K submission for the V1 version of HeartBeam Amygo as an ECG collection device, followed by a second submission for the software that enables 12-lead synthesis from our 3D VECG signals. We expect to file the V1 submission shortly, and the V2 submission is targeted for Q4. Our go-to-market strategy for HeartBeam AMI Go is the phased approach. We'll initially focus on direct pay market segments in which payment is outside of the reimbursement system. Within the direct pay segments, we will initially focus on those where we will demonstrate HeartBeam Amigo as equivalent to 12 lead ECGs. We will then focus on developing clinical and cost effectiveness evidence, which will be the basis of expansion into new direct pay segments and ultimately unique reimbursement. We have a deep product pipeline, starting with the HeartBeam Amigo system. Other products in the pipeline include a 12 lead ECG extended wear monitor or patch, as well as a system that fully integrates HeartBeam AMI-GO and the heart monitoring smartwatch technology we acquired from Livemore. In addition, the product pipeline includes predictive algorithms that result from applying machine learning to our VECG data and a 12-lead ECG smartwatch for heart attack detection, complex arrhythmia monitoring, and other cardiac disorders. I'll now turn the call over to Rick Rodenstein, Chief Financial Officer, to discuss operational updates and financials.
spk09: Thank you, Rob.
spk02: Turning to our financials, I will now give a succinct review of our financial results. A full breakdown is available in our regulatory filings and in the press release that just crossed the wire after the close of market today. But let me start with Silicon Valley Bank. They were our checking account and payroll account. On March 10th last week, SCV was closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. And as a result, we stood to lose approximately $600,000. On March 13th, the Federal Reserve announced that the account holders would not bear the loss of this event. Nevertheless, before the issues with SCV, we had planned to move to a big four bank. and we are currently completing that move. Turning now to the statement of operations, general administrative expenses for the fourth quarter of 2022 were $2.1 million compared to $1.2 million for the fourth quarter of 2021. For the year ended December 31, 2022, G&A expense increased to $7.4 million compared to $2 million in the same period of 2021. This reflects a growth in our team, and other costs in support of our being a public company. Research and development expenses for the fourth quarter of 2022 were $1.6 million compared to $96,000 in the fourth quarter of 2021. For the year ended December 31st, 2022, research and development expenses increased to $5.7 million from $255,000 in the prior year. Most of 2021 was pre-IPO. Our 2022 focus on R&D consisted largely of product development costs for HeartBeam Amy, which is now essentially done, and also HeartBeam AmyGo. HeartBeam AmyGo includes both software and hardware, the latter with our professional services agreement with Triple Ring Technologies. Additionally, there are clinical costs in support of our FDA submissions for both our products this year, as well as research costs in support of the future product pipeline coming from our patented vector 3D ECG platform technology. Other income during the year ended December 31st, 2022 of $69,000, primarily related to the cash balances from the IPO. In 2021, we had $2.1 million of expense, largely tied to the 2015 convertible note accounting. These notes were converted and added to common stock at the November 2021 IPO. and in equity as of December 31st, 2021. Net loss for the fourth quarter of 2022 was 3.7 million compared to a net loss of 2.1 million for the fourth quarter of 2021 and 13 million for the full year of 2022 compared to 4.4 million in the year-ago period. We ended the fourth quarter of 2022 with 3.6 million in cash and cash equivalents compared to $13.2 million as of December 31, 2021, having invested the proceeds from the November 21 IPO to accelerate our product development path. Most of the cash is maintained in short-term investment accounts, not tied to potential bank liquidity problems. As you have seen, we are publicly marketing through our S-1 registration statement, and as noted in the IPO registration statement, we plan to finance ourselves to the next inflection point in 2024, FDA clearance of our HeartBeam Amigo product with a personalized 12-lead simulation display that a physician is used to seeing with a standard 12-lead ECG today, but using our patented ZECG technology. I will now turn the call back over to Bratislava for some closing thoughts.
spk09: Thank you, Abe. Indeed, ours is a true platform technology.
spk10: So far, we have developed two products that are either already submitted to the FDA, in the case of Harbin Amy, or soon to be submitted to the FDA for the Harbin Amy Go product. The recent Libmore asset purchase has also brought to Harbin Libmore's intellectual property, including three US patents, and the LIBMOR technology, including the Halo Plus artificial atrial fibrillation product as well. Halo Plus is the world's first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. During the fourth quarter, we continued to operate from a position of strength, equipped with strategic partnerships to advance product development and near-term milestones. We continue to strengthen our IP with patents granted, most recently with a European patent for signal transformation from vector electrocardiogram to 12 lead ECG, and a new patent for a 12 lead ECG smartwatch-based monitor intended for detection of heart attacks and complex cardiac arrhythmias as well. We also acquired three issued United States patents as part of our Limor asset purchase. All of these enhance our intellectual property and provide protection of our technology in priority global markets. Beyond that, looking at the product pipeline, we think that the application of artificial intelligence will be of great value to us. We will have very unique data set of patients who actually have recorded their ECG on a daily, weekly, or monthly basis. That longitudinal data for our patient population will be of tremendous value. Applying artificial intelligence to this data set that is extremely data-rich, much richer than the standard 12 lead ECG, will yield, we strongly believe, additional insight into cardiovascular disease and further help cardiovascular patients. On the right side of this slide is shown the 12 lead patch. We have recently received a patent for that technology. We are very pleased with that development because it addresses a very large market projected at 4.8 billion by year 2030. This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole. Looking ahead, we remain confident in our anticipated upcoming product milestones. Our next milestones on the commercialization path include FDA submission for the initial HeartBeam AMI-GO 3D vector ECG product and FDA clearance for HeartBeam AMI, both expected in the near future. We approach these milestones from a position of strength with an experienced team bolstered by the recent appointment of Peter Fedorov, Chief Medical Officer, and Rob Hino as President to support these goals. I'd like to share a final thought. We are all very excited about the prospect of helping millions and millions of cardiovascular patients initially heart attack patients but we believe our technology will essentially address all cardiac diseases that are detectable by a 12 lead ecg so that's a very exciting prospect for us and a great motivator to be helping many millions of patients throughout the world i look forward to providing our shareholders with further updates in the near term as we move toward commercialization. Thank you all for attending. And now, the HeartBeam team would like to answer your questions. Operator.
spk01: Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions.
spk09: Our first question comes from the line of Jason Colbert with Dawson James. Please proceed with your question. And Jason, is your line on mute? Hi guys. Can you hear me? Hello? Yes, we can hear you now. Yes.
spk08: Oh, okay. Sorry about that. My first question was regarding the recent acquisition. I know you got a lot of IP, but I think you also had a lot of intellectual capital. Can you talk a little bit about how many of those folks have come over to Heartbeam and what it is that they're really bringing to the company?
spk10: Yes, we covered so far in our presentation the IP aspects of death acquisition in the form of three patents. They are very significant because they really give us an incredibly fast head start into the AFib detection. The company we wanted to get into and with the addition of these three patents, we have an incredibly good entry point into the AFib market. Beyond that, we have acquired the whole team, technical team, that has developed these technologies for Lidmore. And in that sense, we have completed the whole circle in a way because we now have FDA clear product, we have three patents, we have the platform, Halo Plus platform, and we have all the key people that have developed this platform. So we are very excited about this acquisition and what it will mean for the future of Harbin.
spk08: And so I'd like to drill down on that. How does that break down in terms of software versus hardware? And is there even a manufacturing component associated with the hardware that you feel helps support Heartbeam in terms of its commercialization efforts and kind of managing that whole process?
spk10: Limor technology is based on so-called PPG sensor, which is integral part of, in the case of their development, Samsung watch. And so the components of the hardware that Limor has used comes from Samsung. What the real value for us is, is the full ownership of the Halo Plus platform that we previously licensed, and now we have a full ownership of it with all the source code and ability to modify it and extend it, plus the FDA Clear product. So the main value points are centered around software, intellectual property, and the team.
spk08: Okay. And on the manufacturing side, is that something where you feel you're in a good position with your current contract manufacturers that you can make changes, revisions? Because clearly there's next generation, you know, product on the Amy side here.
spk10: Yes, for our initial production goals, we have engaged Evolve Manufacturing and they are clearly capable and willing of producing tens of thousands of our devices. We are working with Triple Ring and Evolve because they form really an incredibly good team on driving the cars down. Initially, these units were not cost effective, and with our current project, we are reducing the cost several times to the tune of four to five times reduction in cost, and we plan to go down that curve even further.
spk08: Yeah, that's exactly what I was looking for, Bratislava, and it's not the type the thing that, you know, it's a hard point for people to understand who haven't been in the business and haven't, you know, you have a concept, you come up with units, but, you know, you know that you have to get the cost down when you get to scale. So, and it makes sense that, you know, a team that's already done that is going to add a lot of value as you pursue that. My last question has to do with both Amy and Amy Go, and it has to do with the time gap between you know, when you complete the submission and when you get FDA clearance. And, you know, that's a relatively short time gap, about six months. And I guess that's pretty standard in the industry. You have confidence that that review time should work for you as well. Is that right?
spk10: Yes, we have a very close interaction with the FDA. We have just completed another meeting with them, and the interaction is very productive, and we remain confident that the results will be positive. And that's all I can say. It has been perhaps a process that extended a bit longer than we expected, but it's very much an unpredictable process. And in our case, including the holiday season and so on and so on. So, yeah, we remain very optimistic about the prospect of getting the clearance for Amy and again submitting Amy go in Q2 of this year.
spk08: And in terms of a successful financing, that seems to be critical now as you look, because clearly there's going to be a rise in SG&A spending as you anticipate, you know, the beginning of commercialization, you know, into the second half of this year and next year, right? That's correct.
spk09: Yes. Rick, maybe you want to comment on this question?
spk02: Sure. Sure, Jason. Yeah, no, absolutely, you know, and obviously, Not only do we have the S-1 registration as it works out, of course, but we have the S-3 in place, the ATM facility, so we have the ability to bridge ourselves as we need. I think most people saw we did a deal with Maverick that gives us a short-term capability for $4 million. We're careful. It's clearly challenging in these times, but we can moderate ourselves and we think we have the capability to get things done.
spk08: Yeah, and that's exactly the comment I was looking for, too, is that you don't have a gun pointing out at you. The ATM offers you a bit of a bridge and some breathing room so that you can kind of build a syndicate towards a successful capital raise, right?
spk09: Yeah, absolutely. Okay, good. Thanks, guys. Really appreciate the update. Thank you, Jason.
spk01: Our next question comes from the line of Bill Sutherland with the Benchmark Company. Please proceed with your question.
spk04: Thank you. Hello, . I was intrigued with the patent on the patch and wondering if there's any preliminary ideas at this point about the path for that to get to a commercial live stage.
spk10: Yes. The more we look at the patch, you know, we have two patents actually that protect this invention extremely well. The more we realize the value of this technology and product for the future of hot beans. As it stands right now, we realize that this market is projected to be about $4.8 billion by the end of the year 2030. And our ability to develop this product is very real. And in terms of time and money needed to arrive at the prototype, we are seeing some estimates that are very attractive. So at this point, it's under consideration. But everything we have seen is pointing to the direction of doing the patch sooner rather than later, which does not put any concrete start date for this project. But we really like what we are seeing in terms of the value and potential disruptive effect it may have on this well-established market with a $3 billion company market cap being the leader.
spk04: Yeah, it's an interesting comparison. The other very fascinating development is the AI development, and I'm curious how you might benefit from the data that you're going to be being able to analyze and work with. Is that going to lead to product or monetization of some kind?
spk10: The data component of our own technology is very powerful, actually, because we have a set of parameters, ECG parameters describing that heart, patient's heart. that go well beyond the 12 lead ECG. And applying AI to this data set, we strongly believe will not only provide an increased value for reacting to an event such as heart attack, but actually offering predictive and preventive value, which will be huge, we strongly believe. So all in all, we are focusing right now on reacting to that heart attack symptom, right, doing the right thing for the patient, getting the right people to care or keeping them at home, you know, basically saving lives and saving healthcare dollars. But we believe strongly that the data component of our data set will be hugely valuable going forward.
spk04: Got it. Very good.
spk09: Thanks again, Brad Sloth. Thank you, Bill.
spk01: And our next question comes from the line of Ben Hainor with Alliance Global Partners. Please proceed with your question.
spk06: Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, Rob, nice to meet you over the conference call, but I was curious on really what attracted you to HeartBeam and what are you most excited about going forward?
spk11: No, thanks, happy to talk about that. Just with my background, I have 28 years in medical technology and it's all based around bringing disruptive new technologies through commercialization and scale up. And I joined because I believe in the company and I believe in the technology and think this could be absolutely a chance to bring a game changing technology to market. you know, being able to get a 12-lead EKG into patients' hands and with the VECG technology potentially being able to go beyond that and the data aspects that Bronislav mentioned. So I see it as a way to really influence a tremendous number of patients' lives, address a major healthcare issue that has not yet been adequately addressed and take part in what I think is going to be an amazing company going forward.
spk06: Okay, good deal. And, you know, have you had quite a few discussions with, you know, folks that could serve or could be potential customers down the road with Amy, Amy Go and the other products?
spk09: Any color on those, if so?
spk11: Sorry, can you repeat that just to make sure I understand? Sure.
spk06: So I was just curious, with your background, clearly you probably have a Rolodex of folks, and you're out there talking to folks that could be potential customers of Amy, Amygo, the other products. Can you talk about any conversations that you've had and any color on those?
spk11: No, sure. Sorry. Thanks. I appreciate that. Yeah, you know, yeah, absolutely talked to a number of cardiologists. And, you know, what strikes me is what I hear constantly is 12-lead EKG itself is limited to hospitals, but it's also 100-year-old technology. And many of them know of the VECG process or the VCG process, vector cardiography, you know, was taught in medical schools years ago. It really, you know, never took off because physicians having to interpret 3D loops in space was very difficult. But they understand that studies, you know, even decades ago show that it had a number of benefits beyond standard EKG. So we get a lot of excitement that the company has figured out a way to take VCG, harness it, and bring it to patients. And then I hear a lot of physicians when we describe the concept of a full WCG or potentially beyond that in the hands of patients, you know, saying game changing and they can think of all kinds of different applications for it. So I've been very pleased with the excitement of the physicians, the willingness to partner with us and help us both in terms of potential clinical studies or early sites and helping us figure out the best strategies to scale the technology.
spk06: Sounds like nice to have the support on your decision to join from folks that are excited about the technology.
spk05: Good deal. And then on Live More, are there, congrats on the acquisition there, are there any plans to commercialize the Halo Plus AF detection system immediately, or what's kind of the commercialization thoughts there?
spk10: Yes, let me answer that question. We have acquired this system and we have established that actually in terms of a potential product, what makes sense is an integration of Halo Plus platform for AP detection with our AMI-GO. Why does that make sense? Well, as I said before, Halo Plus is watch-based, and it can provide a sort of an alert or any goal to do a 12 lead ECG where there are indications from the watch that there are, you know, there are things that are getting outside of the normal, right? You know, and so we believe that getting the AMI goal, you know, to the FDA clearance date will enable us to consider offering an integrated product where you have a watch that's working with Amygo for a full-blown ability to detect a variety of conditions through our 12 lead ETG. And what's interesting about that is that physicians under this scenario here would get something that was alerted by the watch that they have learned is not very reliable, dating very many false positives, false negatives, et cetera, in this case would be validated by any goal device. And that double validation, if you want, would probably mean that they believe in this referral from our system with a much higher degree of credibility. So all in all, And integration makes sense, but Amygo is very much a front and center of that system, potential integrated system. So we are still focused on Amygo totally, and the potential integration into an integrated offering will come later.
spk06: Okay. And that integration definitely makes sense. And then lastly for me, you know, just given the optimism on the FDA timeline, you know, and your interactions with the agency, can you maybe characterize the questions that you've received? I mean, it doesn't sound like there's any showstoppers in there, but, you know, just, you know, any –
spk10: areas that uh you know common questions were arising or anything you can provide that would be helpful well i'm not at liberty to really talk about much detail there uh i would just say uh that at the top level uh they are focused on cyber security and rightfully so So I think that's as much as I can go into details. But all in all, again, productive interactions with the FDA.
spk09: Okay. Fair enough. Thanks for taking the questions, gentlemen, and congrats on the progress. Thank you, Ben. Thanks, Ben.
spk01: And this concludes our dial-in Q&A session, and we will now have questions via the webcast.
spk07: Our first questioner asks, based on your IP, you can pursue several very interesting opportunities between Beyond Amy and the initial AmyGo plan releases. They would like to know, what is the next product that you will start developing?
spk10: yes so let me reiterate that amy go is front and center of our development efforts and commercialization path um as far as uh our ip is concerned the good news is that we have uh incredibly deep uh ip portfolio here and including uh a watch which I happen to believe is the ultimate solution here, where you really don't have to have any other device other than your watch to be able to do a 12-lead ECG. But that's not in the near-term focus. And perhaps that presents a partnership opportunity, right? You know, there are many players, well-known players out there with a single-lead ECG watch, and we have an extremely well-covered agricultural property for the family watch. So that's not going to be our immediate development list, but again, partnership opportunities are probably very significant. Secondly, as far as patch is concerned, you know, as I alluded to, we are very seriously considering the opportunity that it presents. Well-established market, changing four factors, but technology-wise, there is very little change that would be required between going from a credit card-sized Amigo device, hard-in-Amigo device, to a patch.
spk09: So that is very much on our radar screen.
spk07: And the next question asks, direct pay G go-to-market is somewhat of a new direction. Can you shed some light on why this is potentially a superior strategy compared to RPM?
spk11: Sure, I can take that one. Yeah, what we discussed is the refinement of the go-to-market strategy. And first, for those who don't know, RPM, remote physiologic monitoring, are existing codes paid to physicians who prescribe devices to remotely monitor patients. What we've done is we've identified a number of market segments. RPM certainly could be one of them, but we've identified a number of additional market segments that we think are both big size and also where there's an entity that's willing to pay for the solution outside of the reimbursement system. That's what we're describing as direct pay. And some of these require data that shows that we're equivalent to a standard 12 lead ECG, and we had those listed in this slide. And then others that are more value-based will be developing data on clinical and cost effectiveness. And the beauty of that is that we can start right away with the 12 lead ECG, but then the data we gather for the value-based usage is the same data that's going to be useful for our efforts to establish a unique reimbursement code. So we think that these market segments we've identified have the potential to result in more value to HeartBeam potentially than an RPM approach, as well as being in alignment with this long-term strategy of obtaining our own unique reimbursement code.
spk07: And that concludes our webcast Q&A.
spk01: Thank you. And I would now like to turn the call back over to Dr. Vajic for closing remarks.
spk10: Thank you, operator. I would like to thank each of you for joining our early conference call today and look forward to continuing to update you on our ongoing progress and growth. If you were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again and all the best.
spk01: And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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