Q4 2022 Heartbeam Inc Earnings Call
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Speaker 2: Greetings and welcome to the Heartbeam fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation.
Speaker 2: As a reminder, this conference is being recorded.
Speaker 2: Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially.
Speaker 2: You are cautioned not to place undue reliance on these four licking statements, which reflect our opinions only as of the date of this presentation.
Speaker 2: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these four looking statements in light of new information or future events. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these four looking statements in light of new information or future events.
Speaker 2: Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions.
Speaker 2: The press release detailing these results cross the wires this afternoon at 4.01 p.m. Eastern time and is available in the investor relations section of our company's website, heartbeam.com. Your host today, Branislav Vojic, Chief Executive Officer and Founder, Rob Eno, President, and Rick Brownstein, Chief Financial Officer, will present results of operations for the fourth quarter and year ended December 31, 2022. At this time, I will turn the call over to Heartbeam Chief Executive Officer, Branislav Vojic.
Speaker 2: detailing these results across the wires this afternoon at 4.01 p.m. Eastern time and is available in the investor relations section of our company's website, heartbeam.com. Your host today, Branislav Vojic, chief executive officer and founder, Rob Eno, president, and Rick Brownstein, chief financial officer, will present results of operations for the fourth quarter and year ended December 31st, 2022. At this time, I will turn the call over to Heartbeam chief executive officer, Branislav Vojic. You may begin.
Speaker 3: Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's fourth quarter and full year 2022 financial resolve conference call. I could not be more enthusiastic about the future for Heartbeam, the rapid pace of our product timeline and our team's ability to trace our commercialization path. For those of you joining us for the first time or whom I have not had the opportunity to meet, I'd like to take a moment to introduce Heartbeam and our opportunity in a short video introduction.
Speaker 3: The video explores the hard beam A-MINGO technology, need, market, opportunity, and use in the hard attack detection case.
Speaker 3: Hot beam A-B-Go is the first and only credit card size 12-lead ECD device for remote heart attack detection.
Speaker 3: While we are playing the video for our diving participants, unfortunately, it will be about three minutes of silence. But I'd like to remind you that this video is available on our website, heartbeat.com.
Speaker 4: Undiagnosed heart attacks can be lethal for individuals and costly to the health care system. Today, chest pain is the second most common reason for an ER visit in patients over 45. However, 82% of those visits are unnecessary and cost the health care system over $10 billion each year.
Speaker 4: HeartBeam's innovative technology, the HeartBeam Aimee GO device, introduces a simple, patient-friendly solution designed specifically for heart attack detection. This credit card-sized device paired with the smartphone application puts patients in immediate contact with their care team.
Speaker 4: by recording X, Y, and Z projections into a simple, user-friendly platform. The Heartbeam AMIE system provides a comparison of the patient's baseline ECG along with a symptomatic ECG with a marker and a diagnostic suggestion indicating potential heart attack.
Speaker 4: Today, clinicians must rely on 12 lead ECG for heart attack detection performed solely within a hospital or clinic. HeartBeam's Amy and Amy Go technology has the potential to become the standard of care for cardiac patients with the potential to serve over 18 million patients in the US alone.
Speaker 4: technology that can be used anytime, anywhere. HeartBeam, putting tomorrow's technology in patients' hands today. HeartBeam.com
Speaker 3: It is really important to understand how our ECD technology is different and vastly more powerful than ECD technologies that are in the marketplace today. Today, there are many ECD technologies offered to...
Speaker 3: to consumers and patients outside of a medical facility.
Speaker 3: What they all have in common is that they do not offer a standard of care family ECG in a user-friendly, always-in-patient, easy-to-apply solution.
Speaker 3: That means that they are not capable of detecting a heart attack.
Speaker 3: In the great majority of cases, it is a single EDCG that may be adequate for some reasons, but is certainly not capable of detecting a heart attack.
Speaker 3: Stown in this slide is the actual message from Apple Watch warning the user of its inability to detect a heart attack. Similarly, AliveCore with their cardiac products prominently features on their website,
Speaker 3: the same disclaimer about the inability to detect a part of that.
Speaker 3: Our technology, we believe, has solved the problem of heart attack detection outside of our medical institution.
Speaker 3: The hobby technology is intended to quickly and accurately help clinicians identify a heart attack.
Speaker 3: This could reduce the critical time to intervention for heart attack patients.
Speaker 3: saving many lives and reducing healthcare costs by ruling out heart attacks.
Speaker 3: and reducing the number of emergency room visits.
Speaker 3: So on this graph are ECT technologies and their diagnostic capabilities.
Speaker 3: Today, in the market of Ambulosory ECG devices, we see technologies that offer one to six actual leads. When the market has disappeared, we use some technology to willing to invent many products
Speaker 3: What is common to all these technologies is that their diagnostic value is limited to arrhythmia, such as atrial fibrillation or AP.
Speaker 3: There are some well-known players in this space such as iRithm, Apple, and the Lifeborne.
Speaker 3: If we go beyond six leads, in other words, to 12 leads in this graph, we see the standards of care capabilities are achieved, but there are no players in this space that offer a user-friendly, always patient.
Speaker 3: easy to apply from this ECD solution.
Speaker 3: the technology that has the agnostic capability.
Speaker 3: that goes over beyond standards of care-filled ECG is vector electrocardiography or VECG.
Speaker 3: Our hard beam A-MIGO technology is capable of recording and processing VECG signals and using powerful 3D vector-based algorithms to detect heart attacks. Perhaps most importantly, for this initial phase of our technology development, hard beam A-MIGO technology,
Speaker 3: will bring the power of a standard of care, 12-EDC gene to physicians in front of their patients and remotely that are anywhere and at anytime. No other user-friendly, easy to use, all-in-the-patient technology is able to use the world-class starter machine.
Speaker 5: to offer that.
Speaker 3: This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the Harbin Telehealth product,
Speaker 3: This slide shows several companies in the cardiac monitoring market that you are very familiar with. While each product offers some of the capabilities of the Harbin Telehealth product, there are also factors such as heart attack detection,
Speaker 3: quality ECG capability, integration of patient history and symptoms, and the presentation of baseline and symptomatic ECG to the physician.
Speaker 3: The heartbeat AIMiGO device is significantly different and it is offering in a very underserved market.
Speaker 3: We believe hard in any and hard in any goal by leveraging our patented 3D vector ECG technology offers substantial capabilities beyond existing offerings and we continue to engage with potential customers.
Speaker 3: and partners in anticipation of their clearness and commercial launch for our products. Our fourth quarter was highlighted by formal movement
Speaker 3: for production and commercialization of our products.
Speaker 3: underscored by a series of milestones including new partnerships, IP protection, and the strength management team.
Speaker 3: As we look forward, FDA clearance.
Speaker 3: for hardening, we are also making significant progress with our core project.
Speaker 3: the Harbin Amigo 3D VCG collection device as we prepare for FDA submission in the coming weeks.
Speaker 3: Recently, we announced the acquisition of substantially all assets from Limor, a digital health solution company providing a patient engaging remote monitoring system of clinical physiological biomarkers.
Speaker 3: This persisted of Limor's intellectual property, including US patents, and the Limor technology, including the Halo Plus ACF regulation ACF detection system.
Speaker 3: The Halo Plus AFib detection system is developed first at the clear prescription variable for continuous cardiac rhythm monitoring. The Halo Plus system provides continuous monitoring of pulse rhythms for the detection of AFib on demand during the day and automatically overnight.
Speaker 3: The acquisition extends our reach in the most monitoring and detection with full ownership of an existing cutting edge MBA clear product.
Speaker 3: This acquisition is a natural fit, an extension of our successful partnership.
Speaker 3: We live more, and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs. Our newly acquired state-of-the-art FDA cleared.
Speaker 3: watch-based arrhythmia detection tool, once integrated with Harbin's A-N-G-O telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting.
Speaker 3: During the quarter, we partnered with evolved manufacturing technologies, a contact with a medical device manufacturing company to build the credit card sites on the Amigo 3D VECD recording device.
Speaker 3: Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers. We can now leverage Evolve's manufacturing and packaging expertise.
Speaker 3: Initially, European patent strengthens IP for the higher-hundred naming gold technology, offering 12-leg ECG capability as we expand our product applications to reach a variety of regions and global markets.
Speaker 3: We also received a US patent for a 12-EDCG smartwatch-based monitor intended for detection of heart attacks and complex arrhythmias.
Speaker 3: The breakthrough inventions protected by this patent enable our proprietary 3D VECG technology to be built into a smartwatch.
Speaker 3: eliminating the need for a dedicated ECG device while offering 12 lead ECG capabilities, enabling heart attacks, and conflict therapy and detection.
Speaker 3: We believe this patent may prove to be one of our most
Speaker 3: valuable patents and we continue to expand on our granted and pending core patents for remote heart attack detection.
Speaker 3: We recently welcomed Rob Eno.
Speaker 3: to the new creative position of presidents.
Speaker 3: Rob, who you will meet in a moment, is a passionate visionary senior executive with over 28 years experience.
Speaker 3: go-to-market strategies for multiple breakthrough products.
Speaker 3: He is playing a key role in our strategic decisions, commercialization efforts, and day-to-day operations.
Speaker 3: He joins our other recent appointments, Dr. Peter Figero, the Chief Medical Officer.
Speaker 3: Peter is now playing a major role in defining best paths for adoption, clinical strategies, and partnerships.
Speaker 3: to advance our products in the market.
Speaker 3: I would like to turn the call over to our President, Rob Eno, to further discuss our products and commercialization plans. Rob. Thank you, Bronislav. And to everyone joining us today, I'm privileged to join Heartbeam at such an exciting time.
Speaker 6: as the company prepares to enter a new phase of commercialization.
Speaker 6: Since joining in January , I've been incredibly impressed with the Heartbeam team, their accomplishments and diligence in working toward our mission.
Speaker 6: Turning to our product timelines and updates, we had several key developments related to our Heartbeam Aimee and Heartbeam Aimee Go platforms.
Speaker 6: As Bronislav mentioned, we previously announced the 510K submission of our Heartbeam AIMI platform to the FDA.
Speaker 6: We received questions from FDA within the statutory 30-day review deadline, discussed the questions via teleconference with the FDA review team, and provided written responses addressing the questions to the primary reviewer.
Speaker 6: The substantive review is in progress, and we expect to receive FDA clearance in the second quarter, followed by a limited market release in early Q3.
Speaker 6: Briefly, the total available market for the Heartbeam AIMI software solution is $500 million and for AIMI Go it is $12 billion. These are estimated market numbers for the U.S. only.
Speaker 6: Heartbeam Amigo has a 510k regulatory pathway.
Speaker 6: We've already identified predicate devices and plan to demonstrate substantial equivalence with a validation study.
Speaker 6: Importantly, the clearance of the V1 device allows HeartBeam to collect 3D vector cardiogram data and use these data for conducting 12 lead equivalent studies for the V2 product. According to HeartBeam Amygo product updates, the V1 device is not capable of generating
Speaker 6: In September , we were granted a patent that provides additional intellectual property protection for our Heartbeam Amigo technology, offering 12-lead ECG capability in the form of a credit card-sized device with the same footprint as the single-lead products currently in the market today.
Speaker 6: We also partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card size heartbeat Amigo 3D VECG recording device that enables a 12-lead ECG readout for remote heart attack detection.
Speaker 6: We plan to file an initial 510k submission for the V1 version of Heartbeam AIMi GO as an ECG collection device.
Speaker 6: followed by a second submission for the software that enables 12 lead synthesis from our 3D VECG signals. We expect to file the V1 submission shortly and the V2 submission is targeted for Q4. Our go-to-market strategy for Heartbeam AIMI Go is the phased approach.
Speaker 6: We'll initially focus on direct pay market segments in which payment is outside of the reimbursement system.
Speaker 6: Within the direct pay segments, we will initially focus on those where we will demonstrate Heartbeam A-ME-GO as equivalent to 12 lead ECGs.
Speaker 6: We will then focus on developing clinical and cost-effectiveness evidence, which will be the basis of expansion into new direct pay segments and ultimately unique reimbursement.
Speaker 6: We have a deep product pipeline starting with the Heartbeam Amigo system.
Speaker 6: Other products in the pipeline include a 12 lead ECG extended wear monitor or patch, as well as a system that fully integrates Heartbeam AIMi GO and the heart monitoring smartwatch technology we acquired from LiveMore. In addition, the product pipeline includes predictive algorithms that result from applying machine learning.
Speaker 7: Thank you, Rob.
Speaker 6: Turning to our financials, I will now give a succinct review of our financial results. A full breakdown is available in our regulatory filings and in the press release that just crossed the wire after the closing market today.
Speaker 6: Let me start with Silicon Valley Bank.
Speaker 6: They were our checking account and payroll account.
Speaker 6: On March 10th last week, SCD was closed by the California Department of Financial Protection and Innovation
Speaker 6: which appointed the FDIC as receiver. As a result, we stood to lose approximately $600,000.
Speaker 6: On March 13th, the Federal Reserve announced that the account holders would not bear the loss of this event. The Federal Reserve announced that the account holders would not bear the loss of this event.
Speaker 6: Nevertheless, before the issues with SCV, we had planned to move to a big four bank, and we are currently completing that move.
Speaker 6: Turning now to the statement of operations. General administrative expenses for the 4th quarter of 2022 were 2.1 million. Compared to 1.2 million for the 4th quarter of 2021.
Speaker 6: For the year ended December 31, 2022, G&A expense increased to $7.4 million compared to $2 million in the same period of 2021. This reflects growth in our team and other costs in support of our being a public company. Research and development expenses for the fourth quarter of 2021.
Speaker 6: in the prior year. Most of 2021 was pre-IPO.
Speaker 6: Our 2022 focus on R&D consisted largely of product development costs for Heartbeat Nanny, which is now essentially done, and also Heartbeat Nanny Go.
The name EGO includes both software and hardware, the latter with our professional services agreement with Triple Ring Technologies.
Additionally, there are clinical costs in support of our FDA submissions for both our products this year, as well as research costs in support of the future product pipeline coming from our patented Vector3D ECG platform technology.
Other income during the year ended December 31, 2022 of $69,000, primarily related to the cash balances from the IPO.
In 2021, we had $2.1 million of expense, largely tied to the 2015 convertible note accounting. These notes were converted and added to common stock at the November 2021 IPO and in equity as of December 31, 2021. Our loss for the fourth quarter of 2022 was 3.5 million.
$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 S1 registration statement. As noted in the IPO registration statement, we plan to finance ourselves to the next inflection point in 2024, FDA clearance of our HeartBeam InEgo product with a personalized 12-lead simulation display that a physician is used to seeing the patient's heart rate increase
position is used to see with a standard 12 lead ECG today, but using our patented VECG technology.
I will now turn the call back over to Brandeis Laufer for some closing thoughts.
Thank you, Ike. Indeed, ours is a true platform technology. So far, we have developed two products that are either already submitted to the FDA in the case of Heartbeam AMI or soon to be submitted to the FDA for the Heartbeam AMI Go product.
The recent Limor asset purchase has also brought to Harvey Limor's intellectual property including three U.S. patents.
and the LIMOR technology including the Halo Plus artificial atrial fibrillation product as well.
Hemoplasty is the world's first FDA-cleared prescription variable for continuous cardiac rhythm monitoring.
During the fourth quarter, we continued to operate from a position of strength equipped with strategic partnerships to advance product development and near-term milestones.
We continue to strengthen our IP with patents granted, most recently with a European patent for single transformation from Vector electrocardion grant to 12EDCG, and a new patent for a 12EDCG smartwatch-based monitor.
intended for detection of heart attacks and complex cardiac arrhythmias as well. We also acquired three issues United States patent as part of our Limor Asset Purchase.
All of these enhance our intellectual property and provide protection of our technology in priority global markets.
Beyond that, looking at the product pipeline, we think that the application of artificial intelligence will be of great value to us.
We will have very unique data set of patients who actually have recorded their ECG on a daily, weekly, or monthly basis.
That longitudinal data for our patient population will be of tremendous value.
Applying this visual intelligence to this data set.
that is extremely data-rich, much richer than the standard value DCG will need, be strongly believed, additional insight into cardiovascular disease and further help target hospital patients. On the right side of this slide is shown the...
year 2030.
This is a disruptive technology that has the potential to have a significant influence on the patch industry as a whole.
Looking ahead, we remain pocketed in our anticipated upcoming project milestones.
Our next milestones on the commercialization path include FDA submission.
for the initial hard beam Amigo 3D vector ECG product.
and have the experience for had been aiming both expected in the near future. We approach these milestones from a position of strength with an experienced team both as by the recent appointment of Peter Fidel, a Schmeregal Officer in Robino as president.
to support these goals.
I'd like to share a final thought. We are all very excited about the prospect of helping millions and millions of cardiovascular patients.
Initially, heart attack patients, but we believe our technology will essentially address all cardiac diseases that are detectable by a 12 lead ECG.
So that's a very exciting prospect for us and a great motivator to be helping many millions of patients throughout the world.
I look forward to providing our shareholders with further updates in the near term as we move toward commercialization. Thank you all for attending and now the HAVI team would like to answer your questions.
Thank you. And at this time we will be conducting a question and answer session. If you would like to ask a question please press star 1 on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You may press star 2 if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key.
using speaker equipment, it may be necessary to pick up your handset before pressing the start key. One moment please while we poll for questions.
DaunttoR
Come from the line of Jason Colbert with Dawson James. Please proceed with your questions.
Jason is your line on mute.
Hi, guys. Can you hear me? I got to the destroy ceiling up there and I have to get out and meet a poor guy, so
Hello? Yes, we can hear you now. Yes. Oh, okay. Sorry about that. My first question was regarding the recent acquisition. I know you got a lot of IP, but I think you also had a lot of intellectual capital. Can you talk a little bit about how many of those folks have come over to Heartbeam and what it is that they're really...
bringing to the company? Yes, we covered so far in our presentation the IP aspects of death acquisition in the form of three patents. They are very significant because they really give us an incredibly...
fast head start into the A-Fib detection. This is the company we wanted to get into and with the addition of these three patents, we have an incredibly good entry point into the A-Fib market. Beyond that, we have acquired...
the whole technical team that has developed these technologies for lead more.
And in that sense, we have completed the whole circle in a way because we now have FDA-led products, we have three patents, we have the platform, Halo Plus platform, and we have Cara Martin.
all the key people that have developed this platform. So we are very excited about this acquisition and what it will mean for the future of heartbeating.
And so I'd like to drill down on that. How does that break down in terms of software versus hardware? And is there even a manufacturing component associated with the hardware that you feel helps? How does that break down in terms of software versus hardware versus hardware versus hardware?
support Heartbeam in terms of
its commercialization efforts and kind of managing that whole process. Limor technology is based on so-called PPG sensor, which is an integral part of in the case of their development Samsung Watch.
And so the component of the hardware that Lee Moore has used comes from Samsung. What the real value for us is, is the full ownership of the Halo Plus.
platform that we previously licensed and now we have a full ownership of it with all the source code and ability to modify and extend it.
plus the FDA-clear product. So the main value points are centers around the software, intellectual property, and the team. Okay, and on the manufacturing side, is that something where you feel you're in a good position with your current?
have engaged Evolve manufacturing and they're clearly capable and willing of producing tens of thousands of our devices. We are working with Triple Ring and Evolve because they form really an incredibly good team on driving the cars down.
Initially, you know, these units were not cost effective. And with our current project, we have reduced the cost several times, you know, four to five times reduction in cost.
and the plan to go down that curve even further. Yeah, that's exactly what I was looking for, Pranat Swav. And it's not the type of thing that, you know, it's a hard point for people to understand who haven't been in the business and haven't, you know, you have a concept, you come up with units, but you know.
you know that you have to get the cost down when you get to scale. So, and it makes sense that, you know, a team that's already done that is going to add a lot of value as you pursue that. My last question has to do with both Amy and Amigo, and it has to do with the time gap between, you know, when you complete the submission and when you get FDA clearance. And, you know, that's a relatively short answer.
Short time gap about 6 months and I. I guess that's pretty standard in the industry. You have confidence that that review time should work for you as well. Is that right? Yes, we have a very close interaction with the FDA. We have just completed another meeting with them and.
The interaction is very productive and we remain confident that the results will be positive. And that's all I can say. It has been perhaps a process that takes a little bit longer than we expected, but it's very much an unpredictable process.
And in our case, included holiday season and so on and so on. So yeah, we remain very optimistic about the prospect of getting the clearance for Amy and again submitting Amy Go in Q2 of this year. And in terms of a successful financing.
Yes, Rick, maybe you want to comment on this question.
Jason, absolutely. Obviously, not only do we have the S1 registration, as it works out, of course, but we have the S3 in place. That's ridiculous.
the ATM facility so we have ability to sort of bridge ourselves as we need. I think most people saw we did a deal with Maverick that gives us a short-term capability for another four million, so we're you know, we're careful. I mean, it's clearly challenging in these times, but we can moderate ourselves and we think we have the capability to get things done.
Yeah, and that's exactly the comment I was looking forward to is that you don't have a. A gun pointing out at you, the ATM offers you a bit of a bridge and some brief. If you think room so that you can kind of build this and to get towards a successful capital raise. Right? Yeah, absolutely. Okay, good. Thanks guys. Really appreciate the update.
Thank you, Jason. Our next question comes from the line of Bill Sutherland with the Benchmark Company. Please proceed with your question. Thank you. Hello, Brian Aswad. I was intrigued with the patent on the patch and the patent on the
wondering if there's any preliminary ideas at this point about the, you know, the
the path for that to get to a commercial live stage? Yes, the more we look at the patch, we have two patents actually that protect this invention extremely well.
the more we realize the value of this technology and product for the future of hard being. As it stands right now, we realize that this market is projected to be about $4.8 billion by the end of the year 2030.
And our ability to develop this product is very real. And in terms of time and money needed to arrive at the prototype, we are seeing some estimates that are very attractive.
So, at this point, it's under consideration. But everything we have seen is pointing to the direction of doing the patch sooner rather than later, which does not put any, you know, concrete start date for this project, but we really like what we are seeing in terms of.
very fascinating development is the AI development. I'm curious how you might benefit from the data that you're going to be being able to analyze and work with. Is that going to lead to product or monetization of some kind?
The data component of our technology is very powerful actually because we have a set of parameters, ECG parameters describing that heart, patient's heart, that go well beyond the talking rhythm.
and applying AI to this data set, we strongly believe will not only provide an increased value for reacting to an event such as Heart Attack, but actually offering predictive and preventive value, which will be huge, we strongly believe.
So, all in all, we are focusing right now on reacting to that heart attack symptom, right, doing the right thing for the patient, getting the right people to care or keep it at home, you know, basically saving lives and saving healthcare dollars. But we believe strongly that the data component of our data set will be...
hugely valuable going forward. Got it. Very good. Thanks again, Brad. Thank you. And our next question comes from the line of Ben Haynor with Alliance Global Partners. Please.
We'll see what your question is. Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, Rob, nice to meet you over the conference call, but was curious on really what attracted you to Heartbeam and what are you most excited about going forward?
Thanks, happy to talk about that. Just with my background, I have 28 years in medical technology and it's all based around bringing disruptive new technologies through commercialization and scale up. I joined because I believe in the company and I believe in the technology and think this could be.
absolutely a chance to bring a game-changing technology to market. You know, being able to get a 12-week EKG into patients' hands and with the VECG technology potentially being able to go beyond that and the data aspects that Bronislav mentioned. So I see it as a way to...
really influence tremendous number of patients lives address a major health care issue that has not yet been adequately addressed and, and take part in what I think is going to be an amazing company going forward. Okay, good deal. And, you know, have you had a quite a few discussions with, you know, folks that could serve or could be potential you've talked about the potential uncertainty
Customer is down a little the Amy, Amy going the other products, any color on those if so. Sorry, can you repeat that just to make sure I understand? Sure, so I'm just curious on what your background, you know,
Clearly you probably have a roll of decks of folks and you're out there talking to folks that could be potential customers of Amy, Amy Gold, the other products. You know, can you talk about any conversations that you've had and you know any color on those? No, sure. Sorry. Thanks. Appreciate that.
Yeah, absolutely talk to a number of cardiologists. And what strikes me is what I hear constantly is 12 lead EKG itself is limited to hospitals, but it's also 100-year-old technology. And many of them know of the...
They understand that studies, even decades ago, show that it had a number of benefits beyond standard EKG. So we get a lot of excitement that the company has figured out a way to take VCG, harness it and bring it to patients. Then I hear a lot of this.
physicians when we describe the concept of a full WCG or potentially beyond that in the hands of patients, you know, saying game-changing and they can think of all kinds of different applications for it. So I've been very pleased with the excitement of the physicians, the willingness to partner with us and help us and both in terms of potential clinical studies or early sites and helping us figure out the best strategies to scale the technology.
It sounds like nice to have the support on your decision to join from folks at Park Science about the technology. Good deal. And then on Live More, are there any regrets on the acquisition there?
Are there any plans to commercialize the Halo Plus AF detection system immediately? What's the commercialization thoughts there?
Yes, let me answer that question. We have acquired this system and we have established
that actually in terms of a potential product, what makes sense is an integration of Halo Plus platform for AP detection.
with our Amigo product. Why does that make sense? Well, as I said before, the Halo Plus is watch based.
and it can provide a sort of an alert.
for Amy Go to do a 12-EDC-G where there are indications from the watch that there are things that are getting outside of the normal, right? And so we believe that getting the Amy Go to the FDA clearance stage will enable us to...
consider offering an integrated product where you have a watch that's working with Amy Go for a full blown ability to detect a variety of conditions through our quality TV.
And what's interesting about that is that physicians under this scenario here would get something that was alerted by the watch that they have learned is not very reliable, 80% very many positive, false positives, false negatives.
system with a much higher degree.
of credibility. So all in all, an integration makes sense, but Amygo is very much a front and center of that system, potential integrated system. So we are still focused on Amygo totally and the potential integration into an integrated offering.
the questions that you've received. I mean it doesn't sound like there's any showstoppers in there but you know just you know any...
areas that common questions were arising or anything you can provide that would be helpful. Well, I'm not at liberty to really talk about much detail there. I would just say that at the top level,
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.
Okay, fair enough. Thanks for taking the questions gentlemen and congrats on the progress.
Okay, fair enough. Thanks for taking the questions gentlemen and congrats on the progress. Oh, thank you Ben. Thanks Ben.
And this concludes our dial-in Q&A session. And we will now have questions via the webcast. Our first questioner asks, based on your IP, does the IP address have a password or password for the IP address?
You can pursue several very interesting opportunities between Beyond Amy and the initial Amy Go plan releases. They would like to know what is the next product that you will start developing.
Yes, so let me reiterate that Amigo is front and center of our development efforts and commercialization a path.
As far as our IP is concerned, the good news is that we have incredibly deep IP portfolio here, including a watch.
which I happen to believe is the ultimate solution here, where you really don't have to have any other device other than your watch to be able to do a lovely DCG. But that's not in the near term focus. And perhaps that presents a partnership opportunity.
There are many well-known players out there with a single EDCG, a watch.
And we have extremely well covered our agricultural property for the 12-leaf watch. So that's not going to be our immediate development list, but again, partnership opportunities are probably very significant.
Secondly, as far as Tatch is concerned, you know, as I alluded to, we are very seriously considering the opportunities that it presents. Well-established markets changing four factors, but technology-wise, we are very seriously considering the opportunities that it presents.
there is very little change that would be required between going from credit card size Amigo device, or the Amigo device, to a patch. So that is very much on our radar screen.
The next question asks, direct pay Goto Market is somewhat of a new direction. Can you shed some light on why this is potentially a superior strategy compared to RPM? Sure, I can take that one. What we discussed is the refinement of the Goto Market strategy.
number of additional market segments that we think are both big size and also where there's an entity that's willing to pay for the solution outside of the reimbursement system. That's what we're describing as direct pay. And some of these require data that shows that we're equivalent to a standard 12 EDCG.
and we had those listed in the slide. And then others that are more value-based will be developing data on clinical and cost effectiveness. And the beauty of that is that we can start right away with the 12-lead ECG, but then the data we gather for the value-based usage is the same data that's going to be useful for our efforts to establish a unique reimbursement code.
So we think that these market segments we've identified have the potential to result in more value to heart beam potentially than an RPM approach, as well as being in alignment with this long-term strategy of obtaining our own unique reimbursement code. And that concludes our webcast Q&A.
I would now like to turn the call back over to Dr. Vyjek for closing remarks. Thank you, operator. I would like to thank each of you for joining our earliest conference call today and look forward to continuing the conversation.
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.
And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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