HeartBeam, Inc. ($BEAT)

Greetings, and welcome to the HeartBeam Fourth Quarter 2025 Financial Results Conference Call. [Operator Instructions]. As a reminder, today's conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call today 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 revisions 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 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 wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com. Your hosts today, Rob Eno, Chief Executive Officer; Tim Cruickshank, Chief Financial Officer; and Bryan Humbarger, Chief Commercial Officer, will present results of operations for the fourth quarter ended December 31, 2025. It is now my pleasure to turn the call over to HeartBeam Chief Executive Officer, Mr. Rob Eno. You may begin, sir.

Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll start with an overview of the HeartBeam system, the core technology in our platform. Bryan Humbarger, our new Chief Commercial Officer, will provide an overview of our limited commercial launch. We'll then provide updates on heart attack detection. We'll unveil the working prototype of our 12-lead patch and provide the latest on our AI initiatives, followed by the financial results. We'll end with Q&A. I also want to note that this presentation as well as an updated company presentation will be available in the Investor portion of the HeartBeam website. Before we dive into updates since our last call in November, I want to remind everyone about our initial product, the HeartBeam System and our platform technology. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home to allow them to feel confident about their heart health. HeartBeam has developed the first-ever portable cable-free ECG that can synthesize a 12-lead ECG. Our unique IP-protected approach captures the heart's electrical signals in 3 dimensions or non-coplanar directions and synthesizes the signal into a 12-lead ECG. The system is designed to be easy to carry and easy for patients to use at the time of symptom onset anywhere, anytime. The technology is supported by an on-demand cardiologist who can interpret the clinical-grade ECG and triage patients appropriately to ensure timely care. In December, we achieved a major milestone when HeartBeam's 12-lead synthesis software received FDA 510(k) clearance for arrhythmia assessment. This clearance, combined with the foundational 510(k) clearance for the HeartBeam System itself in December 2024, validates the unique approach of our technology and provides the basis for our limited initial commercial launch. Just to note that in November, we received a not substantially equivalent or NSE letter from the FDA, but we immediately engaged with the agency, and we're able to get the NSC overturned in 2.5 weeks, resulting in the FDA clearance in December. This rapid turnaround is a testament to our regulatory team and the willingness of the FDA to work with us productively to achieve a solution. HeartBeam's technology is a true platform. The core of the system is our signal collection technology, which captures the heart's electrical signals in 3 axes, left and right, up and down and into the body. These 3D signals can be converted into a familiar 12-lead waveform. This core technology can be applied to multiple form factors. As I noted, we have our 2 FDA clearances on the HeartBeam system, the credit card size form factor, and we're embarking on a launch of that system. In the background, we also have been developing a second form factor, an on-demand 12-lead extended wear patch. We believe that this patch can disrupt the ambulatory cardiac monitoring market, a $2 billion revenue market with established reimbursement that consists of the long-term continuous monitor and the mobile cardiac telemetry or MCT segments. We're unveiling the details of our 12-lead patch for the first time today. The technology in these 2 form factors has the potential to enable a full range of 12-lead ECG capabilities, including the currently cleared arrhythmia assessment and future indications for heart attack detection and personalized AI algorithms. We'll discuss our progress toward heart attack detection and personalized AI algorithms today. We want to provide updates on our progress on all 4 of our major initiatives. First, Bryan will give an overview of our limited commercial launch. Then I'll provide updates on heart attack detection. We'll unveil our 12-lead patch, and I'll provide the latest on our AI efforts. And with that, I'll hand it over to Bryan Humbarger, who joined HeartBeam in January as our Chief Commercial Officer. Bryan has over 25 years' experience commercializing novel medical technologies, including leading the commercial efforts at HeartFlow, AliveCor and Eko. I'm thrilled to have Bryan lead our commercial efforts. Bryan?

Thank you for the introduction, Rob. I am truly honored to be joining the HeartBeam team at such a pivotal moment for the company. In my first few weeks, I've had the opportunity to travel across the country and witnessed firsthand the strong demand among both patients and physicians for a wireless personal 12-lead ECG platform. The enthusiasm for this level of clinical insight delivered in such an accessible form factor is unmistakable. For our initial commercial launch, we are focusing on concierge and preventive cardiology practices, where we expect, based on early engagements, strong traction. Coming on board, my objectives were clear, prove there is a willingness to pay for the technology and show evidence of demand. In addition to what we are highlighting today, I'm seeing excitement that is leading to HeartBeam building a robust pipeline of accounts that are getting in line to deploy our technology. Today, more than 1.5 million Americans already pay out of pocket for concierge medicine. Many of these patients spend between $3,000 and $10,000 per year on proactive health care. We have conducted extensive market research with high net worth individuals and concierge physicians. High net worth individuals are highly likely to adopt advanced health technology and show a strong willingness to pay for the HeartBeam system, which combines the [ 12-lead ] capabilities with access to cardiology expertise. And importantly, physicians and concierge practices are highly likely to recommend HeartBeam to their patients. Our target price per patient is $500 to $1,000 per year. This is a small fraction of what concierge patients are currently spending for their memberships. Our launch strategy starts with a very focused rollout in concierge cardiology and executive health, which is a small subset of the 1.5 million concierge patients. These practices typically serve between 400 and 4,000 patients and are concentrated in key markets like New York, South Florida, Dallas and Southern California. We are encouraged by these opportunities, and we expect to engage them with a very targeted commercial team. They also tend to be physician-owned and highly innovative in adopting new technologies. Even capturing a relatively small portion of this market can create meaningful early revenue for HeartBeam. In fact, we believe breakeven could be achieved within this segment alone. Once we validate adoption and refine our implementation model, we then go deeper into the broader concierge market. Beyond the concierge market, there are expansion opportunities in the larger patient pay segment, including direct primary care practices, telehealth networks and eventually national health care organizations. This approach allows us to prove the model in a concentrated market first and then scale. We have a clear plan for commercialization. We are in the exciting position of introducing groundbreaking technology, and we don't expect demand to be a limiting factor. But as we build this market, we will be measured and take a staged approach. As we introduce HeartBeam, we will be validating our premium value proposition and refining our systems and processes. In the second half of this year, we will be demonstrating deep adoption with our anchor accounts and establishing a funnel for 2027. 2027 will be all about scaling revenue. Our business model is designed to scale efficiently. Rather than selling directly to individual patients, we will partner with medical practices. One relationship with a practice can result in hundreds or even thousands of patients enrolling in HeartBeam. That approach creates a highly efficient distribution model and a strong recurring revenue stream. Financially, this translates into a subscription model with margins above 70% and a payback period of just 3 to 5 months on initial onboarding costs. We believe that we can reach cash flow breakeven at roughly 30,000 patients. A key part of our launch strategy is partnering with leading cardiology and concierge practices that want to deeply integrate HeartBeam into their care models. We are thrilled to have our first commercial customer, ClearCardio, which will be an excellent early adopter partner. ClearCardio serves a highly engaged premium patient population in markets such as Dallas and New York and are expanding into additional East and West Coast markets this year. Their patients already participate in advanced cardiovascular screening and ongoing monitoring, which makes them an excellent fit for HeartBeam's at-home 12-week ECG technology. Our goal with partnerships like this is to go deep with adoption in the practice. Our launch strategy is laid out here. We will start with a small number of practices like ClearCardio. We will partner with these practices and drive patient adoption and engagement. This will give us the proof points we need, such as white papers and testimonials to allow us to expand to a larger number of practices. And now I'll hand it back to Rob.

Thanks so much, Bryan. With the 12-lead synthesis software clearance, we're embarking on the product launch, but our opportunity is much greater than that. As I mentioned earlier, we have core technology that powers 2 form factors, the card and the patch and enables multiple 12-lead applications. So next, I'd like to discuss our efforts on heart attack detection. As we've discussed previously, one of the major problems in cardiology is that there's no good way for patients who experience chest pain to know if they're having a heart attack. Patients wait an average of 3 to 4 hours before seeking care and every 30 minutes of delay increases the risk of death by 7.5%. The 12-lead ECG is the standard for heart attack detection, but traditional 12-lead ECGs have 10 wired electrodes that need to be placed by a technician and are not applicable for home use. This is a major problem with 20 million people in the U.S. at risk of a heart attack, including 8 million who have had a previous heart attack. HeartBeam's technology has the potential to address this major need. We have multiple proof-of-concept studies showing that the HeartBeam ECG is similar to a standard 12-lead ECG in detecting heart attacks. One important point about this effort is that it's the same HeartBeam system that we're launching with an expanded indication. We announced last week that we have started patient enrollment in the ALIGN-ACS study, a European pilot study comparing the HeartBeam ECG to a standard 12-lead ECG in detecting heart attacks. The study is conducted in the emergency room, enrolling patients who arrive with chest pain. This will allow the study to enroll much more rapidly than a study that prescribed devices to patients and waited for them to have events. We expect the study to complete by the end of the third quarter of 2026, and that study will inform the design of our FDA pivotal study. Our core technology powers 2 form factors. So far, we've spoken about the HeartBeam system with its credit card size ECG collection device, but we've been working behind the scenes on the development of our second form factor, and we're excited to unveil that here today, an on-demand 12-lead patch. We believe that the HeartBeam 12-lead patch can disrupt the ambulatory cardiac monitoring market. This market consists of patches that are worn for up to 30 days and continually record the patient's heart rhythms. This is a rapidly growing $2 billion revenue market with existing reimbursement. It consists of 2 segments, long-term continuous monitors and mobile cardiac telemetry or MCT. These devices are 1 to 3 leads and are limited to arrhythmia detection and monitoring. HeartBeam has developed an on-demand 12-lead patch and has produced a working prototype of the device. It functions just like existing patches, continually recording the patient's heart rhythms with a single lead. But using HeartBeam's patented core technology, a patient simply places 2 fingers on the front of the device to record a clinical-grade 12-lead ECG. This has the potential to bring better diagnostic capabilities and even ischemia detection to the patch segment. The device integrates into existing workflows and leverages the existing reimbursement. We believe this will be the best-in-class patch. We've recently completed a third-party market research survey, which clearly demonstrates the potential of the product. 86% of physicians said they would shift a portion of their patches to the 12-lead patch. On average, they said they would shift 61% of their patch prescriptions. This implies the potential to shift fully half of the market. In addition, 94% of the physicians said they would shift a portion of other cardiac monitoring devices such as Holter monitors. Many Holter monitors are 12 lead, but use traditional wired electrodes so are not practical for extended use. The market research also showed that the 12-lead patch could grow the patch market. Patients who feel cardiac symptoms don't know if their experienced arrhythmias or ischemia. They just know that something doesn't feel right. If there was an on-demand 12-lead patch, 64% of physicians said they would prescribe more patches with an average increase of 45%. This implies that the market as a whole could grow immediately by 30%. Here's a video of the HeartBeam patch in action. Please note, those of you who are dialed into the call will not hear the audio, so experience approximately a minute of silence. [Presentation]

So that is the HeartBeam 12-lead patch. I'm incredibly proud of our technical team led by our founder, Branislav Vajdic, who have progressed the development of the device to the stage. We have a prospective clinical study underway on the device, and we look forward to providing more details soon. We'll continue to engage with interested parties in the possibility of partnering to bring the 12-lead patch to market, and we're excited for these conversations to advance now that we've completed the working prototype of the patch. The final of our strategic initiatives is AI, which can be applied to both the card and the patch form factors. Our 3D signal collection and 12-lead synthesis provide valuable information for physicians, but we're developing AI algorithms that can provide deeper insights. Deep learning algorithms applied to standard 12-lead ECGs exist today and are one of the most powerful use cases of AI in medicine. There are dozens of AI algorithms applied to 12-lead ECGs that can screen for asymptomatic diseases and predict the onset of disease across a number of conditions. But these algorithms are locked in the hospital. They require that the patient undergo a standard 12-lead ECG. HeartBeam has the potential to take deep learning algorithms to the patient, applying them every time a patient takes a reading with the HeartBeam device. This could allow for more robust performance, more personalized risk assessments and greater predictive power. Expanding beyond symptom-driven assessments such as arrhythmia and heart attack detection to disease prediction and ongoing management can open up new markets and has the potential to enable new reimbursement pathways. HeartBeam assembled a top AI team led by Lance Myers, the former Head of AI at Google Verily. And just this week, we announced a strategic collaboration with Mount Sinai. This will combine our expertise and our signal collection technology with Mount Sinai's expertise and clinically annotated ECG data. We're very excited about the potential of this collaboration and the benefits to patients of bringing these advanced algorithms to the HeartBeam device. One of the initial focuses of the joint effort will be an algorithm to help physicians in the assessment of heart attacks. In addition, there are plans for a series of wellness and clinical algorithms, including screening and prediction. We've made a lot of progress in recent months, and we have plans to advance all 4 of these initiatives significantly this year. Here are the major milestones we have planned across our limited commercial launch, heart attack detection, the 12-lead patch and AI. We've already achieved significant milestones on each initiative. For the limited commercial launch, after receiving the clearance of the 12-week synthesis software in December, we hired Bryan as our CCO, and we have signed our initial collaboration agreement with ClearCardio. For heart attack detection, we initiated the ALIGN-ACS pilot study in Europe. We've completed development of the working prototype of the 12-week patch, are conducting clinical studies and are continuing discussions with potential partners. And finally, in the area of AI, we signed a collaborative agreement with Mount Sinai. In the interest of time, I won't go through every milestone listed on this page, but we expect an exciting year of progress on all fronts. And now I'll turn it over to Tim to discuss our financials.

Great. Thanks, Rob. I'll briefly review some key financial highlights for the quarter and the year ended December 31, 2025. Our results continue to reflect strong financial discipline as we advanced key milestones while maintaining a highly capital-efficient operating model. For the full year 2025, net loss was $21 million or $0.62 per basic and diluted share. And for the fourth quarter, net loss was $5.3 million or $0.15 per share, which was directly in line with expectations. Importantly, a meaningful portion of that net loss relates to noncash expenses, primarily stock-based compensation. So as a result, net cash used in operating activities was less than $14 million for the full year and just $2.9 million for the fourth quarter representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year. We believe this reflects our continued focus on maintaining a lean organization and carefully pacing investments that support both commercialization and the continued development of our R&D pipeline. Cash and cash equivalents and restricted cash combined totaled $4.4 million at December 31, 2025. We have demonstrated access to capital markets, and we continue to have multiple vehicles available for capital, including our shelf registration and at-the-market facility as well as continued support from long-term stakeholders who believe strongly in the company's trajectory. So looking ahead to 2026, when we look at our cash flow, we expect baseline operating cash outflows to remain at approximately that $14 million level. And then we have a cost-effective rollout for our commercial launch as we continue to maintain and as we continue to maintain heavily variable cost structure for additional R&D initiatives. So combining those, the incremental investments tied to the milestones Rob outlined on the earlier slide add just $3 million to $5 million to our cost profile. This is prior to factoring in potential cash receipts from customers and implies gross operating cash outflows of approximately $17 million to $19 million for 2026. 2025 was a transformative year for the company, highlighted by FDA 510(k) clearance for our 12-lead ECG synthesis software, which meaningfully derisked the business. And we now enter 2026 with a commercial product, a strong development pipeline and a disciplined operating model and cost structure. So we look forward to updating you all on our continued progress. With that, I'll turn the call back over to Rob in his closing summary.

Thanks, Tim. To summarize, 2025 was a pivotal year for HeartBeam, and we expect 2026 to be one of significant advancement on multiple fronts. The FDA clearance of our 12-lead synthesis software was a major milestone for the company. With that clearance behind us, we're beginning our limited commercial launch. Bryan clearly laid out the opportunity and our strategy. We're building a new market, and we want to be smart in how we're rolling out the product. We're focusing on signing practices that see the value in the technology and want to drive deep adoption with their patients. We're excited to have ClearCardio be the first of these early practices. We expect to take the proof points from the early experience to drive wider adoption. We've made significant strides on heart attack detection with enrollment underway on ALIGN-ACS, the pilot study on the HeartBeam system compared to a standard 12-lead ECG in detecting heart attacks. This study is taking place in emergency rooms, which should lead to rapid enrollment, and the study will inform our FDA pivotal study. On this call, we unveiled the HeartBeam on-demand 12-lead patch. We've been working hard on this second form factor for some time and now have a fully working system that's currently being used in clinical trials. We believe that this is disruptive to the existing patch market and the market research indicates it can drive significant market share shifts and grow the market. We're in discussions with potential partners. Finally, our AI efforts have taken a major step forward with the strategic collaboration we just announced with Mount Sinai. By joining forces, we believe we can accelerate bringing advanced algorithms to the HeartBeam system. As Tim noted, we've made significant progress by maintaining strong financial discipline. We're excited about the major milestones we've achieved and the opportunities in front of us across multiple fronts. We thank you all for attending. We would like to open it up to Q&A. Operator?

[Operator Instructions]. And today's first question comes from Kyle Bauser with ROTH Capital Partners.

Congrats on all the updates. A lot going on. Rob, maybe starting with some of the initiatives. So for the ALIGN pilot study, a really nice trial design. It obviously makes enrollment about as straightforward as you could ask for and also appreciate the updates on the patch initiatives. Can you talk a little bit more about the time lines for both of these? I know things are underway. And as you learn more, it will kind of inform future studies, but just trying to get a sense of kind of the cadence of what are the milestones you need to hit and the time lines associated with those?

Sure, Kyle. Yes, I can talk at a high level. It's obviously still early. So for heart attack detection, as I said, we've started the ALIGN-ACS pilot study. That's on the order of about 100 patients. And as you suggested, because it's done in emergency rooms where there are many patients per day showing up with chest pain, it should enroll rapidly. The study design is basically the patients when they come in, they get a 12-lead ECG, then they're waiting for the next step. They then get enrolled. They'll get another 12-lead ECG and our device very close in time. And we compare both of those to the discharge diagnosis, trying to show that we're comparable in terms of the accuracy of detecting a heart attack with the symptoms, history and the ECG. We're expecting that will enroll quickly. We're saying by the end of Q3 is our expectation. And we also said that, that's going to inform the pivotal study. So there will be a pivotal study needed for FDA. We've had early discussions with them. We need to continue to have discussions. And obviously, this study design and the results will inform the pivotal study. So in general, it's the pilot study followed by the pivotal study and then the regulatory review. We haven't finalized what the regulatory path will be. So that will be forthcoming both the time lines and the official path as we get further in our discussions with FDA, and we'll keep you posted on that. And as far as the patch goes, a couple of things on that. What we know is that we expect, although we haven't vetted it fully, we expect it will be a 510(k) because we have predicates of our HeartBeam system with its 12-lead synthesis as of 510(k) now and then the patch products are 510(k). So those get combined together. As far as the go-to-market strategy and the time lines, still to be determined. We have the ability to bring that to market ourselves. But as I've mentioned, we think if we are able to combine with a partner, we may be able to get this in the hands of more patients quickly. So we're having those discussions. And based on that, we'll have a better sense of how the time lines play out.

Got it. I appreciate that. And then maybe next for Bryan, welcome to the team. Thanks for the thoughts on the commercialization strategy. You talked about the importance of anchor accounts to drive things like white papers and testimonials. Just kind of curious, what does the account pipeline look like? And how many anchor accounts would you expect to have kind of up and running over, call it, the next 6 months or so?

Yes. Thanks for the welcome, and great question. So going back to what we laid out before, we're being very focused, very strategic in our entry to the market. So if you talk about the 5 million patients today that are paying for some sort of concierge or preventive medical care. Within that, about 1.5 million are kind of in this concierge space that are really focused on a higher level. And then where we are really entering the market is that 10% of that, the top 10%. It's about 150,000 patients, and they're really concentrated to 3 or 4 geographies throughout the United States. The reason we're focusing on those is really because there is the strong willingness to pay by that patient population. It's more of a premium patient population as well as because of the type of concierge, the cardiology concierge and the executive concierge, there's a very high-touch patient physician relationship there. And so with that, we are hyper focused. We really feel that focusing that area, it's a very target-rich environment. We don't see or feel that there's going to be a lack of demand. As I mentioned before, we only -- 20% of that population alone could take us to a breakeven point. It's a very large market. It's going to really inform us on what we need to go to scale and move forward. So to answer your question, what we're looking at is really focusing on several accounts in the first couple of quarters here so that we can validate our premium value proposition and then really start to scale after that. The bottom line is we do not need to have very many accounts to do that, and we don't think that the time line is going to be very long for us to be able to execute. What we really want to do is make sure that we're focusing on the right people. We're driving deep adoption, we're validating and then we can go out and replicate it.

And I might just add, that was really great, Bryan. I think when you think about what our goals are for this initial rollout, these initial accounts have between 400 to 4,000 patients. It's all about proving -- the #1 metric we have is proving we can go deep into these accounts efficiently. And so it's less about the number of accounts early days and the proof points of going deep into them for adoption. When we get that, that gives us the blueprint to start to go after that larger 1.5 million patient population, which has large chains that have hundreds of thousands of patients within them. So we want to get the proof points of efficient, deep adoption, and then we can take that blueprint to these larger, more margin-focused chains that have hundreds of thousands of patients and start to scale that way.

Sure. Yes. No, I appreciate that. And Tim, maybe just on OpEx. I think you said $17 million to $19 million for the full year in terms of kind of the cash outflows. In terms of R&D, given all the exciting initiatives going on, how should we think about this line item kind of trending or the cadence? Is it kind of similar levels each quarter? Is it stepping up slightly? Any color here would be helpful.

Yes. The first half of this year, it steps up slightly because of the clinical trials enrollment there as well as these advanced developments we have on the patch. So when you compare it to Q4 and quarterly numbers, it's a slight step-up in the first half of the year, but then goes back down to kind of the levels they're at now by the time you get to the second half of the year. We've been really effective at having milestone-based expenditure. So we're able to keep our kind of baseline $14 million, which a big chunk of that is R&D. The reason our OpEx doesn't go up tremendously this year is because some of that from last year switched off as we hit milestones and now we're basically just replacing existing costs with new focuses on these milestones. So you think about the $17 million to $19 million overall in cash outflow, it's about $1.5 million total over the course of the year incremental for R&D initiatives. So with most of that -- some of that happening in the first half of the year, slightly more than half on a prorated basis.

Okay. Got it. Excellent. Congrats again on all the updates.

And the next question comes from Bill Sutherland with The Benchmark Company.

Congrats on all the progress. Bryan, I was curious on this focus that you have initially on the top 10% inside the concierge practices. Is this something you expect will probably be the focus for -- well into '27 before you feel like you've got the -- everything you need to kind of broaden?

Yes. Thanks, Bill. Good question. Again, I think that we are going to be able to validate very quickly this model. I don't think it's -- we have full intentions of kind of expanding into that [ $1.5 million ] -- or 1.5 million patient slice of the pie, if you will, before 2027. Again, the reason we're focusing on these cardiology concierge groups and the executive health groups is a very target-rich environment, but they also -- these are practices that are owned by the physicians and the pathway to contracting, the sales cycle is not riddled with bureaucracy, which helps us get to the patients quicker. They have very, very high level of patient engagement. And these practices specifically, Bill, are looking at the feedback we are getting from them is that they want all of their practices or all their patients in their practice to have this device, right? So it's not being selective. We are going after that 10% because the profile of that customer is so aligned with what we're doing that when we walk in and they say, we want every patient in our practice to have this, not trying to carve out, there's just a specific type of patient. So I think we're going to be able to learn, again, with a limited number of accounts and a limited number of time. And then based on that playbook we're putting together, I think we're going to be able to start expanding into these other market opportunities very quickly.

And Bill, I'd just add, it's probably hard to predict because it's going to be kind of a gradual transition, whether we're into this larger group in '26 or into early '27. But Bryan is going to continue to build the funnel with lots of interested accounts. And then as he described, we -- as we show the proof points from the deep adoption, then that should accelerate into this next wave. So that kind of comes in parallel.

And does the pricing include the reader service that you've contracted with?

Yes. The pricing that we've laid out, the $500 to $1,000, and there's a range and variables that impact that, but that does include the reading service.

Got you. And so really no plan then and no need to think about reimbursement code for this. Is that true?

Yes. Bryan, I can take that one. I think we said before, now all 3 of us on this call with Bryan and I both work together at HeartFlow and Tim and ImpediMed, we've all gone through the reimbursement journey with previous companies. And it's powerful. It takes some time. One of the things I love about what we're doing is we've got optionality. So we obviously -- not to deviate too hard, but on the patch, that is an existing reimbursed market. On the card, what we're excited about, as Bryan laid out, is we have significant patient pay opportunity starting with concierge and going beyond that. So we don't think we necessarily need to get reimbursement codes right away, but it's clearly part of our vision. And I think the way to think about it as we get more use cases that demonstrate the value to the health care system, and I think heart attack detection is a really big one given the clinical and cost-effectiveness benefits, the work we're starting to do now will pay off there, whether that's in a value-based care world of ACOs and Medicare Advantage and demonstrating the advantages of having this product or into CPT codes. So that's definitely part of the strategy. But what we like is that we can expand and believe we can get to cash flow positive without having to even have the reimbursement kick in, but that becomes the whole second wave on top of this.

And your next question comes from Yi Chen with H.C. Wainwright.

This is Eduardo on for Yi. Congrats on the year and the quarter. I wanted to ask a question again on the ALIGN-ACS study. Just curious what kind of accuracy you think would be sufficient to kind of move forward with the pivotal study? And I know that you've conducted previous studies looking at myocardial infarction more in the context of screening at home. And I'm just kind of curious how you envision both the trials and utilization to get conducted if you kind of still envision the card being used at home for screening and go, no go to the ER or kind of using it in the emergency room per se?

Yes. Thanks [indiscernible] appreciate it. Really great question. Good to clarify. So the use case for heart attack detection is still at home. We just have this, I think, quite interesting study design that's going to allow for quicker enrollment. Basically, the way to think about it is when a patient would have chest pain at home, it's basically the same decision and the same information as when they show up to the emergency room. You would have -- with our device, we'd have the ability to have the ECG and they report their symptoms through our app and then you have their history. And those are the 3 factors that would happen in the first 10 minutes before troponins and other imaging tests are done. So that's why we can use that environment and say, if we're able to show similar accuracy to the 12-lead ECG in that, then that should be an analog for this information that would be there at home. As far as the accuracy, so yes, we've done 2 -- we've done 2 studies, and we've looked at them both with the synthesized 12-lead and the core 3D output. And what we showed in those study designs similar to this, that when we look at the accuracy of the 12-lead and our device compared to the hospital discharge diagnosis, we're just trying to show that we're similar to the 12-lead. There are going to be times when the ECG alone is not enough, but we're expecting to be in the same level as accuracy. So it's less about the number. It's more about how close we come to the 12-lead ECG. If we show that we're similar, the argument is that same information we showed in the emergency room, that's everything the physician and our reader service would have when the patient does this at home. So that's the way that the trial is designed and what we're thinking about that validating really the home use of it. Does that make sense?

Yes, yes, I guess, agreement with the 12-lead. And I guess, naturally, there's some wiggle room, right? Like if you're using this in a screening context, you don't need it to be as good. You just need like you're going to -- the negative predictive value is really important there. You can forgo the false positives.

Yes. So there's right. A couple of key points, right? Obviously, what we'll be arguing is we want to show and the initial studies have shown that within the margin of error, we're similar to a 12-lead ECG. A couple of key points. One is what our previous studies, our proof-of-concept study showed is that for both the standard 12-lead and for ours, when you look at the difference between a baseline asymptomatic and the event ECG, that actually increases the accuracy by about 20 points. We have that by definition in our system for every patient. If you were to show up in an emergency room as an unknown patient, you wouldn't have that comparator. So that's one kind of advantage that we have that we think helps in terms of the accuracy. The other thing is the way we're viewing this in discussions with FDA is very much a rule-in device. What we want to do is attack that 3- to 4-hour delay that comes from indecision or patients being in denial and in a sense, reduce the time to taking a first action. So the way that we're thinking about it is if the physicians notice something in the ECG, the comparative ECG, they'll tell the patient, you really need to call 911 and get in. But if they don't notice a difference, it could be a number of things. So the response -- the physicians will drive the response, but they're going to say something along the lines of you should follow standard of care. If there's significant symptoms or they continue, you should call 911. So the focus really is speeding up the time and getting patients into the system.

Got it. That's really helpful. And then maybe another one on commercial strategy. I guess there's 2 here. I'm curious about any interest in looking at profit sharing models. Right now, how much of that 500 to 1,000 subscription is going to the provider versus you all? And would you be interested in looking at more generous profit-sharing models as you expand to maybe less premium concierge services? Just kind of a little color and ideation there.

Maybe, Bryan, I'll start, and you feel free to add in because I know you're 5, 6 weeks in. But it's a great question. What we believe from what Bryan laid out that these practices have aligned incentives. They want to get new technology to their patients. They want to drive -- differentiate their practice. They want to drive engagement. But we also think there may be -- and this is what Bryan is learning now is there may be an economic incentive as well if they're sharing in the economics that makes sense. So as Bryan is talking to practices, we're talking about list prices and having certain ways that we can work with them along those lines. Bryan, I don't know if you want to give any more detail on that or what your thinking is along those lines.

Yes. I think you outlined it very well. We're really focused on that portion of the 500 to 1,000 that we're talking about is this is a subscription model. It's a model that practices are used to. And we're really focused on that. I think that to Tim's point earlier, as we continue to expand out and scale, there may be optionality for different things like -- things that you're discussing there. But for right now, we're going after kind of those opportunities that we just -- we can have a very easy engagement with the practices in general. And again, I know I've emphasized it many times, but the ones that we're focused on and the ones that are really kind of building our backlog right now, it's a strong willingness to pay by the patients or the practice and the doctors are highly motivated to recommend it to their patients. So that's our starting point, and then we will move from there.

Got it. That's really helpful. And then if I can have a final one. Just any thoughts on telehealth providers. Naturally, that seems well aligned with the kind of services and devices you're providing, and they're seeking to differentiate. I think LifeMD just announced the cardiology telehealth service launch. Kind of curious on your thoughts there, the potential to target that commercial segment.

Yes, Bryan, you can take that one, too.

Yes. So I think it's a great question, and it just kind of reinforces the fact that we're really focusing in the right areas. I mentioned before, I've been fortunate to travel and be in several geographies over the last few weeks and meet with many, many cardiologists. And the great thing about the HeartBeam system is the ability to pull it out of your pocket and demo it and show the clinicians how to use it. What is absolutely clear is that our ability to provide clinical-grade 12-lead ECG, there's been nothing like it on the market before. So when we see other companies that are out there that are doing telehealth cardiology or doing -- working in the same type of environment, it's encouraging because it kind of validates that there's a big need. But what we get excited about is that we're really the only technology out there that can deliver the clinical grade ECG that is the gold standard in the hospital, but put it in the patient's hands. And so yes, I think there's going to be lots of opportunities for things like that. And we've already started to see different companies and potential partnerships where they may have used a consumer-grade product in the past, but it's really never met the expectations of what they've needed clinically and having this 12-lead synthesized ECG is really a game changer. And I think we're going to continue to see a lot of interest as we move forward.

The next question is from Leo Carpio with Joseph Gunnar.

Just a couple of quick wrap-up questions. Regarding the Mount Sinai relationship that you announced, can you give us a little background in terms of how that came about, who approached who? And what was the selling point in terms of pivoting to form this alliance? And then the follow-up question being, are you looking at other similar type alliances with other major cardio hospitals and [ PC ] hospitals across the U.S.

Sure. Great question. We've known the Mount Sinai folks for a while. The original connection is from one of our great Board members, Ken Nelson, who is close to the physicians there and is kind of a leader in this field. And there's a number of key physicians. One of them, Josh Lambert, actually presented on our AI algorithms at a few conference. And so it has been an adviser to us. Vivek Reddy has been on our Medical Advisory Board. So it's a relationship we've had for a while and really have great mutual respect, I believe. And then what we we're able to do is realize things were aligned enough that we wanted to get a deeper type of relationship. And what I see at a high level, as I laid out, we obviously have great expertise in AI algorithms, and they do as well. They really see us as really the only way to get these algorithms that are based on 12 leads out to patients at homes. They're very excited about that. And for us, a group like them have this tremendous -- in addition to their capabilities, they have a tremendous amount of 12-lead ECG data that's annotated, tied to the diseases and the outcomes. So it becomes a perfect combination. On your second question, we really believe this partnership is a great one, but we're always looking for like-minded partners. We definitely get approached a lot. And if there's a like-minded partner that we think we can really find a way to advance this whole area with, that's one of the beauties of something where we believe that we're creating a new market. There's lots of opportunities for collaboration. So definitely open to that if there are other things that seem like they meet the right criteria.

Okay. And then just a clarification question. You said that for new indications that you are pursuing, you're probably able to go through the 510(k) process. Is that correct?

So I said for the patch, our read is that it's likely a 510(k) because our 12-lead system is a 510(k) and patches are 510(k)s. We haven't determined or really haven't gotten a regulatory read for the pathway for heart attack detection. It could be a 510(k), it could be a de novo. There's uncertainty there and part of our discussions with FDA will be to really fine-tune that. As we learn more, we'll certainly keep everybody informed with that as well as the timing of the clinical trials and the overall expectation for clearance.

At this time, I would like to turn the floor over to the team at HeartBeam to address any questions submitted through the webcast.

We have a number of great webcast questions. Unfortunately, we have time to take only a couple. So the first question is, will you need a sales team to market the device? Or will that be done from within the group?

Bryan, do you want to take that one quickly?

Yes, absolutely. So initially, as I mentioned, we're focusing on a very strategic set of accounts. I think initially, the reason that we are doing that is because we have the ability to focus with a lean team and execute very well on it. As we continue to scale, we will look at a few major areas for sales operations, implementation. Implementation is going to be critical to our overall success in growth and adoption. I anticipate that in the near term and sometime in '26, we'll probably expand the team out to 3 to 5 additional folks on the commercial team that are a mixture of sales and implementation. I think, again, what plays very well for us is that many of these target accounts that we're focused on are located in the same geographies. So it really puts us in a good position to be lean, be focused and scale very efficiently.

Next question asks, what is the excitement level among cardiologists who have been able to use or be educated on the HeartBeam system?

Bryan, do you want to take that as well? Talk about your recent experience.

Yes, absolutely. I touched upon it a little bit before, but again, I've had experience in the space for quite some time. And coming to HeartBeam, my expectations were really based off of my experience in the past with other one single lead or 3 or 6 lead ECG systems. Personally seeing the 12-lead synthesized results is incredible. And each physician, I just was at a meeting yesterday with a physician down in Florida and being able to demo the HeartBeam system and immediately see the 12-lead that was taken in a 30-second time period, which traditionally has to be done in an office with the machine. The reaction is almost universal across the board is, number one, the quality of these trade teams are phenomenal. The accuracy and the clarity of the P waves, which is extremely important to these clinicians is phenomenal. And again, this is really a game changer for the cardiologists for them to be able to see not just a sliver of the information that they're looking for with ECGs from prior technologies, but seeing the entire picture of the heart is really exciting. So the excitement is palpable, and we're -- each day that goes by that we get a chance to get in front of surgeons or physicians and them communicating with their patients, it's truly unbelievable.

And that concludes our webcast Q&A. Operator?

Thank you. I would now like to turn the call back over to Mr. Eno for closing remarks.

Thank you, operator. I'd like to thank everyone for joining the earnings call today. We look forward to continuing to update you on our ongoing progress and growth. And I know we couldn't get to all the questions, but if we are unable to answer yours, please reach out to MZ Group, our IR firm, and they'll be more than happy to assist. Thanks again.

The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect your lines.