HeartBeam (BEAT) Q4 2025 Earnings Call Transcript

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DATE

Thursday, March 12, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Robert P. Eno
• Chief Commercial Officer — Brian Humbarger
• Chief Financial Officer — Timothy Cruickshank
• Founder — Branislav Vajdic

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TAKEAWAYS

• FDA Clearance -- HeartBeam(NASDAQ:BEAT) secured FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment in December, following the foundational 510(k) clearance for the HeartBeam system itself in December 2024.
• Commercial launch initiation -- HeartBeam initiated a limited commercial launch targeting concierge and preventive cardiology practices, with ClearCardio signed as the first commercial customer.
• Product pricing -- Target price per patient is $500 to $1,000 per year, which includes the ECG reader service, according to management.
• Breakeven guidance -- Management stated that cash flow breakeven may be reached at approximately 30,000 enrolled patients in the current pricing and adoption model.
• Market adoption metrics -- Cited market research found 86% of surveyed physicians would shift patch usage toward the HeartBeam 12-lead patch, with a mean shift of 61% of their patch prescriptions.
• Patch market growth potential -- According to management, 64% of physicians would prescribe more patches with HeartBeam's technology, with an average intended increase of 45%, potentially expanding the overall patch market by 30%.
• Clinical study update -- Patient enrollment began for the ALIGN ACS European pilot study, designed to compare the HeartBeam ECG to conventional 12-lead ECG in emergency-room settings for heart attack detection, with completion expected by year-end 2026.
• AI development initiative -- HeartBeam established a strategic collaboration with Mount Sinai to develop and deploy advanced AI-powered electrocardiogram algorithms using HeartBeam’s 3D signal technology.
• Financial results -- Full-year 2025 net loss was $21 million ($0.62 per share), with Q4 net loss at $5.3 million ($0.15 per share), closely aligned with expectations.
• Operating cash outflows -- Net cash used in operating activities totaled less than $14 million for the year, and $2.9 million for Q4, representing a 3% year-over-year decrease, and a 30% decrease from Q4 2024.
• Balance sheet -- Cash, cash equivalents, and restricted cash were $4.4 million as of December 31, 2025.
• 2026 cash outflow guidance -- Management projected gross operating cash outflows of $17 million to $19 million for 2026, factoring in $3 million to $5 million of incremental milestone-tied investments.
• AI team formation -- A leadership appointment was made, with Lance Myers, former head of AI at Google Verily, directing HeartBeam’s AI efforts.
• Prospective clinical study -- A clinical study of the newly developed 12-lead patch is underway, with a working prototype completed and in testing.

SUMMARY

HeartBeam highlighted critical recent progress, including inaugural commercialization following regulatory clearance and successful initial adoption with ClearCardio. Management unveiled the company’s 12-lead ECG patch prototype, supported by survey data indicating a shift in physician prescribing habits and prospects for patch market expansion. The company launched the ALIGN ACS trial to compare its device with traditional 12-lead ECG in detecting acute coronary syndromes in emergency settings, with rapid enrollment anticipated. Exclusive collaboration with Mount Sinai aims to implement AI ECG algorithms on HeartBeam’s device for acute care and wellness applications. R&D and clinical investments will be milestone-based, with cash burn guidance incorporating both steady-state operations and project-specific spending.

• Management described a multi-phase rollout strategy beginning with premium, high-touch concierge cardiology practices, and priced for direct patient pay, deferring the need for insurance reimbursement.
• Brian Humbarger stated, “One relationship with a practice can result in hundreds or even thousands of patients enrolling, 70% adoption within accounts, and a payback period of just three to five months on initial onboarding costs.”
• Brian Humbarger indicated an expectation of “a lack of demand” for the product in the target markets, based on inbound physician and patient interest.
• Capital access was referenced, with cash on hand supplemented by available shelf registration, at-the-market facility, and backing from long-term stakeholders.
• The CEO confirmed the technology’s regulatory pathway for new patch indications is likely 510(k), but heart attack detection may require further FDA guidance.

INDUSTRY GLOSSARY

• 510(k) clearance: U.S. FDA process for demonstrating that a new medical device is substantially equivalent to an existing legally marketed device.
• ALIGN ACS: Pilot clinical study enrolling chest pain patients in Europe to compare HeartBeam’s synthesized 12-lead ECG with standard 12-lead ECG for heart attack detection.
• MCT (Mobile Cardiac Telemetry): Segment of wearable ECG monitoring for continuous remote cardiac rhythm assessment, typically employing 1-3 leads.
• Holter monitor: Extended-wear, multi-lead ECG device traditionally used for continuous cardiac rhythm tracking, but limited in form factor and patient comfort.

Full Conference Call Transcript

Robert P. Eno: Thank you, operator. The topics we will cover on today's call are listed on the slide. We will start with an overview of the HeartBeam, Inc. system, the core technology in our platform. Brian Humbarger, our new Chief Commercial Officer, will provide an overview of our limited commercial launch. We will then provide updates on heart attack detection. We will unveil the working prototype of our 12-lead patch and provide the latest on our AI initiatives, followed by the financial results. We will 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, Inc. website.

Before we dive into updates since our last call in November, I want to remind everyone about our initial product, the HeartBeam, Inc. system and our platform technology. HeartBeam, Inc. is dedicated to developing groundbreaking ECG technology for patients to use at home to allow them to feel confident about their heart health. HeartBeam, Inc. 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 three 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, Inc.'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, Inc. system itself in December 2024, validates the unique approach of our technology and provides the basis for a limited, or 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 were able to get the NSE overturned in two and a half 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, Inc.'s technology is a true platform. The core of this system is our signal collection technology, which captures the heart's electrical signals in three 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 two FDA clearances on the HeartBeam, Inc. system—the credit-card-size form factor—and we are 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 are unveiling the details of our 12-lead patch for the first time today.

The technology in these two form factors has the potential to enable a full range of 12-lead ECG capabilities, including the currently cleared arrhythmia assessment and future indications—heart attack detection and personalized AI algorithms. We will discuss our progress toward heart attack detection and personalized AI algorithms today. We want to provide updates on our progress on all four of our major initiatives. First, Brian will give an overview of our limited commercial launch. Then I will provide updates on heart attack detection. We will unveil our 12-lead patch, and I will provide the latest on our AI efforts. I will now turn the call over to Brian Humbarger, who joined HeartBeam, Inc. in January as our Chief Commercial Officer.

Brian has over 25 years’ experience commercializing novel medical technologies, including leading the commercial efforts at HeartFlow, AliveCor, and Echo. I am thrilled to have Brian lead our commercial efforts. Brian?

Brian Humbarger: Thank you for the introduction, Rob. I am truly honored to be joining the HeartBeam, Inc. team at such a pivotal moment for the company. In my first few weeks, I have 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 am seeing excitement that is leading to HeartBeam, Inc. building a robust pipeline of accounts that are getting in line to deploy our technology. Today, more than 1,500,000 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, Inc. system, which combines 12-lead capabilities with access to cardiology expertise. And importantly, physicians and concierge practices are highly likely to recommend HeartBeam, Inc. 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 1,500,000 concierge patients. These practices typically serve between 400 to 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, Inc. 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 do not 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, Inc., we will be validating a premium value proposition and refining our systems and processes in 2026. 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, 70% adoption within accounts, and a payback period of just three to five 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, Inc. into their care models. We are thrilled to have our first commercial customer, ClearCardio, who 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, Inc.’s at-home 12-lead 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 deep 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 will hand it back to Rob. Thanks so much, Brian.

Robert P. Eno: With the 12-lead synthesis software clearance, we are embarking on the product launch. But our opportunity is much greater than that. As I mentioned earlier, we have core technology that powers two form factors—the card and the patch—and enables multiple 12-lead applications. So next, I would like to discuss our efforts on heart attack detection. As we discussed previously, one of the major problems in cardiology is that there is no good way for patients who experience chest pain to know if they are having a heart attack. Patients wait an average of three to four 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, Inc.’s technology has the potential to address this major need. We have multiple proof-of-concept studies showing that the HeartBeam, Inc. ECG is similar to a standard 12-lead ECG in detecting heart attacks. An important point about this effort is that it is the same HeartBeam, Inc. system that we are 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, Inc. 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 2026. And that study will inform the design of our FDA pivotal study. Our core technology powers two form factors. So far, we have spoken about the HeartBeam, Inc. system with its credit-card-size ECG collection device.

But we have been working behind the scenes on the development of our second form factor, and we are excited to unveil that here today: an on-demand 12-lead patch. We believe that the HeartBeam, Inc. 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 two segments, long-term continuous monitors and mobile cardiac telemetry, or MCT. These devices are one to three leads and are limited to arrhythmia detection and monitoring.

HeartBeam, Inc. 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, Inc.’s patented core technology, a patient simply places two 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 have recently completed a third-party market research survey which clearly demonstrates the potential of the product.

Eighty-six percent 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 do not know if they are experiencing arrhythmias or ischemia. They just know that something does not 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 is a video of the HeartBeam, Inc. 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.

Unknown Executive: Introducing the HeartBeam, Inc. 12-lead ECG patch. The HeartBeam, Inc. extended-wear patch continuously monitors heart rhythms using a single-lead ECG, helping detect arrhythmias as they occur. When symptoms arise or when prompted by the HeartBeam, Inc. app, patients can instantly capture a clinical-grade 12-lead ECG. With a simple touch of the integrated finger electrodes, the system activates a full 12-lead ECG recording. The recording is transmitted in near real time, enabling physicians to review detailed cardiac data and make more informed clinical decisions. HeartBeam, Inc.: Continuous monitoring. On-demand clinical insight wherever patients are.

Robert P. Eno: That is the HeartBeam, Inc. 12-lead patch. I am incredibly proud of our technical team, led by our founder, Branislav Vajdic, who have progressed the development of the device to this stage. We have a prospective clinical study underway on the device, and we look forward to providing more details soon. We will continue to engage with interested parties in the possibility of partnering to bring the 12-lead patch to market, and we are excited for these conversations to advance now that we have 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 are developing AI algorithms that can provide deeper insights. Deep learning algorithms are applied to standard 12-lead ECGs 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, Inc. has the potential to take deep learning algorithms to the patient, applying them every time a patient takes a reading with the HeartBeam, Inc. 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, Inc. has 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 in clinically annotated ECG data.

We are very excited about the potential of this collaboration and the benefits to patients of bringing these advanced algorithms to the HeartBeam, Inc. 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 have made a lot of progress in months, and we have plans to advance all four 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 have already achieved significant milestones on each initiative.

For the limited commercial launch, after receiving the clearance of the 12-lead synthesis software in December, we hired Brian 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 have completed development of the working prototype of the 12-lead 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 will not go through every milestone listed on this page, but we expect an exciting year of progress on all fronts.

I will now turn the call over to Timothy Cruickshank for the financial results.

Timothy Cruickshank: Great. Thanks, Rob. I will briefly review some key financial highlights for the quarter and the year ended 12/31/2025. Our results continue to reflect strong financial discipline as we advance key milestones while maintaining a highly capital-efficient operating model. For the full year 2025, net loss was $21,000,000, or $0.62 per basic and diluted share. And for the fourth quarter, net loss was $5,300,000, or $0.15 per share, which was directly in line with expectations. Importantly, a meaningful portion of that net loss relates to non-cash expenses, primarily stock-based compensation.

So as a result, net cash used in operating activities was less than $14,000,000 for the full year, and just $2,900,000 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, 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 $4,400,000 at 12/31/2025.

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 $14,000,000 level. And then we have a cost-effective rollout for our commercial launch as we continue to maintain a 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 $3,000,000 to $5,000,000 to our cost profile.

This is prior to factoring in potential cash receipts from customers and implies gross operating cash outflows of approximately $17,000,000 to $19,000,000 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 de-risked the business. And we now enter 2026 with a commercial product, a strong development pipeline, and a disciplined operating model and cost structure. We look forward to updating you all on our continued progress. With that, I will turn the call back over to Rob in his closing summary.

Robert P. Eno: Thanks, Tim. To summarize, 2025 was a pivotal year for HeartBeam, Inc., 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 are beginning our limited commercial launch. Brian clearly laid out the opportunity and our strategy. We are building a new market, and we want to be smart in how we are rolling out the product. We are focusing on signing practices that see value in the technology and want to drive deep adoption with their patients. We are 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 have made significant strides on heart attack detection, with enrollment underway on ALIGN ACS, the pilot study on the HeartBeam, Inc. 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, Inc. on-demand 12-lead patch. We have been working hard on this second form factor for some time, and now have a fully working system that is 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 are 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, Inc. system. As Tim noted, we have made significant progress by maintaining strong financial discipline. We are excited about the major milestones we have achieved and the opportunities in front of us across multiple fronts. We thank you all for attending. We will now open for questions. Operator?

Operator: Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And today's first question comes from Kyle Bauser with ROTH Capital Partners. Please proceed.

Kyle Bauser: Great. Thanks for taking my questions, and 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 timeline 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, you know, what are the milestones needed to hit and the timelines associated with those?

Robert P. Eno: Sure, Kyle. Yeah. I can talk at a high level. It is obviously still early. So for heart attack detection, as I said, we have started the ALIGN ACS pilot study. That is on the order of about 100 patients, and as you suggested, because it is 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 are waiting for the next step. They then get enrolled.

They will 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 are comparable in terms of the accuracy of detecting a heart attack with the symptoms, history, and the ECG. We are expecting that it will enroll quickly. We are saying by the end of Q3 is our expectation. And we also said that is going to inform the pivotal study. So there will be a pivotal study needed for FDA. We have had early discussions with them. We need to continue to have discussions. And, obviously, this study design and results will inform the pivotal study.

So in general, it is the pilot study followed by the pivotal study and then the regulatory review. We have not finalized what the regulatory path will be. So that will be forthcoming—both the timelines and the official path—as we get further in our discussions with FDA. And we will 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 have not vetted it fully, we expect it will be a 510(k) because we have predicates of our HeartBeam, Inc. system with its 12-lead synthesis as a 510(k) now, and then the patch product are 510(k). So those get combined together.

As far as the go-to-market strategy and the timelines, still to be determined. We have the ability to bring that to market ourselves, but as I have 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 are having those discussions. And based on that, we will have a better sense of how the timelines lay out.

Kyle Bauser: Got it. I appreciate that. And then maybe next for Brian, 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 six months or so?

Brian Humbarger: Yeah. Thanks for the welcome, and great question. So, you know, going back to what we laid out before, we are being very focused and strategic in our entry to the market. So you talk about the 5,000,000 patients today that are paying for some sort of concierge or preventive medical care. Within that, about a million and a half 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 is about 150,000 patients. They are really concentrated in three or four geographies throughout the United States.

The reason we are focusing on those is really because there is a strong willingness to pay by that patient population. It is more of a premium patient population, as well as because of the type of concierge—the cardiology concierge and the executive concierge—there is a very high-touch patient-physician relationship there. And so with that, we are hyper-focused. We really feel that focusing in that area—it is a very target-rich environment. We do not see or feel that there is going to be a lack of demand. As I mentioned before, only, you know, 20% of that population alone could take us to a breakeven point. It is a very large market.

It is going to really inform us on what we need to go to scale and move forward. So, you know, to answer your question, what we are looking at is really focusing on several accounts in the first couple 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 do not think that the timeline is going to be very long for us to be able to execute.

What we really want to do is make sure that we are focusing on the right people, we are driving deep adoption, we are validating, then we can go out and replicate it.

Timothy Cruickshank: And I might just add, that was really great, Brian. I think if you think about what our goals are for this initial rollout, these initial accounts have between 400 to 4,000 patients. It is all about proving—the number one metric we have is proving we can go deep into these accounts efficiently. And so it is less about the number of accounts early days and more about 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 1,500,000 patient population, which has large chains that have, you know, hundreds of thousands of patients within them.

So, you know, 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.

Kyle Bauser: Sure. Yep. No. I appreciate that. And, Tim, maybe just on OpEx, I think you said $17,000,000 to $19,000,000 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 at similar levels each quarter? Is it stepping up slightly? Any color here would be helpful.

Timothy Cruickshank: Yeah. 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 is a slight step up in the first half of the year, but then goes back down to kind of the levels they are at now by the time you get to the second half of the year. We have been really effective at having milestone-based expenditures. So, you know, we are able to keep our kind of baseline $14,000,000, which a big chunk of that is R&D.

The reason our OpEx does not go up tremendously this year is because some of that from last year switched off as we hit milestones, and now we are basically just replacing existing cost with, you know, new focuses on these milestones. So, you know, you think about the $17,000,000 to $19,000,000 overall in cash outflow. It is about $1,500,000 total over the course of the year incremental for R&D initiatives, with most of that—some of that—happening in the first half of the year, you know, slightly more than half on a prorated basis.

Kyle Bauser: Okay. Got it. Excellent. Congrats again on all the updates, and thanks for taking my questions.

Robert P. Eno: Thanks, Kyle. And the next question comes from Bill Sutherland with The Benchmark Company. Please proceed.

Bill Sutherland: Thank you. Afternoon, everybody, and congrats on all the progress. Brian, 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 2027 before you, you know, feel like you have got everything you need to kind of broaden?

Brian Humbarger: Yeah. Thanks, Bill. Good question. Again, I think that we are going to be able to validate very quickly this model. I do not think it is, you know, we have full intentions of kind of expanding into that 1,500,000 patient slice of the pie, if you will, before 2027. Again, the reason we are focusing on these cardiology concierge groups and the executive health groups is it is a very, very target-rich environment. But also, these are practices that are owned by the physicians, and the pathway to contracting—the sales cycle—is not really with bureaucracy, which helps us get to the patients quicker. They have very, very high levels 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 patients in their practice to have this device. Right? So it is not being selective. We are going after that 10% because the profile of that customer is so aligned with what we are doing that when we walk in, they say we want every patient in our practice to have this, not trying to carve out there is just a specific type of patient.

So I think we are going to be able to learn again with a limited number of accounts and a limited amount of time, and then based on that playbook we are putting together, I think we are going to be able to start expanding into these other market opportunities very quickly.

Robert P. Eno: And I would add it is probably—you know, it is hard to predict because it is going to be kind of a gradual transition—whether we are into this larger group, you know, in 2026 or into early 2027. But, you know, Brian is going to continue to build the funnel with lots of interested accounts. And then, as he described, as we show the proof points from the deep adoption, then that should accelerate into this next wave so that it kind of comes in parallel.

Bill Sutherland: And does the pricing include the reader service that you have contracted?

Brian Humbarger: Yes. The pricing that we have laid out, the $500 to $1,000—and there is a range and variables that impact that—but that does include the reading service.

Bill Sutherland: Gotcha. And so really no plan then and no need to think about reimbursement codes for this. Is that true?

Robert P. Eno: Yeah. I can take that one. Sure. You know, I think we have said before—now all three of us on this call, with Brian and I both working together at HeartFlow and Tim at ImpediMed—we have all gone through the reimbursement journey with previous companies. And, you know, it is powerful. It takes some time. One of the things I love about what we are doing is we have got optionality. So we obviously—not to deviate too hard—but on the patch, you know, that is an existing reimbursed market. On the card, what we are excited about, as Brian laid out, is we have significant patient-pay opportunities starting with concierge and going beyond that.

So we do not think we necessarily need to get reimbursement codes right away, but it is 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 are starting to do now will pay off there, whether that is in a value-based care world of ACOs and Medicare Advantage and demonstrating the advantages of having this product, or, you know, into CPT codes.

So that is 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 a whole second wave on top of this.

Timothy Cruickshank: Yeah.

Bill Sutherland: Yeah. Sounds great. Thanks. Thanks to you all. Appreciate it.

Robert P. Eno: Thanks, Bill. And your next question comes from Yi Chen with H.C. Wainwright. Please proceed.

Eduardo (for Yi Chen, H.C. Wainwright): Hi. 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 conducted previous studies looking at infarction more in the context of screening at home. And I am 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.

Robert P. Eno: Yeah. Thanks, Yi. Appreciate it. Really great question. Good to clarify. So the use case for heart attack detection is still at home. We just have this, you know, I think quite interesting study design that is going to allow for quicker enrollment. Basically, the way to think about it is, you know, when a patient would have chest pain at home, it is basically the same decision and the same information as when they show up at the emergency room. You would have our device, we would 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 three factors that would happen in the first 10 minutes before troponins and other imaging tests are done. So that is why we can use that environment and say if we are 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, yeah, we have done two studies, and we have 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 are just trying to show that we are similar to the 12-lead. There are going to be times when the ECG alone is not enough, but we are expecting to be at the same level as accuracy. So it is less about the number. It is more about how close we come to the 12-lead ECG.

If we show that we are similar, the argument is that same information we showed in the emergency room—that is everything the physician in our reader service would have when the patient does this at home. So that is the way that the trial is designed and what we are thinking about—that validating really the home use of it. That makes sense?

Eduardo (for Yi Chen, H.C. Wainwright): Yeah. Yeah. I guess agreement with the 12 leads. And I guess naturally, I get there is some wiggle room. Right? Like, if you are using this in a screening context, you do not need it to be as good. You just need—like, the negative predictive value is really important there. You can forego the soft false positives.

Robert P. Eno: Yeah. So, right, a couple of key points. Right? Obviously, what we will be arguing is, you know, we want to show, and the initial studies have shown, that, you know, within the margin of error, we are 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 would not have that comparator.

So that is one kind of advantage that we have that, you know, we think helps in terms of the accuracy. The other thing is the way we are viewing this in discussions with FDA is very much a rule-in device. What we want to do is attack that three- to four-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 are thinking about it is if the physicians notice in the ECG, the comparative ECG, they will tell the patient, you really need to call 911 and get in.

But if they do not notice a difference, it could be a number of things. So the response—the physicians will drive the response. But they are going to say something along the lines of, you know, you should follow standard of care; if there are significant symptoms or they continue, you should call 911. So the focus really is speeding up the time and getting patients into the system.

Eduardo (for Yi Chen, H.C. Wainwright): Got it. That is really helpful. And then maybe another one on commercial strategy. I guess there are two here. I am 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, you know, more generous profit-sharing models as you expand to maybe less premium concierge services? Just kind of a little color and ideation there.

Robert P. Eno: Yeah. Maybe, Brian, I will start, and you feel free to add in because I know you are five, six weeks in. But it is a great question. What we believe from what Brian laid out is that these practices have aligned incentives. They want to get new technology to their patients. They want to differentiate their practice. They want to drive engagement. But we also think there may be—and this is what Brian is learning now—there may be an economic incentive as well if there is sharing in the economics that makes sense.

So as Brian is talking to practices, you know, we are talking list prices and having certain, you know, ways that we can work with them along those lines. Brian, do not know if you want to give any more detail on that or what your thinking is along those lines.

Brian Humbarger: Yeah. I think you outlined it very well. We are really focused on that portion of, you know, the $500 to $1,000 that we are talking about. This is a subscription model. It is a model that practices are used to, and we are 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, you know, things—like things that you are discussing there. But for right now, we are going after kind of those opportunities that, you know, we can have a very easy engagement with the practices in general.

And, again, I know I have emphasized it many times, but the ones that we are focused on and the ones that are really kind of building our backlog right now, it is strong willingness to pay by the patients or the practice, and the doctors are highly motivated to recommend it to their patients. So that is our starting point, and then we will move from there.

Eduardo (for Yi Chen, H.C. Wainwright): Got it. That is really helpful. And then if we could have a final one—just any thoughts on telehealth providers. It actually seems well aligned with the kind of services and devices you are providing, and they are seeking to differentiate. I think LifeMD just announced a cardiologist telehealth service launch. Kind of curious on your thoughts there, the potential to target that commercial segment.

Robert P. Eno: Yeah. Brian, you can take that one too.

Brian Humbarger: Yeah. So, you know, I think it is a great question, and it just kind of reinforces the fact that we are really on the right areas. You know, I mentioned before, I have 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, Inc. 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 has been nothing like it on the market before.

So when we see other companies that are out there that are doing telehealth cardiology or, you know, working in the same type of environment, it is encouraging because it kind of validates that there is a big need. But what we get excited about is that we are 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, yeah, I think there are going to be lots of opportunities for things like that.

And I, you know, we have already started to see different companies and potential partnerships where they may have used a consumer-grade product in the past, but it has really never met the expectations of what they have needed clinically. And, you know, having this 12-lead synthesized ECG is really a game changer, and I think we are going to continue to see a lot of interest as we move forward.

Eduardo (for Yi Chen, H.C. Wainwright): Great. Thanks so much for taking the questions.

Robert P. Eno: Thanks, Yi. The next question is from Leo Carpio with Joseph Gunnar. Please proceed.

Leo Carpio: Good afternoon, gentlemen. Just a couple of quick wrap-up questions. Regarding the Mount Sinai relationship 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 teaching hospitals across the U.S.?

Robert P. Eno: Sure. Yeah, great question. We have known the Mount Sinai folks for a while. The original connection was from one of our great board members, Ken Nelson, who was close to the physicians there and is kind of a leader in this field. And there are a number of key physicians. One of them, Josh Lampert, actually presented on our AI algorithms at a few conferences and so has been an adviser to us. Vivek Reddy has been on our medical advisory board. So it is a relationship we have had for a while and really have, you know, great mutual respect, I believe.

And then what we were able to do is realize things were aligned enough that we wanted to get a deeper type of relationship. And what I see, you know, 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 are very excited about that. And for us, a group like them has this tremendous—in addition to their capabilities, they have a tremendous amount of 12-lead ECG data that is annotated, tied to the diseases and the outcomes. So it becomes a perfect combination.

On your second question, you know, we really believe this partnership is a great one, but we are always looking for like-minded partners. We definitely get approached a lot. If there is a like-minded partner that we think we can really find a way to advance this whole area with, you know, that is one of the beauties of something where we believe that we are creating a new market. There are lots of opportunities for collaboration. So definitely open to that if there are other things that seem like they meet the right criteria.

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

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

Leo Carpio: Alright. Thank you, and congrats on the quarter.

Robert P. Eno: Thanks so much. At this time, I would like to turn the floor over to the team at HeartBeam, Inc. to address any questions submitted through the webcast.

Robert P. Eno: We have a number of great webcast questions.

Unknown Executive: 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?

Robert P. Eno: Brian, do you want to take that one quickly?

Brian Humbarger: Yeah. Absolutely. So initially, as I mentioned, we are 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 and 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 2026, we will probably expand the team out to three to five 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 are 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.

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

Robert P. Eno: Brian, do you want to take that as well? Talk about your recent experience?

Brian Humbarger: Absolutely. I touched upon it a little bit before, but again, I have had experience in this space for quite some time, and coming to HeartBeam, Inc., you know, my expectations were really, you know, based off of my experience in the past with other single-lead or three- or six-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 RPM 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 a machine, the reaction is almost universal across the board.

Number one, the quality of these tracings is phenomenal. The accuracy and the clarity of the P waves, which is extremely important to these clinicians, is phenomenal. And, again, this is really, really a game changer for the cardiologist. For them to be able to see not just a sliver of the information that they are looking for with ECGs from, you know, prior technologies, but seeing the entire picture of the heart is really exciting. So the excitement is palpable, and we are, you know, each day that goes by that we get a chance to get in front of physicians and them communicating with their patients, it is truly unbelievable.

Unknown Executive: And that concludes our webcast Q&A. Operator,

Robert P. Eno: Thank you. I would now like to turn the call back over to Mr. Eno for closing remarks. Thank you, operator. I would 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 could not get to all the questions, but if we were unable to answer yours, please reach out to MZ Group, our IR firm, and they will be more than happy to assist. Thanks again.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

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