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DATE
Wednesday, August 13, 2025 at 4:30 p.m. ET
CALL PARTICIPANTS
Chief Executive Officer — Rob Eno
Chief Financial Officer — Tim Cruickshank
Vice President, Investor Relations — Ian Scargill
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TAKEAWAYS
FDA Milestones-- The initial HeartBeam system received foundational FDA 510(k) clearance in December 2024 for arrhythmia assessment, including device, patient app, physician portal, and signal quality algorithms.
Pending FDA Submission-- The software 510(k) application for synthesized 12-lead ECG remains under review, with management expecting clearance by year-end.
Commercial Launch Timing-- Pilot commercial launch is planned to commence immediately after clearance of the 12-lead synthesis software.
Pilot Geographies-- Initial launch will target concierge practices in Florida and Southern California with outreach to secure letters of intent prior to commercial rollout.
Ecosystem and AI Expansion-- The HeartBeam system will integrate AccuCardia’s automated arrhythmia assessment (pending FDA submission in Q4), wearable-triggered readings, AI features such as ECG-based cardiac age, and community education elements.
Market Focus-- Initial commercialization targets direct-pay patients via concierge and preventive cardiology practices, an estimated 1.5 million patients in the US who use concierge medicine.
Cash Position-- The company reported $5.1 million in cash, cash equivalents, and short-term investments at the end of Q2 2025.
Operating Cash Burn-- Net cash used in operating activities decreased by 23% sequentially from the previous quarter to $3.4 million, with baseline expenditures at $3.1 million, an 11% reduction from the historical baseline of $3.5 million per quarter.
Margin Commentary-- CFO Cruickshank said, "we still have about a 50% margin on those upfront costs. So you've got the device that goes out, you've got onboarding cost. Training, things like that, train the trainer. So we've got about a 50% margin on those upfront costs. It's about a three to five month period of payback in order to, from a cash flow perspective. After the payback period, margins for recurring revenue are projected to exceed 70% based on all the modeling we've done.
Cost Efficiency Initiatives-- Following Q2 2025, board fees and executive salaries were partially paid in shares to further reduce cash burn and extend runway through Q4 2025.
Industry Partnerships-- Management notes a "marked increase in interest from industry partners" as 12-lead synthesis clearance approaches; business development lead recently added to capitalize on partnership opportunities.
Intellectual Property-- HeartBeam now holds 21 patents worldwide following the most recent issuance.
Awards and Recognition-- The company was awarded the Innovation in Remote Cardiac Diagnostics honor from the Medical Device Network Excellence Program and is a finalist for the 2025 Octane High-Tech Awards.
SUMMARY
Management affirms the timeline for FDA clearance of the synthesized 12-lead ECG software remains on track for Q4, and both pilot commercialization and supporting infrastructure are set to activate immediately upon clearance. The core business model is structured around a subscription model, with annual revenue per unit estimated between $500 and $1,000, and recurring margins projected to exceed 70%, based on company modeling. Initial commercialization efforts are focused on high-margin, direct-pay concierge medicine channels in select geographies, with rigorous pricing validation and outreach to practices underway. Recent product, AI, and ecosystem enhancements, along with secured partnerships, suggest the platform will offer multi-faceted value and be adaptable to home-centered digital healthcare trends. Strategic commitment to capital efficiency is evident, as direct actions to curb cash burn—such as share-based compensation and spending discipline—are expected to free capacity for critical launch expenditures while minimizing shareholder dilution.
The FDA VALID e ECG study data supporting the 12-lead synthesis submission met the performance goals set by management and was submitted as part of ongoing discussions.
Early access program feedback has directly informed enhancements to commercial software and product design.
Leadership stated, "our intent is to continue this discipline" regarding minimizing shareholder dilution and maintaining a clean cap table through strategic financing.
Pilot ecosystem features—automated arrhythmia, wearables integration, and on-demand cardiologist reviews—will be available at launch or in phased rollouts as additional FDA clearances are secured.
CFO commentary confirms that results for Q3 and Q4 2025 will reflect further realized cost reductions and extend runway ahead of scaling commercial activities.
INDUSTRY GLOSSARY
510(k) clearance: U.S. FDA process by which a medical device is shown to be substantially equivalent to a legally marketed device.
Arrhythmia: An irregular heartbeat that can indicate heart disease or risk of cardiac arrest.
Synthesized 12-lead ECG: A methodology enabling a compact device to digitally construct a standard 12-lead electrocardiogram by using multiple directional cardiac signal inputs.
Concierge medicine: A membership-based model in which patients pay direct fees for enhanced access and services, often outside traditional insurance reimbursement.
Full Conference Call Transcript
Rob Eno: Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll provide a brief reminder of the HeartBeam system and its status, followed by our product vision. We'll discuss our progress to 2025 milestones, our commercial readiness efforts, followed by financial results, before turning it over to Q&A. Before we dive into updates since our last call in May, I wanted to remind everyone about our initial product, the HeartBeam system, and its regulatory status. HeartBeam is developing 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 three noncoplanar directions: side to side, top to bottom, and into the body.
The system is designed to be easy to carry and easy for patients to use at home or on the go at the time of symptom onset. In December 2024, we received our foundational FDA 510(k) clearance. This is for the system as a whole for arrhythmia assessment. The credit card signal collection device, the patient application, a physician portal, and signal quality algorithms. This was a major milestone as it validated our unique approach. And in January, we submitted our second 510(k) application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for arrhythmia assessment.
This is important because it takes the high-resolution signals collected by the HeartBeam system and synthesizes them into a familiar 12-lead ECG. This application is currently being reviewed by the FDA. We continue to expect clearance for the software by the end of the year. This clearance will be a watershed event for HeartBeam, and these two clearances together will form the product with which we'll start our initial commercialization. Now I'd like to describe the ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. Everything starts with the HeartBeam system, the first and only credit card size cable-free device that synthesizes a 12-lead ECG.
Our extensive market research has demonstrated that the easy-to-use and always-available HeartBeam System Combined With An On-Demand US-based board-certified cardiologist available to review ECG readings 24/7 is a valuable combination. The concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. And around this core, we're creating an ecosystem to unlock the unparalleled performance of our technology. Key components of our ecosystem include automated arrhythmia assessments through our integration with AccuCardia. We want to encourage our users to take readings to practice and to build up their data.
When this functionality is cleared by the FDA, the user will receive an automated arrhythmia assessment immediately after each of these routine recordings. Integration with wearables. Our system will prompt users to take a HeartBeam reading upon specific parameters from a wearable, whether that be an inconclusive reading with a one-lead ECG or potentially worrisome parameters noted by the wearable. In addition, when a patient experiences symptoms and uses the HeartBeam device, we'll be able to present relevant contextual information from the wearable to the physician for richer context. Next, our AI team is developing AI wellness features to enhance the experience.
We'll announce more details on these features, but one we're excited about is ECG-based cardiac age, in which an AI model determines the user's cardiac age. Differences between this and the user's actual age can provide valuable insights. Also, we'll be creating community features with tailored educational content. This has been a top request for potential users and will allow them to connect more deeply with the platform. And finally, our system will allow long-term trending of the HeartBeam synthesized 12-lead ECGs, allowing the patient's physician to get insights, including the trending of specific parameters over time. For example, changes in ECG intervals can provide important information on cardiac health.
Creating this ecosystem will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of HeartBeam. In the future, adding artificial intelligence to our high-resolution signals acquired by patients longitudinally over time can further enrich these insights and provide even greater value. Next, I'd like to take a moment to articulate HeartBeam's vision beyond arrhythmias and how we believe our technology will ultimately align with the significant shift that's occurring within health care. One of the most important trends in medicine today is the movement of medical-grade devices from the hospital and clinic to the patient.
Accurate, connected medical-grade technologies have been shown to expand access, reduce health care costs, and enable personalized medicine. For example, this has been seen in the emergence of continuous glucose monitors, at-home blood pressure monitoring, and portable oxygen monitors. These technologies empower patients. They provide clinicians with richer information and shift the balance toward proactive home-centered care. But within cardiac diseases, there's a major gap and a huge opportunity. Cardiac diseases are the leading cause of death worldwide. And most cardiac events, whether arrhythmias or ischemia, happen outside of the health care setting.
Diagnosing these events is crucial to patients and for the health care system, and we believe as we implement our vision, our technology will be well-positioned to accomplish this. An ECG is the most common cardiac test and it's crucial to monitoring and early detection. But the most common at-home options have been limited to downgraded versions, unable to provide a 12-lead output that's standard in the hospital and clinic. The most common at-home ECGs have just a single lead. Bringing a synthesized 12-lead ECG into the patient's pocket is a transformative step.
Patients and physicians want a 12-lead ECG, not a one-lead or a six-lead, for the peace of mind should they have symptoms, but also to track their cardiac health with best-in-class technology. We believe this is also crucial for the health care system as a whole as care moves to the home. As discussed in our last earnings call, the main focus of the company for the remainder of 2025 is working with the FDA on the review of our 510(k) application and on our commercial readiness efforts as we prepare for commercialization. And we've made significant strides toward both of these goals.
On the regulatory front, we continue to engage in positive and productive discussions with the FDA on the 12-lead synthesis software submission. The FDA review team is familiar with HeartBeam from our initial 510(k) clearance, and we have submitted the results of the valid ECG in which we achieved our performance goals. As we're in active and ongoing discussions, we can't give specific details but we continue to anticipate clearance by the end of the year. As we've discussed, that clearance together with our existing clearance will form the basis of our commercial launch. In addition, we started our interactions with the FDA on expanding our indication to include ischemia, or inadequate blood flow to the heart.
ECGs can detect electrical changes that occur during ischemic events such as heart attacks. We're engaging with the FDA to discuss our rationale and clinical study plans. As discussed previously, in order to optimize time to commercialization, we've signed an agreement with AccuCardia to bring their automated arrhythmia assessment algorithm to the HeartBeam system. When our users take a recording, we'll provide them with an automated arrhythmia assessment powered by AccuCardia. We're currently working with the AccuCardia team to prepare an FDA submission for the application of their algorithm to the HeartBeam system.
I'll go into more detail on our go-to-market and business development efforts in upcoming slides, but I'll quickly highlight that we continue to execute on commercial readiness plans such as finalizing a cardiology reader service and establishing the necessary infrastructure for commercial launch. Additionally, we're seeing a marked increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. On other fronts, an abstract on our AI algorithm was accepted, and will be presented during the HRX live conference in Atlanta in September. We've had an additional patent issued, giving us a total of 21 patents worldwide.
The team has done an exceptional job of achieving the milestones we said we were going to achieve. And we're on track for the remaining milestones in 2025. To reiterate the key points, our discussions with the FDA around the 12-lead synthesis continue to be productive, and we believe the timeline for FDA clearance remains firmly on track for Q4. This clearance will be followed by our pilot commercial launch. The other two major milestones that we're expecting in Q4 are the FDA submission of the tachycardia algorithm applied to the HeartBeam system and the start of enrollment in our MI pilot study that's part of our effort to expand our initial indication.
In the past month, we're pleased to be honored with two additional industry recognitions. In July, we were awarded the Innovation in Remote Cardiac Diagnostics honor through the Medical Device Network Excellence Program. The MDN program analyzes over 1 billion datasets annually to recognize forward-thinking companies that drive positive change and set new standards for excellence across the global medical device sector. Additionally, HeartBeam is a finalist for the 2025 Octane High-Tech Awards which recognizes top innovators, entrepreneurs, and technology leaders with a presence in our County.
These latest awards add to the growing list of industry recognitions and we're honored that the company and its groundbreaking ECG technology is being recognized as it validates the team's hard work and the substantial progress that we've made. On the commercial readiness front, the team continues to build and refine the systems needed for our commercial launch. These efforts include establishing the third-party cardiology reader service, and setting up the customer service infrastructure, contract manufacturing, and logistics and fulfillment efforts. We're also finalizing the commercial software, which has been significantly enhanced by feedback we've received during our beta testing.
On the hardware side, we've completed development of our next-generation hardware, which further enhances the quality of our system and will be the hardware version we launch with. Meanwhile, we're working to finalize our commercial offering and pricing model. We've selected our initial two geographies for pilot commercialization, Florida and Southern California. We've identified our initial target concierge practices in these areas, and we're engaging in discussions with them. The plan is to have signed letters of intent with these practices so that everything is in place to launch commercially after receiving FDA clearance on the 12-lead synthesis software. Our initial commercialization is focused on patients paying directly for the technology.
We plan to reach these patients through concierge and preventive cardiology practices. We estimate there are 1.5 million patients with concierge medicine in the US. And assuming just one-third have elevated cardiac risk, a family history, or are interested in the latest cardiac monitoring technology, that's between $250 and $500 million in annual recurring revenue as an initial segment. Proving the concept and demonstrating market acceptance through our targeted commercial launch will open up multiple avenues for scaling, including building a targeted sales force of our own, rolling out through major concierge and preventive cardiology practices, and leveraging our sales efforts with strategic partners.
We're seeing a marked increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. We obviously can't talk about any ongoing discussions, but there's one common theme. These players understand that HeartBeam's technology is transformative and an ideal platform for platform. There are multiple ways for partners to get involved in the HeartBeam ecosystem, including data and AI, companion products and services, and complementary diagnostics and treatments. To that end, we've added a recognized industry to help drive business development and partnership opportunities. This resource brings a wealth of knowledge and relationships in the space, and also is an existing shareholder of HeartBeam.
The additional capacity will help drive our efforts and keep up with the growing inbound demand. Now I'll turn it over to Tim to walk through the financials.
Tim Cruickshank: Great. Thank you, Rob. Our focus over the past quarter has been on capital efficiency. We're already a lean organization under 20 employees. But as a precommercial company, we're also of course, highly sensitive to cash burn and maximizing our resources. So to that end, we've been undergoing a continuous process of reviewing costs and ensuring they directly align with our company's critical objectives at hand. Those efforts resulted in net cash used in operating activities of $3.4 million for the quarter, a 23% decrease from the previous quarter. Inside that number is a baseline recurring expenditure of $3.1 million which is 11% lower than the historic baseline I've talked about of $3.5 million per quarter.
The additional $300,000 we spent to go from $3.1 to $3.4 was related to investments in commercial readiness activities and manufacturing capabilities in preparation for the pilot launch and all of the activities that Rob walked you through on the previous slide. Additionally, following the end of Q2, the company has continued to take measures to extend our runway by further decreasing cash burn over the course of 2025. One example of those measures is the temporary reduction to board fees and executive-based salaries with an individual taking a portion of compensation as shares in lieu of cash for a short period of time.
Part b we have a dedicated board and management team here that's willing to show their belief in this mission and prepare to put the company in the best position for success. So you can expect to see those impacts, you know, the impact to these reductions to operating cash flows as early as Q3, and we'd expect them to continue through Q4. These savings will give us more flexibility in timing the additional expenses required for our pilot commercial launch and could allow us the opportunity to pull some of those commercial expenditures forward as we as FDA clearance approaches.
So for cash, we finished Q2 2025 with a cash balance of $5.1 million when cash, cash equivalents, short-term investments are added together. With our continued strong financial discipline in place, we're focused on strategic financing the business, as we continue to achieve milestones and derisk the business. We have the continued support of MDB Capital, and we'll be working with them and our other partners to ensure that the business is adequately capitalized. I'll remind you, unlike most precommercial microcap businesses, we've been able to secure financing and keep a clean cap table all the while keeping a heavy focus on minimizing dilution for our shareholders. And our intent is to continue this discipline.
Rob, with that, I'll hand it back over to you.
Rob Eno: Thanks, Tim. In summary, the team remains focused on securing FDA clearance for the 12-lead synthesis software, which remains on track for Q4. This will be the culmination of tremendous efforts from the team and will be followed by commercialization. We continue to make solid progress in multiple commercial readiness areas, advancing the software and hardware for the commercial system and putting the infrastructure in place from customer service to logistics to the cardiology reader. We've signed the agreement with AccuCardia to leverage their arrhythmia assessment algorithm. We have strong interest from concierge and preventive cardiology practices, and we're now engaging in outreach to target practices to further validate our pricing model.
As we're approaching FDA clearance and commercialization, discussions with strategic partners are accelerating as these partners recognize that our platform is the best technology for providing high-quality ECGs. Additionally, we've heightened our capital efficiency efforts and have reduced our cash burn, to minimize dilution to shareholders. I'm more optimistic about the potential for this business than ever before. Once we receive clearance, we have a strong plan in place for launch. And we have extensive feedback from physicians and patients that the system delivers the data that they need, and they see great value in HeartBeam's unprecedented technology. Soon after our launch, with a small and growing community of users, we believe that we'll demonstrate a path toward profitability.
We further believe that with just a small fraction of adoption compared to other popular devices, we'll create a valuable platform, and our share value should reflect this. HeartBeam has developed the only personal cable-free ECG device capable of producing a synthesized 12-lead ECG. There's a clear trend of moving medical-grade technologies to the home and as we implement our vision, HeartBeam will be well-positioned to bring the latest and most sophisticated ECG technology to the patient at home. We thank all of you for attending, and now we'd like to open it up to Q&A. Operator?
Operator: Certainly. 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. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Bill Sutherland with The Benchmark Company. Please go ahead.
Bill Sutherland: Thank you. Good afternoon, Rob and Tim. I apologize, Rob. I missed your opening comments, but I did want to see and if you cover this, we can go offline. But on your commercial strategy, I was just curious about getting a little bit of an update maybe in terms of your progress on the early and perhaps some numbers there?
Rob Eno: Yeah. Bill, great to hear you. Yeah. So we can certainly talk in more detail offline. The early access program that we've had, the beta program, you know, is primarily focused on us learning, the end-to-end system, training patients and practices and it's going well. We're making a lot of progress. We have as I mentioned, actually made some iterations to further enhance the software based on the feedback that we've got. So that's going well. And the other part that I mentioned is we've identified for our commercial launch, our pilot commercial launch, we've identified the two geographic areas. That'll be the focus.
That's Southern California and Florida, and we're starting to do outreach to the key practices in those areas to do things like further validate the pricing and the business model as we make progress within that area. So hope that answers your question, Bill. We can talk more offline if you want.
Bill Sutherland: No. No. No. That's great. And then you are in the search for a chief commercial officer. Has that been updated?
Rob Eno: Yes. Great question. We do have a candidate actually lined up, and we're just really trying to figure out, you know, as a company with that candidate when the right time is start kinda balancing, you know, the real focus on cash burn and dilution together with when we wanna start things. We've got an internal team and some consultants that we've been able to make great progress in finalizing the commercial offering and outreach to initial sites. And so we still plan to bring on that person. We're just kind of waiting to finalize the timing a little closer to the actual launch.
Bill Sutherland: Yeah. It makes sense. And I'm just I have to ask the OBBB Act question. Any ripples in terms of your plans in prior you know, you know, where you're pointing the ship.
Rob Eno: No. So, Tim, feel free to add on my perspective, no change to our plans from anything related to government policy now from tariffs, from the bill, from anything else. We're obviously monitoring the statements coming out that are very positive in terms of the desire to push for wearable and other technology with patients. We see that as obviously, incredibly positive for this industry as a whole. But I haven't seen anything from my perspective that we see as a negative coming out of any policy measures.
Bill Sutherland: Excellent. And then last one, curious, you've spoken about potential strategic partners beginning to contact you. Just give us a sense of a couple of the more likely types of strategic partners that would where you'd fit in.
Rob Eno: Yeah. You try to obviously, can't give details on that. You know, one of the areas that is of interest is ways in which we can expand our and scale more quickly, whether that is from places where patients are aggregated, whether that's chains of practices, and also companies that call on the same call point. So there has been interest in those kinds of things. And from our perspective, there's interest in anything that can help us as we start as we've described, we'll start with our core team in doing the pilot commercialization and those are ways in which we can expand. But there's also the kind of categories I talked about.
There's interest in companies that have ties into our platform in terms of data and AI. There's also ties into, you know, what I call companion products and services and even complementary, you know, diagnostics and treatment. So don't wanna go too deep into that, but there's a range of things that either help us to scale or help to even make more real and kind of deeper this ecosystem that I described earlier.
Bill Sutherland: Mhmm. Great. Well, good work this quarter. Appreciate the effort. Thank you.
Rob Eno: Appreciate it. Thanks so much. Thank you.
Operator: As we have no further audio questions, I would now like to hand the call over to Ian Scargill for any web questions.
Ian Scargill: Thank you, operator. Our first webcast question will be surrounding, can you provide more details on the productive discussions that you've had with the FDA? And secondarily, can you state what specific timeline there is for the clearance?
Rob Eno: I'll take that. You know, I guess I'd just say because there are ongoing discussions with FDA, I can't provide more detail than what I presented. You know, I'll just reiterate they're positive and productive discussions. The FDA team is familiar with our technology because it's the same team that was involved in our initial 510(k) clearance. And one of the key parts of this submission, as we talked about in previous calls, is the VALID e ECG study. That's what compared the output of our 12-lead synthesis software to a simultaneously gathered standard 12-lead in patients in arrhythmia clinics. That one met the performance goals we had set out, and that's been submitted.
So can't give any more details than I said beyond that characterization. And that we continue to believe we're on track for clearance in Q4.
Tim Cruickshank: Perfect. Our next question from the webcast line.
Ian Scargill: What are the plans for future funding, and how will you manage dilution associated with potentially that?
Tim Cruickshank: Sure. I'm happy to take that one, Ralph. Yeah. We remain acutely focused on managing dilution. I think in my comments, I brought that up and it's a major focus area for the company. We're very proud of the fundraisings we've done in the past in keeping our cap table clean and managing dilution through that as well. When you look at our cash, $5.1 million in the bank, we spent $3.4 million last quarter. We're continuing to refine our expenditure and make sure we give ourselves maximum flexibility in terms of what a future the future timing of a raise could look like.
And so that's the name of the game for us is really just creating flexibility, hitting our milestones, executing, and while doing that, we believe we'll come up with a structure to manage dilution effectively. We're more optimistic about the potential for this business than ever before. The inbound interest as well as the early access program and the insights we're getting give us a lot of confidence that following FDA clearance and launch, with a small and growing community, as Rob talked about, of users, we believe we'll be able to then demonstrate a path to profitability and we're heavily focused on that.
Ian Scargill: Thank you, Tim. Our next question is, when will an anticipated unit price for the device and subscription the data cost be determined?
Rob Eno: Yeah. I'll start on that, and, Tim, feel free to add on after this. As I mentioned, you know, in my remarks, we've got some really extensive market research, including talking to high net worth individuals and getting feedback on pricing. And we're now working out with target practices to basically further validate that information. And it's both the pricing level that you asked about, but also the elements of our system. So we know it'll be a subscription model. You know, one of the questions we're working through is, is the device separate? With a subscription, or is it all bundled together? Do we have multiple options? So we're working through things like that.
Few other parameters that we're trying to finalize. So the real matrix of things, our goal is to simplify the offering so there's very straightforward to physicians and patients. You know, we've talked about for a while and it's in the numbers that I gave of, we would expect kinda all in that the annual revenue per unit is somewhere between $50 and $100 per month or $500 and $1,000 per year. We'll be dialing in that a little bit more. So the specific question is, you know, over the next, you know, three months as we're getting closer to the launch, we'll dial in both the price and the business model. In the specific offering in more detail.
Tim, anything?
Tim Cruickshank: Yeah. Really good. That was really well spoken. I think just yeah. So we're honing in on that $500,000 range as we continue to validate. When you look at the cost profile for the business, we still have about a 50% margin early days. So you've got the device that goes out, you've got onboarding cost. Training, things like that, train the trainer. So we've got about a 50% margin on those upfront costs. It's about a three to five month period of payback in order to from a cash flow perspective. To cover those costs? And then you're into 70 plus percent margins for that recurring revenue based on all the modeling we've done.
And so we'll continue to refine that as we speak with accounts and learn more and see this in action. But really, strong, high recurring revenue, high margin business, and that ecosystem Rob walked through earlier on this call is so critical to both reducing churn, but keeping you know, so keeping customers, but also engaging customers over extended periods of time so that we get to see the see those larger margins for longer periods of time and keep customers.
Ian Scargill: Great. Thanks, guys. Our next question from the webcast touches a little bit on the industry. How are you guys viewing other players like iRhythm and the opportunity for market share that HeartBeam can capture with these other established technologies?
Rob Eno: Yeah. I'll take that one. A really interesting question. So I could talk for hours on this, but, you know, the iRhythm is an incredible company with incredible technology. We don't believe that we're competing directly against them. So the iRhythm market is prescribed to patients to wear a patch for, you know, the general is fourteen days, collects, you know, heart all of the beats during that, goes to the physician, and gives a snapshot of what's happening is really valuable in diagnosing arrhythmias. Our device is meant to be with the patient carried with them for a lot longer period of time.
Obviously, not a continuous wearable, but something that people carry with them establish a baseline, do routine recordings, and then have for the peace of mind when they have symptoms. So we think it's in a different place in the market than iRhythm and the various wearable patches. One thing we have talked about earlier is we have IP on taking our unique approach to create a synthesized 12-lead through this three-dimensional approach by we can apply that to patches such as what iRhythm and their competitors have. And that's something that we're certainly thinking about going forward, not as the first product but because we think that is a very interesting market.
So short answer is that, you know, we think that we're complementary to that and in a different use case to iRhythm. So you don't see it as necessarily, you know, competing or stealing share from them. We see that existing alongside in a different part of the ecosystem.
Ian Scargill: Perfect. Thanks, Rob. Our next webcast question talks a little bit about the HeartBeam device. Which seems like an intuitive device to use. Is HeartBeam planning to ensure doctors and hospitals are getting training question answering time, to ensure that, you know, market failures that look place with, you know, perhaps the butterfly device, you know, we have those checks set in place.
Rob Eno: Yeah. It's another great question. Yeah. You know, my long experience in medical devices, you know, this is really one of those where the rubber hits the road. Is the device easy to use? We hope we're designing it to be easy to use, but how are people trained both the patient and the physician? So part of our rollout and part of the reason for doing our early access program to learn and then also why we're doing a controlled pilot commercialization in a couple of geographies is to really make sure we're optimizing it.
Specifically, our plan is to have a, you know, the sense is to have a salesperson within the region as well as a clinical application specialist, and that clinical application specialist is the expert on the product. In the early days, they might actually train the patients, and then they'll move on to train the trainer model, as Tim said. But we want to make sure that our physicians are trained on their element of the portal. We also want to make sure that all the patients are adequately trained, and then our customer service is going to revolve around that. Troubleshooting and answering questions.
And then the last part of our kind of network is signing up this cardiologist reader service. That's the front line for interpreting the ECGs. And there'll obviously be extensive discussions and training of them. It's looking at a 12-lead output that they're used but making sure they're understanding how it works with us. So absolutely understand the importance of training for all folks who are involved with the product and have we'll have the resources in place to make sure that we're training everyone. It is really key to the success of a new technology like this.
Ian Scargill: Great. And our last webcast question of the day, which comes in three parts, We've described this larger ecosystem going to be part of your initial commercial launch. You know, when do what do the pilot program timelines look like, and when would they begin? And lastly, can you guys talk a little bit more about wearable integration to conclude today's call?
Rob Eno: Sure. Let me start, touching on them. So the pilot timeline question. So, again, we've got we've done we have this what we're calling early access program, basically a beta program where we're getting feedback on the product, and that's underway. The plan is upon the second FDA clearance in Q4 to immediately start our commercial launch, which we're calling a pilot commercial launch. So that's why we have the outreach work to initial practices. So we're planning that our commercial pilot program will begin soon after the FDA clearance. As far as the ecosystem, that's something that's developing over time.
So what we have from the market research is the thing that is the greatest value and what our potential users are excited about is the ECG that creates a synthesized 12-lead combined with this on-demand cardiologist to read the ECG 24/7. That's really, as I described, the core offering that we're planning to launch with. We've talked about AccuCardia as a key part of the ecosystem. That is, as I mentioned, is a separate FDA filing, which is going to happen later this year. And our initial commercial launch is not gated to the AccuCardia algorithm. We'll launch either way, and then that functionality, if not available upon the initial launch, would come in soon after that.
Then there's things like wearable integration. And the other things I described. They're on the road map. To be available, you know, in the months or so after the initial rollout once we get the initial product out there. So we're developing those things right now. And I guess I'll just go back to that's one of the things I'm excited about this subscription service from the perspective of our users is they'll be paying a subscription, and then we'll be rolling out additional features as I described that really help enhance the ecosystem that's all part of that subscription.
Ian Scargill: Great. Thanks, Rob. So with this, we formally conclude our webcast Q&A. For any additional questions, please feel free to reach out to the email listed in the slide as shown. I'll now turn the call back over to the operator before some final remarks from Rob. Thank you.
Operator: This concludes our question and answer session. I would like to turn the conference back over to Rob Eno for any closing remarks.
Rob Eno: Thank you, operator. Now I just want to thank everybody for joining today. We look forward to continuing to update you on our ongoing progress and growth. And if we're not able to answer any of questions today, please reach out to MZ Group, our IR firm, and they'll be more than happy to assist you. Thanks again.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.