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Date

Thursday, Nov. 13, 2025 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Rob Eno
  • Chief Financial Officer — Tim Cruickshank
  • Operator — [Operator Name not provided; included due to procedural statements]

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Risks

  • Cash position — Tim Cruickshank stated, "Cash and cash equivalents at September 30 were $1.9 million," highlighting the company's tight liquidity and ongoing need for strategic funding.
  • Near-term funding requirement — Cruickshank noted, "with the tight balance sheet, we're monitoring things closely," and plans for additional funding remain unspecified, underscoring potential risk if near-term milestones are delayed.

Takeaways

  • FDA 510(k) submission and anticipated clearance -- The company is in the "final steps with the FDA" for software that synthesizes a 12-lead ECG, expecting a decision before year-end.
  • Clinical validation -- The VALID ECG pivotal study showed a 93.4% overall diagnostic agreement between HeartBeam (BEAT 5.99%)'s synthesized 12-lead ECG and a standard 12-lead ECG for arrhythmia assessment.
  • Net loss -- Net loss was $5.3 million, or $0.15 per basic and diluted share, consistent with the prior quarter.
  • Net cash used in operating activities -- Net cash outflow was under $3.2 million, representing an 8% decrease quarter over quarter, following a 23% reduction in the previous period.
  • Patent portfolio -- HeartBeam holds 24 issued patents worldwide, with three newly issued during the quarter.
  • Intellectual property recognition -- HeartBeam ranked number two globally for 12-lead ECG innovation among 243 companies analyzed, according to PatentVest.
  • Commercialization strategy -- The initial market entry targets prominent concierge and preventive cardiology practices in Southern California and South Florida, with roughly 75,000 patients in the initial target regions.
  • Partnerships -- An agreement with HeartNexus enables 24/7 on-demand, board-certified cardiologist ECG interpretation across the US for HeartBeam users.
  • Subscription model -- Management described a planned one-year subscription model that includes the device and access to a set number of cardiology reads, with unlimited routine recordings for users, and credits allocated for symptomatic events.
  • Manufacturing readiness -- All device components are off-the-shelf, and current manufacturing capacity is positioned to support the commercial launch without concerns over supply constraints.
  • Clinical evidence expansion -- New data presentations highlighted HeartBeam’s AI capabilities in arrhythmia classification, and the 3D3Lead technology's promise for coronary occlusion detection.
  • Future indications -- Management is pursuing additional FDA indications for heart attack (myocardial infarction) detection, with initial regulatory discussions already underway.

Summary

The call emphasized the anticipated FDA clearance for HeartBeam's 12-lead ECG synthesis software by year-end as a pivotal milestone. Commercialization is planned to start with targeted rollouts in Southern California and South Florida following FDA clearance, using a direct sales and subscription model focused on concierge and preventive cardiology practices. Management highlighted operational discipline with a reduction in quarterly cash burn by 8%, adding context to ongoing funding strategy discussions in light of a $1.9 million cash position. New partnerships, particularly with HeartNexus, expand the service offering to include on-demand cardiologist access for diagnostics. HeartBeam’s leadership continues to prioritize non-dilutive funding and expanding their patent estate, which now totals 24 issued patents, and a number two global innovation rank in 12-lead ECG by PatentVest.

  • CEO Eno stated, "We continue to anticipate the FDA 510(k) clearance for the 12-lead ECG synthesis software for arrhythmia assessment this quarter," underscoring management's confidence in near-term regulatory progress.
  • CFO Cruickshank described ongoing "judiciously timing the key investments we need into the commercial readiness activity," reflecting the company’s approach to maintaining financial flexibility ahead of a critical inflection point.
  • The company highlighted its ecosystem approach, integrating device, cloud software, and AI tools, supported by clinical data presented at national meetings.
  • Management did not provide formal sales guidance, but indicated that initial market penetration and revenue expectations are modest, with meaningful sales acceleration expected in the second half of 2026 and beyond.
  • HeartBeam is exploring additional strategic and distribution partnerships to achieve efficient scaling following initial market validation.

Industry glossary

  • 510(k) clearance: FDA regulatory process for premarket notification to demonstrate a device is substantially equivalent to an existing legally marketed device.
  • 12-lead ECG: An electrocardiogram configuration that records heart electrical activity from 12 perspectives, considered the clinical standard for cardiac diagnostics.
  • Arrhythmia assessment: Evaluation of abnormal heart rhythms using ECG or related cardiac monitoring technology.
  • Concierge practice: A healthcare delivery model where patients pay an annual fee for enhanced, personalized medical care and access.
  • HeartNexus: A US-based provider group of board-certified cardiologists contracted to deliver real-time remote ECG interpretation for HeartBeam.
  • VALID ECG pivotal study: The clinical trial supporting HeartBeam’s FDA application, demonstrating diagnostic accuracy for arrhythmia detection.
  • PatentVest: An intellectual property analytics firm whose methodologies ranked HeartBeam's innovation in the portable 12-lead ECG category.
  • 3D3Lead technology: HeartBeam’s proprietary method for capturing three-dimensional cardiac electrical signals and synthesizing a clinical-grade 12-lead ECG.

Full Conference Call Transcript

Rob Eno: Thank you, operator. The topics we will cover in today's call are listed on the slide. We will start with an overview of the HeartBeam system and the product vision. We will touch on our recently achieved and upcoming milestones and highlight the upcoming commercial launch strategy followed by financial results. And we will end with a Q&A. Before we dive into updates since our last call in August, I wanted to remind everyone about our vision and our initial product, the HeartBeam system. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home, to allow them to feel confident about their heart health.

HeartBeam is developing the first-ever portable cable-free ECG that can synthesize the 12-lead ECG. A unique IP-protected approach captures the heart's signals in three dimensions or non-coplanar directions and synthesizes the signals 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. As a reminder, in December 2024, we received our foundational 510(k) clearance. This was 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 major milestone validated our unique approach. In January, we submitted our second FDA 510(k) application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for arrhythmia assessment. We are engaging in the final steps with the FDA related to our 510(k) submission and continue to anticipate clearance by the end of the year. This clearance will be a major inflection point for HeartBeam, as these two clearances together will form the product with which we will start our initial commercialization.

We believe that the HeartBeam system can be part of one of the most important trends in medicine today, the movement of clinical-grade devices from the hospital and clinic to becoming a part of daily life at home. Connected clinical-grade technologies are changing the healthcare landscape by expanding access, reducing healthcare costs, and enabling personalized medicine. From continuous glucose monitors to home blood pressure cuffs, these technologies empower patients and provide physicians with insights that lead to identifying conditions earlier and monitoring trends over time. Heart disease is the leading cause of death worldwide, and most cardiac events, whether arrhythmias or ischemia, happen outside of the medical setting.

Diagnosing these events is crucial, and ECGs are the most common cardiac test. Yet most at-home have been limited to downgraded versions, unable to provide a clinical-grade 12-lead output. HeartBeam's credit card-sized system will change that by delivering a synthesized 12-lead ECG into the patient's hands starting with the arrhythmia assessment application. The ability to get clinical-grade insights when they need it, wherever they are, will enable patients to get more timely care. When a patient has symptoms and uses the HeartBeam system, they first open the smartphone application, which guides the patient through the process of taking a recording.

Once the recording is complete, it's sent to the HeartBeam cloud, where it's processed and immediately sent to a cardiologist for review. Last month, we announced an agreement with HeartNexus, a group of US-based board-certified cardiologists with coverage across The United States. When a patient has arrhythmia symptoms and takes a recording with the HeartBeam system, a HeartNexus cardiologist will send an ECG interpretation back to the patient. This agreement is a key part of the product and one of the final pieces needed for our commercial launch, which is anticipated to be early next year after our FDA clearance for the 12-week synthesis software for arrhythmia assessment which we anticipate receiving before the end of the year.

Next, I'd like to remind you about the larger ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. As I mentioned, at the core of the ecosystem is the HeartBeam system itself, the first and only credit card-sized cable-free device that synthesizes a 12-week ECG. This is complemented by an on-demand US-based board-certified cardiologist available to review ECG readings 24/7. Our market research confirms that this concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. Building around this foundation, we're creating an ecosystem to maximize the benefits of our technology and encourage stronger engagement among patients.

Key components of our ecosystem include automated arrhythmia assessments for use during routine recordings, integration with wearables that trigger patients to take readings when their wearable produces inconclusive results, or if worrisome underlying parameters are detected. Community features with tailored educational content, and AI wellness features such as ECG-based cardiac age insights. We'll also be able to provide long-term trending of the HeartBeam synthesized 12-lead ECGs, allowing the patient's physician to get longitudinal insights, including the trending of specific ECG parameters over time. Creating the sequence 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.

The team has done an exceptional job of achieving the milestones we said we are going to achieve over the past year. The highlights are listed here. Last December, we received our foundational FDA clearance for the HeartBeam system for arrhythmia assessment. In January, we submitted our second FDA 510(k) application for the 12-lead ECG synthesis software for arrhythmia assessment. We successfully met the clinical endpoints in the VALID ECG pivotal study, which is the basis for this 12-lead synthesis submission. The study demonstrated a 93.4% overall diagnostic agreement between the HeartBeam synthesized 12-lead ECG and a standard 12-lead ECG in the assessment of arrhythmia. These results were presented at the Heart Rhythm Society meeting in April.

We also started our early access program or beta testing which has provided us with valuable feedback, allowing us to enhance the onboarding, training, and overall user experience. And finally, as I mentioned, we signed the agreement with HeartNexus to service the cardiology reader service. We have a number of important milestones in the coming weeks and months. We continue to anticipate the FDA 510(k) clearance for the 12-lead ECG synthesis software for arrhythmia assessment this quarter. In 2026, we expect to start enrollment on additional clinical trials on the clinical and cost-effectiveness benefits of HeartBeam. The focus of our clinical studies to date has been a comparison with standard 12-lead ECGs.

These planned post-market studies will be important for adoption and ultimately for payment and reimbursement. We're also preparing for commercialization. We anticipate hiring the Chief Commercial Officer and other key members of the commercial team upon FDA clearance. We also anticipate initial commercial agreements with concierge and preventive cardiology practices. While our focus remains squarely on working with the FDA, toward the 12-week ECG synthesis clearance and preparing for commercial launch, we achieved several milestones that help us toward our longer-term goals. Important data were presented at two recent scientific meetings. First, at the HRX live meeting in September, an abstract was presented on the capabilities of the HeartBeam AI algorithm in classifying arrhythmias.

And earlier this week at the American Heart Scientific Sessions, data were presented on the promise of the HeartBeam 3D3Lead technology for the detection of coronary occlusions. These studies add to the growing body of clinical evidence. They demonstrate the progress and promise of our AI efforts as well as the potential to apply the HeartBeam technology to heart attack detection. IP continues to be at the core of the company's efforts. With three newly issued patents, we now have 24 issued patents worldwide.

In addition, HeartBeam was recognized as a global IP and technology leader in portable cardiac diagnostics in a report from the IP firm PatentVest, with HeartBeam ranking number two worldwide in the 12-lead ECG innovation out of 243 companies analyzed. As we prepare for the initial launch, we've established clear strategic pillars. First, we're creating a new product category. And the overarching focus of our efforts will be establishing the HeartBeam system as the first personal cable-free synthesized 12-lead ECG. We believe that the HeartBeam system is clearly differentiated from other offerings, by combining an easy-to-use device that can produce a 12-lead ECG with an on-demand cardiologist who can provide ECG assessments. Second, we're preparing a controlled market entry.

We anticipate starting with a small number of prominent concierge and preventive cardiology practices, both independent practices and those associated with major healthcare systems. These practices will provide an opportunity to get early, real-world feedback and will serve as reference accounts. Beyond that, our strategy is to focus initially on two US geographic regions to prove the business model followed by expansion of this model into additional regions. We plan to establish a small direct sales and marketing organization in The US with sales reps and implementation specialists focused on a geographic region. We're exploring multiple options that will allow efficient expansion including distribution partners, and chains of concierge practices.

A final key element of this strategy is demonstrating the value of the HeartBeam system to patients and practices, driving retention of our users over time. We'll focus on the patient experience and provider engagement to drive recurring use of the system as part of our strategy of developing a subscription model. And now I'll turn it over to Tim to discuss our financials.

Tim Cruickshank: Great. Thank you, Rob. I'll quickly go through some of the key financial data for the quarter ended September 30, 2025. We continue to be focused on our cash management as we maintain strong financial discipline aligned to achieving milestones. When we look at the quarter, net loss for the period was $5.3 million or $0.15 per basic and diluted share. Consistent with the prior quarter. And also in line with our expectations and analyst consensus. Of that net loss, I'll note a significant portion was related to noncash expenses. Expenses such as stock-based compensation. So the resulting net cash used in operating activities was under $3.2 million.

That's an 8% decrease quarter over quarter, and it builds on the 23% we had from the prior quarter. So we're pleased with our ability to balance competing priorities we have over the recent quarters. By both maintaining a capital-efficient organization and also judiciously timing the key investments we need into the commercial readiness activity. So you're seeing evidence of this as we continue to reduce our cash outflow. And we'll continue to take this approach as we de-risk the business and while we're building the proof points we need prior to accelerating investments into commercial traction and scale. Cash and cash equivalents at September 30 were $1.9 million. Obviously, with the tight balance sheet, we're monitoring things closely.

But we're confident in our approach of strategically funding the company consistent with how we've outlined it in the past. We've got optionality in place both in the vehicles and the sources of funding and we have confidence in our ability to achieve near-term milestones. Including the FDA clearance which we believe will be a major inflection point for the company. We remain committed to minimizing dilution for our shareholders so that they're rewarded for their time and commitment to our company and our vision. Our board, management team, and key insiders are more excited than ever about what lies ahead with commercialization on the near-term horizon.

We believe very strongly in the value we're creating here at HeartBeam, and getting this critical technology into the hands of clinicians and patients is going to be a really rewarding step for us here in the very near future. With that, Rob, I'll turn the call back over to you for a closing summary.

Rob Eno: Thanks so much, Tim. So to summarize, this is an incredibly exciting time for HeartBeam. We continue to engage in positive and productive discussions with the FDA, and our anticipated timeline for the clearance by year-end remains intact. Combined with the foundational FDA clearance received in December 2024, this clearance will mark a pivotal milestone for the company to initiate our commercial launch. We've made significant progress with our commercial readiness plans in anticipation of the FDA clearance. Of note, we announced a partnership with HeartNexus to provide on-demand board-certified cardiologist reviews of synthesized 12-week ECGs for arrhythmia assessment.

These two elements, an ECG that's capable of synthesizing a 12-lead ECG and a cardiologist on call 24/7 able to provide ECG assessments to the patient. They're the core of our system. While our focus is squarely on the interactions with the FDA, and preparing for the commercial launch, we continue to prepare for the company's future. We added to the body of clinical evidence with two recent presentations at scientific meetings, one on AI and the other on heart attack detection. In addition, we added three newly issued patents, bringing the total to 24, and we're pleased to be recognized for our IP, ranking number two worldwide in 12-lead ECG innovation out of 243 companies analyzed.

HeartBeam is at a very exciting inflection point and we'll continue to work with our partners to strategically finance the company in a manner that adds to and creates shareholder value. We believe that HeartBeam's technology is poised to be a fundamental advance in cardiac care. Our team has worked incredibly hard on the development and validation of the technology and we're excited to be nearing the next stage in the company's growth. Introducing the groundbreaking technology of HeartBeam for patients to use at home to allow them to feel confident about their heart health. We thank you all for attending, and now we'd like to open it up to Q&A.

Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're 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. And our first question for today will come from Kyle Bauser with ROTH Capital Partners. Please go ahead.

Kyle Bauser: Hey, Rob and Tim. Thanks for all the updates. Appreciate it. Taking my questions here. Maybe we could start off on the discussions you've had with the FDA. Can you talk a little bit more about sort of what you're working on and responses and factors that you'll want to address ahead of a clearance?

Rob Eno: Yeah. It can't really comment much more than that. You know, I guess what I'd reiterate is that we continue to categorize our interactions with FDA as productive. The normal process of FDA and us answering them. And we're continuing to anticipate the FDA clearance before the end of the year. But you know, from the last clearance in this one, we haven't gone into more details of the characterization of the questions. I'll just leave it there.

Kyle Bauser: No. Fair enough. Good to know the timeline is still on track before year-end. As you gear up for the commercial launch, you sort of talked about it a little bit, Rob. Are you still kind of focused on a couple of territories initially to gather feedback and intel ahead of a broader launch to say, five to 10 territories?

Rob Eno: That's exactly right. Yeah. I think the nuance on that is the very first accounts we believe will be prominent accounts, some really exciting ones that we're talking to. Some of them are independent. Some of them are associated with major healthcare institutions, and in a sense, those can be reference accounts, those can be our pilot accounts. And then beyond that, we start to go deep into the two regions to start. And then exactly as you say, we want to prove the model there to show everything around our sales model that the expected coverage we think. And as we get that, we can expand to a large number of regions. Exactly.

Kyle Bauser: Got it. Got it. And how should we be thinking about pricing regarding sort of symptomatic versus asymptomatic readings? I know you've been able to charge a premium potentially for symptomatic readings. And great to know about the recent partnership with HeartNexus. But just trying to understand how you're thinking through that.

Rob Eno: Now it's a little bit early. Sure. Yeah. Sure. No. Yeah. It is a little bit early, but, you know, what we've identified so far are a few things. We're planning on a subscription offering. The initial thought is that it'll be upfront a one-year subscription, and that one-year subscription gives you the device itself. And access to a certain number of cardiology reads. And so we'll work on the details of that pricing level and how many reads. What we're building into the system, not exactly at the initial launch, but we're building in is the automated assessment algorithmic assessment. So the vision that we're building toward there is that comes in. That requires an FDA clearance.

As that comes in, we'll be one pathway for routine recordings, which for the patient will have an unlimited number of routine recordings because we want them to practice and to build up their data. And then when they're having symptoms, they go down this symptomatic pathway and that's what uses one of their credits and activates the reader service. That's helpful. Got it. And maybe one more. As you prepare for the commercial launch, how are you managing inventory levels and how does your sort of manufacturing capabilities look at this point?

Tim Cruickshank: Great. Tim, do you want to take that one?

Tim Cruickshank: Sure. Yeah. Thank you so much. Yeah. We've got a great partner for manufacturing, US-based contract manufacturer. What's great about the latest round of our device that we have for commercialization is it's all off-the-shelf componentry. Nothing customized. So from a product line or from a build line standpoint, we've got the capabilities built out. So it's all about for us, in the near term, when you talk about launch over the first year plus, the building of devices isn't a concern to us. Line of sight to park no real long lead time parts, obviously dynamic situation, so monitoring that.

But given they're all off-the-shelf components, we've got a number of different areas we can source known areas we can source parts from. So really confident in the manufacturing side, and it's all about determining the demand and building into it. And then the real area of focus is on workflow and really making sure we nail the onboarding piece. So I would say that is more of a focal area of getting it right than the manufacturing side.

Kyle Bauser: Okay. Appreciate that. Well, I'll jump back in queue. Congrats on all the progress here, and thanks for the updates.

Rob Eno: Thanks so much, guys. Thank you, Kyle, for your coverage. Appreciate it. The next question will come from Bill Sutherland with The Benchmark Company. Please go ahead.

Bill Sutherland: Thanks. Hey, Tim and Rob. For the questions. Wanted to just maybe find out a little more color on the two initial market launches that you had planned. Maybe a sense of the avail you know, TAM that you're gonna be, you know, looking at there and you know, just a couple of assumptions help us think about the numbers that we might just begin to think about for next year and maybe the following year?

Tim Cruickshank: Great.

Rob Eno: Tim, would you take that?

Tim Cruickshank: Yeah. Sure. No problem at all. Yeah. So the first two geographies, we've said before, most likely we have that Southern California and South Florida to really strong territories with a lot of great accounts and inbound demand there. The way we sort of look at it is, you know, the territory size, if you think about an average the initial territories for going after 75,000 patients roughly in those that we would be targeting in those regions. You can do a really concentrated rollout in terms of the number of accounts that you really need to talk to start to get some good penetration there.

And we plan on going to, as Rob indicated, individual practices and some of the institutions that have concierge practices associated with them. The nail workflow really makes sure that the patient experience is right. But then within those territories, as we build that out, there are a number of concierge chains that we'll be able to look at to help accelerate adoption and growth. So it's all about getting it right in the first couple of quarters, so keeping expectations modest in terms of you know, what that means for revenue and user perspective. But as we get to the '26 is when we start to see some of the real penetration into those geographies.

And as we head to '27, you know, when those concierge chains likely come on, obviously, we'll be working to accelerate that faster, but I think that those three waves are how we're looking at it.

Bill Sutherland: Okay. And how does the how do you sort of target the marketing? Because it's partly I guess, involving the cardiologist themselves, but then some direct to the patient. I know that this is an out-of-pocket type of expense.

Rob Eno: Sure. Yeah. I'll take that one. The right. With the plan so it's a to start with, it's a obviously, Fertiline is a prescription device. And we're targeting these practices, concierge and preventive cardiology practices. These are practices that have these patients and are comfortable having discussions about items that are patient pay. And so the first stage in our process is talking to those accounts explaining the product, explaining that how it can help their practice. And then we plan to work with the practice to support them in outreach to their patients, so to really be the practice talking to their patients about the technology and potentially adopting it.

We can certainly give the materials and support them through that. So in a sense, working with and through the practices. You know, we think over time, part of the part of the way of thinking about this region by region is there are other ways to move beyond the patients that are already at these concierge practices. We think that can happen through a referral business where patients can refer patients who can either go join the concierge practice or get access to the technology through other clinicians and potentially some direct-to-consumer marketing.

We obviously think we to be as efficient as possible, those first couple approaches of working with the concierge practice an apprentice cardiology practice, and adding referral is probably the most efficient. But that's, you know, part of what we learn as we do the early stages of these commercialization in these couple of regions.

Bill Sutherland: Great. Thanks. And then I'm wondering, you know, you are establishing this as a new category. But when you go into the practices, are they using something at this point that gets at some of the functionality of HeartBeam and that you'll have to you know, take that you know, take their position.

Rob Eno: Yeah. There's it's gonna vary. Some of them don't have anything like this. Some of them may be using the existing one-lead ECGs that are out there from various companies. We don't think there's anything that is commonly used that's that can synthesize the 12-lead but also has the reader service tied to it. So it's a mix. So some might be new and some might have be offering things already or encouraging their patients to use things already.

The feedback has been very positive, you know, in our market research with patients and in market research to practices and in direct conversations with practices that you know, even despite that current landscape, they see incremental value in this offering and are excited about taking advantage of it.

Bill Sutherland: Mhmm. Great. Okay. Thanks for all the updates. Appreciate it, guys.

Tim Cruickshank: Thank you, Bill. Thank you. We will now turn for any webcast questions.

Bill Sutherland: Our first webcast question asks, you ended Q3 with $2 million in cash, what are your plans for additional funding?

Tim Cruickshank: Sure. Happy to take that one.

Rob Eno: Yeah.

Tim Cruickshank: Yeah. I can't share specifics on plans, but I'm happy to add as much color as I can from my prepared remarks. I think I mentioned the optionality we have in place both vehicle and sources of funding. And just reiterating our confidence in our ability to achieve these near-term milestones right ahead of us. So we believe you know, with those at the inflection point, we're gonna see will provide us an opportunity to strategically look at the balance sheet. You know, we're balancing two important priorities. One, heavily we care deeply about minimizing dilution for our existing shareholders. We've got you know? But having a proper balance sheet to capitalize the opportunity ahead of us is obviously important.

And I believe it'll unlock the stock by having a proper capital market profile in place, you know, one that this company deserves based on the opportunity ahead of us. So we are strategically balancing those priorities and believe we're getting close to having the opportunity to make both of them a reality. For the company. But we're gonna stay steadfast on the path to get there.

Bill Sutherland: And one of the webcast questioner asked if there are any contracts that are currently sitting on your front burner.

Rob Eno: Yeah. I characterize that as we've had you know, we're having great discussions with sites that we think could be the early users of the system. And there are some large practices. There are some very prominent practices. And, you know, we'll be so we had really good discussions there and, you know, post FDA clearance and early commercialization, we're looking forward to being able to announce more of those.

Bill Sutherland: And do you have any expectations for the level of sales next year following the commencement of commercialization?

Tim Cruickshank: Yeah. Happy to take that, Rob, if you want.

Bill Sutherland: Please.

Tim Cruickshank: So haven't provided guidance, but again, let me provide as much color as I can in context to help answer it. I think first, HeartBeam's becoming a commercial entity for the first time in 2026. So we're gonna be hyper-focused on user experience, getting things right, for physicians and patients. That means we may need to go slow in the very early days of the first quarter of launch, the first half of the year. But we anticipate, as I was describing to Bill, the second half of the year is where sales and user base begins to increase in a more meaningful way.

Obviously, I mean, based on some of the inbound demand we've gotten we believe we can begin we can get things going faster than that, but just knowing that we are becoming commercial for the first time, we're trying you know, when we model this out, we try to be pragmatic in doing so. We've got new newly issued coverage on the company, and so the active research for reports that are out there do a really good job of capturing how we model things out early days. As we get the data points, we need to expand into additional territories, we're gonna be looking for ways to accelerate growth and have some inbound demand on how that's gonna happen.

Based on the conversations we've had with concierge and preventative cardiology accounts to date, we are we're very excited by what could be meaningful demand.

Bill Sutherland: And once you obtain FDA clearance for arrhythmia detection, what is your plan pathway for pursuing an additional indication for myocardial infarction detection?

Rob Eno: Yeah. It's a great question. We've addressed that previously, but I'll go through it again here. We have announced that we already have started initial discussions with FDA. So, we are planning to pursue that. We believe it's the same product and an expanded indication. We have two proof of concept studies that have been done and presented. Of the similarity between our output and, that of a standard 12-lead in patients with ischemia or heart attacks. We have what we'll do is we'll we want to talk to FDA to understand more about the regulatory path and more about the clinical trial needs.

So the expectation is that we will need to do a clinical study in one way or another that will show the performance of our system in comparison to a 12-lead. In that population. We have ideas of that and looking forward talking more with FDA about, what they're looking for and how to implement in those plans.

Bill Sutherland: And will you work exclusively with HeartNexus, or are you planning to or open to expanding your network to other telecardiology firms?

Rob Eno: Yeah. We first of all, we think HeartNexus is great and excited to partner with them. And the real the strategy is we want this to be something that patients can use if they have symptoms 24/7. And we want to make sure that we don't put the prescribing physician necessarily on the front line if they don't want to be 24/7. We are getting feedback from some accounts that they might want to take on that themselves. So we're working on a version of the product offering to specific accounts in which the account themselves will take on the capability to do the reading. You know, beyond that, we don't have any plans right now to go beyond HeartNexus.

We think their ability to scale with us is there, but have this option if accounts are interested in doing that function of the offering themselves.

Tim Cruickshank: Yeah. I would just add I think what's great about HeartNexus at our stage of launch is they have coverage across The US. So for a company of ours where we're gonna be learning what our usage rates are, they have the ability to go quickly with us early days. And then I think it's just an amazing group over at HeartNexus, and they want they believe in this technology and want what's best. So they're open to exploring all sorts of avenues with us as we really start to scale. So I think both of us are open to expanding, you know, as we really learn what demand looks like.

Rob Eno: And thanks, Jim. That's great context. They really are a great partner.

Bill Sutherland: And regarding your commercial launch, are you looking or considering partnering with other companies as strategic partners to increase production or operational capabilities in any way?

Rob Eno: Yeah. Sorry. Let me just yeah. Absolutely. So I'm just trying to make sure I can answer the question, in the best way. We're definitely looking at all different types of strategic partners. You know, we've talked a lot about that one of the areas we want to focus on is how do we scale most efficiently. And there's a couple of ways we believe we can scale efficiently, and that's with distribution partners or focusing on concierge and preventive cardiology chains. So that from a sales and distribution perspective is one of the key things we're gonna look into as we prove the concept and start to progress.

We are open to and have had ongoing discussions with strategic partners you know, in all kinds of different areas and are certainly open to exploring collaborations. We've talked about collaborations in the past on the AI algorithm side and the data side. And even, potential partners that could be co-development partners for some of the technologies that are in our pipeline.

Operator: Thank you. And that concludes our webcast questions. Thank you. I would like to turn the call back over to Mr. Eno for his closing remarks. Please go ahead.

Rob Eno: Great. Thank you, operator. I wanted to thank each one of you for joining the earnings conference call today. We look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who'd be more than happy to assist. Thank you.

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