HeartBeam, Inc. (NASDAQ:BEAT) Q1 2025 Earnings Call Transcript

HeartBeam, Inc. (NASDAQ:BEAT) Q1 2025 Earnings Call Transcript May 13, 2025

HeartBeam, Inc. misses on earnings expectations. Reported EPS is $-0.18 EPS, expectations were $-0.15.

Operator: Greetings and welcome to the HeartBeam First Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference call is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of presentation.

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision of these forward-looking statements in light of new information or future events. Throughout today’s discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company’s website, heartbeam.com. Your host today, Rob Eno, Chief Executive Officer; and Tim Cruickshank, Chief Financial Officer, will present results of operations for the first quarter ended March 31st, 2025.

At this time, I will turn the call over to HeartBeam, Chief Executive Officer, Mr. Rob Eno.

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 progress to 2025 milestones. We’ll then provide more details on the VALID-ECG data and the recently announced collaboration with AccurKardia. Next, we’ll touch on our commercial readiness efforts and our long-term vision, followed by financial results before turning it over to Q&A. Before we dive into updates from the last quarter, I wanted to remind everyone about our initial product, the HeartBeam System. HeartBeam is developing the first-ever personal 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 non-coplanar directions; side-to-side, top-to-bottom, and into the body.

We believe bringing this 12-lead capability directly into the hands of patients is extremely disruptive to how cardiac conditions are currently managed. The system is designed to be easy to carry and easy for patients to use wherever and whenever they have symptoms. We also believe this has the potential to be the highest resolution ambulatory ECG monitor and that adding artificial intelligence to these high-resolution signals acquired by patients longitudinally over time can result in unsurpassed algorithms, providing personalized cardiac insights. In December of last year, 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.

The system outputs three ECG waveforms representing the three non-coplanar directions captured by our technology. 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. This is important because it takes the high-resolution signals collected by the HeartBeam System and synthesizes them into a familiar 12-lead ECG, something that physicians are used to reviewing on a daily basis. This application is currently being reviewed by the FDA. We continue to expect clearance for the software by the end of the year. These two clearances together will form the product with which we’ll start our initial commercialization. We’ve achieved a number of important milestones since our last call.

At the Heart Rhythm Society meeting last month, Dr. Tom Deering from the Piedmont Heart Institute presented the results of our VALID-ECG study. He announced that we met the endpoint for the study, which formed the basis of our FDA submission for the 12-lead synthesis software for arrhythmia assessment. We’ve also made progress on the regulatory front. We’re in positive and productive discussions with the FDA on the 12-lead synthesis software submission. We’re in the substantive review portion of the process, and we continue to anticipate clearance by the end of the year. FDA staff have been very engaged and responsive, and we have not experienced any delays or issues related to the recent events of the FDA. In addition, we started our interactions with the FDA on expanding our indication to include ischemia, which is 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. While we make progress with the FDA on the regulatory side, we’re executing on our plans to become commercial-ready. We’re working to have the processes and systems in place to launch commercially after receiving FDA clearance on the 12-lead synthesis software. The collaboration we recently announced with AccurKardia will add to our commercial efforts, and we’ll describe that collaboration in more detail today. Other recent developments include two new issued U.S. patents, bringing the total to 20 issued patents worldwide. Intellectual property is very important to HeartBeam, and we’ll continue to invest in protecting our unique technology.

Also, I was appointed to the Board of Directors. I’m excited to join the Board and to continue to work closely with our existing Board members as we drive toward commercialization of the HeartBeam System. Another expansion was to the membership of our Scientific Advisory Board, adding Dr. Vivek Reddy from Mount Sinai. Dr. Reddy is a world-leading electrophysiologist and his appointment further enhances this group of preeminent cardiology advisers, both in interventional cardiology and electrophysiology. At our call in November, we laid out this framework, demonstrating the key milestones for the end of 2024 and all of 2025. I’m pleased to say that we continue to make great progress in achieving these milestones. The three milestones in the circle are the ones we achieved since the call two months ago, announcing a strategic collaboration with AccurKardia on the arrhythmia classification algorithm, initiating discussions with the FDA on our ischemia indication and the presentation of the VALID-ECG data.

On the arrhythmia classifications, I mentioned on the last call that we made a decision to prioritize a collaboration for the arrhythmia detection algorithm pivoting from the earlier plan of conducting a clinical study on the algorithm that we developed internally. We anticipate that the collaboration will result in significant savings, both in time and money. I’ll describe the AccurKardia collaboration in more detail in a minute. On the ischemia indication, we have strong proof-of-concept data on our system’s ability to detect ECG changes that are related to heart attacks and other acute coronary changes. We’re excited to be engaging with the FDA to determine the regulatory and clinical plan to expand into this new indication. We continue to anticipate that later this year, we’ll initiate a pilot clinical study on the use of our system in patients with ischemia.

On the VALID-ECG data, the results of the pivotal study were presented last month at the Heart Rhythm Society, and I’ll provide more details on the next slide. Before moving on, I wanted to add that one of the main objectives that Tim and I had when we started in our new positions late last year was communicating and then executing on these important milestones. Since creating this list and showing it at the earnings call in November, the team has done an exceptional job to achieve the milestones we said we’re going to achieve. The main focus for the company for the remainder of 2025 is working with FDA on the review of our 510(k) application and on our commercial readiness efforts. Completing these milestones will put us in a great position for a successful commercial launch.

Next, I’d like to spend a little time providing more details on two of the recent milestones, the VALID-ECG study and the AccurKardia collaboration as well as on our commercial readiness efforts. I wanted to dive deeper into the clinical results of the VALID-ECG pivotal study, which forms the basis of our submission to the FDA on the 12-lead synthesis software for arrhythmia assessment. Dr. Tom Deering from Piedmont Heart Institute in Atlanta and the former President of the Heart Rhythm Society presented the results. The study enrolled 198 patients at five U.S. centers. These patients were in arrhythmia clinics and included patients with sinus rhythm and a variety of arrhythmias. They had simultaneously recorded standard 12-lead ECG and our device.

Our system then synthesized the 12-lead ECG from our signals, and these were compared to the standard 12 -lead ECGs. The heart beam system is designed to be used by patients at home. So, this is a very important study to determine how similar our synthesized 12-lead ECGs are compared to standard 12-lead ECGs for arrhythmia assessment. The study compared the ECG signals quantitatively. You can see an example from one of the patients here and how similar the waveforms are. The study looked at a series of ECG intervals. Those are the time between different points of the signals and amplitude. That’s the height of specific points of the signals. We reported mean differences between the standard 12lead ECGs and our synthesized 12-lead ECGs for several intervals and amplitudes.

For each of these, the differences were less than the margin of error you would normally see when a person measures an ECG. As you can see on the graph, the standard ECG paper is made up of large boxes and small boxes. The differences between the synthesized and standard 12-lead ECGs in the study were tiny, all less than one-fifth of the size of a small box. In addition, physicians reviewed all of the ECGs and classified them as normal sinus rhythm or one of a series of arrhythmias. The physicians looked at the ECGs independently and in a blinded manner. A total of 93.4% of the time, the classification was the same between the standard 12 lead and the HeartBeam 12 lead. This is a high level of agreement, similar to what you would expect when two physicians review the same ECG.

So, in short, the goal of the study was to demonstrate for physicians and for the FDA that synthesized 12-lead ECGs produced from our ECG used by patients closely approximate the signals from a standard 12-lead ECG for arrhythmia assessment. The study met these performance goals. Thank you to Dr. Deering and all the investigators, collaborators and the patients in the study for helping us achieve this very positive result. Next, we’re very excited to have recently announced the strategic collaboration with AccurKardia. Based in New York, AccurKardia is an ECG-led diagnostics software company. They’re developing a suite of ECG algorithms, both classification and detection algorithms. The collaboration is focused on adding to the HeartBeam System.

AccurKardia is FDA-cleared, accurate ECG algorithm, which automatically classifies the rhythm from the ECG signals. The HeartBeam System is designed to have two workflows. When a patient is experiencing symptoms, the ECG will be sent to a cardiologist to review and to provide the interpretation back to the patient. However, we want to encourage our users to take as many readings that they like to practice and to build up their data. Over time, the patient’s prescribing physician can review the ECGs and notice any underlying trends. For this asymptomatic use case, we like our patients to receive an automated assessment of the rhythm. This is where AccurKardia’s accurate ECG comes in. We’ve reported previously that HeartBeam has developed a deep learning-based algorithm to classify arrhythmias.

We determined that the time and the expense required to bring our own solution to market would be prohibitive right now. We’re excited that we can combine AccurKardia’s FDA-cleared solution with the FDA-cleared HeartBeam solution. We’re currently working with AccurKardia to determine the steps to clear this joint solution, and we’ll have more details in the upcoming call. In addition, the agreement with AccurKardia has an economic framework that we’ll be finalizing as we move to the commercial stage. At a high level, there’s no upfront payment, but we will be paying a reasonable per user fee for integrating their algorithm. Finally, while the scope of the collaboration is currently limited to their accurate ECG algorithm, AccurKardia has an exciting pipeline of technology and there’s a potential for expanded collaborations in the future.

The two major efforts for HeartBeam this year are securing the FDA clearance for a 12-lead synthesis software and undertaking the necessary steps to become commercial ready in advance of our commercial launch, which is expected by the end of the year. We’ve started our early access program in which we’re testing the product with concierge accounts and patients. This program is giving us incredibly valuable feedback on all aspects of our offering, including the onboarding workflow and physician and patient training, while generating additional data on real-world use of the HeartBeam System. Other aspects of commercial readiness that are underway include building out the infrastructure to support the end-to-end workflow from the physician’s office to the patient’s home and implementing the customer support function.

We’re also establishing inventory and logistics support and have selected a contract manufacturer, all of which will allow us to scale the business. Meanwhile, we’re developing a comprehensive launch plan, and we’ll share more details as launch approaches. In summary, our preparations for initial commercial launch are progressing well. Before Tim discusses the financials, I wanted to step back and articulate what we see as the value we’re creating here at HeartBeam. Everything starts with our strong IP position. We now have 20 issued patents worldwide. The core of the technology enables us to create the smallest easy-to-use and first cable-free ECG device that synthesizes a 12-lead ECG. We’ve significantly de-risked the business through our foundational FDA clearance and significant clinical data showing similarity to a standard 12-lead ECG for arrhythmia assessment.

Next, the upcoming market introduction holds significant promise. As we described previously, our target market segment of patients who are members of concierge and preventive cardiology practices is a $500 million serviceable market in the U.S. with a high-margin recurring revenue model. Market research indicates that there’s extremely strong demand from our target patients and physicians. We believe the concept is compelling and it’s resonating. The unique combination of a cable-free ECG that produces a 12-lead read by cardiologists. We’re exploring a number of wraparound features and services to add additional value and to drive adoption and stickiness. Beyond our initial indication of arrhythmia, the potential to expand into ischemia and heart attack detection opens up a huge opportunity.

The coronary artery disease market is larger than the atrial fibrillation market with 20 million patients in the U.S. who have had a prior heart attack or who are at elevated risk for one. We intend to demonstrate our system’s ability to reduce the time from the onset of symptoms to the emergency room door. A technology that achieves this will have dramatic clinical and health care economic benefits and the potential for significant payment by the health care system and that ties to our next area. There are a number of ways which we can expand beyond patient pay and have our technology paid for by the health care system. As we discussed in our last call, there are new Category III CPT codes that has a potential to cover our technology. In addition, there are several clinical use cases in which high-risk patients can benefit from having an easy-to-use 12-lead ECG with them at home to drive more proactive and less expensive care.

We intend to engage with Medicare Advantage plans, including the so-called special needs plans or SNPs, who have an incentive to include technologies that improve clinical care and reduce costs. Finally, one of the most exciting elements of our technology is the breadth of opportunities that the core technology can address. Predictive algorithms on 12-lead ECGs can screen for or even predict the likelihood of developing a variety of medical conditions. Applying these algorithms could allow a HeartBeam users to have valuable and proactive information about their heart health. Training algorithms on longitudinal data taken with the HeartBeam system could allow for trending data that has not been possible. HeartBeam has issued patents on additional form factors and on-demand 12-feet patch could be a best-in-class offering in the multibillion dollar extended wear patch market.

Incorporating HeartBeam’s technology into a watch form factor would seamlessly integrate with continuous monitors in a single device. In-all we’re excited about HeartBeam’s IP protection, de-risking, and the immediate market opportunity, but we also see it as an open-ended opportunity with the ability to make a dramatic impact on a large number of patients and change the way that cardiac care is managed. So, now I’ll turn it over to Tim to walk through the financials.

Tim Cruickshank: Thanks Rob. Great updates. Our focus on cash management is directly in line with these updates Rob gave. We’ve got strong financial discipline in place as we continue to de-risk the business and execute on near-term milestones. And we’ll make proper lead-time investments into commercial readiness to be prepared to launch on the back of this upcoming FDA clearance, all the while managing to keep an eye out on the future and opportunities for strategic collaborations for our technology. Our Q1 cash flow is indicative of this approach. We had net cash used in operating activities of $4.5 million for the quarter, but let’s dive into that number. Within that spend, $3.6 million related to the recurring baseline expenditure.

This is predominantly our R&D spend for clinical, regulatory, and product development initiatives in G&A, directly aligned with our stated milestones. In addition to that, to the baseline spend, we invested $400,000 in the quarter into commercial readiness activities and manufacturing capabilities related to launch. Rob took you through a number of those initiatives on the previous slide, which included testing with concierge accounts and patients in the early access program as well as onboarding a contract manufacturer designed for scale. Initial feedback from concierge accounts remains extremely positive and our current anticipated throughput for manufacturing is in the thousands of devices per month with the ability to duplicate and stand up production lines at a reasonable cost.

So, we’re very confident in our investments, that they’re well-timed and that they’ll lead to tremendous gains for the company in time. Main expense of $500,000 was for one-off or annual payments associated with Q1 of each year. And included in that were employee expenses related to a handful of roles to be eliminated during the quarter. I mentioned this just to point out that even with an already lean organization, we continue to make the necessary decisions in the best interest of the company and shareholders to ensure spend is aligned with our primary objectives and our timeline for achieving milestones. Within the deep prioritization of a few long-term initiatives, we were able to reduce our recurring spend slightly. So to give some context, the one specific example would be the ECG study for arrhythmia classifications that Rob took you through.

We were able to construct the alternative plan of licensing an algorithm versus conducting a full-blown clinical trial this year. And in going this other route, we were able to eliminate the cost of the trial and some of the resources previously assigned to this area. As I stated last quarter, baseline for 2025, spend last year was $14.5 million for operating activities in 2024. That’s a good baseline for this year. And on top of that, will be some well-timed expenditure on commercial readiness activities. That spend ranges from $1.5 billion to $3.5 billion million in 2025 depending on a number of factors, including the timing of when we bring those things on. We accomplished a lot with a relatively modest investment this past quarter of $400,000 and will continue to be prudent in timing moving forward.

So, to summarize, we’ve got strong financial discipline in place as we continue to de-risk the business, but also as we look to make timely investments into commercial readiness. Also of note, during the quarter, we completed the $11.5 million common stock public offering with MDB Capital, and we’ll continue to strategically fund the company as we execute on milestones all the while managing dilution. We’re really excited about the progress we’ve made so far this year and the road ahead. We’re confident we’re putting ourselves in a great position for inflection points throughout this year and that we have the partners and pieces in place to strategically capitalize the business as we prepare for commercialization. So, we’re looking forward to updating you more along the way and executing on upcoming milestones.

Rob, back over to you.

Rob Eno: Thanks Tim. So, in summary, we’ve made significant progress in the two months since our last call. On the clinical and regulatory front, the results of the VALID-ECG study were presented and the study successfully met the clinical endpoints for arrhythmia assessment. This study is the basis of the FDA submission on the 12-lead synthesis software. We’re in positive and productive discussions with the FDA on the 12-lead synthesis software submission. We continue to anticipate clearance before the end of the year. We also began engaging with the FDA on expansion of our indication into ischemia, and we expect to start a pilot study later this year. We’re making solid progress with our early access program and in setting up our internal systems and processes.

We also signed a strategic collaboration with AccurKardia, which will provide an important enhancement for our commercial product. The main corporate priorities for 2025 remain unchanged, working with the FDA on our 12 lead synthesis submission and preparing for commercialization. We will continue to report on progress towards these two priorities. As Tim mentioned, we raised $11.5 million earlier this year and are managing spending closely as we approach commercialization. We will continue to strategically fund the company in line with our near-term milestones. I’m impressed with the amazing job our employees are doing and the team’s dedication and success in hitting the milestones we previously described. I look forward to continuing to update you as we make additional progress in the coming quarters.

We thank you all for attending and I would like to open it up to Q&A. Operator?

Q&A Session

Operator: Thank you. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Bill Sutherland with The Benchmark Company. Please go ahead.

Bill Sutherland: Thanks operator. Hey Rob and Tim, congrats on all the progress. I wanted to — Rob, could you give us a little more color on kind of the — what you learned in the early access program currently, I guess, and last quarter, just some of the information that’s helping you understand kind of the commercial opportunity?

Rob Eno: Sure. The first thing is actually getting the device into real patients’ hands. So, we did extensive, what we call the alpha testing, which was employees and investors and friends and family but it’s a whole other level when there’s patients who don’t know who we are and getting them engaged and training and onboarded and in looking at ongoing readings. So, that’s been having to do onboardings in a real-world setting of a clinic, a cardiology clinic or a concierge clinic, and then having the patients be trained well enough to continue on their own has been really helpful. Then also the patients are providing great feedback from their perspective of features they like to add or how it’s going. So, that’s the main thing we’ve learned, I would say, from the efforts so far.

And then in parallel, obviously, there’s a lot of things we’re doing of the supporting systems. So, we have some of the systems in place, building out, as I mentioned, the customer service and customer support. We’ll start to learn from as we spin those up, learn to how those work and the details of those things in practice. So, Bill, hope that helps.

Bill Sutherland: Are you — is it too early to kind of think about how pricing may develop as you go commercial?

Rob Eno: Yes, I think it’s — we’ve done a fair amount of market research, which is good on this, and it’s resonating with what we’ve said before, which is we believe it’s likely somewhere between, call it, $50 to $100 per month on a recurring revenue basis, if you include the device as well as the ongoing service. What we’re also exploring lots of different things in terms of pricing levels. We think we might have tiers where a higher tier gets you things like more cardiologists reads per time period, et cetera. So, we’re going to get a lot more detail as we get closer, but that’s kind of the general direction. Tim, I don’t know if you have anything else you want to add on that.

Tim Cruickshank: No, I think that’s really helpful. The pricing will have optionality in terms of bundled versus upfront, but we’re expecting most of it to be within the range of $50 to $100 that Rob gave from a bundled perspective based on the data we have so far.

Bill Sutherland: Got it. Tim, while you’re on, what — how should we think about the timing of building out the commercial infrastructure as well as you can kind of view it at this point?

Tim Cruickshank: Yes. Great. Rob talks a lot about this. We’ve got two target markets, which we haven’t officially announced, but we’re going to start with two specific markets. They have about 45,000 patients between the two markets. We believe we can cover that with the sales — two sales reps and two, I’ll call them, clinical specialists in terms of onboarding of patients and training the trainers. And so the relatively modest cost of a few hundred thousand dollars between the — each of those geographies to kind of get them onboarded on an annualized basis, covers about 45,000 patients in the early days. What we plan to do is continue to gain learnings from those two markets. And as we get data that tells us to invest, we’ll start to look to additional markets in the U.S. as a second phase.

And then the third part is there’s a high number of concierge practices, the — sorry, Rob, forgot the term, for the concierge practices that are more nationwide. And so the third wave will be going after that portion.

Rob Eno: Change of shared practices, in other words.

Bill Sutherland: So, the first stage could be, Tim — the first stage, the two target markets could be as soon as what quarter?

Tim Cruickshank: On the back side of the FDA clearance, which at this point we have in the second half of the year in Q4, so we begin commercializing at the end of the year with really Q1 of 2026 being when you start to see it really come on.

Bill Sutherland: Okay, great.

Rob Eno: Yes. And Bill, let me just — that’s a great overview. I’ll just add quickly that what we’ve been doing now is a lot of work on pre-commercialization. Our Head of Product, Richa, is amazing and does kind of covers area as well, and we have consultants, et cetera. The first thing we’ll do with the appropriate time, timing it, as Tim said, to the expenditure is bringing on a person to lead the sales effort. And then that person will help us finalize the plan, including the initial sales folks to cover those two regions, which will kick-off once we, as I say, once we get the FDA clearance and finish our commercial readiness is when we start that commercialization in those two initial markets to prove the concept.

Bill Sutherland: Right. Okay. Well, let me jump back in queue and let other people ask questions. Thanks guys.

Rob Eno: Sure.

Operator: Thank you. [Operator Instructions] The next question comes from Leo Carpio with Joseph Gunnar.

Leo Carpio: Good afternoon gentlemen. I have two quick questions. First, have you been able to have any updates and conversation with the FDA in terms of where the process is going for the approval? And have you seen any disruption from the FDA in terms of giving the whole staff attrition they’ve had lately? And then I have a follow-up question.

Rob Eno: Great. I’ll take that. So, first, on the disruption, the good news is we haven’t seen any. We haven’t seen — and just speaking, obviously, from our experience with our group and our team, we really haven’t seen any disruption or any delays related to things that have happened with the FDA. They continue to be very engaged and very responsive to us and hitting all of the deadline. So, that’s great. As far as the other question, all I can say is we continue to be engaged in productive discussions with them. I believe Debbie Castillo runs our regulatory effort. We’ve got great relationships with FDA and really trying to be as collaborative as possible with them. So, we’re in what’s called the substantive review phase.

We’re going back and forth in terms of questions, et cetera. I can’t give any more clarity beyond what we’ve said, which is we believe things are still on track for what we’ve said, which is clearance by the end of the year. We’ll obviously keep you posted as things are going, but we continue to be encouraged by all the interactions.

Leo Carpio: Okay. And then the second follow-up question is regarding your AccurKardia partnership. How does that bolster your competitive position against other potential competitors in terms of technologies and space? And does it make your proposition a bit more palatable toward the end markets that you’re trying to address?

Rob Eno: Yes, it definitely does. Like I mentioned in the — earlier in the call, I think of it in terms of workflow. And I think one of our key elements of our workflow is that when patients have symptoms. So, in patients — we expect the workflow will be patients will decide to use our device. There’s a smartphone application. And the first thing they get asked is, are you having symptoms? Or is this a routine recording? When they’re having symptoms, they will use one of their credits as they go to a cardiology reader service for them to interpret and get back to the patient. But we want to encourage the patients to take readings as often as they like to train and to build up their data. So, having this automated assessment is really important.

Without that, we believe there’s a bit of a hole in the product where either we’d have to have everything go to the reader service or they don’t get a response back. So, we think it’s a key part of the competitive offering to make sure that we can provide for these routine recordings an automated assessment of basic rhythms. And then actually, they get that every time they do it, whether it’s asymptomatic or symptomatic, and then the symptomatic ones also get read by a cardiologist. So, in a sense, it completes or really fills out the product pipeline. And that, when combined with the reader service and the synthesized 12-lead, we think leads to a compelling package. And then as I mentioned, the collaboration is limited to that, but one of the exciting things about working with AccurKardia is they have a really exciting pipeline, including predictive algorithms.

And so getting to know them and working with them, there’s always the possibility the big things we can do to expand the partnership deeper in the future.

Leo Carpio: Perfect. Thank you.

Operator: [Operator Instructions] As we have no audio questions at the moment, I would like to turn the call over to Larry Holub for any web questions.

Larry Holub: Our first webcast question asked, congratulations on the results of the pivotal study. You stated the study was the basis for your FDA submission. So, can you expand on your takeaways from this study and what it means for clearance?

Rob Eno: Sure. Well, thank you, first of all. The goal of the study was to demonstrate that our synthesized 12-lead ECG that’s similar to a standard 12-lead ECG, and we did that, as I mentioned, through simultaneously gathered ECGs. And as I said, the study met the clinical endpoints. And I think the key thing — the reason why this is important is 12-lead ECGs are the standard, generally done in a health care setting with a health care practitioner placing the ECG. And our system is designed to be used by patients outside of a health care facility. So, whenever they’re feeling arrhythmia symptoms, they can take the reading at home instead of having to go in and have it taken by a professional. So, we have the core system cleared and we’re working with FDA on the 12-lead synthesis software clearance.

And this study supports that application because it showed the similarity between the ECGs. So, the point is if we can demonstrate that our synthesized 12 leads are very similar to a standard 12-lead, we think that really bolsters the case for FDA and also for physicians in terms of acceptance of our product.

Larry Holub: Our next and last webcast question asks, what are your manufacturing capabilities? And what is your exposure to tariffs?

Tim Cruickshank: Great. Happy to take that one, Rob. We mentioned on the call, we signed a contract manufacturer this quarter for scaling. And we’re also excited that these questions are becoming more relevant to us as we become commercial ready as we get through this year. So, a bunch of updates on this front. In addition to mentioning the tariffs, I’ll give an update on our manufacturing capabilities. So, our contract manufacturer is going to be manufacturing devices and doing final assembly at the U.S. facility — at their U.S. facilities. It’s a U.S.-based approach for this initial launch, which should help shield us from direct tariff impacts and keep our supply chain relatively stable. Most importantly, it’s going to allow us to be intimately involved in the early manufacturing runs to ensure quality builds.

Right now, U.S.-based components represent the majority of our parts with a portion sourced from Europe, Japan, Taiwan. Less than 1% right now of our parts are sourced from China at present. We’re exploring opportunities to use automated manufacturing in the future as well, which we believe, at a minimum, should serve as a mitigation plan for unforeseen pricing impacts from tariffs and supplier costs as we start to scale. Other areas related to manufacturing we’re actively monitoring, I’d say part shortages and long lead time components. Obviously, a very fluid environment, but our team and our contract manufacturer have a great handle on procurement. There’s two components that we’re aware of right now that we’re strategizing on that we’ll likely make advanced purchases on.

But we’re talking about a cost in the order of around $20,000 for those two parts to stay ahead of the issue. So, it continues to be very manageable at present, but we obviously keep an open eye on this. Our current anticipated throughput is in the thousands of devices per month, which I mentioned earlier, and we have the ability to duplicate and stand up production lines at a reasonable cost. So, as we stand today, we’re in a really good position to ramp up on the manufacturing capability perspective, and we’ll continue to monitor componentry lead times and availability as the time comes.

Larry Holub: That concludes our webcast Q&A.

Operator: Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Rob Eno, Chief Executive Officer, for any closing remarks.

Rob Eno: Thank you, operator. Just like to thank each of you for joining the earnings conference call today. We look forward to continuing to update you on our ongoing progress and growth. And if we weren’t able to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thanks.

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