Heartbeam, Inc.

Greetings and welcome to the HeartBeam 4th 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, today's conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call today and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent form 10-K for a more complete discussion of these factors and other risks, particularly under the heading risk factors. A press release detailing these results crossed the wire this afternoon and is available in the investor relations section of our company's website, heartbeam.com. Your hosts today, Rob Eno, Chief Executive Officer, Tim Cruikshank, Chief Financial Officer, and Brian Humbarger, Chief Commercial Officer, will present results of operations for the fourth quarter ended December 31, 2025. It is now my pleasure to turn the call over to Heartbeam Chief Executive Officer, Mr. Robbino. You may begin, sir.

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

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