Heartbeam, Inc.

Greetings, and welcome to the HeartBeam Third 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, and other information that might be considered for looking. While these four looking statements represent our current judgment on what the future holds, they are subject to risk and uncertainties that could cause actual results to differ materially. We are cautioned not to place undue reliance on these four looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we're not obligating ourselves to revise or publicly release the results of any revision to these four 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 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 Brookshank, Chief Financial Officer. We'll present results of operations for the third quarter ended September 30th of 2025. And at this time, I would like to turn the call over to HeartBeam's Chief Executive Officer, Mr. Rob Eno. Please go ahead.

Thank you, operator. The topics we'll cover in today's call are listed on the slide. We'll start with an overview of the HeartBeam system and the product vision. We'll touch on our recently achieved and upcoming milestones and highlight the upcoming commercial launch strategy, followed by financial results. And we'll 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 a 12-lead ECG. A unique IP-protected approach captures the heart's electrical 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 FDA 510 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 510K application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for arrhythmia assessment. We're engaging in the final steps with the FDA related to our 510K 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'll start our initial commercializations. 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 options have been limited to downgraded versions, unable to provide a clinical grade 12 lead output. Heartbeam's credit card size 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 U.S.-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 heart nexus 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-lead 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 the 12-lead ECG. This is complemented by an on-demand, U.S.-based, board certified cardiologists 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-read ECGs allowing the patient's physician to get longitudinal insights, including the trending of specific ECG parameters over time. 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. The team has done an exceptional job of achieving the milestones we said we're 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 510K 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 heart beam 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 Heart Nexus to serve as the cardiology reader service. We have a number of important milestones in the coming weeks and months. We continue to anticipate the FDA 510 clearance for the 12-week 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-lead 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 Association Scientific Sessions, data were presented on the promise of the HeartBeam 3D 3-lead 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 our initial launch, we've established clear strategic pillars. First, we're creating a new product category, and the overarching focus of reference 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 U.S. 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 the 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.

Great.