Robert P. Eno
Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll provide a brief reminder of the HeartBeam system and its status, followed by our product vision. We'll discuss our progress to 2025 milestones and our commercial readiness efforts, followed by financial results before turning it over to Q&A. Before we dive into updates since our last call in May, I wanted to remind everyone about our initial product, the HeartBeam system and its regulatory status. HeartBeam is developing the first-ever portable cable-free ECG that can synthesize a 12-lead ECG. Our unique IP-protected approach captures the heart's electrical signals in three dimensions or three non-coplanar directions, side to side, top to bottom and into the body. The system is designed to be easy to carry and easy for patients to use at home or on the go at the time of symptom onset. In December 2024, we received our foundational FDA 510(k) clearance. This is for the system as a whole for arrhythmia assessment, the credit card signal collection device, the patient application, a physician portal and signal quality algorithms. This was a major milestone as it validated our unique approach. And in January, we submitted our second 510(k) application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for arrhythmia assessment. This is important because it takes the high-resolution signals collected by the HeartBeam system and synthesizes them into a familiar 12-lead ECG. This application is currently being reviewed by the FDA. We continue to expect clearance for the software by the end of the year. This clearance will be a watershed event for HeartBeam, and these two clearances together will form the product with which we'll start our initial commercialization. Now I'd like to describe the ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. Everything starts with the HeartBeam system, the first and only credit card sized cable-free device that synthesizes a 12-lead ECG. Our extensive market research has demonstrated that the easy-to-use and always available HeartBeam system, combined with an on-demand U.S.-based board-certified cardiologist available to review ECG readings 24/7 is a valuable combination. The concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. And around this core, we're creating an ecosystem to unlock the unparalleled performance of our technology. Key components of our ecosystem include automated arrhythmia assessments through our integration with AccurKardia. We want to encourage our users to take readings to practice and to build up their data. When this functionality is cleared by the FDA, users will receive an automated arrhythmia assessment immediately after each of these routine recordings. Integration with wearables. Our system will prompt users to take a HeartBeam reading upon specific parameters from a wearable, whether that be an inconclusive reading with a 1-lead ECG or potentially worrisome parameters noted by the wearable. In addition, when a patient experiences symptoms and uses the HeartBeam device, we'll be able to present relevant contextual information from the wearable to the physician for richer context. Next, our AI team is developing AI wellness features to enhance the experience. We'll announce more details on these features, but one we're excited about is ECG-based cardiac age in which an AI model determines the user's cardiac age. Differences between this and the user's actual age can provide valuable insights. Also, we'll be creating community features with tailored educational content. This has been a top request from potential users and will allow them to connect more deeply with the platform. And finally, our system will allow long-term trending of the HeartBeam synthesized 12-lead ECGs, allowing the patient's physician to get insights, including the trending of specific parameters over time. For example, changes in ECG intervals can provide important information on cardiac health. Creating this ecosystem will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of HeartBeam. In the future, adding artificial intelligence to our high-resolution signals acquired by patients longitudinally over time can further enrich these insights and provide even greater value. Next, I'd like to take a moment to articulate HeartBeam's vision beyond arrhythmias and how we believe our technology will ultimately align with the significant shift that's occurring within health care. One of the most important trends in medicine today is the movement of medical-grade devices from the hospital and clinic to the patient. Accurate, connected medical-grade technologies have been shown to expand access, reduce health care costs and enable personalized medicine. For example, this has been seen in the emergence of continuous glucose monitors, at-home blood pressure monitoring and portable oxygen monitors. These technologies empower patients, they provide clinicians with richer information and shift the balance toward proactive home-centered care. But within cardiac diseases, there's a major gap and a huge opportunity. Cardiac diseases are the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia happen outside of the health care setting. Diagnosing these events is crucial to patients and for the health care system. And we believe as we implement our vision, our technology will be well positioned to accomplish this. An ECG is the most common cardiac test, and it's crucial to monitoring and early detection, but the most common at-home options have been limited to downgraded versions, unable to provide a 12-lead output that's standard in the hospital and clinic. The most common at-home ECGs have just a single lead, bringing a synthesized 12-lead ECG into the patient's pocket is a transformative step. Patients and physicians want a 12- lead ECG, not a 1-lead or a 6-lead for the peace of mind should they have symptoms, but also to track their cardiac health with best- in-class technology. We believe this is also crucial for the health care system as a whole as care moves to the home. As discussed in our last earnings call, the main focus of the company for the remainder of 2025 is working with the FDA on the review of our 510(k) application and on our commercial readiness efforts as we prepare for commercialization, and we've made significant strides toward both of these goals. On the regulatory front, we continue to engage in positive and productive discussions with the FDA on the 12-lead synthesis software submission. The FDA review team is familiar with HeartBeam from our initial 510(k) clearance, and we have submitted the results of the VALID- ECG study in which we achieved our performance goals. As we're in active and ongoing discussions, we can't give specific details, but we continue to anticipate clearance by the end of the year. As we've discussed that clearance together with our existing clearance will form the basis of our commercial launch. In addition, we started our interactions with the FDA on expanding our indication to include ischemia or inadequate blood flow to the heart. ECGs can detect electrical changes that occur during ischemic events such as heart attacks. We're engaging with the FDA to discuss our rationale and clinical study plans. As discussed previously; in order to optimize time to commercialization, we've signed an agreement with AccurKardia to bring their automated arrhythmia assessment algorithm to the HeartBeam system. When our users take a recording, we'll provide them with an automated arrhythmia assessment powered by AccurKardia. We're currently working with the AccurKardia team to prepare an FDA submission for the application of their algorithm to the HeartBeam system. I'll go into more detail on our go-to-market and business development efforts in upcoming slides, but I'll quickly highlight that we continue to execute on commercial readiness plans such as finalizing a cardiology reader service and establishing the necessary infrastructure for commercial launch. Additionally, we're seeing a market increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. On other fronts, an abstract on our AI algorithm was accepted and will be presented during the HRX Live Conference in Atlanta in September, and we've had an additional patent issued, giving us a total of 21 patents worldwide. The team has done an exceptional job of achieving the milestones we said we're going to achieve, and we're on track for the remaining milestones in 2025. To reiterate the key points, our discussions with the FDA around the 12-lead synthesis software continue to be productive, and we believe the time line for FDA clearance remains firmly on track for Q4. This clearance will be followed by our pilot commercial launch. The other two major milestones that we're expecting in Q4 are the FDA submission of the AccurKardia algorithm applied to the HeartBeam system and the start of enrollment in our MI pilot study that's part of our effort to expand our initial indication. In the past months, we're pleased to be honored with two additional industry recognitions. In July, we were awarded the Innovation in Remote Cardiac Diagnostics honor through the Medical Device Network Excellence Program. The MDN program analyzes over 1 billion data sets annually to recognize forward-thinking companies that drive positive change and set new standards for excellence across the global medical device sector. Additionally, HeartBeam is a finalist for the 2025 Octane High-Tech Awards, which recognizes top innovators, entrepreneurs and technology leaders with a presence in Orange County. These latest awards add to the growing list of industry recognitions, and we're honored that the company and its groundbreaking ECG technology is being recognized as it validates the team's hard work and the substantial progress that we've made. On the commercial readiness front, the team continues to build and refine the systems needed for our commercial launch. These efforts include establishing the third-party cardiology reader service and setting up the customer service infrastructure, contract manufacturing and logistics and fulfillment efforts. We're also finalizing the commercial software, which has been significantly enhanced by feedback we've received during our beta testing. On the hardware side, we've completed development of our next-generation hardware, which further enhances the quality of our system and will be the hardware version we launch with. Meanwhile, we're working to finalize our commercial offering and pricing model. We've selected our initial two geographies for pilot commercialization, Florida and Southern California. We've identified our initial target concierge practices in these areas, and we're engaging in discussions with them. The plan is to have signed letters of intent with these practices so that everything is in place to launch commercially after receiving FDA clearance on the 12-lead synthesis software. Our initial commercialization is focused on patients paying directly for the technology. We plan to reach these patients through concierge and preventive cardiology practices. We estimate there are 1.5 million patients with concierge medicine in the U.S. And assuming just 1/3 have elevated cardiac risk, a family history or are interested in the latest cardiac monitoring technology, that's between $250 million and $500 million in annual recurring revenue as an initial segment. Proving the concept and demonstrating market acceptance through our targeted commercial launch will open up multiple avenues for scaling, including building a targeted sales force of our own, rolling out through major concierge and preventive cardiology practices and leveraging our sales efforts with strategic partners. We're seeing a marked increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. We obviously can't talk about any ongoing discussions, but there's one common theme. These players understand that HeartBeam's technology is transformative and an ideal platform. There are multiple ways for partners to get involved in the HeartBeam ecosystem, including data and AI, companion products and services and complementary diagnostics and treatments. To that end, we've added a recognized industry expert to help drive business development and partnership opportunities. This resource brings a wealth of knowledge and relationships in the space and also is an existing shareholder of HeartBeam. The additional capacity will help drive our efforts and keep up with the growing inbound demand. Now I'll turn it over to Tim to walk through the financials.