Heartbeam, Inc.

Greetings and welcome to the HeartBeam 3rd Quarter 2024 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. Your caution 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 revision 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 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 hosts today, Rob Eno, Chief Executive Officer, Bronislav Bajdic, President and Finder, Tim Cruikshank, Chief Financial Officer, We'll present results of operations for the third quarter ended September 30, 2024. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Mr. Rob Guino.

Thank you, Operator.

The topics we'll cover in today's call are listed on the slide. I'll provide a brief overview of the company's vision and then quickly get into providing an update on the status of our FDA submission, which is top of mind for everyone. We'll then walk you through our management and company updates, financial results, and upcoming milestones before turning it over to Q&A. Heartbeam has developed core technology that enables a new paradigm in cardiac care. Heartbeam's developed the first-ever cable-free 12-lead ECG that patients can use wherever they are. We do this by using a vector-based approach, capturing the heart's electrical signals from three dimensions, and then synthesizing a 12 lead ECG. This allows users to capture the highest resolution data possible in a patient carried device far greater than with existing wearables. On top of this, applying AI algorithms to this high resolution data opens up a world of possibilities, driving personalized insights. We believe that there are multiple large markets where our technology is applicable and together, These addressable markets are worth more than $100 billion per year in the U.S. alone. HeartBeam is well positioned to disrupt these markets with a strategy that starts with symptom-driven diagnosis, moves to monitoring and screening, and ultimately to replacing traditional 12-lead ECGs in hospitals and beyond as a new standard of care. In an upcoming slide, we'll provide you with an update on our FDA submission We believe this clearance is a foundational clearance for our technology and opens multiple product paths. Over the past few months, we've put significant effort into further refining our go-to-market strategy. Our initial plan is focused on direct patient pay, targeting concierge and preventive cardiology practices. Beyond this, we'll gather evidence of the clinical and cost-effectiveness benefits of our system in specific use cases, which we believe will be the basis for payment by insurers hospitals, and integrated delivery networks. There are three fundamental advances which form the core of our IP and enable our approach. First, we use a vector-based approach. Vector cardiography has been an alternative to 12-lead ECG for decades. It captures the heart's electrical signals from three axes, X, Y, and Z. Ambulatory ECG devices that are available today do not use this vector approach. Next, we're able to capture the three dimensions through a novel and protected way. Two chest electrodes capture the vertical axis, two finger electrodes capture the horizontal dimension, and the key invention is a novel resistive network that captures the Z-axis into the body. And finally, we take the 3D vector signals and synthesize the 12-lead ECG. There are established ways to make this conversion, but they're population-based. In order to create an even more accurate 12-lead ECG, we use a personalized transformation matrix. When the patient's onboarded, we take a single 12-lead ECG and combine this with a heartbeat reading. This creates the patient's personalized transformation matrix, which is saved and used going forward. These three fundamental advances enable the breakthrough application, and we have a total of 17 issued patents worldwide. Now let's get into our update on our FDA submissions. Our 510 case submission continues to progress through active review by the FDA. Since our last update, we've responded to the questions asked by the FDA and are working through clarifications. We continue to be confident in the FDA clearance. The FDA is engaged and fully responsive, and we continue to work interactively with them. While we can't predict timelines or results related to FDA submissions, we remain optimistic that we will achieve our foundational FDA clearance and we will update the market as soon as it's achieved. Over the past quarter, we've evolved our management team as we prepare for commercialization. I'm honored to lead the organization at such a pivotal time. My career over the past 30 years has focused on creating go-to-market strategies for multiple breakthrough products. The Heartbeam technology is truly transformative and will have a huge impact on how cardiac care is managed. I look forward to leveraging my commercial expertise to ensure the company is set up for success. I'm also thrilled to partner with Tim Cruikshank as our new CFO. He brings an incredible wealth of knowledge to growing businesses with disruptive technologies, and I know we'll benefit from that. Additionally, I look forward to working with Lance Myers, who leveraged his prior experience from Google to guide the company in how we apply AI to our core technology. Of course, none of this would have been possible without our founder, Branislav Vajdic. His vision and drive to change how cardiac care is managed is what got the company to this point. And I look forward to my continued partnership with Branislav, who will play an integral role in our success going forward.