Heartbeam, Inc.

Greetings, and welcome to the HeartBeam second quarter 2023 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 is being recorded. This time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Zazdik. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's second quarter 2023 financial results conference call. On today's call, we will be relating some very important updates about our business and our products. Recently, we completed $26.5 million in funding, which will enable us to execute on upcoming... product development, clinical and regulatory milestones and extends our cash runway into late 2024. With this funding, we took the opportunity to adjust our strategic focus to enable timely delivery of our ambulatory vector electrocardiogram or VECG products, our key future value drivers. Our first step is to obtain an 510K FDA clearance for the hard beam AMI-GO VECG device. This application was submitted to the FDA in May, and we will be following this with a second FDA application on the system's ability to synthesize a 12 lead ECG. Given this strategic focus on our AMI-GO system, we withdrew the 510K application for our Amy product, which is a software applied to 12 lead ECG in the emergency department. This will allow us to devote all of our resources and energy to products that are being powered for our 12 lead ECG into the hands of patients and outside of a medical facility. We just announced the publication of our first peer-reviewed paper, a foundational study demonstrating the ability of our VECG platform to detect the presence of coronary artery blockages. The study comparing our 3D VECG approach to conventional standard 12 lead ECG appeared in Jack Advances, a journal of the American College of Cardiology. We also strengthened our board with the appointment of three respected industry executives, Dr. Michael Jaffe, Ken Nelson, and Mark Strom, bringing the number of HeartBeam board members to eight. We also are excited to report that we recently welcomed to our team Debbie Castillo, PhD, as Vice President of Regulatory Affairs. Debbie is an experienced biomedical engineer and brings more than 12 years experience in regulatory affairs and quality assurance for medical devices and diagnostics, both with the FDA and the private sector. Finally, we continued to solidify our intellectual property portfolio in the second quarter with a new patent issued by US Patent Office on automated cardiac detection with the HeartBeam Amigo system. We believe this patent underscores our leadership effort in the ambulatory VECT space. As previously reported, on May 3rd of this year, we closed a secondary offering of $25 million. followed by a registered direct offering of $1.5 million, for a total of $26.5 million. We worked with Public Ventures as our placement agent. They are wholly owned subsidiary of MDB Capital Holdings. MDB and Public Ventures have proven to be tremendous strategic partners for Heartbeat. Public Ventures is a member-driven investor community with the mission of backing visionary public companies that have potential to become market leaders in their technology category. We continue to work with them as we execute on our strategic plan. And in fact, our moment with PatentFest, also an MDB entity, is ongoing example of how we plan to continue to use their services. We believe that we are the leader in the mobile VECG space, and as we build on our global interactive property portfolio, our work with Patentvest is a tangible example of our commitment. Patentvest is a unified technology development and patent law firm focused on creating IP leadership for development state technology companies like HeartBeam, and we expect They will support our goal of creating clear leadership in the area of ambulatory BCG cardiac detection. I would like now to turn the call over to our President, Rob Eno, to further discuss our strategic focus and provide product updates. Rob?

Thank you, Branslav, and thanks to everyone joining us today. We mentioned this last quarter, but I wanted to reiterate the key points. We've refined our strategic focus and are concentrating on our AmyGo platform, bringing the performance of a 12-lead ECG into patients' hands. We see this platform, which will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events as an important value creation path. In addition, we'll be undertaking clinical studies in 2023 and beyond to demonstrate the performance of the HeartBeam Amygo platform, which we believe is the most advanced ambulatory cardiac detection platform available. As Bratislav mentioned, the first peer-reviewed study related to our technology was recently published in Jack Advances. This publication highlighted the capabilities of the technology to detect the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12-lead ECG. It also demonstrated the advantages of including a baseline recording for comparison in the analysis. This is something that is integral to the HeartBeam technology, but today when 12-lead ECGs are analyzed, it's not common that a baseline ECG is used for comparison. The significance of this study is in demonstrating the potential to provide patients with an easy-to-use system to record a diagnostic quality ECG signal outside of a medical institution. which could improve heart attack detection, speed up access to care, and save lives. We'll be conducting additional studies focused on our 12-lead synthesis and on the performance of the system as a whole, and we believe these studies will be key to driving clinical and patient adoption. Our commercial launch activities will be for the second version of Heartbeat Mamico after we obtain FDA clearance for the algorithms that synthesize the 12-lead ECG. I'll describe this in more detail in just a minute. And this year, we're undertaking aggressive pre-commercial efforts, defining the initial market segments for HeartBeam AME Go and identifying potential business partners for HeartBeam AME Go and other technologies in our portfolio. And finally, as Breneslav mentioned, we'll continue to address the aggressive development of our intellectual property through our partnership with PatInvest. Turning to our product timelines and updates, we have two planned FDA 510K submissions. The first, which we call version one, is for the hardware. In other words, obtaining clearance as a three-lead ECG collection device. Next, version two builds upon version one and includes the algorithms that take the three-lead VECG signals and synthesize a 12-lead ECG for physician review. In May, we submitted our 510K application for version one. We've also started the process for version two. In June, we submitted a request for a pre-submission meeting to FDA. The pre-sub process is an excellent means to get feedback on key elements of the submission. That pre-sub meeting has been scheduled. It has been scheduled, and we look forward to working closely with FDA on both of these applications. The result of these two submissions, once cleared by FDA, will be a device carried by patients that can synthesize a 12-lead ECG for physician review. We'll focus then on a limited market release, which we estimate in the second half of 2024. With the appointment of Debbie Castillo as Vice President of Regulatory Affairs, we've strengthened our team. Debbie's an experienced biomedical engineer with extensive knowledge of the FDA. In addition to her private sector experience, Debbie held various roles at FDA, including acting branch chief, senior lead reviewer, and lead scientific reviewer. And finally, in an effort to focus on the HeartBeam AmyGo product, we withdrew our 510K application for HeartBeam Amy. HeartBeam Amy is focused on emergency room reuse, which is significantly smaller opportunity than the HeartBeam AmyGo ambulatory ECG market. This decision will allow the company to focus on the product development, clinical, regulatory, and market preparation efforts for HeartBeam AmyGo. I'll now turn the call over to Rick Bronstein, Chief Financial Officer, to discuss operational updates in financial.