5/11/2023

speaker
Ranaslav Vadich
Conference Call Host (Introducer)

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 wires this afternoon at 4.01 p.m. Eastern Time and is available in the investor relations section of our company's website, heartsbeam.com. Your host today, Ranaslav Vadich, Chief Executive Officer and Founder, Rob Eno, President, and Rick Brownstein, Chief Financial Officer, will present results of operations for the first quarter ended March 31st, 2023. If you require operator assistance, please press star then zero. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Bratislav Vatic.

speaker
Bratislav Vatic
Chief Executive Officer

Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's first quarter 2023 financial results conference call. On today's call, we will be speaking with you about some very important updates concerning our recent fundraising efforts and adjustments to our strategic focus. Recently, we completed a $25 million secondary offering and a $1.5 million registered direct offering. This $26.5 million will enable us to execute on upcoming product development, clinical and regulatory milestones, and it sets our cash runway into late 2024. With the addition of 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. Going forward, our immediate focus is on obtaining an FDA 510 clearance for the Harbin Amigo credit card size VECG device, followed by a second FDA clearance on the system's ability to synthesize a 12-lead electrocardiogram or ECG. Rob will focus on that topic and discuss in more detail our strategic focus and product timelines in a moment. Recently, we announced the acquisition of substantially all assets from Libmore, a digital health solution company. Libmore's Halo Plus AP detection system is the world's first FDA-cleared prescription variable for continuous cardiac rhythm monitoring. This acquisition extends our reach in remote monitoring and detection with full ownership of an FDA-cleared product. On May 3rd of this year, we closed a secondary offering of $45 million followed by a registered direct offering of $1.5 million for a total of $26.5 million. Working with public ventures, the offering was oversubscribed from the initial $15 million raise. Even at the $25 million level, we did not meet the demand. I believe this speaks to the quality of our company and the public venture community's understanding of our future. So, who is Public Ventures? They are fully owned subsidiary of MDB Capital Holdings. MDB and Public Ventures have proven to be a tremendous strategic partner to Harvey. Public Ventures is a member-driven investor community with a mission of backing visionary public companies that have the potential to become market leaders in their technology category. We are pleased that after extensive due diligence, MDB and Public Ventures strongly supported Hardin and themselves actually invested in our financing. We believe that we are the leader in the mobile VECG space, and we are encouraged that public ventures build their investment thesis around this position. 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.

speaker
Rob Eno
President

Thank you, Branislav, and thanks to everyone joining us today. Expanding on Branislav's mention of our strategic focus, we're now primarily focused on obtaining an initial 510 clearance from FDA for the HeartBeam Amygo VECG device, followed by a second clearance on the system's ability to synthesize a 12-lead ECG. Together, these two HeartBeam Amygo FDA clearances, the hardware, and the system's ability to synthesize a 12-lead ECG will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events. We see this as an important value creation path. In addition, we'll be undertaking clinical trials 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. These initial studies will focus on the 12-lead synthesis and on the performance of the system as a whole. We believe these studies will be key to driving clinical and patient adoption. We also plan to add world-leading key opinion leaders to our medical advisory board. These KOLs will help guide our clinical and regulatory development will be announced in the near future. Our initial commercial launch activities will be for the second version of HeartBeam AmyGo after we obtain the FDA clearance for the 12 lead equivalents. We are not currently emphasizing commercial activities for either the HeartBeam Amy software product or the HeartBeam AmyGo V1 system. This year we will be undertaking an aggressive pre-commercial effort. We'll be defining the initial market segments for the HeartBeam AmyGo system and identifying potential business partners, both for HeartBeam AMI Go and other technologies in our portfolio. And finally, we'll continue aggressive development of our intellectual property through our partnership with PatentVest, a unified technology development and patent law firm focused on creating IP leadership for development stage technology companies. The partnership is focused on the goal of creating clear leadership in the area of ambulatory VECG cardiac detection. Now turning to our product timelines and updates, we expect to file for FDA 510 clearance for version one of the HeartBeam Amigo VECG device in the coming days. This submission is focused on the HeartBeam Amigo hardware as a three lead collection device. Our current estimate is for clearance by the fourth quarter of 2023. Following this first clearance, We're planning a second FDA submission for version two, which includes generation of a synthesized 12-lead ECG from the same device. Once we have both clearances in hand, we'll focus on a limited market release in pursuit of initial commercialization.

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