HeartBeam sees ‘no meaningful FY23 commercial revenue’ amid strategic focus

HeartBeam has adjusted its strategic focus to enable timely delivery of its breakthrough ambulatory VECG products, the Company’s key future value drivers, as follows: Immediately focus on obtaining an FDA 510(k) clearance for the HeartBeam AIMIGo credit card- sized VECG device, followed by a second 510(k) clearance on the system’s ability to synthesize an electrocardiogram . The goal of this second FDA clearance is to demonstrate that HeartBeam’s synthesized 12-lead ECG is equivalent to standard recorded 12-lead ECGs. These clearances provide a key value creation path, as they will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events. Demonstrate through clinical trials in 2023 the performance of the HeartBeam AIMIGo platform, which we believe is the most advanced ambulatory cardiac detection platform available. HeartBeam believes this will drive clinical and patient adoption. Shift the commercial launch until obtaining the 510(k) clearance for 12-lead equivalence. The company plans to submit this application to the FDA in late 2023 and pursue initial commercialization in 2024. Undertake an aggressive pre-commercial effort to define initial market segments and identify potential business partners. Continue aggressive development of its 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 clearly focused on the goal of creating clear leadership in the area of ambulatoryVECG cardiac detection. Add world leading Key Opinion Leaders to our Medical Advisory Board to help guide our clinical and regulatory development. These Advisory Board members will be announced in thenear future. As a result of these strategic goals, we are updating our financial guidance and expect no material commercial revenue for 2023.