HeartBeam reports FY23 EPS (72c), consensus (76c)

“We have continued to make steady progress on regulatory and clinical milestones for the AIMIGo 3D VECG technology platform,” said Branislav Vajdic, CEO. “We have filed a 510(k) submission to the FDA for our AIMIGo VECG device system. When cleared, this will be a major milestone for the company, as we expect this to be the first patient-held 3D VECG to be cleared by the FDA. Additionally, this clearance is the cornerstone of our regulatory efforts as it will be the basis for future FDA submissions, including our planned second FDA application on the system’s ability to synthesize a 12L ECG. We continue to anticipate that our limited launch of AIMIGo will occur by the end of 2024. Based on feedback from the FDA and our clinical experts, we designed the VALID-ECG clinical study, a prospective single-arm multicenter trial with the goal to validate the AIMIGo 12L ECG Synthesis Software by comparing its results with those of a standard FDA-cleared 12L ECG using both quantitative and qualitative assessment methodologies. We recently enrolled the first patients, with a plan to enroll a total of approximately 198 adult patients. We anticipate completion of enrollment in the VALID-ECG study in Q2 2024 and submission of the second 510(k) application by Q3 2024. We also previously completed an 80-patient pilot study using the same protocol as the VALID-ECG study. Based on the pilot results, we initiated the VALID-ECG study. During the fourth quarter, we announced significant developments related to the use of artificial intelligence (AI) applied to our VECG technology. By leveraging AI to analyze our data-rich signals, we believe we will be able to improve diagnostic accuracy and extract unique information that today’s ambulatory ECGs are unable to detect, such as complex heart rhythms, subtle signs of deteriorating heart health and cardiac events that may have previously been missed. This presents a unique opportunity to create a comprehensive repository of data that could unlock personalized AI-driven insights to improve cardiac care. Our team includes world class AI experts in previous positions with Google, Apple and Microsoft. In addition, two abstracts on our deep learning algorithm have been accepted for presentation at scientific meetings in April and May of this year. Importantly, we continued expanding our intellectual property footprint, recently receiving two new patents on our VECG technology. ”