HeartBeam, Inc. (NASDAQ: BEAT) has announced the submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its innovative 12-lead electrocardiogram (ECG) synthesis software. This software is designed for the assessment of a range of cardiac rhythms and arrhythmias, potentially transforming cardiac care by providing personalized insights.
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The company believes that the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG to standard 12-lead ECGs for rhythm and arrhythmia assessment. The software synthesizes signals captured from three distinct directions into a familiar 12-lead ECG format using a personalized transformation matrix.
VALID-ECG Study Details
The VALID-ECG study, which completed enrollment in June 2024, followed the same protocol as an 80-person pilot study presented at the AHA 2024 Scientific Sessions. The company plans to present the full results from VALID-ECG at a scientific conference in 2025. The pilot study demonstrated alignment with standard ECGs for arrhythmia detection, achieving 94% sensitivity and 100% specificity.
Technology and Future Advancements
HeartBeam's technology captures the heart's electrical signals from three different directions. The software then synthesizes these signals into a 12-lead ECG using a personalized transformation matrix. This builds upon HeartBeam’s recent FDA clearance for its arrhythmia assessment system. Future advancements are anticipated to include AI-based classification algorithms and heart attack detection, potentially minimizing the critical "symptom to door" times.
Commercial Launch and Early Access Program
Upon FDA clearance, HeartBeam plans to initiate a commercial launch, leveraging learnings and feedback from its Early Access Program. Hundreds of physicians and patients have already joined the waitlist, underscoring the widespread interest in a convenient cardiac monitoring option that can be used outside of a medical facility.
Executive Commentary
Robert Eno, Chief Executive Officer of HeartBeam, commented, "The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam’s vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected."
Clinical Significance
The ability for patients to capture high-fidelity ECG signals from three directions, wherever they are, when symptoms occur, will help patients get the care they need in a timelier manner. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.
