BEAT News & Events

HeartBeam announced completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Enrollment was completed ahead of the Company's previously communicated third quarter 2026 timeline. "Completing enrollment ahead of schedule reflects both the quality of the study design and the operational discipline our team has built, providing us a strong foundation as we move into pivotal study planning," said Branislav Vajdic, Ph.D., Founder and President of HeartBeam. "We believe the data from the ALIGN-ACS pilot study will be an important input into our discussions with the FDA, and we are evaluating whether this milestone supports a more accelerated path toward an expanded indication for heart attack detection. We look forward to sharing full results later this year and advancing this program with the same discipline and pace our team has demonstrated throughout this study."

The company states: "HeartBeam announced a reorganization to prioritize global market reach and capital efficiency while accelerating execution. The company has aligned its operations around focused implementation teams which will be led by Branislav Vajdic, Ph.D., Founder and President, and Rich Ferrari, Executive Chairman. The teams are focused on a single goal: to provide every at-risk cardiac patient access to HeartBeam's groundbreaking technology. This structure streamlines decision-making, improves accountability, and enables leadership to concentrate resources on achieving key milestones while maintaining disciplined management. The reorganization is expected to sharpen the Company's focus on delivering results and create a meaningfully lower cost structure. As part of these changes, Robert Eno, former Chief Executive Officer, will transition to a consulting role for HeartBeam. The company received FDA marketing clearance for its synthesized 12-lead ECG signal for arrhythmia assessment in December 2025 giving physicians a familiar format they already trust. The company believes this unique capability will be critical to adoption in many use cases."

HeartBeam announced a peer-reviewed article in JACC: Advances, a journal of the American College of Cardiology, demonstrating that a risk prediction algorithm incorporating the credit card-sized HeartBeam ECG device can accurately identify heart attack risk in patients presenting with chest pain. The publication is available in the June 2026 issue and online. Key findings include: when the algorithm used a single ECG reading from the HeartBeam device combined with the patient's risk factors and symptoms, it achieved an AUC of 86.5%. AUC or area under the curve is a key measure of performance. When a personal, symptom-free baseline ECG previously recorded on the same HeartBeam device was available for comparison, AUC increased to 92.9%. The algorithm's false-positive rate was significantly lower than the physician panel, indicating fewer patients would be sent unnecessarily to the emergency department.