HeartBeam’s Heart Attack Detection Study Enrollment Completed

HeartBeam Inc. has completed patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.

Heart attacks remain a leading cause of death in the United States, with millions of patients at elevated risk. Patients with heart attack symptoms often delay seeking care for more than two hours¹ because the symptoms can be vague or subtle, which contributes to higher mortality, more complications, and greater care costs. HeartBeam’s 3D ECG technology allows patients to record a clinical-grade ECG at the onset of symptoms, wherever they are, with the goal of shortening symptom-to-door times and supporting faster, more informed care decisions outside a clinical setting.

“Completing enrollment reflects both the quality of the study design and the operational discipline our team has built, providing us with a strong foundation as we move into pivotal study planning,” HeartBeam Founder/President Branislav Vajdic, Ph.D., said. “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 study enrolled 120 patients presenting with chest pain in the emergency department across two clinical sites in Belgrade, Serbia. Patients were evaluated with both a standard 12-lead ECG and the HeartBeam System, with physician assessment for acute coronary syndrome using both ECG modalities compared against an independently adjudicated, clinical-data-based gold standard. Data analysis is underway, and the company plans to present the results at a major cardiology conference in the coming months.

Results from the ALIGN-ACS pilot study will inform the design of a planned pivotal U.S. study and support a future U.S. Food and Drug Administration (FDA) submission seeking to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment. The company plans to use learnings from the pilot, together with prior proof-of-concept data, including a study recently published in JACC: Advances, to inform discussions with the FDA about the program’s design and scope.

This study recruitment milestone reinforces HeartBeam’s focus on its path toward an expanded indication for heart attack detection and its broader platform strategy.

HeartBeam Inc. is a medical technology company dedicated to transforming cardiac detection and monitoring. The company has developed the first cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians can identify cardiac health trends and acute conditions and direct patients to the appropriate care—all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.** The company holds more than 20 issued patents related to technology enablement.

** Cleared Indications for Use: The HeartBeam System with 12-Lead ECG synthesis software is FDA-cleared for arrhythmia assessment only. The heart attack detection indication is not FDA-cleared and not available in the United States or any other geography at this time.

References
¹ De Luca G. Circulation. 2004 Mar 16;109(10):1223-5, Heidenreich PA, J Card Fail. 2022 Mar;28(3):453-466