HeartBeam Inc. (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for detecting heart attacks. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia. Each participant was evaluated using both a standard 12-lead ECG and HeartBeam's proprietary 3D ECG technology. Data analysis is now underway, and the company plans to present the results at a major cardiology conference later this year.
The early completion of enrollment marks a significant milestone for HeartBeam, as the study results are expected to support discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a planned U.S. pivotal trial. This trial is a critical step toward expanding the HeartBeam System's cleared indication beyond arrhythmia assessment to include heart attack detection. The company noted that completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could enable a more accelerated regulatory pathway.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025. The ALIGN-ACS study aims to demonstrate the system's ability to detect acute coronary syndrome, the underlying cause of most heart attacks, potentially broadening its clinical utility. According to the company, the technology is designed as a cable-free device that collects ECG signals in three dimensions and synthesizes them into a standard 12-lead ECG, enabling remote cardiac monitoring outside medical facilities.
HeartBeam holds over 20 issued patents related to its technology. The company's platform is intended to allow physicians to identify cardiac health trends and acute conditions, directing patients to appropriate care from any location. The successful completion of the ALIGN-ACS study could position HeartBeam to address a significant unmet need in cardiovascular diagnostics, where timely detection of heart attacks remains a critical challenge.
For more information on HeartBeam's cleared indications for use, visit https://www.heartbeam.com/indications. The full press release is available at https://ibn.fm/GEYtp.
