HeartBeam Inc. (NASDAQ: BEAT) announced that it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia. Participants were evaluated using both a standard 12-lead ECG and the company’s 3D ECG technology. Data analysis is now underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The completion of enrollment ahead of the previously anticipated third-quarter 2026 timeline has significant implications. According to the company, the study results are expected to support discussions with the U.S. Food and Drug Administration (FDA) on the design of a planned U.S. pivotal trial and a future submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack detection. HeartBeam is also evaluating whether the accelerated timeline could support a more expedited regulatory pathway.
The ALIGN-ACS pilot study marks a key milestone for HeartBeam, which is developing the first cable-free device capable of collecting ECG signals from three non-coplanar directions and synthesizing them into a 12-lead ECG. The technology already received FDA clearance for arrhythmia assessment in December 2024 and for the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology.
If successful, the expanded indication could transform how heart attacks are detected and monitored, potentially allowing patients to use the portable device outside of medical facilities. Physicians would be able to identify cardiac health trends and acute conditions remotely, directing patients to appropriate care sooner. This could improve outcomes for individuals experiencing chest pain or other symptoms of acute coronary syndrome.
The broader impact on the healthcare industry could be substantial. Current heart attack detection typically requires a 12-lead ECG administered in a clinical setting, which can delay diagnosis and treatment. HeartBeam’s 3D ECG technology aims to provide actionable heart intelligence wherever the patient is, reducing reliance on hospital-based testing. For investors, the completion of enrollment ahead of schedule signals operational efficiency and potential for faster market expansion.
For more information about HeartBeam and its technology, including cleared indications for use, visit the company’s website at https://www.heartbeam.com/indications. Additional updates and news are available in the company’s newsroom at https://ibn.fm/BEAT.
