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 company stated that the study results are expected to support discussions with the 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 completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could support a more accelerated regulatory pathway. For more details, the full press release can be viewed at https://ibn.fm/GEYtp.
HeartBeam is a medical technology company focused on transforming the detection and monitoring of critical cardiac conditions. The company is developing the first cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is, delivering actionable heart intelligence to physicians. The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. More information on cleared indications for use is available at https://www.heartbeam.com/indications.
The pilot study's early completion signals potential for faster regulatory progress, which could be significant for patients at risk of heart attacks. HeartBeam's 3D ECG technology aims to improve cardiac care outside traditional medical facilities, redefining how cardiac health is managed. The company holds over 20 issued patents related to its technology. For the latest news, visit the company’s newsroom at https://ibn.fm/BEAT.
