HeartBeam (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia, with participants evaluated using both a standard 12-lead ECG and the company's 3D ECG technology. Data analysis is underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The company said 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.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The ALIGN-ACS study's early completion may expedite the availability of a cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG for heart attack detection.
Physicians using the HeartBeam System could identify cardiac health trends and acute conditions, directing patients to appropriate care outside a medical facility. The platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. The company's technology aims to redefine the future of cardiac health management by enabling detection and monitoring of critical cardiac conditions.
To view the full press release, visit https://ibn.fm/GEYtp. For further information on HeartBeam and its technology, refer to the company's cleared indications for use at https://www.heartbeam.com/indications. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
