HeartBeam Inc. (NASDAQ: BEAT) announced the completion of patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is evaluating 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 assessed using both a standard 12-lead ECG and the company’s 3D ECG technology. Data analysis is currently underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The company expects the study results to support discussions with the U.S. Food and Drug Administration (FDA) regarding 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 enable a more accelerated regulatory pathway.
HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology. The HeartBeam System is designed as a cable-free device capable of collecting ECG signals in three non-coplanar directions and synthesizing them into a 12-lead ECG, enabling portable use for cardiac monitoring outside medical facilities.
For more details, the full press release is available at https://ibn.fm/GEYtp. Additional information about HeartBeam’s cleared indications for use can be found at https://www.heartbeam.com/indications.
