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 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 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 U.S. Food and Drug Administration (FDA) on the design of a planned U.S. pivotal trial, as well as 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.
This milestone is significant because the HeartBeam System, which received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025, represents a novel cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing the signals into a 12-lead ECG. The platform is designed for portable use, enabling physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside medical facilities. The company holds over 20 issued patents related to its technology.
For more details on the press release, visit https://ibn.fm/GEYtp. Additional information about the company’s cleared indications for use is available at https://www.heartbeam.com/indications.
