HeartBeam Inc. (NASDAQ: BEAT) announced that it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is evaluating the HeartBeam System for detecting heart attacks. 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 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 support a more accelerated regulatory pathway. For more details, refer to the full press release at https://ibn.fm/GEYtp.
HeartBeam is a medical technology company focused on transforming cardiac care through its innovative 3D ECG technology. The company’s platform is designed for portable devices that can collect ECG signals from three non-coplanar directions and synthesize them into a 12-lead ECG, enabling physicians to identify cardiac health trends and acute conditions outside of medical facilities. The HeartBeam System 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 successful and early completion of enrollment in the ALIGN-ACS pilot study marks a significant milestone for HeartBeam, potentially accelerating the timeline for bringing a heart attack detection capability to market. This advancement could have important implications for patients, as early and accurate detection of heart attacks outside of hospital settings may improve outcomes and reduce healthcare costs. The company’s technology aims to provide actionable intelligence to physicians, allowing for timely intervention.
For additional information about HeartBeam and its cleared indications for use, visit https://www.heartbeam.com/indications. The latest news and updates regarding BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
