HeartBeam Inc. (NASDAQ: BEAT) announced it has completed 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 evaluated 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 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.
This development is significant because it brings HeartBeam closer to potentially offering a portable, cable-free device capable of detecting heart attacks outside of a medical facility. The HeartBeam System, which received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025, is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a standard 12-lead ECG. If approved for heart attack detection, the device could enable physicians to identify acute cardiac conditions remotely, directing patients to appropriate care more quickly.
For the broader industry, this advancement could shift how cardiac monitoring is performed, reducing reliance on traditional, bulky ECG machines in clinical settings. For patients, particularly those in remote or underserved areas, access to such technology could mean earlier diagnosis and treatment of heart attacks, potentially improving outcomes. HeartBeam holds over 20 issued patents related to its technology, underscoring its innovative position in the cardiac diagnostics market.
The full press release is available at https://ibn.fm/GEYtp. More information about HeartBeam and its cleared indications for use can be found at https://www.heartbeam.com/indications.
