HeartBeam Completes Patient Enrollment Ahead of Schedule in Heart Attack Detection Pilot Study

HeartBeam Inc. (NASDAQ: BEAT) announced that it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is evaluating the company’s HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia, and participants were evaluated using both a standard 12-lead ECG and HeartBeam’s proprietary 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.

Notably, HeartBeam is 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 could expedite the availability of a novel, cable-free device capable of collecting ECG signals in three dimensions, synthesizing them into a standard 12-lead ECG.

The HeartBeam System’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025. The company holds over 20 issued patents related to its technology.

The ability to detect heart attacks outside of a medical facility could transform cardiac care by enabling physicians to identify acute conditions and direct patients to appropriate care more quickly. The pilot study’s completion ahead of schedule suggests strong momentum for HeartBeam’s technology.

For more details, the full press release is available at https://ibn.fm/GEYtp. Additional information about HeartBeam and its cleared indications for use can be found at https://www.heartbeam.com/indications.

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