HeartBeam, Inc. (NASDAQ: BEAT) announced it has completed patient enrollment in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection, ahead of its previously stated third-quarter 2026 target.

The study enrolled 120 patients presenting with chest pain in emergency departments across two clinical sites in Belgrade, Serbia. Participants were evaluated using both a standard 12-lead ECG and the HeartBeam System, with physician assessments compared against an independently adjudicated clinical data-based reference standard.

Data analysis is underway, and the company plans to present full results at a cardiology conference in the coming months.

HeartBeam said findings from the pilot are intended to inform the design of a planned pivotal study in the United States and support a future FDA submission. The company is seeking to expand the HeartBeam System's cleared indication beyond arrhythmia assessment to include heart attack detection. The heart attack detection indication is not currently FDA cleared and is not available in the U.S. or any other market.

"Completing enrollment ahead of schedule reflects both the quality of the study design and the operational discipline our team has built, providing us a strong foundation as we move into pivotal study planning," said Branislav Vajdic, Ph.D., Founder and President of HeartBeam.

The company said it plans to use pilot study data alongside prior proof-of-concept data, including a study published in JACC: Advances, to inform discussions with the FDA on the design and scope of the pivotal program. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and its 12-lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.