HeartBeam (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia, with participants 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 said the study results are expected to support discussions with the FDA on 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.
HeartBeam’s 3D ECG technology, which received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025, is designed for portable devices that can be used wherever the patient is. The platform aims to deliver actionable heart intelligence, allowing physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility.
The successful completion of this pilot study marks a significant milestone for the company, potentially accelerating the path to market for a heart attack detection indication. The company holds over 20 issued patents related to its technology enablement. For more details on the intended use of its technology, refer to the Cleared Indications for Use at https://www.heartbeam.com/indications.
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