HeartBeam, Inc. (NASDAQ: BEAT) announced the completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Enrollment was finished ahead of the company’s previously communicated third quarter 2026 timeline. The medical technology company is shifting its strategy to license its 3D ECG signal technology to established partners to accelerate global adoption, while advancing toward heart attack detection as a key platform expansion.

The study enrolled 120 patients presenting with chest pain in the emergency department across two clinical sites in Belgrade, Serbia. Patients were evaluated with both a standard 12-lead ECG and the HeartBeam System, with physician assessment for acute coronary syndrome compared against an independently adjudicated clinical-data-based gold standard. Data analysis is currently underway, and the company plans to present the results at a major cardiology conference in the coming months.

HeartBeam’s 3D ECG technology is designed to allow patients to record a clinical-grade ECG at the onset of symptoms, wherever they are. This capability aims to shorten symptom-to-door times and support faster, more informed care decisions outside a clinical setting. Heart attacks remain a leading cause of death in the United States, with millions of patients at elevated risk.

"Completing enrollment ahead of schedule reflects both the quality of the study design and the operational discipline our team has built," said Branislav Vajdic, Ph.D., Founder and President of HeartBeam. "We believe the data from the ALIGN-ACS pilot study will be an important input into our discussions with the FDA, and we are evaluating whether this milestone supports a more accelerated path toward an expanded indication for heart attack detection."

Results from the pilot study are intended to inform the design of a planned pivotal study in the United States and support a future FDA submission seeking to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment. The company will use learnings from the pilot, together with prior proof-of-concept data recently published in JACC: Advances, to inform upcoming discussions with the FDA regarding the design and scope of the pivotal program.

The company has aligned its operations around focused implementation teams led by Branislav Vajdic, Ph.D., and Rich Ferrari, Executive Chairman. HeartBeam holds over 20 issued patents related to technology enablement and previously received FDA clearance for its 3D ECG technology for arrhythmia assessment in December 2024.