Healthcare

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

SANTA CLARA, Calif., July 01, 2026--HeartBeam Completes Enrollment in Heart Attack Detection Pilot Study Ahead of Schedule

articleHeartbeam, Inc.July 1, 20265 min read/news/heartbeam-completes-enrollment-in-heart-attack-detection-pilot-study-ahead-of-schedule
HeartBeam Completes Enrollment in Heart Attack Detection Pilot Study Ahead of Schedule

About this update from Heartbeam, Inc.

SANTA CLARA, Calif., July 01, 2026--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through powerful cardiac insights, today announced completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Enrollment was completed ahead of the Company's previously communicated third quarter 2026 timeline. Heart attacks remain a leading cause of death in the United States, with millions of patients at elevated risk. Patients with heart attack symptoms often delay seeking care for more than 2 hours1 because the symptoms can be vague or subtle, which contributes to higher mortality, more complications, and greater care costs. HeartBeam's 3D ECG technology is designed to allow patients to record a clinical-grade ECG at the onset of symptoms, wherever they are, with the goal of shortening symptom-to-door times and supporting faster, more informed care decisions outside a clinical setting. "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. "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. We look forward to sharing full results later this year and advancing this program with the same discipline and pace our team has demonstrated throughout this study." 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 using both ECG modalities compared against an independently adjudicated clinical-data-based gold standard. Data analysis is underway, and the Company plans to present the results at a major cardiology conference in the coming months.

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HeartBeam, Inc.heart attackThe Companypivotal studyFDAmedical technology companyECG