HeartBeam Inc. (NASDAQ: BEAT), a medical technology company developing advanced cardiac monitoring solutions, announced the completion of patient enrollment ahead of schedule in its HEADSTART-ACS study at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia. The study enrolled 486 patients to evaluate the diagnostic accuracy of the HeartBeam System in detecting acute coronary syndrome (ACS), including heart attacks, by comparing its three-dimensional electrocardiogram (ECG) technology with standard 12-lead ECGs. The early completion of enrollment is significant because it accelerates the timeline for generating clinical evidence that could support regulatory clearance and commercialization of the HeartBeam System for heart attack detection, a condition where rapid diagnosis is critical. Data analysis is underway, with results expected to be presented at a cardiology conference in 2027.
Combined with the 132-patient ALIGN-ACS pilot study, HeartBeam has now enrolled more than 600 patients across its heart attack detection studies. This cumulative clinical experience is intended to support preparations for a pivotal U.S. study planned for the first quarter of 2027. The company is also exploring potential deployment of its portable, credit card-sized technology across community health centers in Indonesia, which could extend access to cardiac monitoring in underserved settings. The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational. For additional details, the full press release is available at https://ibn.fm/1c6Br.
HeartBeam, Inc. (NASDAQ: BEAT) is dedicated to transforming the detection and monitoring of critical cardiac conditions. The company is creating the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
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