HeartBeam Inc. (NASDAQ: BEAT), a medical technology company developing advanced cardiac monitoring solutions, announced the completion of 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 (NASDAQ: BEAT) System in detecting acute coronary syndrome, including heart attacks, by comparing its three-dimensional electrocardiogram technology with standard 12-lead ECGs.
The early completion of enrollment is significant because it accelerates the timeline for gathering data that could support regulatory clearance 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, supporting 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, according to the press release. The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational. The technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025. Details on the intended use of the technology are available at https://www.heartbeam.com/indications.
For investors, the enrollment milestone reduces uncertainty around the company’s clinical timeline and brings it closer to a U.S. pivotal trial. The full press release can be viewed at https://ibn.fm/1c6Br, and the latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
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