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 System in detecting acute coronary syndrome (ACS), including heart attacks, by comparing its three-dimensional electrocardiogram (ECG) technology with standard 12-lead ECGs. Data analysis is underway, with results expected to be presented at a cardiology conference in 2027.
The early completion of enrollment is significant because it accelerates the clinical development timeline for HeartBeam's portable, credit card-sized technology. Combined with the 132-patient ALIGN-ACS pilot study, HeartBeam has now enrolled more than 600 patients across its heart attack detection studies. This body of evidence will support preparations for a pivotal U.S. study planned for the first quarter of 2027, a critical step toward potential regulatory clearance and commercialization in the United States.
The HeartBeam System is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, all without cables. This platform technology is intended for portable devices that can be used wherever the patient is, delivering actionable heart intelligence. Physicians could identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility, redefining cardiac health management. 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. For details on the cleared indications, refer to the company's Cleared Indications for Use.
Beyond the U.S. market, HeartBeam is exploring potential deployment of its technology across community health centers in Indonesia. This initiative could expand access to advanced cardiac monitoring in underserved regions, where timely detection of heart attacks is often challenging. The HEADSTART-ACS study, conducted at a leading Indonesian cardiovascular center, provides valuable data that could support such deployment and demonstrate the technology's effectiveness in diverse populations.
The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational. For investors, the accelerated enrollment and the planned pivotal U.S. study represent key milestones. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. To view the full press release, visit https://ibn.fm/1c6Br.
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