HeartBeam Inc. (NASDAQ: BEAT), a medical technology company developing advanced cardiac monitoring solutions, has completed patient enrollment ahead of schedule in its HEADSTART-ACS study, the company announced. The study, conducted at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia, 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 data analysis, 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. For investors and the medical community, the milestone signals progress toward a potential new tool for detecting heart attacks outside of traditional hospital settings.
HeartBeam’s technology is designed to be a portable, credit card-sized device that collects ECG signals in 3D from three non-coplanar directions and synthesizes them into a 12-lead ECG. The company is also exploring potential deployment of its technology across community health centers in Indonesia. The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational. However, the company’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. According to the company, its cleared indications for use are detailed at https://www.heartbeam.com/indications.
The implications of this announcement extend beyond the company itself. Heart disease remains a leading cause of death globally, and portable ECG solutions that can be used wherever a patient is could enable earlier detection and faster direction to appropriate care. For HeartBeam, the successful enrollment of over 600 patients across its studies provides a foundation for its planned U.S. pivotal trial, a critical step toward potential regulatory clearance for heart attack detection. The company holds over 20 issued patents related to technology enablement.
For those following the company, the latest news and updates relating to BEAT are available in its newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/1c6Br. The announcement was distributed through BioMedWire, a specialized communications platform focused on the biotechnology, biomedical sciences and life sciences sectors. BioMedWire is one of more than 75 brands within the Dynamic Brand Portfolio at IBN, which provides wire solutions through InvestorWire and other services. The platform also offers editorial syndication to 5,000+ outlets and social media distribution to millions of followers.
