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 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 marks a significant milestone for the company as it seeks to validate its portable, credit card-sized technology for heart attack detection.
Data analysis is now underway, with results expected to be presented at a cardiology conference in 2027. Combined with the 132-patient ALIGN-ACS pilot study, HeartBeam has enrolled more than 600 patients across its heart attack detection studies. This cumulative experience is supporting preparations for a pivotal U.S. study planned for the first quarter of 2027. The company is also exploring potential deployment of its technology across community health centers in Indonesia, which could expand access to cardiac care in underserved regions.
The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational. However, the technology has received FDA clearance for arrhythmia assessment in December 2024 and for its 12-lead ECG synthesis software in December 2025. According to the company’s cleared indications for use, the system is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, enabling physicians to identify cardiac health trends and acute conditions outside of a medical facility.
For investors, the early enrollment completion reduces timeline risk for the HEADSTART-ACS study and reinforces the company’s clinical execution capabilities. The planned pivotal U.S. study in early 2027 represents the next major regulatory step toward potential market approval for heart attack detection. HeartBeam holds over 20 issued patents related to technology enablement, underscoring its intellectual property position in the cardiac monitoring space. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
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 via InvestorWire, editorial syndication to 5,000+ outlets, press release enhancement, and social media distribution to millions of followers. For full terms of use and disclaimers applicable to all content provided by BioMedWire, visit https://www.BioMedWire.com/Disclaimer.
