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. Data analysis is now underway, with results expected to be presented at a cardiology conference in 2027. The early completion of enrollment is significant because it accelerates the timeline for generating clinical evidence that could support regulatory clearance and adoption of the HeartBeam System, a portable, credit card-sized device designed to collect ECG signals in 3D and synthesize them into a 12-lead ECG.
Combined with the 132-patient ALIGN-ACS pilot study, HeartBeam has now enrolled more than 600 patients across its heart attack detection studies. This growing body of evidence 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 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 its 12-lead ECG synthesis software received clearance in December 2025. Details on the cleared indications for use are available at https://www.heartbeam.com/indications.
The implications of this announcement extend beyond the study itself. By completing enrollment ahead of schedule, HeartBeam demonstrates operational efficiency and strong clinical site collaboration, which could enhance investor confidence and expedite the path to market for a device that aims to redefine cardiac health management by enabling physicians to identify cardiac trends and acute conditions outside of a medical facility. The company holds over 20 issued patents related to technology enablement, underscoring its commitment to innovation in portable cardiac monitoring. For investors, the latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/1c6Br.
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