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HeartBeam Completes Enrollment Ahead of Schedule in 486-Patient Heart Attack Detection Study

By FisherVista•
HeartBeam has completed enrollment ahead of schedule in its HEADSTART-ACS study, bringing its total heart attack detection study population to over 600 patients and advancing preparations for a pivotal U.S. trial in 2027.
HeartBeam Completes Enrollment Ahead of Schedule in 486-Patient Heart Attack Detection Study

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.

The milestone matters because it moves the company closer to a pivotal U.S. study and, eventually, a potential new way to detect heart attacks outside of a hospital setting. 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 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.

HeartBeam is also exploring potential deployment of its portable, credit card-sized 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. For a closer look at the company’s work, see the HeartBeam (NASDAQ: BEAT) profile and the full press release at https://ibn.fm/1c6Br.

According to the company, HeartBeam is dedicated to transforming the detection and monitoring of critical cardiac conditions. It is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care—all outside of a medical facility, thus redefining the future of 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. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT, and details on the intended use of its technology can be found in the company’s Cleared Indications for Use at https://www.heartbeam.com/indications.

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 that delivers wire solutions via InvestorWire, among other services. For full terms of use and disclaimers applicable to all content provided by BMW, see https://www.BioMedWire.com/Disclaimer.

FisherVista

FisherVista

@fishervista