HeartBeam Completes Enrollment Ahead of Schedule in Heart Attack Detection Pilot Study

HeartBeam (NASDAQ: BEAT) has announced the completion of patient enrollment in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection, ahead of the previously anticipated third-quarter 2026 timeline. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia, and assessed participants using both a standard 12-lead ECG and the company’s 3D ECG technology. Data analysis is currently underway, and HeartBeam plans to present the results at a major cardiology conference later this year.

The ALIGN-ACS study is a critical step for HeartBeam as it seeks to expand the indication of its system beyond arrhythmia assessment to include heart attack detection. The company stated that the study results are expected to support discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a planned U.S. pivotal trial and a future submission for an expanded indication. The completion of enrollment ahead of schedule may also support a more accelerated regulatory pathway, according to the company.

The HeartBeam System, which received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025, is a cable-free device that collects ECG signals in 3D from three non-coplanar directions and synthesizes them into a 12-lead ECG. This platform technology is designed for portable use, enabling physicians to identify cardiac health trends and acute conditions outside of medical facilities. The company holds over 20 issued patents related to its technology.

The pilot study’s completion marks a significant milestone for HeartBeam, as the company aims to redefine cardiac health management by providing actionable heart intelligence wherever the patient is. The results from the ALIGN-ACS study will be crucial in determining the next steps for regulatory approval and potential commercialization of the technology for heart attack detection. For more information, the full press release is available at https://ibn.fm/GEYtp.

HeartBeam’s technology has the potential to transform the detection and monitoring of critical cardiac conditions, offering a portable solution that could reduce the time to diagnosis and treatment for heart attacks. The company’s progress in the ALIGN-ACS study underscores its commitment to advancing cardiac care through innovative technology. Further updates and news related to HeartBeam can be found in the company’s newsroom at https://ibn.fm/BEAT.

This announcement is important because it brings HeartBeam closer to potentially offering a non-invasive, portable method for detecting heart attacks, which could have significant implications for patient outcomes and healthcare costs. The timely completion of enrollment suggests strong momentum for the company’s regulatory strategy.

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