HeartBeam Finishes 120-Patient Enrollment Early in ALIGN-ACS Pilot Study
BEAT•HeartBeam completed enrollment of 120 patients ahead of schedule in its ALIGN-ACS pilot study in Belgrade, Serbia, comparing its 3D ECG technology to standard 12-lead ECG. Data analysis is underway, with results slated for a major cardiology conference to support a planned U.S. pivotal trial and expanded FDA submission.
1. Pilot Study Enrollment Milestone
HeartBeam enrolled 120 chest-pain patients at two Belgrade clinical sites ahead of its Q3 2026 target, evaluating the HeartBeam System’s 3D ECG against standard 12-lead ECG in the ALIGN-ACS pilot study.
2. Data Analysis and Conference Presentation
Analysis of the collected patient data is in progress, with HeartBeam planning to present initial findings at a major cardiology conference later this year to showcase the system’s heart attack detection capabilities.
3. Regulatory Implications
Completing enrollment early could accelerate discussions with the FDA on designing a U.S. pivotal trial and pursuing an expanded indication for heart attack detection, beyond the current arrhythmia assessment clearance.
4. Technology Platform and Intellectual Property
HeartBeam’s cable-free device synthesizes 3D ECG signals into a 12-lead ECG. The company holds over 20 issued patents and has FDA clearances for arrhythmia assessment and 12-lead ECG synthesis.
