HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that results from its ALIGN-ACS pilot study will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego. The study evaluated the company's 3D electrocardiogram (ECG) technology for heart attack assessment, comparing the HeartBeam System—a credit card-sized, three-lead device—with a standard 12-lead ECG for detecting acute coronary syndrome in 132 emergency department patients presenting with chest pain at two clinical sites in Belgrade, Serbia.
The presentation, scheduled for Nov. 1 at 1:20 p.m. Pacific time, will be delivered by Dr. Graham Nichol of the University of Washington. According to Branislav Vajdic, HeartBeam founder and President, the study represents an important step in evaluating the company's technology against conventional ECG systems in patients with suspected heart attacks. The results could have significant implications for how heart attacks are detected outside of traditional hospital settings, potentially enabling faster and more accessible cardiac assessment.
HeartBeam's 3D ECG technology has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and has been accepted into the agency's Total Product Life Cycle Advisory Program. The company expects the pilot study findings to help guide the design of a U.S. pivotal study anticipated to begin in the first quarter of 2027. This timeline underscores the potential for the technology to advance toward regulatory submission and eventual commercialization. For investors, the presentation at TCT 2026 represents a critical milestone that could influence the company's trajectory and validate its approach to portable cardiac monitoring. More details are available in the full press release at https://ibn.fm/IA88r.
The HeartBeam System is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, a platform technology intended for portable devices that can be used wherever the patient is. The company's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025. HeartBeam holds over 20 issued patents related to technology enablement, and its cleared indications for use are detailed at https://www.heartbeam.com/indications.
The announcement was distributed through AINewsWire, a communications platform focused on AI advancements and part of the Dynamic Brand Portfolio within IBN. The platform provides wire solutions via InvestorWire and other services. For ongoing updates on HeartBeam, the company's newsroom is available at https://ibn.fm/BEAT.
