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. The presentation is scheduled for Nov. 1 at 1:20 p.m. Pacific time and will be delivered by Dr. Graham Nichol of the University of Washington.
The ALIGN-ACS pilot study enrolled 132 emergency department patients presenting with chest pain at two clinical sites in Belgrade, Serbia. It compared the HeartBeam System—a credit card-sized, three-lead device—with a standard 12-lead ECG for detecting acute coronary syndrome. HeartBeam founder and President Branislav Vajdic said the study represents an important step in evaluating the company’s technology against conventional ECG systems in patients with suspected heart attacks.
The announcement matters because it brings HeartBeam’s portable 3D ECG platform one step closer to a U.S. pivotal study, which is anticipated to begin in the first quarter of 2027. The pilot findings are expected to help guide the design of that trial. If validated in larger studies, the technology could enable earlier and more accessible cardiac assessment outside traditional hospital settings, potentially improving outcomes for patients with suspected acute coronary syndrome.
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’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. HeartBeam holds over 20 issued patents related to technology enablement. Members of the management team will also be available for meetings during the conference.
For investors and industry observers, the TCT 2026 presentation offers a public look at how the HeartBeam System performs against the standard of care in a clinical setting. The results could influence the company’s regulatory pathway and commercial strategy. More information about HeartBeam (NASDAQ: BEAT) is available through HeartBeam (NASDAQ: BEAT), and the full press release can be viewed at https://ibn.fm/IA88r. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. Details on the intended use of its technology are available at https://www.heartbeam.com/indications.
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