HeartBeam Inc. HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that results from its ALIGN-ACS pilot study evaluating its 3D electrocardiogram technology for heart attack assessment will be presented at the Transcatheter Cardiovascular Therapeutics 2026 conference in San Diego. 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.
The study enrolled 132 emergency department patients presenting with chest pain at two clinical sites in Belgrade, Serbia, and 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 technology has received U.S. Food and Drug Administration Breakthrough Device Designation and has been accepted into the agency’s Total Product Life Cycle Advisory Program. HeartBeam 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. Members of the management team will also be available for meetings during the conference.
The announcement matters because it places HeartBeam’s portable 3D ECG platform under peer scrutiny at a major interventional cardiology meeting, potentially accelerating clinical validation and adoption. If the pilot data support the device’s performance against standard 12-lead ECGs, the results could inform a larger U.S. trial and bring cardiac monitoring closer to point-of-care settings outside hospitals. That could reshape how emergency and remote care teams triage chest pain, reducing dependence on bulky equipment and enabling faster, more accessible heart attack assessment.
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. For details on the intended use of its technology, refer to the company’s cleared indications at https://www.heartbeam.com/indications.
For investors and industry observers, the TCT presentation represents a near-term catalyst that could influence the design and timing of the U.S. pivotal study. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/IA88r.
The announcement was distributed through AINewsWire, a specialized communications platform focused on AI advancements. AINewsWire is one of 75+ brands within the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire and other communications services. For more information, visit www.AINewsWire.com.
