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 in emergency department patients presenting with chest pain.
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 study enrolled 132 emergency department patients 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 (FDA) Breakthrough Device Designation and has been accepted into the agency's Total Product Life Cycle Advisory Program.
The pilot study findings are expected 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. To view the full press release, visit https://ibn.fm/IA88r.
HeartBeam is dedicated to transforming the detection and monitoring of critical cardiac conditions. The company is creating the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence, enabling physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility.
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 for Use at https://www.heartbeam.com/indications.
The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. The announcement was distributed through AINewsWire, a specialized communications platform focused on advancements in artificial intelligence and related technologies. AINewsWire is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire and other services.
For investors, the presentation at TCT 2026 represents a critical milestone for HeartBeam as it seeks to validate its portable 3D ECG technology against the standard of care in a clinical setting. Positive results could accelerate the pathway to a U.S. pivotal trial and eventual commercialization, potentially disrupting the cardiac monitoring market by offering a more accessible, cable-free alternative for heart attack detection. The company's FDA Breakthrough Device Designation and participation in the Total Product Life Cycle Advisory Program underscore the regulatory recognition of its innovative approach. As heart disease remains a leading cause of death worldwide, technologies that enable faster and more accurate diagnosis in emergency settings could have significant implications for patient outcomes and healthcare costs. The pilot study results, therefore, will be closely watched by industry stakeholders and could influence HeartBeam's future trajectory in the competitive medical device landscape.
