HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the results of the ALIGN-ACS pilot study evaluating the HeartBeam 3D ECG technology for heart attack assessment will be presented at TCT 2026, taking place at the San Diego Convention Center, October 31-November 3, 2026.
The abstract presentation titled “Detection of Acute Coronary Syndrome by a Credit Card–Sized 3-Lead Device Versus Standard 12-Lead ECG in Emergency Department Patients” will be delivered by Graham Nichol, MD, MPH, of the University of Washington on Sunday, November 1 at 1:20 PM Pacific time.
The pilot study evaluated the HeartBeam System and a standard 12-lead ECG in detecting acute coronary syndrome (ACS), of which up to 80% is diagnosed as a heart attack. The study enrolled 132 patients presenting with chest pain in the emergency department across two clinical sites in Belgrade, Serbia.
“Heart attack assessment is our top strategic priority and ALIGN-ACS is a key step in comparing our 3D ECG technology to the standard 12-lead ECG in patients with a suspected heart attack. We look forward to Dr. Nichol’s presentation of the ALIGN-ACS pilot study results at TCT 2026,” said Branislav Vajdic, PhD, Founder and President of HeartBeam. “With FDA Breakthrough Device Designation and acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP) in place, these results will help shape the design of our U.S. pivotal study which we anticipate initiating in first quarter 2027. We look forward to Dr. Nichol’s presentation and to sharing the findings.”
Members of the HeartBeam management team will be available to meet with key opinion leaders, industry leaders, media, and sell-side analysts during the event. To schedule a meeting with HeartBeam management, please contact BEAT@mzgroup.us.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company believes it has developed the first 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. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 20251. The technology is currently being studied for heart attack assessment and is considered investigational in that indication. The Company holds more than 25 issued patents related to technology enablement. For additional information, visit HeartBeam.com.
Forward-Looking Statements
All statements in this release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
1Cleared Indications for Use
The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment only. The technology’s use for heart attack assessment is investigational and not FDA cleared. For full details on the intended use of the HeartBeam technology, refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications.
MKT-171 v0
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