HeartBeam Announces New Peer-Reviewed Article Demonstrating Potential to Help Identify Heart Attack Risk at Home
- Publication in JACC: Advances demonstrates that an algorithm combining the HeartBeam ECG device with patient risk factors and symptoms can accurately identify heart attack risk
- Study advances the scientific foundation supporting HeartBeam's planned indication expansion into heart attack detection
- Large market potential with over 20 million patients in the U.S. at risk of a heart attack
HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced a peer-reviewed article in JACC: Advances, a journal of the American College of Cardiology, demonstrating that a risk prediction algorithm incorporating the credit card-sized HeartBeam ECG device can accurately identify heart attack risk in patients presenting with chest pain. The publication is available in the June 2026 issue and online.
The article is titled "Acute Coronary Syndrome Risk Prediction Using Portable Cable-Free ECG Device Combined With Clinical Risk Assessment". The study was led by Alexei Shvilkin, MD, PhD, Clinical Cardiac Electrophysiologist, Beth Israel Deaconess Medical Center in Boston, MA. The goal of this proof-of-concept study was to determine if a risk score combining HeartBeam ECG data with patient risk factors and symptoms could accurately identify which patients with chest pain were at high risk for heart attack compared to an expert physician panel.
"This study is an important piece of the scientific foundation we are building toward heart attack detection as a future indication for the HeartBeam System," said Robert Eno, Chief Executive Officer of HeartBeam. "The results demonstrate that a clinical-grade ECG provided by our device, combined with a patient's clinical history and symptoms, can deliver risk assessment comparable to physician evaluation with a traditional 12-lead ECG. In practical terms, a patient experiencing chest pain could use the HeartBeam System at home, reducing hesitation to seek medical help, reducing time to intervention and potentially improving outcomes in the event of a heart attack."
One of the most persistent problems in heart attack care is reducing "symptom to door" times as patients experiencing chest pain often wait hours before seeking care due to uncertainty around symptoms. Current tools for assessing heart attack risk outside the hospital are limited. A standard 12-lead ECG, which remains the most reliable tool, requires bulky equipment and trained personnel that are only available in clinical settings.
More Details on Study Results
The proof-of-concept study evaluated whether a risk prediction algorithm could close that gap by combining three independent inputs into a single risk score: an ECG from the HeartBeam device, a patient's pre-existing cardiovascular risk factors, and a structured symptom assessment. Key findings include:
- Prospective study enrolled 212 patients presenting to the emergency department with chest pain with 184 patients included in the final analysis.
- When the algorithm used a single ECG reading from the HeartBeam device combined with the patient's risk factors and symptoms, it achieved an AUC of 86.5%. AUC or area under the curve is a key measure of performance.
- When a personal, symptom-free baseline ECG previously recorded on the same HeartBeam device was available for comparison, AUC increased to 92.9%. This is an important finding, as physicians evaluating an ECG from the HeartBeam System will always have the patient's baseline ECG for comparison, potentially increasing the ability to detect a heart attack.
- The algorithm's false-positive rate was significantly lower than the physician panel (19.8% for algorithm vs. 55.6% for physician panel, P=0.004), indicating fewer patients would be sent unnecessarily to the emergency department.
The authors concluded that integrating clinical risk factors, symptom characteristics, and ECG data from the HeartBeam System into a single algorithm "may enable clinically meaningful ACS (heart attack) risk stratification at the early stages of chest pain" and could help shorten the time between symptom onset and treatment. The article can be accessed here.
Heart attack detection represents a potential major expansion opportunity for HeartBeam addressing a U.S. population of more than 20 million high-risk patients. This study, combined with the ALIGN-ACS pilot study currently underway in Europe and enrolling ahead of schedule, advances and expands HeartBeam's clinical program.
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 has developed 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. 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 Company holds over 20 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 heart attack detection indication and algorithm are not FDA cleared and not available in the US or any other geography at this time. Refer to the Company's Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.
MKT-139 v0
View source version on businesswire.com: https://www.businesswire.com/news/home/20260602704375/en/
Media Contact:
media@heartbeam.com
Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us