HeartBeam Touts Data from Study of Vector-Based Tech

HeartBeam released results from two studies evaluating its vector-based technology during the American Heart Association’s annual Scientific Sessions.

The data added to clinical evidence for the company’s key clinical indications, specifically arrhythmia and heart attack detection.

HeartBeam’s vector-based technology captures the heart’s electrical signals from three dimensions. The company’s first application of its technology is a cable-free, credit card-sized device designed to be capable of synthesizing a 12-lead electrocardiogram (ECG).

The company said the small size makes it convenient for patients to always have the device with them, ready to record an ECG when they feel symptoms to minimize delays in care. The HeartBeam system is currently under review with the U.S. Food and Drug Administration (FDA).

“The data presentations at AHA are a testament to HeartBeam’s dedication to building a robust body of clinical evidence to support our groundbreaking technology as we strive to make it easier for patients and physicians to monitor cardiac symptoms and seek timely diagnosis outside of a healthcare facility,” said Robert Eno, CEO of HeartBeam. Eno was named chief executive of the company last month.

“We thank our physician collaborators for their commitment to evaluating the value our technology can bring in different clinical situations and transform how cardiac conditions are managed in the future,” Eno went on.

The first presentation

Thomas Deering, MD, FACC, FHRS, Chief of Arrhythmia Center, Piedmont Healthcare in Atlanta, Ga., highlighted results from an 80-patient pilot study. This study evaluated HeartBeam’s synthesized 12-lead ECG waveforms compared to simultaneously collected, standard 12-lead ECGs for arrhythmia detection.

The study found “excellent agreement” using the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (sensitivity: 94%, specificity: 100%).

Arrhythmias assessed include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). This study is a precursor to the company’s VALID-ECG pivotal study, which finished enrollment in June.

VALID-ECG will support the clinical equivalence basis for the synthesized 12-lead ECG software in the HeartBeam’s next FDA submission.

The second presentation

Alexei Shvilkin, MD, Ph.D., Clinical Cardiac Electrophysiologist, Beth Israel Deaconess Medical Center in Boston evaluated the feasibility of calculating an acute coronary syndrome (ACS) risk score to assess chest pain using HeartBeam’s algorithm.

The algorithm could lessen the time between when heart attack symptoms start and when patients arrive at a medical facility. The study found HeartBeam’s algorithm accurately spotted ACS and matched expert emergency department physicians’ assessment. These physicians usually rely on standard 12-lead ECGs for ACS evaluation.