HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights wherever the patient is, announced the results from two studies evaluating HeartBeam’s groundbreaking vector-based technology. The data add to the body of clinical evidence for the Company’s key clinical indications, specifically arrhythmia and heart attack (myocardial infarction) detection, and showcase the technology’s pivotal role in advancing patient care for these clinical indications. The studies were presented during the American Heart Association’s annual Scientific Sessions in Chicago, November 16-18, 2024.
HeartBeam’s vector-based technology captures the heart’s electrical signals from three dimensions. The Company’s first application of its groundbreaking technology is a cable-free, credit card-sized device that is designed to be capable of synthesizing a 12-lead electrocardiogram (ECG). The small size makes it convenient for patients to always have the device with them, ready to record an ECG whenever they feel symptoms to minimize delays in care. The HeartBeam system is currently under review with the 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, Chief Executive Officer, HeartBeam. “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.”
The first presentation by Thomas Deering, MD, FACC, FHRS, Chief of Arrhythmia Center, Piedmont Healthcare in Atlanta, GA, highlighted results from an 80-patient pilot study, which evaluated the performance of HeartBeam’s synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (Sensitivity: 94%, Specificity: 100%). Arrhythmias evaluated 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 pivotal study, VALID-ECG, which completed enrollment in June. VALID-ECG will support the clinical equivalence basis for the synthesized 12-lead ECG software in the Company’s next FDA submission.
“One of the main challenges with timely assessment of arrhythmias is that a single-lead ECG does not contain complete diagnostic information, and at the same time, obtaining a standard 12-lead ECG is highly impractical outside of a medical setting,” commented Dr. Deering. “Our study showed that the synthesized 12-lead ECG obtained from the HeartBeam device is similar to a 12-lead ECG, allowing patients to easily obtain the highest fidelity ECG data wherever they are upon symptom onset and greatly reduce any potential delays in receiving care.”
A second study presented by Alexei Shvilkin, MD, PhD, Clinical Cardiac Electrophysiologist, Beth Israel Deaconess Medical Center in Boston, MA, evaluated the feasibility of calculating an acute coronary syndrome (ACS) risk score for assessment of chest pain using the Company’s proprietary algorithm. This algorithm has the potential to shorten the time between when heart attack symptoms begin and when patients arrive at a medical facility, which is essential for improving outcomes. The study found HeartBeam’s algorithm accurately detected ACS and matched the assessment of expert Emergency Department physicians who typically rely on standard 12-lead ECGs for ACS assessment. This data builds on the previously published JACC: Advances study, which demonstrated that HeartBeam’s technology is comparable to 12-lead ECGs in identifying coronary occlusions. The latest findings reinforce the potential of the Company’s technology to facilitate evaluation of patient’s chest pain symptoms outside of a medical facility to reduce delays in care.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The Company is creating the first ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in 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. The Company holds 13 US and 4 international issued patents related to technology enablement.
For additional information, visit HeartBeam.com.
Forward-Looking Statements
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