HeartBeam Inc. (NASDAQ: BEAT) Launches Study Focused on Testing Proprietary Patch Capable of Generating On-Demand 12-Lead ECG for Ischemia Detection

• The seriousness of coronary artery disease continues to intensify as populations age and cardiovascular risk factors become more common.
• HeartBeam announced the launch of a pilot study focused on evaluating its on-demand 12-lead ECG patch in detecting coronary artery disease and inadequate blood flow and oxygen supply to tissue, or ischemia.
• The study represents a significant step in the development of the HeartBeam patch, which has the potential to disrupt the $2 billion long-term continuous monitor and mobile cardiac telemetry (“MCT”) markets.

Coronary artery disease remains one of the most urgent and widespread health threats worldwide, contributing to millions of deaths each year and often progressing silently until a major cardiac event occurs. As healthcare providers search for faster and more accessible ways to identify high-risk patients earlier, HeartBeam (NASDAQ: BEAT) has launched a new pilot study designed to evaluate its technology — a proprietary on-demand 12-lead ECG patch — in detecting coronary artery disease and inadequate blood flow and oxygen supply to tissue, or ischemia. 

“Ischemia detection has not been possible on patch-based ambulatory monitors, and they do not provide clinical-grade insights over an extended period of time,” said HeartBeam CEO Robert Eno. “The HeartBeam patch is designed to change that. A device capable of generating an on-demand 12-lead ECG at the moment symptoms occur — wherever the patient may be — could fundamentally expand the role of ambulatory cardiac monitoring beyond rhythm assessment alone.”

The seriousness of coronary artery disease continues to intensify as populations age and cardiovascular risk factors become more common. According to the Centers for Disease Control and Prevention, coronary heart disease is the most common type of heart disease and was responsible for more than 900,000 deaths each year. The condition develops when plaque accumulates inside the coronary arteries, reducing blood flow to the heart and increasing the risk of chest pain, heart attacks and heart failure.

One of the most concerning aspects of coronary artery disease is that symptoms may not appear until the disease has significantly progressed. The American Heart Association notes that many patients experience warning signs intermittently or only during physical exertion, making diagnosis difficult if testing does not occur while symptoms are present. This challenge has fueled interest in portable cardiac technologies capable of capturing clinically relevant information outside hospitals and clinics.

The broader burden of cardiovascular disease further highlights the urgency surrounding coronary artery disease detection and treatment. The World Health Organization estimates that cardiovascular diseases account for approximately more than 19 million deaths globally each year, representing nearly one-third of all deaths worldwide. Delayed diagnosis remains a major factor contributing to poor outcomes, particularly among patients who do not seek immediate medical care when symptoms first appear.

Against this backdrop, the pilot study announced by HeartBeam “represents a significant step in the development of the HeartBeam patch, which has the potential to disrupt the long-term continuous monitor and mobile cardiac telemetry (“MCT”) markets,” the company stated, noting that patch-based ambulatory cardiac monitoring represents an approximate $2 billion market with established reimbursement pathways. 

“Entering a $2 billion market with established reimbursement is compelling on its own,” observed Eno. “Adding ischemia detection as a capability makes the opportunity significantly larger.”

According to the company, today’s ambulatory patch ECG monitors are limited to one to three leads and are primarily designed to assess heart rhythms, not ischemia. “As a result, patients experiencing intermittent chest pain or cardiac symptoms outside the clinic often cannot obtain a clinical-grade ECG at the moment symptoms occur,” the announcement stated.

The study, which will be conducted at two leading hospitals in Belgrade, Serbia, is designed to provide key data and information about the HeartBeam on-demand patch, which is currently investigational and not yet FDA-cleared. “The patch device follows HeartBeam’s credit card-sized device as the second form factor and leverages the same patented 3D ECG technology that captures the heart’s electrical signals from 3 noncoplanar dimensions,” the company explained. “The HeartBeam patch continuously records a single-lead ECG and enables patients to initiate a full synthesized 12-lead ECG recording on demand by placing two fingers on the device. This approach is intended to provide clinicians with high-quality cardiac insights when symptoms occur outside of traditional care settings.”

The pilot study will enroll approximately 50 patients who have a high risk of coronary artery disease and whose resting ECGs show no evidence of ischemia. During the study, each participant will undergo exercise stress testing, a standard diagnostic procedure used to identify ischemic changes. Immediately following the stress testing, patients will activate the HeartBeam patch to generate a synthesized 12-lead ECG, which will then be compared directly with a standard 12-lead ECG, which has been recorded at the same time. “The results will help inform the company’s broader regulatory strategy for the HeartBeam patch in the future,” HeartBeam explained. 

The significance of this research extends beyond a single device platform. Earlier and more accessible identification of coronary artery disease could potentially improve outcomes by allowing physicians to intervene before conditions escalate into heart attacks or other serious events. As healthcare systems increasingly emphasize preventive care and decentralized diagnostics, technologies capable of capturing high-quality cardiac data remotely may become increasingly important.

HeartBeam’s ongoing clinical research also highlights the growing convergence of medical devices, software analytics and patient-centered care models. By continuing to evaluate and expand the capabilities of its ECG platform, the company is seeking to position itself within a rapidly evolving segment of cardiac monitoring focused on portability, accessibility and earlier detection.

For more information, visit www.HeartBeam.com.

NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT

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