Peerbridge Kicks Off Ambulatory ECG Wearables Trial

Peerbridge Health has launched a study—COR-INSIGHT—to validate the screening and diagnostic capabilities of its Peerbridge Cor ambulatory ECG wearables, which aim to revolutionize cardiovascular and cardiopulmonary monitoring and screening by providing a seamless, non-invasive alternative to traditional diagnostic modalities. 

The trial will leverage two new proprietary, cutting-edge artificial intelligence (AI) Software-as-a-Medical-Device (SaMD) platforms: CardioMIND, an ECG+ analytical pipeline for cardiovascular indications and sleep disorders; and CardioQSync, a quantum-resonance based approach for extraction of cardiopulmonary and hemodynamic indications from respiratory ECG.

The trial is the first to prospectively evaluate multiplexed on-demand diagnostics directly from continuous ECGs in hospital and home settings, integrating data-rich metrics for more than 30 different indications. American Heart Association statistics place more than 160 million adult Americans at risk for the indications being validated in this trial.  The conditions range from previously announced ejection fraction severity, heart failure, and sleep apnea diagnostics to more advanced cardiopulmonary insights and hemodynamic measurements including cardiac output and stroke volume. By eliminating the reliance on imaging, catheter-based techniques, and biochemical assays, COR-INSIGHT offers a paradigm shift in diagnostic precision and accessibility from a single low-burden Cor ECG wearable, according to the company.

“This trial represents an exciting leap forward in inexpensive, remote patient care,” Peerbridge Health CEO Chris Darland said. “The Cor Insight trial allows us to provide over 30 cardiac and cardiopulmonary indications all from one simple wearable ECG study. Just as important as the clinical innovation is our ability to deliver these insights to clinicians at ultra-low cost. Bringing inexpensive hospital grade diagnostics to a patient’s doorstep is a critical first step to reaching tens of millions of underserved patients and communities today.”

The COR-INSIGHT trial underscores the versatility of the Peerbridge Cor wearable, which attempts to cater to patients across the clinical spectrum—from asymptomatic individuals to critically ill patients and those awaiting procedures like TAVR or ICD placement. The trial is designed to provide monitoring in diverse settings, including outpatient, in-hospital, and home environments.

A successful trial could have far-reaching implications. Use cases include:

• Early disease detection with rapid cardiac screening and diagnostics: As 50% of indications can be computed with as little as five minutes of wear, inexpensive assessments can be completed in routine care settings such as a primary care office, urgent care, or clinics within local pharmacies.
• Reduce re-admissions with at-home hemodynamic monitoring: Twenty-five percent of heart failure patients are re-admitted within 30 days. The ability to non-invasively measure hemodynamic stability from home allows for remote care and early intervention to improve readmission rates.
• Enhance virtual cardiology appointments with cardiac function snapshot: There are no cardiologists in 90% of America’s rural counties. Enabling inexpensive and remote hospital grade cardiac and cardiopulmonary assessments before a virtual cardiology appointment extends the reach of cardiologists to tens of millions of patients currently being missed.

The trial will enroll up to 15,000 participants from diverse demographics, ensuring the data reflects real-world clinical challenges. In addition to Peerbridge sites, the company will also be partnering with the HeartX program to expand participation with leading cardiologists at HCA, Mercy Health, and Louisiana Cardiology Associates.

Peerbridge Health is reportedly the first company to bring the quality and accuracy of hospital-grade cardiac diagnostics and monitoring to the home. The company’s AI-enabled device (Peerbridge Cor) includes a three-lead, patented AECG wearable device that features a design based on the Einthoven Triangle. The Peerbridge platform leverages ECG to diagnose and monitor the most important elements of cardiac care at a lower cost. Data captured provides actionable insights that promote early invention, reduce hospital visits, and saves lives.