Summary: Peerbridge Health has launched the COR-INSIGHT trial to validate the diagnostic capabilities of its Peerbridge Cor ambulatory ECG wearables, which leverage two AI-enabled SaMD platforms—CardioMIND for cardiovascular and sleep disorder indications and CardioQSync for cardiopulmonary and hemodynamic monitoring. The trial aims to provide a non-invasive, cost-effective alternative for over 30 diagnostic indications in hospital and home settings. Enrolling up to 15,000 participants, the trial seeks to improve accessibility to diagnostics and remote patient care.
Key Takeaways:
- ECG Wearables Under Review: The COR-INSIGHT trial will assess the diagnostic nad screening capabilities Peerbridge Cor ambulatory ECG wearables.
- Expanding Access to Diagnostics: The trial highlights the wearable’s potential to provide low-cost diagnostics across hospital, outpatient, and home settings, with applications in early disease detection, remote monitoring, and virtual cardiology.
- Large-Scale Trial for Real-World Data: With up to 15,000 participants, the study aims to evaluate the wearable’s performance in addressing conditions affecting millions of Americans, including heart failure and obstructive sleep apnea.
Peerbridge Health, known for its AI-powered ambulatory ECG wearables capable of detecting obstructive sleep apnea and heart conditions, has launched the COR-INSIGHT trial, which will validate the screening and diagnostic capabilities of its Peerbridge Cor ambulatory ECG wearables.
The trial seeks to improve cardiovascular and cardiopulmonary monitoring and sceening by providing a seamless, non-invasive alternative to traditional diagnostic modalities. The trial will leverage two artificial intelligence software as a medical device platforms: CardioMIND, an ECG+ analytical pipeline for cardiovascular indications and sleep disorder, and CardioQSync, a quantum-resonance based approach for extraction of cardiopulmonary and hemodynamic indications from respiratory ECG.
The trial will prospectively evaluate multiplexed on-demand diagnostics directly from continuous ECG in hospital and home settings, integrating data-rich metrics for 30-plus indications. The American Heart Association statistical estimates place over 160 million adult Americans at risks 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.
“This trial represents an exciting leap forward in inexpensive, remote patient care,” says Chris Darland, CEO of Peerbridge Health, in a release. “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.”
Expanding Accessibility Across Care Settings
The COR-INSIGHT trial underscores the versatility of the Peerbridge Cor wearable, which aims 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 the monitoring in diverse settings, including outpatient, in-hospital, and home environments.
A successful trial will have far-reaching impact across the cardiology space. Use cases include:
- Early disease detection with rapid cardiac screening & diagnostics: As 50% of indications can be computed with as little as five minutes of wear, inexpensive assessments can be done 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: 25% 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: 90% of US rural counties do not have a cardiologist. Enabling inexpensive and remote hospital-grade cardiac and cardiopulmonary assessments prior to a virtual cardiology appointment extends the reach of cardiologists to tens of millions of patients that are being missed today.
Enrollment
The trial will enroll up to 15,000 participants from diverse demographics, ensuring robust data that reflects real-world clinical challenges. In addition to Peerbridge sites, the company will also be partnering with the HeartX program to expand participation with cardiologists at HCA, Mercy Health, and Louisiana Cardiology Associates in the first quarter of 2025.
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