BaroPace

BaroPace, Inc. is a medical device company developing PressurePace, a real-time physiologic control software and hardware system designed to regulate cardiac pacemakers. The company's primary focus is on treating drug-resistant hypertension and heart failure with preserved ejection fraction (HFpEF). PressurePace is a proprietary pacemaker control algorithm that, for the first time, regulates a cardiac pacemaker according to blood pressure. This innovative approach aims to provide a more physiologic pacemaker-mediated heart rate response at rest and during exercise for patients with pacemakers.

The company's technology is based on the long-known relationship between heart rate and blood pressure, which had not been previously incorporated into pacemaker function. BaroPace's system is designed to mimic the body's normal physiology by integrating blood pressure data in real-time. The company successfully completed benchtop development of the PressurePace prototype in collaboration with Medtronic in 2021, followed by testing in an anesthetized animal model.

BaroPace has conducted several clinical studies to evaluate its technology. In 2021, the company completed a pilot prospective human study (Chairside-I) testing the PressurePace system in drug-resistant hypertension. In August 2022, BaroPace completed a randomized prospective human study comparing exercise tolerance in HFpEF patients using PressurePace versus standard pacemaker rate modulation. The results showed significant improvement in treadmill exercise tolerance with BaroPacing in all ten HFpEF patients tested.

In July 2023, BaroPace received approval from India's Central Drugs Standard Control Organisation (CDSCO) to conduct its first-in-human clinical trial, RelieveHFpEF-II. This multicenter, double-blind, crossover study aims to evaluate the safety and effectiveness of PressurePace in patients with HFpEF caused by hypertension. The first patient was enrolled in August 2023.