RELIEF CARDIOVASCULAR REPORTS POSITIVE FIRST-IN-HUMAN DATA FOR DEVICE-BASED DECONGESTION THERAPY IN HEART FAILURE PATIENTS

• Designed to directly modulate venous pressure and disrupt the negative physiological loop between the heart and kidneys to reduce congestion.
• RELIEF-FIH met primary and functional endpoints, confirming device safety, enhanced renal flow, and accurate hemodynamic sensing.

IRVINE, Calif., March 3, 2026 /PRNewswire/ -- Relief Cardiovascular, Inc., a private medical device company developing intelligent device-based therapy solutions for heart failure (HF) congestion, today announced positive 90-day results from the prospective, multi-center RELIEF-FIH study. The study met all study endpoints, confirming procedural safety, sustained on-demand renal vein flow, and accuracy of the system's automatic hemodynamic pressure measurements. Data was presented by Dr. Alex Rothman, Professor of Cardiology from the University of Sheffield, at the Technology and Heart Failure Therapeutics (THT) 2026 Conference in Boston.

"The RELIEF-FIH study provides encouraging early evidence on a novel approach to HF congestion management," stated Dr. Alex Rothman. "By targeting the negative physiological cardiorenal loop, the Relief System modulates venous congestion in response to in vivo hemodynamic data. Early study data demonstrated sustained renal flow enhancement. The ability to actively drive decongestion while supporting renal function may represent a significant advancement over pharmaceutical strategies, which are often constrained by renal impact."

The Relief System is an integrated valve-and-sensor implant positioned in the inferior vena cava below the renal veins to directly modulate venous pressure and increase renal perfusion. The system collects daily venous pressure waveforms and enables programmed valve activation through a secure cloud platform, allowing clinicians to seamlessly deliver hemodynamically guided therapy in the home setting.

Promising data from the RELIEF-FIH study, which included 8 participants across 3 European sites, demonstrated:

• 100% procedural success, with a 7-minute average time from introducer insertion to removal post-implant.
• Favorable safety profile at 30 and 90 days, with zero device-related adverse events.
• Accurate hemodynamic measurement (R²=0.9) at 90 days as compared to right heart catheterization data.
• Sustained on-demand renal flow enhancement and pressure reduction with valve activation at 90 days.

"Sharing our positive FIH data is a significant milestone for the company and validates the promise of our integrated solution to driving decongestion based on venous hemodynamics," said Alex Cooper, Chief Executive Officer of Relief Cardiovascular. "Our FIH study lays a foundation as we expand our clinical experience to demonstrate the safety, functional, and efficacy benefits of the Relief System to reduce congestion in heart failure."

Additional findings confirmed seamless daily transmission of hemodynamic data, consistent valve performance, and successful delivery of hemodynamically guided therapy through the system's cloud-enabled interface in 100% of subjects over the 90 days. Across the study cohort, a reduction in heart failure hospitalizations compared to baseline was observed, supporting the potential for device-based congestion management.

About Relief Cardiovascular

Relief Cardiovascular, a privately held medical device company based in Irvine, California, is committed to extending relief from heart failure congestion from hospital to home. The company's first-of-its-kind valve-and-sensor implant intelligently modulates venous pressure using hemodynamic data. The system aims to actively adjust flow in the inferior vena cava (IVC), lowering venous pressure to drive durable decongestion in heart failure. An inQB8 Medical Technologies incubator company, Relief Cardiovascular, is backed by prominent medtech investors including Broadview Ventures, Advent Life Sciences, Good Growth Capital, and Heartwork Capital.

For inquiries, contact: [email protected]

SOURCE Relief Cardiovascular