Nuwellis terminates REVERSE-HF trial to focus on outpatient heart failure care

Nuwellis (NUWE) announced the termination of its REVERSE-HF clinical trial, a randomized post-market trial evaluating ultrafiltration vs. IV loop diuretic therapy for fluid management in hospitalized heart failure patients. This decision reflects the company’s strategic commitment to prioritize resources in areas demonstrating the greatest potential for patient impact and business growth-namely, outpatient heart failure, pediatric, and critical care. Nuwellis is seeing increasing demand and interest of its ultrafiltration therapy in hospital-based outpatient heart failure programs. Redirecting investment from REVERSE-HF allows the company to accelerate progress in this high-potential area, while continuing to support ongoing strong growth in its pediatric and critical care customer categories. The company anticipates it will save approximately $4M over the next 2.5 years by terminating the REVERSE-HF clinical trial. The REVERSE-HF Trial collected data that may be helpful in informing clinical practice. The trial began enrolling patients in 2022, and at the time of its termination, it had enrolled 167 patients. The company intends to work with the steering committee, investigators, and biostatisticians to identify what statistical value can be derived from the existing data to support potential future clinical publications or podium presentations. The decision to terminate the post-market clinical study was not related to device performance or patient safety concerns. The Nuwellis SmartFlow remains on the market as an FDA cleared treatment for patients suffering from fluid overload.