Nuwellis, Inc. announced on July 17, 2025, the termination of its REVERSE-HF clinical trial, a randomized post-market study comparing ultrafiltration therapy to IV loop diuretic treatment for fluid management in hospitalized heart failure patients. The Minneapolis-based medical device company made this strategic decision to redirect resources toward markets with higher scalable impact potential, specifically outpatient heart failure care, pediatric applications, and critical care settings.
Strategic Shift Toward Outpatient Care
"We're incredibly grateful to the hospitals, investigators, and clinical teams who contributed their time and expertise to REVERSE-HF," said John Erb, CEO of Nuwellis. "The trial was thoughtfully designed, and we remain confident in the role of ultrafiltration as a vital therapy for fluid management in heart failure. However, as we evaluate where we can make the most meaningful and scalable impact, it's clear that the hospital-based outpatient setting presents the strongest opportunity in heart failure—for patients, our hospital customers, and for our business."
The company is experiencing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs. This growing interest has influenced the strategic decision to terminate the inpatient-focused REVERSE-HF trial and accelerate investment in outpatient applications.
Financial and Operational Impact
The termination of REVERSE-HF is expected to generate significant cost savings for Nuwellis, with the company anticipating approximately $4.0 million in savings over the next 2.5 years. These resources will be redirected to support the company's growth in outpatient heart failure care while continuing to expand its pediatric and critical care customer segments.
Trial Data and Future Applications
The REVERSE-HF trial began enrolling patients in 2022 and had successfully enrolled 167 patients at the time of termination. Despite the early conclusion, the company believes the collected data may provide valuable insights for clinical practice. Nuwellis intends to collaborate with the steering committee, investigators, and biostatisticians to analyze the existing data and identify statistical value that could support future clinical publications or conference presentations.
Device Safety and Market Position
The company emphasized that the decision to terminate the post-market clinical study was not related to device performance or patient safety concerns. The Nuwellis SmartFlow® system remains FDA-cleared and continues to be available as a treatment option for patients suffering from fluid overload.
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system provides ultrafiltration therapy for removing excess fluid from patients with hypervolemia (fluid overload). The device is indicated for both temporary (up to 8 hours) and extended use (longer than 8 hours in hospitalized patients) in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by trained healthcare providers in clinical settings under physician prescription.
