08:09 AM EDT, 07/17/2025 (MT Newswires) -- Nuwellis ( NUWE ) said Thursday it has terminated its REVERSE-HF clinical trial evaluating ultrafiltration in hospitalized heart failure patients, as part of a strategic shift to focus resources on outpatient heart failure, pediatric, and critical care areas.

The randomized post-market trial, which evaluated ultrafiltration versus IV loop diuretics for fluid management, had enrolled 167 patients at the time of termination.

Nuwellis ( NUWE ) said that the decision was not related to device performance or patient safety concerns. It said it is seeing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs and will redirect investment there. It said it expects to save about $4 million in the next 2.5 years by terminating the REVERSE-HF clinical trial.

Nuwellis SmartFlow system remains available on the market as an FDA-cleared treatment for fluid overload, the company said.

The shares of the company were down more than 11% in premarket activity.