Nuwellis has ended its REVERSE HF randomized trial comparing ultrafiltration with IV loop diuretics in hospitalized heart failure patients after enrolling 167 participants since 2022. The decision aims to reallocate resources toward outpatient markets with greater growth potential.
CEO John Erb emphasized confidence in ultrafiltration’s role but noted hospital-based outpatient settings offer stronger opportunities for patients and business growth. The trial shutdown is expected to save about $4 million over 2.5 years.
The company clarified the termination is unrelated to device safety or performance. Its FDA-cleared Aquadex SmartFlow ultrafiltration system remains available for adults and pediatric patients unresponsive to diuretics, with increasing demand in outpatient heart failure programs and pediatric critical care.
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