Nuwellis Inc (NASDAQ:NUWE) saw its stock decline by 10% after announcing it will discontinue its REVERSE-HF clinical trial, which was assessing the effectiveness of ultrafiltration versus intravenous loop diuretics for managing fluid overload in hospitalized heart failure patients.
The company explained that ending the trial is part of a broader effort to concentrate resources on areas with greater clinical and commercial potential—namely, outpatient heart failure care, pediatric applications, and critical care.
By suspending the study, Nuwellis estimates it will conserve around $4 million in expenses over the next two and a half years. Importantly, the company clarified that the decision was not driven by concerns about the device’s performance or safety. The SmartFlow system remains FDA-cleared and available for treating fluid overload in patients.
“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.”
Launched in 2022, the REVERSE-HF trial had enrolled 167 patients by the time of its cancellation. Nuwellis plans to collaborate with the trial’s steering committee, investigators, and biostatisticians to evaluate whether meaningful insights can be extracted from the current dataset for future clinical publications.
Looking ahead, the company highlighted growing interest in its ultrafiltration technology among hospital-based outpatient heart failure programs. It believes reallocating resources to this segment will help speed development while supporting continued momentum in pediatric and critical care markets.
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