S&P 500 slips, but losses kept in check as Nvidia climbs ahead of results
Investing.com -- Nuwellis Inc (NASDAQ:NUWE) stock tumbled 10% after the company announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for fluid management in hospitalized heart failure patients.
The company said the decision to end the trial reflects its strategic commitment to prioritize resources in areas showing the greatest potential for patient impact and business growth, specifically outpatient heart failure, pediatric, and critical care settings.
Nuwellis expects to save approximately $4.0 million over the next 2.5 years by terminating the clinical trial. The company noted that the decision was not related to device performance or patient safety concerns, and its SmartFlow system remains on the market as an FDA-cleared treatment for patients suffering from fluid overload.
"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."
The REVERSE-HF trial began enrolling patients in 2022 and had enrolled 167 participants at the time of termination. Nuwellis plans 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.
The company indicated it is seeing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs and believes redirecting investment will allow it to accelerate progress in this area while supporting ongoing growth in pediatric and critical care customer categories.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.