Nuwellis, Inc. operates as a medical device company. It engages in the provision of products for the treatment of fluid overload. The firm's products include Aquadex FlexFlow System, which provides an ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload. It operates through Cardiac and Coronary Disease Products segment. The company was founded by Crispin Marsh and William S. Peters in November 1999 and is headquartered in Eden Prairie, MN.
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- Nuwellis successfully completed an FDA pre-submission meeting to expand Aquadex SmartFlow System labeling for pediatric patients weighing 5 kg and above, down from the current 20 kg minimum. - Multiple publications from leading pediatric centers over the past 10 years have demonstrated safe and effective use of Aquadex in patients weighing less than 20 kg. - The FDA provided constructive feedback on the regulatory pathway, including requirements for 510(k) submission supported by bench testing, toxicological assessments, and pediatric clinical evidence. - The company anticipates submitting the 510(k) application to the FDA by the end of 2026 to address significant unmet needs in low-weight pediatric patients with fluid overload.
- Nuwellis received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC) to support ultrafiltration therapy for fluid overload patients. - The catheter features coil reinforcement and dual-lumen design to provide reliable peripheral venous access with central-line performance for up to 72 hours. - The cleared portfolio now includes two catheter lengths (11 cm and 15 cm) designed to accommodate different patient anatomies and clinical workflows across care settings. - This clearance advances Nuwellis' multi-year strategy to build a comprehensive fluid management platform targeting critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.
- Nuwellis announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for hospitalized heart failure patients. - The company will redirect resources toward outpatient heart failure programs, pediatric, and critical care markets where it sees greater scalable impact and business growth potential. - The decision will save approximately $4.0 million over the next 2.5 years and was not related to device performance or safety concerns. - The terminated trial had enrolled 167 patients since beginning enrollment in 2022, and the company plans to analyze existing data for potential clinical publications.
