Nuwellis’ Vivian Receives $3 Million NIH Grant to Accelerate Pediatric Platform and Strengthen Fluid-Management Portfolio

Core Insights - Nuwellis Inc. has received a $3 million multi-year grant from the NIH to support the development of its pediatric continuous renal replacement therapy (CRRT) device, Vivian, aimed at patients weighing between 2.5 and 20 kg [1][3] - The grant will facilitate critical software and firmware development, as well as an FDA investigational device study expected to enroll approximately 15 patients [3] Company Overview - Nuwellis is focused on transforming the lives of patients suffering from fluid overload through innovative medical devices, with its Aquadex SmartFlow system currently indicated for patients weighing 20 kg and above [8] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [8] Product Development - Vivian is designed specifically for neonates and children, featuring an extracorporeal blood volume of 29–67 mL and integrated sensors for real-time monitoring [5] - The device aims to provide tailored therapies for pediatric patients, including ultrafiltration (UF), continuous venovenous hemofiltration (CVVH), and continuous venovenous hemodialysis (CVVHD) on a single platform [5] Market Need - There is a significant gap in therapeutic options for babies and small children with kidney failure, often requiring adaptations of adult technologies, which can pose challenges [2] - The development of Vivian is a response to the need for pediatric-specific solutions that prioritize safety, precision, and simplicity for vulnerable patients [5]