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MINNEAPOLIS - Nuwellis, Inc. (NASDAQ:NUWE), a medical device company with $8.3 million in trailing twelve-month revenue and a 62% gross margin, announced Tuesday findings from its ULTRA-Peds registry showing that 92% of critically ill pediatric patients survived treatment with the company’s Aquadex ultrafiltration system. According to InvestingPro analysis, while the company maintains strong liquidity with a current ratio of 2.16, it faces challenges with rapid cash burn.
The multi-center observational study, which enrolled 91 pediatric patients across eight U.S. centers, examined real-world use of Aquadex in children with acute kidney injury, fluid overload, or congenital kidney failure. The registry included patients with congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%).
Beyond the high treatment survival rate, the study reported that 66% of patients survived to hospital discharge, while 86% of circuits completed their intended treatment course without interruption.
"Seeing 92% of patients survive their treatment course is remarkable given the severity of illness in this population," said Dr. Michelle Starr, Associate Professor of Pediatrics at Indiana University School of Medicine and lead investigator of the registry, according to the company’s press release.
The Aquadex System is FDA-cleared for adult patients with fluid overload who have failed diuretic therapy, as well as for pediatric patients weighing 20kg or more. The registry included both retrospective and prospective arms, with some patients below this weight threshold in the retrospective portion.
Nuwellis is also developing Vivian, a dedicated pediatric continuous renal replacement therapy system for neonates and small children weighing between 2.5kg and 20kg. The company recently received a $3 million NIH development grant for this program.
The ULTRA-Peds registry was funded by Nuwellis as part of its commitment to advancing knowledge in pediatric kidney support.
In other recent news, Nuwellis, Inc. has been granted a U.S. patent for its hemolysis sensor technology used in blood filtration systems, including ultrafiltration therapy and continuous renal replacement therapy. This patent aims to enhance the detection of red blood cell destruction within or around the filtration circuit, supporting the development of Nuwellis’s pediatric device, Vivian. Additionally, the National Institutes of Health awarded approximately $3 million in grant funding to Koronis Biomedical Technologies Corporation, Nuwellis’s development partner, to advance the Vivian device for pediatric patients.
Nuwellis also plans to introduce a new 24-hour circuit for its Aquadex therapy in the United States this fall, designed for single-day outpatient sessions. This will complement their existing 72-hour option used for multi-day therapy or inpatient care. Meanwhile, New Era Energy & Digital, Inc. announced a significant fiber network development deal through its joint venture with Sharon AI. The agreement involves developing a 1,600-mile fiber optic network across Texas, aiming to create one of the region’s largest digital backbones for artificial intelligence, hyperscale, and cloud workloads.
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