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Nuwellis Announces 92% Survival in Children with Acute Kidney Injury (AKI), Fluid Overload or Congenital Kidney Failure Following Treatment with Aquadex®
Globenewswire· 2025-09-30 12:45
Core Insights - The ULTRA-Peds registry reveals that Aquadex therapy is well-tolerated in critically ill children, highlighting significant gaps in pediatric care and Nuwellis' commitment to innovation in this field [1][3][4] Study Overview - The ULTRA-Peds registry enrolled 91 pediatric patients across eight U.S. centers, with diagnoses including congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%) [2] - The registry provides a comprehensive real-world dataset for understanding treatment in this vulnerable population [2] Results and Findings - The results indicate strong survival rates, with 92% of patients surviving their treatment course and 66% surviving to hospital discharge [7] - 86% of circuits completed their intended treatment course without interruption, demonstrating the feasibility of Aquadex therapy in this demographic [7] Future Developments - Nuwellis is advancing the development of Vivian, a dedicated pediatric continuous renal replacement therapy (CRRT) system designed for neonates and small children weighing between 2.5 kg and 20 kg [6] - Vivian aims to address the unique physiological needs of infants, providing a safer and more precise tool for kidney support [6][11] Company Strategy - The company's roadmap focuses on moving from evidence to innovation to leadership in pediatric kidney support, supported by NIH funding and new intellectual property [5][6] - The ULTRA-Peds registry serves as a foundation for Nuwellis' pediatric and cardio-renal strategy, emphasizing the urgent need for dedicated technology in this area [6][8]