Nuwellis Announces 92% Survival in Children with Acute Kidney Injury (AKI), Fluid Overload or Congenital Kidney Failure Following Treatment with Aquadex

ULTRA-Peds Registry, the largest multi-center dataset of its kind, shows Aquadex therapy was well-tolerated in critically ill children, a population with extremely limited treatment options

Results highlight life-threatening gaps in pediatric care and underscore Nuwellis’ commitment to pediatric innovation and integrated cardio-renal care

MINNEAPOLIS, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today announced findings from the ULTRA-Peds registry, a multi-center observational study examining the real-world use of the Aquadex System in children with acute kidney injury (AKI), fluid overload, or congenital kidney failure.

The ULTRA-Peds registry enrolled 91 pediatric patients across eight U.S. centers, representing a comprehensive real-world dataset to date in this vulnerable population. Diagnoses included congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%).

Results demonstrated strong survival and procedural success:

• 92% of patients survived their Aquadex treatment course
• 66% survived to hospital discharge
• 86% of circuits completed their intended treatment course without interruption
• Heparin anticoagulation was associated with longer circuit duration compared to bivalirudin

These findings show that Aquadex therapy is both feasible and well tolerated in critically ill children, a population with extremely limited treatment alternatives.

“The ULTRA-Peds registry provides insight into how young children and infants are treated with ultrafiltration and modified dialysis using the Aquadex device,” said Dr. Michelle Starr, Associate Professor of Pediatrics at Indiana University School of Medicine and Riley Hospital for Children’s Division of Pediatric Nephrology and lead investigator of the registry. “Seeing 92% of patients survive their treatment course is remarkable given the severity of illness in this population. These results not only help us understand what is happening at the bedside, they highlight why new pediatric-specific devices are urgently needed.”