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."
"ULTRA-Peds registry validates the potential of Aquadex and points us directly toward the future," said Dr. Stuart Goldstein, Professor of Pediatrics at University of Cincinnati and Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center.
"These results highlight both the resilience of these children and the urgent need for dedicated technology," said Kelsey Newell, Senior Director of Medical Affairs at Nuwellis. "They also inform our Vivian program, which is supported by NIH funding and new intellectual property. Combined, this positions Nuwellis to transform pediatric kidney support while advancing our broader mission in cardio-renal care."
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 ULTRA-Peds registry included two distinct arms, one of which was a retrospective review of prior use cases already completed, so included some patients under this weight threshold and the other, which was exclusively prospective and on -label.
The ULTRA-Peds registry is more than a dataset - it highlights a critical gap in care and provides a foundation for Nuwellis' pediatric and cardio-renal strategy. Building on these findings, Nuwellis is advancing development of Vivian, a dedicated pediatric continuous renal replacement therapy (CRRT) system designed specifically for neonates and small children weighing between 2.5kg and 20kg. Unlike existing technologies adapted from adult use, Vivian is purpose-built to address the delicate physiology of infants and provide clinicians with a safer, more precise tool for kidney support. The program recently received a $3 million NIH development grant and is protected by newly issued patents, underscoring both the clinical importance and innovation behind this technology. Together, ULTRA-Peds and Vivian represent a deliberate, staged approach to transforming pediatric kidney support and advancing Nuwellis' broader leadership in cardio-renal care.
The company's roadmap is designed to move from evidence to innovation to leadership:
- Support evidence generation through registries like ULTRA-Peds to better understand real-world care.
- Advance Vivian development to provide a device designed specifically for infants and small children.
- Lead in cardio-renal care across all ages by addressing the interconnected needs of the heart and kidneys.
The registry was funded by Nuwellis as part of the company's commitment to advancing knowledge in pediatric kidney support.
For more information, visit www.nuwellis.com.
About Nuwellis Nuwellis, Inc. (NASDAQ:NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.
About the Aquadex SmartFlow® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
About Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.
Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.
Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
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