MINNEAPOLIS, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced the publication of results from a multicenter study titled "Kidney Support in Infants and Children using Aquadex: Findings from the ULTRA-Peds Registry” in Pediatric Nephrology. It provides important clinical evidence supporting the use of the Company's Aquadex SmartFlow® System ultrafiltration technology in pediatric patients, including infants and children weighing less than 10 kg. The publication examining the outcomes and implications was authored by Michelle C. Starr, M.D., MPH; Stuart L. Goldstein, M.D.; Shina Menon, M.D.; David Askenazi, M.D., MSPH; David M. Kwiatkowski, M.D.; and Alexandru R. Constantinescu, M.D. The ULTRA-PEDS study was funded by Nuwellis, Inc via a grant to the Acute Kidney Injury Critical Care Research Foundation, managed by Watermark Partners (Indianapolis, IN). Nuwellis had no input on data analysis, presentation or publication of these results.
“The ULTRA-Peds Registry represents an important addition to the growing body of clinical evidence supporting Aquadex therapy in pediatric patients,” said Michelle Starr, M.D., first author of the ULTRA-Peds publication. “This study brings together clinical experience from seven pediatric hospitals and provides valuable real-world evidence on the use of Aquadex in some of our smallest and most vulnerable patients.”
The study evaluated 91 pediatric patients treated with Aquadex across seven leading children's hospitals, examining patient outcomes, treatment characteristics, and device performance. Of the enrolled patients, 62% weighed less than 10 kg, including 41 patients weighing less than 5 kg. Results demonstrated that 87% of patients survived their Aquadex treatment course, and 86.5% of procedures were completed without interruption. The findings provide additional evidence of the system's ability to support kidney replacement therapy and fluid management in critically ill pediatric patients, including those with acute kidney injury, fluid overload, and kidney failure.
The ULTRA-Peds Registry was designed to collect both clinical and machine-level data from pediatric patients receiving Aquadex therapy. In addition to evaluating patient outcomes, the study examined technical performance, including circuit duration, blood flow rates, and treatment interruptions. Researchers found that approximately 68% of cases with complete data lasted their planned treatment duration, providing additional insights into the system's performance in critically ill pediatric patients. Most circuits that ended early did so because of vascular access problems or clotting, challenges common in this patient population.
"Providing extracorporeal kidney support to infants and small children presents significant clinical and technical challenges, particularly given their small blood volume and the precision required to manage fluid balance safely," said Stuart Goldstein, M.D., Director of Clinical Strategy at Nuwellis and a co-author of the study. "The ULTRA-Peds Registry provides important multicenter data on both clinical outcomes and device performance, demonstrating the feasibility of Aquadex therapy in critically ill pediatric patients, including very small infants. These findings add to our understanding of how to optimize kidney support and fluid management in this unique patient population." Dr. Goldstein’s appointment as Director of Clinical Strategy was first announced in March of this year. The registry first opened in March of 2021.
The study also builds on previously published research involving Aquadex therapy in children. By combining findings from the ULTRA-Peds Registry with earlier studies looking at 3 cohorts of patients determined by weights of <10 kg, 10-20 kgs, and >20Kgs being treated with Aquadex, researchers evaluated clinical outcomes across a total of 208 pediatric patients, further expanding the available evidence on Aquadex use in this population.
Earlier this year, Nuwellis announced the successful completion of a pre-submission meeting with the U.S. Food and Drug (FDA) seeking to expand Aquadex’s FDA-cleared labeling from patients weighing 20 kg and above to those weighing 5 kg and above.
About Aquadex
The Aquadex SmartFlow System is currently indicated for the continuous ultrafiltration therapy 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 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis' strategy includes expanding its portfolio through internally developed technologies and strategic commercial partnerships that broaden its presence across acute and chronic critical care. For more information, visit www.nuwellis.com.
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 2026 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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