Nuwellis Announces Acceptance of Multicenter Pediatric Aquadex Study in Pediatric Nephrology

Combining the registry with earlier studies expanded the clinical evidence evaluated to 208 pediatric patients.

Rhea-AI Summary

Nuwellis (NUWE) announced publication in Pediatric Nephrology of a multicenter study evaluating Aquadex kidney support in pediatric patients. The ULTRA-Peds Registry included 91 patients across seven hospitals; 62% weighed less than 10 kg, including 41 patients below 5 kg. During Aquadex treatment, 87% survived their treatment course, and 86.5% of procedures were completed without interruption.

Approximately 68% of cases with complete data lasted their planned treatment duration. Most circuits ending early did so because of vascular access problems or clotting. Nuwellis intends to use the evidence to support a proposed labeling expansion from patients weighing 20 kg and above to those weighing 5 kg and above, following a completed FDA pre-submission meeting.

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 3 points

How the balance works

Positive

• Moderate pointFDA pre-submission meeting completed for the proposed expansion to patients weighing 5 kg and above.
• Minor pointPediatric Nephrology publication adds multicenter clinical evidence from 91 pediatric patients across seven hospitals.
• Minor point87% of patients survived their Aquadex treatment course.
• Minor point86.5% of procedures were completed without interruption.
• Minor pointCombined research evaluated clinical outcomes across 208 pediatric patients, expanding the available evidence.

Negative

• Moderate pointLabel expansion remains proposed; current FDA-cleared labeling covers patients weighing 20 kg and above.
• Minor pointApproximately 68% of cases with complete data lasted their planned treatment duration.
• Minor pointVascular access problems or clotting caused most circuits that ended early to stop.

News Explained

The publication adds more than the 91-patient registry alone: researchers combined its findings with three earlier Aquadex cohorts—patients under 10 kg, 10–20 kg, and over 20 kg—for reported outcomes across 208 pediatric patients.

Key Figures

Registry participants and hospitals: 91 patients across 7 hospitals Patients weighing less than 10 kg: 62% Patients weighing less than 5 kg: 41 patients +5 more

Registry participants and hospitals

91 patients across 7 hospitals

ULTRA-Peds Registry

Patients weighing less than 10 kg

62%

Enrolled patients

Patients weighing less than 5 kg

41 patients

Enrolled patients

Survived Aquadex treatment course

87%

Registry patients

Procedures completed without interruption

86.5%

Registry procedures

Cases lasting planned treatment duration

approximately 68%

Cases with complete data

Combined pediatric patients

208 patients

ULTRA-Peds Registry and earlier studies

Proposed minimum patient weight

5 kg and above

Proposed Aquadex label expansion; article states current labeling is 20 kg and above

Historical Context

1 past event · Latest: Oct 08

1 event

1. Oct 08

   Pediatric development update

   24h Move

   -2.3%

   Prior notice cited a proposed Aquadex label expansion to patients weighing 5 kg or more, versus the 20 kg minimum.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ultrafiltration, acute kidney injury, kidney replacement therapy, extracorporeal, +1 more

5 terms

ultrafiltration medical

"Aquadex SmartFlow® System ultrafiltration technology"

Ultrafiltration is a process that separates small particles and liquids from larger molecules or substances using a filter with tiny pores. It is often used in water treatment and medical applications to remove impurities or excess fluids. For investors, understanding ultrafiltration is important because innovations or changes in this technology can impact industries focused on clean water, healthcare, and filtration products.

acute kidney injury medical

"including those with acute kidney injury, fluid overload, and kidney failure"

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

kidney replacement therapy medical

"support kidney replacement therapy and fluid management"

Kidney replacement therapy is medical treatment that takes over the blood-cleaning and fluid-balancing jobs of failed kidneys, most commonly via dialysis machines or by transplanting a donor kidney. Investors watch it because it drives durable demand for devices, drugs, clinics and transplant services, and changes in technology, regulation or reimbursement can materially affect costs, patient access and the revenues of companies in the renal care market.

extracorporeal medical

"Providing extracorporeal kidney support to infants and small children"

Extracorporeal describes medical treatments or devices that act on blood, organs, or tissues outside the body for a period of time, such as filtering, oxygenating, or warming blood using a machine. Investors care because extracorporeal technologies form a distinct product market with specific regulatory paths, manufacturing needs, and recurring revenue from disposables; think of it like a laundromat for the body's fluids—specialized equipment doing work externally that patients and hospitals must repeatedly buy or use.

fluid overload medical

"including those with acute kidney injury, fluid overload, and kidney failure"

Fluid overload is an excess buildup of fluid in the body that can cause swelling, shortness of breath, and strain on the heart and lungs — like overwatering a sponge so it bulges and drips. It matters to investors because it drives demand for treatments, affects hospital length of stay and costs, can create safety risks in clinical trials, and therefore influences revenue, regulatory scrutiny, and valuation for healthcare companies.

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ULTRA-Peds Registry evaluated 91 pediatric patients across seven leading children's hospitals, providing important clinical evidence which the Company intends to use to support its proposed label expansion of Aquadex’s indication to patients weighing 5 kg and above

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.

For further information, please contact:

Investor Relations:
CORE IR
ir@nuwellis.com

Media Contact:
CORE PR
media@nuwellis.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Nuwellis's ULTRA-Peds Aquadex study find?

Among 91 pediatric patients across seven hospitals, 87% survived their Aquadex treatment course, while 86.5% of procedures were completed without interruption. Approximately 68% of cases with complete data lasted their planned treatment duration. These measures describe different aspects of treatment outcomes and performance.

What pediatric label expansion is Nuwellis seeking for Aquadex?

Nuwellis is seeking to expand Aquadex's FDA-cleared labeling from patients weighing 20 kg and above to those weighing 5 kg and above. The company intends to use the registry evidence to support that proposed expansion and completed an FDA pre-submission meeting earlier this year.

Who funded Nuwellis's ULTRA-Peds Aquadex study?

Nuwellis funded the study through a grant to the Acute Kidney Injury Critical Care Research Foundation, managed by Watermark Partners. Nuwellis had no input on data analysis, presentation or publication of the results.