Nuwellis Expands Aquadex® for Pediatric Fluid Management to Two New Hospital Systems

The Company has 47 Pediatric Centers utilizing Aquadex

/EIN News/ -- MINNEAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for patients with fluid overload, today announced a meaningful step forward for children facing fluid overload with the recent expansion of its Aquadex SmartFlow^® therapy into two additional pediatric centers across the Southeastern United States. The company now has 47 pediatric centers that have adopted Aquadex therapy as part of their fluid management approach.

Even in well-managed care settings, fluid overload can be a turning point in recovery for pediatric patients—who often have a narrow margin for error. When alternative therapies fall short, the patient risks can escalate quickly. More hospitals are now turning to Aquadex to support pediatric life-saving intervention, helping teams act before fluid overload drives complications and, in some cases, mortality.

“Pediatric patients require an added level of precision. The margin for error is narrow, and the clinical stakes are often immediate,” said John Jefferies, MD, MPH, FACC, FHFSA, Chief Medical Officer of Nuwellis. “That is why this expansion matters—it provides care teams with an additional therapeutic option for managing fluid overload in critically ill children.”

Aquadex is a nurse-managed, bedside-compatible therapy that allows for controlled, gentle fluid removal. Designed for use in adults and pediatric patients weighing 20 kg and above, it offers an approach that supports stability without the need for aggressive intervention—especially important in pediatric care.

For Nuwellis, the expansion is not just a number. It is a signal that more clinical teams are rethinking how and when they intervene. Early, precise fluid management is increasingly viewed as a path to better outcomes, and fewer setbacks, for this vulnerable population.

“Every new hospital that brings in Aquadex is one more team empowered to act with confidence and control,” said John Erb, Interim Chief Executive Officer of Nuwellis. “We are immensely proud to support that shift.”

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.

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.

For further information, please contact:

Investor Relations:
Louisa Smith
Gilmartin Group
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com