Nuwellis to Exit International Operations to Accelerate U.S. Revenue Growth and Strategic Focus

MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced its decision to exit international operations in order to focus exclusively on the U.S. market—where the company is seeing the strongest growth and clinical demand.

This strategic realignment supports Nuwellis’ core business strategy: investing in the markets driving revenue growth. With expanding traction in U.S. cardiac surgery and pediatric programs, and a rising opportunity in the hospital-based outpatient space, the company is streamlining to prioritize investment in markets where it can have the most immediate and long-term impact.

“This move allows us to fully align our operations where the fastest growth is happening,” said John Erb, CEO of Nuwellis. “We’re investing in the areas that are showing momentum—and that means doubling down on the U.S. market. Our focus is on delivering results for patients and providers in high-acuity and hospital-based outpatient settings.”

Cardiac surgery, pediatrics, and outpatient models are emerging as the strongest growth drivers for Nuwellis, offering faster intervention, better patient outcomes, and more efficient resource use. This strategic pivot positions the company to lead in this evolving care landscape.

The company will continue to support its international partners through a structured wind-down period. This shift underscores Nuwellis’ broader strategy to align operations with market demand and deliver shareholder value through operational discipline and customer focus.

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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 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:

Robert Scott

Chief Financial Officer

Media Contact:

Leah McMullen

Director of Communications