Nuwellis Announces Termination of REVERSE-HF Clinical Trial to Focus on Strategic Growth in Outpatient Heart Failure Care

MINNEAPOLIS, July 17, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. today announced the termination of its REVERSE-HF clinical trial, a randomized post-market trial evaluating ultrafiltration vs. IV loop diuretic therapy for fluid management in hospitalized heart failure patients. This decision reflects the company’s strategic commitment to prioritize resources in areas demonstrating the greatest potential for patient impact and business growth—namely, outpatient heart failure, pediatric, and critical care.

“We’re incredibly grateful to the hospitals, investigators, and clinical teams who contributed their time and expertise to REVERSE-HF,” said John Erb, CEO of Nuwellis. “The trial was thoughtfully designed, and we remain confident in the role of ultrafiltration as a vital therapy for fluid management in heart failure. However, as we evaluate where we can make the most meaningful and scalable impact, it’s clear that the hospital-based outpatient setting presents the strongest opportunity in heart failure— for patients, our hospital customers, and for our business.”

Nuwellis is seeing increasing demand and interest of its ultrafiltration therapy in hospital-based outpatient heart failure programs. Redirecting investment from REVERSE-HF allows the company to accelerate progress in this high-potential area, while continuing to support ongoing strong growth in its pediatric and critical care customer categories. The company anticipates it will save approximately $4.0M over the next 2.5 years by terminating the REVERSE-HF clinical trial.

The REVERSE-HF Trial collected valuable data that may be helpful in informing clinical practice. The trial began enrolling patients in 2022, and at the time of its termination, it had enrolled 167 patients. The company intends to work with the steering committee, investigators, and biostatisticians to identify what statistical value can be derived from the existing data to support potential future clinical publications or podium presentations.

The decision to terminate the post-market clinical study was not related to device performance or patient safety concerns. The Nuwellis SmartFlow^® remains on the market as an FDA cleared treatment for patients suffering from fluid overload. 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:
Robert Scott
Chief Financial Officer
ir@nuwellis.com

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

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