Lenox Hill Hospital Study Highlights the Broad Utility of Aquadex in Managing Fluid Overload Across Critical Care Settings

MINNEAPOLIS, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, addressing the critical interplay between the heart and kidneys, today announced the presentation of new real-world data from New York City’s Lenox Hill Hospital at the 2025 American Society of Nephrology (ASN) Kidney Week, reinforcing the versatility of Aquadex ^® ultrafiltration therapy in patients with acute kidney injury (AKI) and complex fluid management needs.

The retrospective analysis, titled “Diversifying Aquapheresis Applications in Critical Care: Nephrology-Led Institutional Experience” (Presentation #FR-PO0590), reviewed 69 cases treated with Aquadex between 2018 and 2024. The study demonstrated effective and predictable fluid removal in patients with multiple underlying conditions—ranging from oliguric AKI and post-cardiac-surgery volume overload to pre-operative optimization in end-stage renal disease.

The analysis found that patients had an average of 6.4 liters of ultrafiltrate removed over a mean duration of 78 hours , with stable hemodynamics even among those on vasopressor support.

“Volume optimization remains a cornerstone of critical-care management,” said Eduardo Pino Domenech, MD , Nephrologist at Lenox Hill Hospital and lead author of the study. “Our experience shows that Aquadex can be safely applied across a wide range of complex patients, offering clinicians an additional tool to achieve euvolemia when other measures are insufficient.”

The study was conducted in collaboration with Maria V. DeVita, MD , Chief of Nephrology at Lenox Hill Hospital, and Andrew A. Moses, MD , Nephrologist at Lenox Hill Hospital—both of whom play key roles in advancing innovative approaches to fluid management and renal care across the institution.

The findings build on growing evidence supporting precision ultrafiltration as a complement to traditional kidney replacement therapy. As outlined in Cardiorenal Medicine (Kazory et al., 2022), moderate and individualized ultrafiltration rates are associated with improved outcomes in critically ill patients with AKI and fluid overload. The 2023 POQI/ERAS Cardiac consensus similarly highlights goal-directed, patient-specific volume management as essential to preventing AKI and improving recovery following cardiac surgery.

By extending its application beyond traditional heart-failure cases, aquapheresis demonstrates increasing relevance in nephrology and critical care—where early, controlled fluid removal can stabilize hemodynamics, support renal recovery, and reduce downstream complications.

“This study reflects how clinicians are redefining fluid management as a vital sign of patient stability,” said Kelsey Newell, Senior Director of Medical Affairs at Nuwellis . “The ability to achieve predictable and gentle ultrafiltration with Aquadex is supporting care teams across the continuum—from cardiac ICUs to nephrology units.”

For more information, visit www.nuwellis.com .

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to advancing cardio-renal care by enabling earlier, safer, and more controlled fluid management for patients. 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.

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