Nuwellis Announces Acceptance by Frontiers in Pediatrics of New Single-Center Retrospective Study Supporting Alternative Anticoagulation Strategy for Aquadex Ultrafiltration Therapy

Peer-reviewed research demonstrates epoprostenol maintained circuit performance without observed bleeding events or increased vasoactive support in critically ill pediatric patients

MINNEAPOLIS, July 30, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, announces the acceptance of a new single-center retrospective study in Frontiers in Pediatrics, a multi-disciplinary peer-reviewed journal that addresses challenges in pediatric patient care and child health, demonstrating that epoprostenol may serve as a safe and feasible alternative anticoagulant during Aquadex therapy in critically ill pediatric patients. The study, “Epoprostenol as an Alternative Anticoagulant for Pediatric Aquadex Therapy: A Safe and Feasible Option,” reports the first documented use of epoprostenol, a short-acting drug that prevents platelet clumping, as the sole anticoagulant for children undergoing Aquadex ultrafiltration therapy in the intensive care unit. In the critically ill children studied, the approach maintained the filtering circuit, did not increase the need for blood-pressure support, and was not associated with any bleeding events.

“Acceptance of a study in a respected peer-reviewed journal represents another important milestone in the expanding clinical evidence supporting Aquadex therapy in pediatric critical care,” said Nuwellis CEO Mike McCormick. “As physicians care for increasingly complex pediatric patients, high-quality clinical evidence becomes essential to expanding confidence in Aquadex therapy. This study provides important real-world data supporting an alternative anticoagulation strategy for patients who may not be candidates for conventional therapies and further strengthens the growing body of evidence supporting broader adoption of Aquadex.”

“For our sickest children, the usual ways of keeping these circuits open aren't always good options. This study suggests epoprostenol could give us another tool at the bedside, one that doesn't add to bleeding risk or require intensive metabolic monitoring,” said Dana Y. Fuhrman, DO, MS, the study's senior author.

The retrospective study reviewed 46 children (52 treatment courses) treated at UPMC Children's Hospital of Pittsburgh from September 2022 to September 2025. Filters lasted a median of roughly two days each, platelet counts held steady or rose modestly, the need for vasoactive support did not increase, and no bleeding was attributed to the drug. Epoprostenol's short half-life means its effect wears off quickly when therapy stops. The authors frame the findings as a feasibility report, not proof of superiority. 

The research adds to the growing body of evidence supporting Aquadex therapy in pediatric critical care and may provide clinicians with an additional therapeutic option for patients in whom conventional anticoagulation is not appropriate.

Nuwellis’ Aquadex system provides precise, controlled ultrafiltration for patients suffering from fluid overload. Its low extracorporeal blood volume has made it an important option for pediatric patients requiring extracorporeal fluid removal, especially those who may not tolerate traditional renal replacement therapies.

Nuwellis provided modest financial support to the study site to underwrite the cost of open access publication for this paper. It provided no funding for the conduct of this research.

About Aquadex
The Aquadex SmartFlow System is 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’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. 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.

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