Nuwellis Announces Acceptance by Frontiers in Pediatrics of New Single-Center Retrospective Study Supporting Alternative Anticoagulation Strategy for Aquadex Ultrafiltration Therapy
Rhea-AI Summary
Nuwellis (Nasdaq: NUWE) reported that a single-center retrospective study on its Aquadex ultrafiltration therapy in critically ill pediatric patients has been accepted for publication in Frontiers in Pediatrics. The study evaluated epoprostenol, a short-acting agent that inhibits platelet clumping, as the sole anticoagulant during Aquadex therapy.
The review of 46 children (52 treatment courses) at UPMC Children's Hospital of Pittsburgh (September 2022–September 2025) found that circuit performance was maintained, vasoactive support did not increase, platelet counts were stable or modestly higher, and no bleeding events were attributed to epoprostenol. The authors describe the work as a feasibility report rather than proof of superiority. Nuwellis said it only provided modest funding for open-access publication, with no support for conducting the research.
Positive
- 46 pediatric patients in 52 Aquadex treatment courses analyzed
- No bleeding events attributed to epoprostenol in the study cohort
- Vasoactive support requirements did not increase during epoprostenol use
- Filter life had a median duration of roughly two days
- Nuwellis funded only open-access publication costs, not study conduct
Negative
- Study was single-center, limiting generalizability of findings
- Authors classify results as feasibility report, not evidence of superiority
Market reaction after pediatric clinical data: NUWE +135.45% in the Jul 30 session
In the Jul 30 session, NUWE gained 135.45%, reflecting a significant positive market reaction. Argus tracked a peak move of +46.5% during that session. Argus tracked a trough of -63.5% from its starting point during tracking. Our momentum scanner triggered 192 alerts that day, indicating very high trading interest and price volatility. Trading volume was exceptionally heavy at 162.1x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 28 | Pediatric expansion | Positive | -3.0% | First Aquadex SmartFlow installations expanded Nuwellis's pediatric critical-care footprint. |
| Jul 27 | Revenue growth update | Positive | -2.9% | Preliminary second-quarter revenue showed double-digit year-over-year growth. |
| Jul 16 | Patent award | Positive | -5.8% | The USPTO issued a patent covering the company's dual-lumen catheter technology. |
| Jul 07 | Conference showcase | Neutral | -4.3% | Nuwellis planned to showcase Aquadex therapy at the KidneyBee Summit. |
| Jun 26 | Conference support | Neutral | -0.3% | The company marked five years supporting the pediatric cardiac critical-care consortium. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
All five recent news events had negative 24-hour reactions, including announcements describing pediatric expansion, revenue growth, and intellectual-property progress.
Key Terms
epoprostenol medical
anticoagulant medical
ultrafiltration medical
extracorporeal technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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.
For further information, please contact:
Investor Relations:
CORE IR
ir@nuwellis.com
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