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

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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.

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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

+135.45% 162.1x vol
192 alerts
+135.45% Session close to close
+46.5% Peak Tracked
-63.5% Trough Tracked
$590,335 Market Cap
162.1x Rel. Volume

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.

Market Context

The stock surged +135.4% in the session following this news. -3.02% followed Nuwellis's pediatric-in...
Analysis

The stock surged +135.4% in the session following this news. -3.02% followed Nuwellis's pediatric-installation announcement on July 28, providing a platform comparison for this pediatric evidence update. The active S-3 is a resale registration, while moderate short positioning remains a separate volatility risk.

Key Figures

Study population: 46 children Treatment courses: 52 treatment courses Study period: September 2022 to September 2025 +1 more
4 metrics
Study population 46 children Single-center retrospective study
Treatment courses 52 treatment courses UPMC Children's Hospital of Pittsburgh
Study period September 2022 to September 2025 Retrospective review
Median filter duration roughly two days Filters used during Aquadex therapy

Historical Context

5 past events · Latest: Jul 28 (Positive)
Pattern 5 events
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.

Pattern Detected

All five recent news events had negative 24-hour reactions, including announcements describing pediatric expansion, revenue growth, and intellectual-property progress.

Key Terms

epoprostenol, anticoagulant, ultrafiltration, extracorporeal
4 terms
epoprostenol medical
"demonstrating that epoprostenol may serve as a safe and feasible alternative anticoagulant"
A prescription drug that is a synthetic form of prostacyclin, used mainly to widen blood vessels and prevent clotting in conditions like pulmonary arterial hypertension. It acts like a chemical brake on vessel tightening and platelet clumping, helping blood flow through the lungs. For investors, its clinical trial outcomes, regulatory approval, manufacturing complexity, dosing method, and patent or exclusivity status influence commercial prospects and healthcare spending.
anticoagulant medical
"as the sole anticoagulant for children undergoing Aquadex ultrafiltration therapy"
An anticoagulant is a medicine that helps prevent blood from clotting or slows the formation of clots, used to reduce the risk of strokes, heart attacks, and other clot-related problems. For investors it matters because anticoagulants are widely prescribed, carry safety and regulatory risks, and drive sales and competition in drug markets—like a key product line whose approval, label changes, or safety concerns can materially affect a healthcare company’s revenue and stock outlook.
ultrafiltration medical
"children undergoing Aquadex ultrafiltration therapy in the intensive care unit"
Ultrafiltration is a process that separates small particles and liquids from larger molecules or substances using a filter with tiny pores. It is often used in water treatment and medical applications to remove impurities or excess fluids. For investors, understanding ultrafiltration is important because innovations or changes in this technology can impact industries focused on clean water, healthcare, and filtration products.
extracorporeal technical
"Its low extracorporeal blood volume has made it an important option"
Extracorporeal describes medical treatments or devices that act on blood, organs, or tissues outside the body for a period of time, such as filtering, oxygenating, or warming blood using a machine. Investors care because extracorporeal technologies form a distinct product market with specific regulatory paths, manufacturing needs, and recurring revenue from disposables; think of it like a laundromat for the body's fluids—specialized equipment doing work externally that patients and hospitals must repeatedly buy or use.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

Media Contact:
CORE PR
media@nuwellis.com


FAQ

What did the new pediatric Aquadex study reported by Nuwellis (NUWE) show?

The study found epoprostenol maintained Aquadex circuit performance without observed bleeding or increased vasoactive support. According to Nuwellis, platelet counts stayed stable or rose modestly, and filters lasted a median of roughly two days in critically ill children.

How many pediatric patients were included in the Nuwellis (NUWE) Aquadex epoprostenol study?

The retrospective study included 46 children across 52 Aquadex treatment courses. According to Nuwellis, all patients were treated at UPMC Children's Hospital of Pittsburgh between September 2022 and September 2025 in an intensive care setting.

Is epoprostenol considered a safe anticoagulant option for pediatric Aquadex therapy?

The study suggests epoprostenol may be a safe and feasible alternative anticoagulant. According to Nuwellis, no bleeding events were attributed to the drug and vasoactive support did not increase, but the authors classify the work as a feasibility report only.

How does epoprostenol affect bleeding risk and blood pressure support in the Nuwellis (NUWE) study?

Epoprostenol was not associated with bleeding events or higher vasoactive support needs in the cohort. According to Nuwellis, the drug maintained circuit patency while its short half-life allowed effects to wear off quickly once therapy stopped.

What are the key limitations of the pediatric Aquadex epoprostenol study highlighted by Nuwellis (NUWE)?

The authors present the findings as a feasibility report, not proof of superiority. According to Nuwellis, the research was single-center and retrospective, which may limit broader applicability and requires further study before changing standard practice.

Did Nuwellis (NUWE) fund the conduct of the pediatric epoprostenol Aquadex study?

Nuwellis did not fund the conduct of this research. According to Nuwellis, the company only provided modest financial support to the study site to cover open-access publication costs for the paper in Frontiers in Pediatrics.

What does the new Aquadex study mean for critically ill pediatric patients who cannot receive conventional anticoagulation?

The study indicates epoprostenol may offer an additional anticoagulation option for such patients. According to Nuwellis, the findings provide real-world data supporting Aquadex use when traditional anticoagulants are not appropriate, while emphasizing that evidence is still at the feasibility stage.