Nuwellis Expands Pediatric Footprint with First Aquadex SmartFlow® Installations in Wisconsin
Rhea-AI Summary
Nuwellis (Nasdaq: NUWE) announced its entry into Wisconsin’s pediatric critical care market through the first installations of its Aquadex SmartFlow® systems at a leading pediatric academic medical center. The collaboration aims to build clinical pathways and integrate Aquadex therapy into the hospital’s pediatric program.
The company continues to focus on pediatric and critical care expansion, targeting fluid-overloaded patients unresponsive to diuretics and weighing 20 kilograms or more. Nuwellis recently completed a pre-submission meeting with the FDA on expanding the Aquadex label to patients 5 kilograms and above and anticipates a 510(k) submission by the end of 2026.
Positive
- First Aquadex SmartFlow pediatric installations in Wisconsin
- Expansion into a premier regional pediatric academic medical center
- Strategic focus on pediatric programs as a growth opportunity
- Completed FDA pre-submission for label expansion to patients ≥5 kg
- Planned 510(k) submission for expanded pediatric label by end of 2026
Negative
- None.
Market reaction after pediatric expansion: NUWE -3.02% in the Jul 28 session
In the Jul 28 session, NUWE declined 3.02%, reflecting a moderate negative market reaction. Argus tracked a peak move of +96.1% during that session. Argus tracked a trough of -12.0% from its starting point during tracking. Our momentum scanner triggered 107 alerts that day, indicating very high trading interest and price volatility. Trading volume was exceptionally heavy at 63.1x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 16 | Patent award | Positive | -5.8% | USPTO issued a patent covering dual-lumen catheter technology for extracorporeal therapies. |
| Jul 07 | Therapy showcase | Positive | -4.3% | Company planned pediatric clinician engagement at the KidneyBee Summit in Colorado. |
| Jun 26 | Conference support | Positive | -0.3% | Company marked five years supporting the Pediatric Cardiac Critical Care Consortium conference. |
| Jun 25 | Pediatric expansion | Positive | +6.3% | Company installed three Aquadex SmartFlow systems at its first Michigan pediatric program. |
| Jun 24 | Leadership update | Positive | -30.5% | Incoming CEO outlined pediatric expansion, revenue growth, margin improvement, and capital priorities. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent company news was followed by negative 24-hour reactions in four of five events, with the Michigan pediatric expansion as the exception.
Key Terms
cardiorenal medical
ultrafiltration medical
510(k) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Entry into Wisconsin’s pediatric critical care market supports the continued growth of Nuwellis' pediatric ultrafiltration platform
MINNEAPOLIS, July 28, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, announces its expansion into Wisconsin with the installation of its first Aquadex SmartFlow® systems at a leading pediatric healthcare institution. The installation further expands the Company's growing presence in pediatric critical care at one of the region's premier academic medical centers.
"Establishing our first pediatric program in Wisconsin reflects the continued momentum of our pediatric growth and increasing clinical adoption of our Aquadex therapy and entry into a key market facilitating continued growth in our largest customer category," said Nuwellis’ CEO Mike McCormick. "Leading pediatric hospitals continue to recognize the importance of precise fluid management for critically ill children. This collaboration provides an opportunity to establish clinical protocols and workflows that can support broader utilization of Aquadex therapy over time while strengthening our presence in another important pediatric market."
The new system installations will support the development of clinical pathways and integrate Aquadex therapy into the hospital's pediatric care program. Nuwellis continues to prioritize expansion within pediatric and critical care settings, where clinicians are increasingly adopting Aquadex therapy to provide controlled, predictable fluid removal for patients suffering from fluid overload. Pediatric programs remain a strategic growth opportunity as the Company works to broaden access to the therapy and further strengthen its leadership position in the category.
The Aquadex SmartFlow System is designed to provide precise ultrafiltration therapy for adult and pediatric patients weighing 20 kilograms and above who are suffering from fluid overload and are unresponsive to medical management, including diuretics. Nuwellis recently completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed expansion of the Aquadex label to support pediatric patients weighing 5 kilograms and above. The Company anticipates a 510(k) submission to the FDA for the expanded label by the end of 2026.
About Aquadex
The Aquadex SmartFlow System is currently 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
