Nuwellis Announces Pediatric Expansion in Michigan with First Aquadex SmartFlow® Installations
Rhea-AI Summary
Nuwellis (Nasdaq: NUWE) announced installation of three Aquadex SmartFlow systems at a leading Michigan pediatric hospital, marking its first pediatric program in the state. The placement expands its pediatric critical care presence and supports development of clinical protocols and workflows for fluid management in children.
The Aquadex SmartFlow system provides ultrafiltration therapy for adult and pediatric patients ≥20 kg with fluid overload unresponsive to diuretics. Nuwellis also recently held an FDA pre-submission meeting on a proposed label expansion to include pediatric patients ≥5 kg.
Positive
- Three Aquadex SmartFlow systems installed at leading Michigan pediatric hospital
- First Nuwellis pediatric program established in Michigan
- Supports development of pediatric clinical protocols and workflows for Aquadex therapy
- Creates foundation for future consumable utilization and potential long-term growth
- Targets expansion into an untapped pediatric fluid management market
- FDA pre-submission meeting completed for proposed Aquadex pediatric label expansion to ≥5 kg
Negative
- None.
News Market Reaction – NUWE
In the Jun 25 session, NUWE gained 6.29%, reflecting a notable positive market reaction. Argus tracked a peak move of +4611.1% during that session. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 24 | Strategy & CEO letter | Positive | -30.5% | CEO transition, strong Q1 growth, and focus on pediatric-driven revenue expansion. |
| Jun 18 | Education initiative | Positive | -1.6% | Aquadex training for over 280 critical care cardiology clinicians at summit. |
| Jun 16 | Leadership change | Positive | -0.9% | Appointment of Mike McCormick as CEO while prior CEO remains Board Chair. |
| Jun 10 | Hospital collaboration | Positive | +4.7% | Expanded collaboration and new Aquadex installs at South Carolina children’s hospital. |
| Jun 08 | Equity offering | Negative | -1.0% | Dilutive $6.0M registered public offering with new common shares and warrants. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent NUWE news, even when operationally positive, has often been followed by downside or muted price reactions, with collaborations receiving the most favorable responses.
Key Terms
ultrafiltration therapy medical
fluid overload medical
pre-submission meeting regulatory
u.s. food and drug administration (fda) regulatory
clinical pathways medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Three systems placed at leading Michigan pediatric hospital, establishing foundation for future growth
MINNEAPOLIS, June 25, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, announces its expansion in Michigan with the installation of three Aquadex SmartFlow® systems at a leading pediatric healthcare provider. This represents Nuwellis’ first pediatric program in the state of Michigan and further expands the Company’s growing presence in pediatric critical care into a significant healthcare market.
“Adding our first pediatric program in Michigan advances our strategy to expand Aquadex adoption in pediatric care,” said Nuwellis’ Incoming CEO Mike McCormick. “Leading pediatric centers continue to recognize the value of precise fluid management for critically ill patients. This collaboration provides an opportunity to establish protocols and clinical pathways that can support broader utilization of Aquadex therapy over time, creating a key entry into an as yet untapped market for Nuwellis.”
The new system installations support the development of clinical protocols and workflows designed to integrate Aquadex therapy into the hospital’s pediatric care program, creating a foundation for future consumable utilization and long-term growth. As 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 represent a strategic growth opportunity to broaden access to the therapy and further strengthen the Company’s 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) to discuss a proposed expansion of the Aquadex label to support pediatric patients weighing 5 kilograms and above, further reinforcing the Company’s commitment to serving the pediatric population.
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:
ir@nuwellis.com
Media Contact:
CORE PR
media@nuwellis.com
