Nuwellis Expands Collaboration with Major South Carolina Healthcare System to Install New Aquadex SmartFlow® Devices at One of its Children’s Hospitals
Rhea-AI Summary
Nuwellis (Nasdaq: NUWE) announced an expanded collaboration with a major South Carolina healthcare system to install new Aquadex SmartFlow devices at one of its children’s hospitals and upgrade devices at two existing sites. Aquadex provides precise ultrafiltration for adult and pediatric patients ≥20 kg with fluid overload.
Nuwellis recently held a pre-submission meeting with the FDA to discuss expanding Aquadex labeling to patients weighing ≥5 kg and expects to submit by the end of 2026.
Positive
- Expanded Aquadex SmartFlow integration into a South Carolina children’s hospital
- Upgrades to latest Aquadex devices at two existing South Carolina locations
- Aquadex indicated for adult and pediatric patients weighing 20 kg and above
- Pre-submission FDA meeting completed for label expansion to patients ≥5 kg
Negative
- Aquadex label currently limited to patients weighing 20 kg and above
- FDA submission for pediatric label expansion not expected until end of 2026
News Market Reaction – NUWE
In the Jun 10 session, NUWE gained 4.68%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.3% during that session. Argus tracked a trough of -7.9% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
South Carolina healthcare provider also upgrades to latest Aquadex devices at its two locations that already use the technology
MINNEAPOLIS, June 10, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announces an expanded collaboration with a major South Carolina healthcare system to integrate Aquadex SmartFlow® devices into the clinical care programs at one of its children’s hospitals. The provider has also upgraded to the latest Aquadex devices at its two locations that already use the technology, helping clinicians provide controlled, predictable fluid removal for pediatric patients.
“Expanding this important collaboration will bring our Aquadex therapy to more pediatric patients in need,” said Nuwellis’ CEO John Erb. “This further validates Nuwellis’ ultrafiltration system as a clinically important and increasingly adopted solution for managing fluid overload, while reinforcing our growing leadership and continued momentum in the pediatric category.”
Nuwellis’ Aquadex system is designed to provide precise ultrafiltration therapy for adult and pediatric patients weighing 20 kg and above who are suffering from fluid overload. The therapy supports improved patient management and may help reduce rehospitalizations associated with heart failure and related conditions.
Nuwellis recently completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) to propose expansion of the Aquadex SmartFlow® System’s label to support pediatric patients weighing 5 kg and above. The Company anticipates submitting to the FDA by the end of 2026.
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
