Nuwellis to Convene Pediatric Medical & Nursing Advisory Board to Advance Development of Vivian™ Pediatric CRRT System

Medical Advisory Board represents another milestone in Nuwellis’ broader pediatric strategy, alongside proposed Aquadex SmartFlow® label expansion seeking to extend to pediatric patients weighing 5 kilograms or more

MINNEAPOLIS, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced that it will convene a Medical & Nursing Advisory Board on November 18–19, 2026, to support the continued development of Vivian™, the Company’s next-generation pediatric continuous renal replacement therapy (CRRT) platform. Vivian is under development for children as small as 2.5kg and it incorporates multiple fluid management therapies in one platform.

“Vivian is being purpose-built around the unique clinical and operational needs of pediatric patients and the clinicians who care for them,” said Mike McCormick, Nuwellis President and Chief Executive Officer. “Direct provider and nurse input at this critical stage provides the opportunity to validate the progress we have made and ensure that the voice of the customer continues to shape the system as we move forward. We believe the advisory board is an important development milestone within our pediatric strategy and reflects our commitment to building solutions that address unmet needs across the continuum of care.”

The meeting assembles approximately a dozen pediatric providers, nurses, and clinical advisors representing 11 nationally recognized pediatric institutions across the U.S. for an immersive, hands-on evaluation of the latest Vivian System. The advisory board marks the Company’s first dedicated Vivian Medical & Nursing Advisory Board in several years and represents an important step as Nuwellis advances the system through its next phase of product development.

Feedback from the Medical & Nursing Advisory Board is expected to help Nuwellis validate design decisions, identify unmet clinical and workflow needs, and prioritize future system enhancements. Nuwellis will incorporate insights gathered during the meeting into development priorities and refinements intended to guide Vivian toward its next major program milestones.

The Vivian Medical & Nursing Advisory Board is part of Nuwellis’ broader strategy to strengthen its position in pediatric fluid management and renal support. The Company has built a growing presence in pediatric hospitals using its Aquadex SmartFlow ultrafiltration system and is working through regulatory procedures to is seeking to expand the Aquadex indication to pediatric patients weighing 5 kilograms or more, compared with the system’s current 20-kilogram minimum labeled patient weight.

Together with continued development of Vivian, these initiatives represent a multi-pronged pediatric strategy spanning near-term expansion of Aquadex and longer-term development of a purpose-built pediatric CRRT platform.

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' strategy includes expanding its portfolio through internally developed technologies and strategic commercial partnerships that broaden its presence across acute and chronic critical care. 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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