Nuwellis’ Vivian Receives $3 Million NIH Grant to Accelerate Pediatric Platform and Strengthen Fluid-Management Portfolio

Awarded grant supports dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients between 2.5 and 20 kg where therapeutic options are scarce

Company working to advance Vivian™ towards an investigational device study to support the path to US regulatory clearance

MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis Inc. (Nasdaq: NUWE), announced today that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nuwellis’ dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients under 20 kilograms, and advance core software and firmware that strengthen the company’s broader portfolio.

For babies and small children with kidney failure or who require artificial kidney support, therapeutic options remain limited. Clinicians often adapt technologies built for adults, which can create challenges for the smallest patients. Vivian is being designed to meet these needs head-on with a pediatric-specific approach to precise, gentle fluid management. The program builds on the company’s Aquadex SmartFlow^® technology, which is currently indicated for adults and pediatric patients 20 kg and above, and aims to extend support to children under 20 kg.

“Every conversation with a pediatric ICU team brings us back to the same truth — families need options that were built for their child, not borrowed from adult care,” said John Erb, Chief Executive Officer of Nuwellis. “This grant helps us finish critical software and firmware development, run the initial investigational study, and move Vivian toward commercial readiness. Just as important, the technology we’re building for these kids strengthens our entire platform and opens real avenues for growth for Nuwellis.”

The award will fund firmware and software development and support an FDA investigational device study expected to enroll approximately 15 patients. KBT will administer the program and disburse funds to Nuwellis under the collaboration, and Nuwellis retains full rights to the technology and intellectual property created.

For more information, visit www.nuwellis.com.

About Vivian Vivian is a purpose-built pediatric CRRT system designed from the ground up for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—UF, CVVH, and CVVHD—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.

Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.

About the Aquadex SmartFlow^® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated 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 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow^® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.

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 2025 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:
Jenene Thomas
JTC
NUWE@jtc.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com

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