NUWE Newellis Inc

Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, is pleased to announce its newest pediatric hospital customer, a nationally ranked hospital in Utah. The hospital, Nuwellis’ 44th pediatric account, will be utilizing the Aquadex SmartFlow® system to treat children suffering from fluid overload caused by kidney and heart disease. Since 2020 when the FDA granted clearance, Nuwellis has increased the number of accounts from 13 to 44.

This launch initiates a new a collaboration between Nuwellis and the children’s hospital, which is a part of a prominent healthcare network in the western U.S. This collaboration will enable the hospital to provide advanced therapy for highly tailored fluid management in vulnerable pediatric patients. Fluid overload is a critical challenge for children battling severe kidney and heart conditions, and therapy with Aquadex SmartFlow® can provide these patients hope for improved outcomes and quality of life.

Nuwellis President and CEO Nestor Jaramillo expressed his excitement: "We are honored to collaborate with this children’s hospital, a leader in pediatric healthcare, to bring life-saving solutions to children in need. This announcement exemplifies how Nuwellis continues to grow its pediatric business, expanding our reach to hospitals across the country. By providing innovative technology like Aquadex, we aim to transform care and improve lives for patients and families facing serious health conditions."

Disease, injury, and surgery can all cause the body to retain too much fluid, negatively impacting patient recovery. The Aquadex SmartFlow® system is an ultrafiltration therapy device that is proven to remove excess fluid from the body safely and predictably, helping patients regain fluid balance and stability in critical care situations. This therapy is particularly impactful for children, offering a gentler alternative to traditional fluid management methods such as conventional CRRT therapy.

Nuwellis remains committed to expanding access to Aquadex SmartFlow® for pediatric and adult patients alike, empowering healthcare providers with a therapy that predictably and gently removes excess fluid from patients suffering from fluid overload.

About NuwellisNuwellis, 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 ir.nuwellis.com or visit us on LinkedIn or X.

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.

Forward-Looking StatementsCertain 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 2024 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.

CONTACTS

Investors:Vivian CervantesGilmartin Groupir@nuwellis.com