NUWE Newellis Inc

Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce that University of Iowa Health Care Stead Family Children’s Hospital in Iowa City, Iowa, has adopted the Aquadex SmartFlow® system to treat pediatric patients suffering from fluid overload due to heart and kidney disease.

The Stead Family Children’s Hospital will use the Aquadex SmartFlow system to provide adjustable ultrafiltration therapy for critically ill children experiencing excess fluid buildup. This therapy will allow for safe and effective fluid removal, which is critical in managing severe heart and kidney conditions.

Kyle Merrill, MD, MS, Associate Medical Director of Pediatric Dialysis and Director of Acute/Inpatient Dialysis, the physician leading the implementation of Aquadex SmartFlow at Stead Family Children’s Hospital, expressed his enthusiasm for the new treatment option. “Several of our patients experience fluid overload due to both heart disease and kidney disease. Significant fluid overload if left untreated increases time in the ICU, time on the ventilator and overall hospital length of stay as well as mortality of our patients. Previously, we relied on medical management including diuretics or medications to improve urine output or conventional dialysis modalities like hemodialysis or continuous renal replacement therapy to remove excess fluid. We are excited to have access to Aquadex therapy, which offers a new and innovative way to manage fluid overload in our sickest pediatric patients. Having this advanced option means we can better support children with heart and kidney disease, improve their outcomes, and provide them with a better quality of life.”

Nuwellis’ President and CEO, Nestor Jaramillo, also commented on the partnership. “We are thrilled to partner with University of Iowa Health Care Stead Family Children’s Hospital, Dr. Merrill, and his team to be part of their mission to provide world-class care to children. This collaboration reflects our commitment to expanding access to life-saving fluid management solutions for hospitals across the country and growing our pediatric business. By working together, we are helping more patients receive the care they need when it matters most.”

The Aquadex SmartFlow system is designed to safely remove excess fluid in patients suffering from fluid overload, a condition that often accompanies heart failure, kidney disease, and other critical conditions. This system is an important tool in pediatric care, where precise fluid management is crucial to improving patient outcomes.

About NuwellisNuwellis, Inc. (Nasdaq: NUWE) is a medical technology 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.

About the Aquadex SmartFlow® SystemThe 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