NUWE Newellis Inc

Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the launch of a new pediatric ultrafiltration program utilizing Nuwellis' Aquadex SmartFlow System® at one of the largest health integrated delivery networks (IDN) in Florida. This program marks an expansion by this network to offer ultrafiltration to its pediatric patients, in addition to its current heart failure and critical care patients.

This launch builds upon the longstanding relationship between this hospital network and Nuwellis. Currently, Nuwellis' technology is utilized by seven hospitals within the network for adult cardiac and critical care. Expanding this collaboration to the pediatric setting allows for a more comprehensive approach to fluid management across the entire healthcare system.

“We are excited to collaborate on the expansion of the pediatric Aquadex ultrafiltration program at this leading hospital network,” said Nestor Jaramillo, Jr., President and Chief Executive Officer at Nuwellis. “The expansion of Aquadex into pediatric care underscores the success of this therapy and the commitment of the network to advance ultrafiltration therapy and improve patient outcomes across all age groups. Additionally, this expansion exemplifies the ongoing and successful execution of our strategy to grow our pediatric customer category.”

Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. The device’s built-in, customizable hematocrit monitoring technology provides real-time measurement of percent blood volume changes that can be tailored to individual patients’ needs. A customizable fluid removal rate is particularly important for pediatric patients who have a small amount of blood in their bodies. The Aquadex system is cleared by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients weighing 20 kg or more.

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 Twitter.

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 impact of the COVID-19 pandemic, 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