NUWE Newellis Inc

Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced a new purchase agreement with one of the top 25 largest integrated delivery networks (IDN) in the U.S.

Nuwellis has a successful history of collaborating with individual member hospitals within the IDN on Aquadex utilization. This new network-wide agreement signifies a broader commitment to providing advanced ultrafiltration technology to improve patient care across the entire 50 hospital system.

“We are thrilled to be working with this leading hospital network to expand access to Aquadex therapy for a wider range of heart failure, critical care, and pediatric patients,” said Nestor Jaramillo, Jr., President and Chief Executive Officer at Nuwellis. “Aquadex offers a safe and effective ultrafiltration option for patients with fluid overload who are unresponsive to diuretics, and this agreement demonstrates the dedication of this IDN to provide innovative treatment options for its patients and economic benefits to the hospitals in the system.”

This agreement comes on the heels of exciting new data presented at the recent Technology and Heart Failure Therapeutics (THT) conference in early March. During a late-breaking clinical trials session, the data showed a clinically and statistically significant reduction in both 30-day hospitalizations and heart failure events for patients treated with Aquadex. This clinical data milestone aligns with Nuwellis' ongoing commitment to build a robust body of clinical and economic evidence supporting the use of Aquadex for managing fluid overload in patients unresponsive to diuretics.1

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 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 ir.nuwellis.com or visit us on LinkedIn or X.

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.

     1)   Pinney S., et al. Aquapheresis for Management of Decompensated Heart Failure: a re-appraisal of AVOID-HF. Poster from the THT Annual Scientific Meeting 2024

CONTACTS

Investors:Vivian CervantesGilmartin Groupir@nuwellis.com