Nuwellis Secures New Patent for Innovative Pediatric Continuous Renal Replacement Therapy, Vivian™

MINNEAPOLIS, June 25, 2024 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the recent grant of a new patent from the United States Patent and Trademark Office (USPTO) related to its groundbreaking pediatric continuous renal replacement therapy (CRRT), Vivian™. This patent covers critical advancements that will significantly improve the performance and user experience of Vivian. This is the second of several forthcoming patents for Vivian, underscoring Nuwellis’ commitment to development of novel technology designed to improve treatment options for critically ill children.

The patent claims, include self-centering fluid bag hangers and density compensation mechanisms for enhanced accuracy in fluid management. Ease of use is increased with self-sealing access ports for easy configuration of various dialysis modes, streamlining the treatment process. Additionally, reliability is boosted by a temperature-adjusting auto-clamp that ensures secure seals, reducing the risk of leaks and enhancing overall system dependability.

“We are thrilled to announce the issuance of this patent, which represents a significant milestone in the development of our pediatric continuous renal replacement therapy, Vivian,” said Nestor Jaramillo, President and Chief Executive Officer at Nuwellis. “These innovations not only reinforce our position as a leader in fluid management solutions but also highlight our dedication to advancing technology that can make a real difference in the lives of thousands of pediatric patients across the U.S. Our focus on increased accuracy, ease of use, and reliability will help ensure that children receiving critical care have access to the best possible treatment options.”

About Vivian
Nuwellis is currently developing Vivian, a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device designed to provide care for small babies and children with limited or no kidney function. Vivian is not yet cleared by the FDA. This development effort was funded in part by a $1.7 million grant from the National Institutes of Health (NIH). The company has partnered with Minneapolis-based research and development firm Koronis Biomedical Technologies Corporation (KBT), the grant recipient, in the design and development of Vivian.

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 or visit us on LinkedIn or Twitter.

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 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 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.


Vivian Cervantes
Gilmartin Group