MINNEAPOLIS, May 02, 2024 (GLOBE NEWSWIRE) — Nuwellis, Inc. Nasdaq: NUWE, a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application related to its innovative pediatric Continuous Renal Replacement Therapy (CRRT) device branded Vivian™. This patent strengthens Nuwellis’ intellectual property portfolio and paves the way for the development of novel technology designed to improve treatment options for critically ill children.

The patented technology focuses on a design feature that allows healthcare providers to switch seamlessly between stationary operation and “transport” or “ambulation” mode, enabling unprecedented patient mobility. This innovative feature offers unmatched flexibility, allowing clinicians to tailor treatment plans to the specific needs of each young patient.

“We are thrilled to receive this patent allowance from the USPTO,” said Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis. “A core focus of our business strategy is developing novel technology and a strong IP portfolio. This innovative technology will empower healthcare providers with the ability to adapt treatment plans as needed, ultimately leading to improved patient care and outcomes for critically ill children and neonates.”

Nuwellis is currently developing a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device designed to provide care for small babies and children. This development effort is 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 a custom pediatric product that will enable clinicians to better care for babies with limited kidney function.

Nuwellis is committed to developing life-saving technologies specifically designed for the unique needs of pediatric patients. This patent allowance represents a significant advancement in the company’s mission to revolutionize pediatric fluid management.

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 www.nuwellis.com 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.

CONTACTS

Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com