News Release
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U.S. Patent and Trademark Office Awards Nuwellis Patent for Innovative Pediatric Technology

August 25, 2022
Enabling improved fluid balance and safety when performing dialysis and hemofiltration in pediatrics and neonates

MINNEAPOLIS, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) a commercial stage company dedicated to transforming the lives of patients suffering from fluid overload, today announced that it was awarded a patent from the United States Patent and Trademark Office for a novel innovation that provides for improved fluid balance and safety in pediatric dialysis and hemofiltration.

“We continue to invest in technological advancements that have a meaningful impact for patients and clinicians,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “Clinicians rely on us to provide advanced technology that affords them with the flexibility to safely and easily expand treatment options for their young patients. We are pleased to have received a patent for this novel innovation that can enhance current and future technology development initiatives.”

The novel innovations included in this patent will provide healthcare providers with the ability to sense pressure changes in the function of externally connected pumps so clinicians can make any necessary therapeutic modifications.

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 device 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.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The Company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly-owned subsidiary in Ireland.

About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable 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 2022 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 as a result of new information, future events or otherwise.


CONTACTS

INVESTORS:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.ir@nuwellis.com

Matt Bacso, CFA
Gilmartin Group LLCMatt.Bacso@gilmartinir.com

MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com

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Source: Nuwellis, Inc.

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