Nuwellis Expands IP Portfolio with Patent That Reduces Clinical Burden, Preserves Precision

MINNEAPOLIS, April 24, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on fluid management solutions for patients with fluid overload, today announced the issuance of U.S. Patent No. 12,280,007 by the U.S. Patent and Trademark Office. The newly granted patent covers a fluid bag design that passively drains once full—reducing the need for manual intervention by clinical staff while preserving the system's precise weight-based measurement.

This design uses a novel siphon mechanism built into the geometry of the bag, allowing it to automatically empty without disconnecting from the scale. By maintaining measurement integrity and automating a routine task, the feature offers a more seamless experience in therapy delivery.

Fluid overload is a common and serious complication in critically ill patients, and accurate, efficient ultrafiltration is essential in managing it effectively. Design enhancements like those disclosed in this patent can have a meaningful impact on both care and workflow.

"Clinicians in critical care are constantly balancing precision and efficiency," said John Erb, Interim Chief Executive Officer of Nuwellis. "This patent reflects our commitment to supporting them with smarter design — simplifying routine tasks without compromising the accuracy their patients depend on."

While not expected to be included in the initial release, the design may be integrated into future Aquadex SmartFlow system enhancements, including Nuwellis' Vivian pediatric-focused CRRT device currently under development. The patent represents one of several steps the company is taking to expand its portfolio and advance continued innovation in fluid management.

The patent officially issued on April 22, 2025, and includes a 224-day extension to its standard term granted by the USPTO.

For more information, visit www.nuwellis.com.

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 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 X, formerly known as 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 2025 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 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.

For further information, please contact:

Investor Relations:

Louisa Smith

Gilmartin Group

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Media Contact:

Leah McMullen

Director of Communications

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