Nuwellis Announces Issuance of New U.S. Patent Supporting Advanced Safety Design for Pediatric Extracorporeal Therapy

MINNEAPOLIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company advancing precision fluid management technologies across the cardio-renal continuum today announced that the United States Patent and Trademark Office recently issued a new U.S. patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems. The issued patent corresponds to U.S. Patent Application No. 18/298,810 and is assigned to Nuwellis.

The newly issued patent protects safety-focused design innovations intended to improve the reliability and consistency of blood flow control in extracorporeal circuits, with particular relevance for pediatric applications, where precision and safety are critical. These mechanisms are designed to support stable system performance and enhance protection in therapies involving small patient volumes and sensitive extracorporeal conditions.

This patent issuance follows the previously announced Notice of Allowance and represents the formal issuance of intellectual property supporting the Vivian™ Pediatric Continuous Renal Replacement Therapy (CRRT) System, which is currently in development. The issuance further strengthens Nuwellis’ growing portfolio of issued and pending patents supporting pediatric system design and circuit-level safety.

“Each issued patent reflects continued progress in building a strong foundation of protected innovation,” said John Erb, Chief Executive Officer of Nuwellis. “This milestone reinforces our commitment to engineering precision and safety into technologies intended for the most vulnerable patient populations.”

The patent adds to Nuwellis’ expanding intellectual property portfolio, supporting its pediatric development roadmap and broader cardio-renal strategy and underscoring the Company’s focus on advancing precision fluid management technologies that support safe, reliable care across diverse patient populations and clinical settings.

For more information, visit www.nuwellis.com.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company advancing precision technologies across the cardio-renal continuum. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardio-renal conditions, with a focus on safety, precision, and scalability across patient populations.

Nuwellis is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland. For more information, visit www.nuwellis.com or follow the Company on LinkedIn and X.

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 Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO? sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.

Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.

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 2026 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:
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com