Nuwellis Receives Notice of Allowance of a New U.S. Patent Strengthening Vivian™ Pediatric System with Advanced Clamp Safety Technology

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) announced a notice of allowance from the U.S. Patent and Trademark Office dated Nov 10, 2025 for a patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems, including the Vivian Pediatric CRRT System in development.

The technology dynamically adjusts clamping force, reconditions tubing under defined thermal conditions, and adds thermal insulation to improve material stability. This patent supplements a Sept 2025 patent for hemolysis sensing and complements NIH grant-funded research and Aquadex pediatric use data to inform Vivian design.

Positive

• Notice of allowance issued on Nov 10, 2025
• Patent covers dynamic clamp force and thermal reconditioning
• Adds to IP after Sept 2025 hemolysis patent
• Supports Vivian pediatric CRRT system development

Negative

• Vivian system remains in development, not yet commercial
• Press release discloses no financial or commercialization timelines

Insights

Medical device IP strategist

Notice of allowance strengthens device IP around pediatric clamp safety for the Vivian system; useful but not a commercial milestone.

Nuwellis secured a U.S. notice of allowance on November 10, 2025 for clamp-safety innovations that dynamically adjust clamping force, recondition tubing under set thermal conditions, and add thermal insulation. These features address a core safety function in pediatric extracorporeal blood filtration and directly support the Vivian™ Pediatric CRRT System development already linked to a prior September 2025 patent on hemolysis sensing.

The business mechanism is straightforward: stronger, specific patents can raise technical-entry barriers and protect design choices that differentiate the pediatric platform. Key dependencies remain the translation of these patents into validated device features and any downstream regulatory or clinical evidence that demonstrates safety improvements; the press release cites NIH grant-funded research and Aquadex® use in patients ≥20 kg as inputs to design decisions, which anchor the technical claims in funded research and practical experience.

Watch for firm, monitorable items: issuance of the final U.S. patent, additional granted claims, and any disclosed clinical or regulatory milestones referencing these clamp technologies; note the company highlighted a related patent in September 2025 and NIH-supported research as context. Expect these items to influence technology defensibility and product messaging in the nearer term rather than immediate commercial impact.

Continues momentum in pediatric innovation and platform development

MINNEAPOLIS, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today announced that the United States Patent and Trademark Office has issued Nuwellis a notice of allowance for a new patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems, including the company’s Vivian™ Pediatric Continuous Renal Replacement Therapy (CRRT) System currently in development.

Many extracorporeal blood filtration systems rely on automated clamps as part of their safety design to prevent air embolism or pressure imbalances. The newly patented technology enhances this core function by dynamically adjusting clamping force based on environmental factors, automatically reconditioning the tubing under defined thermal conditions, and adding thermal insulation for improved material stability. Together, these innovations strengthen one of the most critical safety components in pediatric extracorporeal therapy—ensuring consistent, reliable protection for the smallest patients.

“Every element of the Vivian system is being designed with safety and precision in mind,” said John Erb, Chief Executive Officer of Nuwellis. “This new patent reinforces our commitment to advancing the pediatric platform with intelligent engineering that supports both clinician confidence and patient safety.”

This patent adds to a growing portfolio of intellectual property supporting the Vivian system and Nuwellis’ pediatric technology roadmap, following the September 2025 patent issuance for hemolysis sensing in extracorporeal circuits. Together, these advancements reflect meaningful progress toward safer, smarter, and more responsive pediatric fluid management.

The company’s innovation in this space is further supported by National Institute of Health (NIH) grant-funded research and the use of the Aquadex® system in pediatric patients weighing 20 kg or more, helping to inform design decisions and guide future clinical applications for Vivian.

“Our advancements in both Aquadex and Vivian underscore a continuous commitment to pediatric innovation,” added Erb. “We’re building a foundation that spans today’s therapies and tomorrow’s breakthroughs in fluid management.”

With each patent, Nuwellis continues to strengthen its leadership in precision fluid management and its mission to deliver safer, smarter solutions for patients across the cardio-renal continuum.

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.

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 SvO₂ 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 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:
ir@nuwellis.com

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

FAQ

What did Nuwellis announce on Nov 10, 2025 about NUWE?

Nuwellis received a U.S. notice of allowance for a patent covering advanced clamp safety technology for pediatric extracorporeal systems.

How does the new NUWE patent improve clamp safety for Vivian pediatric CRRT?

The patent describes dynamic clamping force, tubing thermal reconditioning, and thermal insulation to stabilize materials and reduce risk.

Does the Nov 10, 2025 patent affect NUWE's existing intellectual property portfolio?

Yes; it adds to the company’s IP alongside a Sept 2025 hemolysis sensing patent supporting the Vivian roadmap.

Is the Vivian (NUWE) pediatric CRRT system commercially available after this patent?

No; the release states the Vivian system is in development and does not announce commercialization or clearance.

What external research supports the NUWE Vivian design?

The company cites NIH grant-funded research and pediatric use data from the Aquadex system for patients ≥20 kg.