Nuwellis Secures New U.S. Patent, Strengthening Its Position as a Leader in Fluid Management Innovation

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) has been granted U.S. Patent No. 12,357,734 for its innovative blood filtering technology. The patent, titled "Extracorporeal Blood Filtering Machine and Methods," focuses on improving fluid balance calculation accuracy in continuous renal replacement therapy (CRRT) systems.

The patented technology addresses a critical issue in CRRT systems by accounting for varying fluid densities, moving beyond the standard assumption of 1 g/mL. This advancement enables more precise volumetric flow tracking, potentially reducing clinically relevant fluid balance errors.

The patent strengthens Nuwellis' intellectual property portfolio and reinforces its position in the fluid management therapy sector.

Positive

• Patent strengthens intellectual property protection for core technology
• Innovation addresses a known source of error in CRRT systems
• Technology enables more accurate fluid balance calculations in medical treatments

Negative

• None.

Insights

Intellectual Property & Medical Technology Expert

Nuwellis strengthens its competitive position with a new patent for more accurate fluid management in critical medical applications.

Nuwellis (NUWE) has secured an important addition to its intellectual property assets with U.S. Patent No. 12,357,734 for "Extracorporeal Blood Filtering Machine and Methods." This patent addresses a critical clinical issue in continuous renal replacement therapy (CRRT) systems by improving fluid balance calculation accuracy—a significant advancement over current systems that typically assume a standard fluid density of 1 g/mL.

The innovation's significance lies in its potential to reduce medical errors. Current CRRT systems using weight-based measurements without accounting for varying fluid densities can produce clinically relevant fluid balance errors. For patients requiring precise fluid management, such as those with heart failure or kidney disease, even small miscalculations can impact clinical outcomes.

From an IP perspective, this patent strategically strengthens Nuwellis' market position in the fluid management space. By protecting methods to incorporate actual fluid density measurements—whether through user input, direct machine measurement, or derived calculations—the company has created barriers to competition in a specialized medical technology niche.

While the immediate revenue impact isn't quantified in the release, the patent contributes to Nuwellis' long-term value proposition by potentially enhancing the precision and safety profile of their fluid management systems. This supports both clinical differentiation in competitive hospital purchasing decisions and the company's stated commitment to innovation-driven growth.

The patent joins what the company describes as a "robust and growing portfolio" of pending U.S. patents, indicating a systematic approach to IP development rather than an isolated innovation, which suggests continued R&D investment in their core technology platform.

WHO	WHAT	WHERE	WHEN	WHY
Nuwellis, Inc.	Issuance of U.S. Patent No. 12,357,734	United States Patent and Trademark Office	July 15, 2025	To protect innovations in blood filtering system design and methods that support safe and precise fluid removal during ultrafiltration therapy.

MINNEAPOLIS, July 15, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, today announced the issuance by the U.S Patent and Trademark Office of U.S. Patent No. 12,357,734, titled “Extracorporeal Blood Filtering Machine and Methods.” The patent was officially granted on July 15, 2025, further strengthening the company’s growing intellectual property portfolio.

The patent covers methods for improving the accuracy of fluid balance calculations by incorporating the density of replacement fluids and effluent—a known source of error in continuous renal replacement therapy (CRRT) systems that use weight-based measurements. While most systems assume a default fluid density of 1 g/mL, actual fluid densities vary. This discrepancy, if uncorrected, can lead to clinically relevant fluid balance errors. The patented approach enables CRRT systems to account for density—via user input, machine measurement, or derived data—resulting in more accurate volumetric flow tracking.

The patent joins Nuwellis’ robust and growing portfolio, of pending U.S. patents related to its proprietary system and methods.

“Expanding our intellectual property portfolio is a key part of our strategy,” said John Erb, Chief Executive Officer of Nuwellis. “Each new patent reinforces our commitment to building long-term value through innovation that supports patients, clinicians, and our future growth.”

This addition reflects Nuwellis’ investment in protecting advancements in extracorporeal fluid management and reinforces its position in the evolving field of fluid management therapies.

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:
Robert Scott
Chief Financial Officer
ir@nuwellis.com

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

FAQ

What is the new patent granted to Nuwellis (NUWE) in July 2025?

Nuwellis was granted U.S. Patent No. 12,357,734, titled 'Extracorporeal Blood Filtering Machine and Methods,' which improves fluid balance calculation accuracy in CRRT systems.

How does Nuwellis' (NUWE) new patented technology improve CRRT systems?

The technology improves accuracy by accounting for varying fluid densities instead of assuming a standard 1 g/mL density, reducing potential fluid balance errors in continuous renal replacement therapy systems.

What is the significance of Nuwellis' (NUWE) new patent for the company?

The patent strengthens Nuwellis' intellectual property portfolio, supports their position in fluid management innovation, and contributes to their strategy of building long-term value through innovation.

Who is the CEO of Nuwellis (NUWE) commenting on the patent grant?

John Erb is the Chief Executive Officer of Nuwellis, who stated that expanding their IP portfolio is key to their strategy and demonstrates commitment to innovation.