Nuwellis Receives New US Patent Reinforcing Vivian™ Pediatric Device Focused on Safer, More Precise Ultrafiltration
Nuwellis (NASDAQ:NUWE) has secured U.S. Patent No. 12,415,021 for innovative hemolysis sensing technology in blood filtration systems. The patent, issued on September 16, 2025, specifically supports their pediatric device Vivian and future platform developments.
The technology enables detection of red blood cell destruction through hemolysis sensors placed at the circuit inlet and ultrafiltrate line, helping medical teams distinguish between external hemolysis and issues within the extracorporeal circuit. This advancement is particularly significant for improving the safety of ultrafiltration therapy and continuous renal replacement therapy (CRRT).
- New patent strengthens intellectual property portfolio for pediatric device Vivian
- Technology enables better safety monitoring in blood filtration treatments
- Innovation allows care teams to better identify the source of hemolysis during treatment
- None.
Insights
Nuwellis secures strategic patent for hemolysis detection in blood filtration, strengthening their pediatric Vivian device's competitive position.
Nuwellis's newly issued U.S. Patent No. 12,415,021 represents a significant advancement in pediatric fluid management safety. The patent covers a critical safety mechanism: using hemolysis sensors in extracorporeal blood filtration systems to detect red blood cell destruction. This addresses an important clinical safety gap since standard blood-leak detectors often miss hemolyzed blood, which can be dangerous for patients.
The technical innovation lies in the dual-sensing configuration—monitoring at both the circuit inlet and ultrafiltrate line—enabling clinicians to determine whether hemolysis originates from the patient or occurs within the treatment circuit. This differentiation capability is crucial for appropriate intervention and represents meaningful innovation beyond existing detection methods.
For Nuwellis, this patent strengthens their intellectual property portfolio in three ways: it protects a core safety feature of their Vivian pediatric device currently in development, creates barriers to competition in the pediatric ultrafiltration space, and establishes a foundation for future platform innovations. In the medical device sector, such patents typically provide 15-20 years of market protection, allowing companies to maintain premium pricing and defend market share.
The company's focus on improving safety in pediatric fluid management addresses a specialized but essential clinical need. Pediatric patients represent a particularly vulnerable population where precision and safety in fluid removal are critical, making this technology potentially valuable for intensive care settings and specialized pediatric facilities.
EDEN PRAIRIE, Minn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc., a fluid management company, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,415,021 on September 16, 2025, based on Application No. 18/298,860.
The patent relates to the use of one or more hemolysis sensors with extracorporeal blood filtration systems—such as ultrafiltration therapy and continuous renal replacement therapy (CRRT)—to help detect and localize red blood cell destruction occurring within or around the circuit. The intellectual property supports Nuwellis’ pediatric device, Vivian, in development and future platform innovation.
Why hemolysis matters
Hemolysis is the destruction of red blood cells, which releases hemoglobin and reduces oxygen-carrying capacity. Significant hemolysis is dangerous for patients. In extracorporeal therapies, red cell fragments and free hemoglobin can pass through a filter and may tint the ultrafiltrate pink or red, resembling a filter issue. Standard blood-leak detectors typically look for intact cells and may not flag hemolyzed blood.
What the patent enables
The patent covers configurations that use hemolysis sensing at the circuit inlet and on the ultrafiltrate line, with the option to compare readings. This approach may help care teams assess whether hemolysis originates outside the system or within the extracorporeal circuit and respond appropriately.
“Protecting IP around sensing and signal interpretation is central to how we advance fluid management safety,” said John Erb, Chief Executive Officer of Nuwellis. “This patent strengthens our pediatric roadmap and underscores our focus on technologies that give care teams clearer information during ultrafiltration.”
For more information, visit www.nuwellis.com.
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.
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.
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:
Jenene Thomas
JTC
NUWE@JTC.com
Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com
FAQ
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