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EDEN PRAIRIE, Minn. - Nuwellis, Inc. (NASDAQ:NUWE), a medical device company with $8.32 million in trailing twelve-month revenue, has been granted U.S. Patent No. 12,415,021 for technology that detects red blood cell destruction in extracorporeal blood filtration systems, the company announced Thursday. According to InvestingPro analysis, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The patent, issued on September 16, covers configurations using hemolysis sensors at the circuit inlet and ultrafiltrate line to help medical teams determine whether hemolysis originates outside or within the extracorporeal circuit during treatments like ultrafiltration therapy and continuous renal replacement therapy.
Hemolysis, the destruction of red blood cells, can be dangerous for patients as it releases hemoglobin and reduces oxygen-carrying capacity. In extracorporeal therapies, hemolyzed blood may pass through filters undetected by standard blood-leak detectors that typically look for intact cells.
"Protecting IP around sensing and signal interpretation is central to how we advance fluid management safety," said John Erb, Chief Executive Officer of Nuwellis, according to the company’s press release.
The intellectual property supports Nuwellis’ pediatric device in development called Vivian, which is designed for neonates and children weighing between 2.5 and 20 kg. The investigational device aims to provide three therapies—Ultrafiltration, Continuous Veno-Venous Hemofiltration, and Continuous Veno-Venous Hemodialysis—on a single platform with an extracorporeal blood volume of 29-67 mL.
Nuwellis specializes in fluid management technologies, with its flagship Aquadex SmartFlow system for ultrafiltration therapy.
The company noted that Vivian remains an investigational device under development and is not yet available for sale.
In other recent news, New Era Energy & Digital, Inc. announced a significant development deal through its joint venture, Texas Critical Data Centers LLC. The company revealed a Memorandum of Understanding with GlobeLink Holdings to create a 1,600-mile fiber optic network across Texas. This network aims to become a major digital backbone for artificial intelligence, hyperscale, and cloud workloads in the region. Meanwhile, Nuwellis Inc. has been awarded approximately $3 million in grant funding from the National Institutes of Health to advance its pediatric kidney therapy device, Vivian. Additionally, Nuwellis plans to launch a new 24-hour circuit for its Aquadex therapy in the United States this fall. This circuit is designed for single-day outpatient sessions, complementing its existing 72-hour option. Furthermore, Nuwellis received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter. The newly approved catheter includes a 15 cm insertable length option, adding to the existing 11 cm version.
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