MINNEAPOLIS, MN — January 6, 2026 — Leads & Copy — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company, announced that the United States Patent and Trademark Office issued a new U.S. patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems.
The patent, corresponding to U.S. Patent Application No. 18/298,810 and assigned to Nuwellis, protects design innovations intended to improve blood flow control reliability and consistency in extracorporeal circuits. These mechanisms are designed to support stable system performance and enhance protection in therapies involving small patient volumes and sensitive extracorporeal conditions, with particular relevance for pediatric applications.
The 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.
John Erb, Chief Executive Officer of Nuwellis, said each issued patent reflects continued progress in building a strong foundation of protected innovation. He added that the milestone reinforces the company’s commitment to engineering precision and safety into technologies intended for 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.
Nuwellis, Inc. (Nasdaq: NUWE) 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.
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.
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.
Leah McMullen, Director of Communications, Leah.mcmullen@nuwellis.com
Source: Nuwellis
