Nuwellis Receives NIH Grant to Advance its Pediatric CRRT Platform

The National Institutes of Health (NIH) has awarded a $3 million multi-year grant to Nuwellis Inc.’s development partner, Koronis Biomedical Technologies Corporation (KBT) to further develop its pediatric continuous renal replacement therapy (CRRT) device, Vivian. The product is designed for patients weighing less than 20 kilograms (44 pounds).

Therapeutic options are limited for babies and small children who suffer from kidney failure or require artificial kidney support. Clinicians often adapt technologies built for adults, which can create challenges for the smallest patients. Vivian is designed to meet these needs head-on with a pediatric-specific approach to precise, gentle fluid management. The program builds on the company’s Aquadex SmartFlow technology, which is currently indicated for adults and pediatric patients 20 kg and above, and aims to extend support to children under 20 kg.

“Every conversation with a pediatric ICU team brings us back to the same truth—families need options that were built for their child, not borrowed from adult care,” Nuwellis CEO John Erb said. “This grant helps us finish critical software and firmware development, run the initial investigational study, and move Vivian toward commercial readiness. Just as important, the technology we’re building for these kids strengthens our entire platform and opens real avenues for growth for Nuwellis.”

The award will fund firmware and software development and support a 15-patient U.S. Food and Drug Administration investigational device study. KBT will administer the program and disburse funds to Nuwellis under the collaboration, and Nuwellis will retain full rights to the technology and intellectual property created.

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—UF, CVVH, and 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 six-port circuit provides flexible vascular-access options. Intended for patients 2.5 kg–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity.

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 eight hours) or extended (longer than eight 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.

Nuwellis Inc. is a medical device company attempting to improve 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 and operates a wholly owned subsidiary in Ireland.