Kidney Support in Pediatric Patients using an Ultrafiltration Device

Koronis Biomedical Technologies Corporat, Maple Grove MN

Investigators

Abstract

Abstract In this Phase IIb grant, Koronis Biomedical Technologies (KBT) and its commercial and manufacturing partner Nuwellis, Inc. propose to bring to market Vivian, a Continuous Renal Replacement Therapy (CRRT) platform for treating critically ill pediatric and neonatal patients. In critically ill children, especially neonates, acute kidney injury (AKI) and volume overload are common and associated with significant morbidity and mortality. These patients require CRRT, but the large extracorporeal blood volume (ECV) of current systems relative to patient body volume poses significant risks. Vivian will address a market that is currently not served by any product, leveraging ultrafiltration technology to yield an extra-low ECV, a critical enabling feature for this market segment.