Nuwellis Marks First Commercial Sale Of QUELIMMUNE Therapy To Cincinnati Children's For Pediatric Patients Suffering From An Uncontrolled Inflammatory Response Triggered By Their Immune Systems
Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, is proud to announce its first commercial sale of QUELIMMUNE™, a novel therapy developed by SeaStar Medical Holding Corporation for pediatric patients suffering from an uncontrolled inflammatory response triggered by their immune systems, to Cincinnati Children's. We believe this milestone marks a significant advancement in pediatric critical care and underscores Nuwellis' commitment to revolutionizing pediatric patient outcomes.
QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients suffering from acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring kidney replacement therapy (KRT). Early clinical data suggest a 77% survival rate for patients treated with this new therapy1. Through Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical (NASDAQ:ICU), the developer of QUELIMMUNE, this therapy is now accessible under a Humanitarian Device Exemption (HDE) from the Food and Drug Administration (FDA) to medical institutions like Cincinnati Children's, giving nephrologists and intensive care physicians a novel option to address the needs of these critically ill pediatric patients.