Nuwellis, Inc. announced 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. The company 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, 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.