SeaStar Medical's QUELIMMUNE Recognized by National Kidney Foundation for Innovation in Pediatric AKI Treatment
SeaStar Medical's QUELIMMUNE device, designed to treat pediatric acute kidney injury, has been awarded the 2025 Corporate Innovator Award by the National Kidney Foundation, highlighting its potential to significantly reduce mortality rates and improve quality of life for affected children.
SeaStar Medical's QUELIMMUNE, a medical device aimed at treating pediatric acute kidney injury (AKI) due to sepsis, has been honored with the 2025 Corporate Innovator Award by the National Kidney Foundation (NKF). This recognition places SeaStar Medical among past awardees like Janssen Pharmaceuticals and Merck & Co., underscoring the device's innovative approach to addressing a critical unmet need in nephrology.
QUELIMMUNE operates by targeting the cytokine storm, a dysregulated immune response common in severe illnesses, through integration with an existing continuous kidney replacement therapy circuit. Approved under a Humanitarian Device Exemption by the FDA in February 2024, clinical data has demonstrated its safety and efficacy, including a 77% reduction in mortality rates among treated pediatric patients and no instances of dialysis dependency after 60 days.
The significance of this award is magnified by the NKF's 75-year legacy of advancing kidney disease treatment and patient care. With over 35 million adults in the U.S. estimated to have kidney disease, the foundation's recognition of QUELIMMUNE underscores the device's potential to make a profound impact on pediatric AKI treatment, a condition with a mortality rate of 51-58% among affected children requiring continuous renal replacement therapy.
SeaStar Medical is currently expanding its research to evaluate QUELIMMUNE's effectiveness in adult AKI patients, with ongoing trials aiming to enroll 200 participants. This award not only celebrates the device's current achievements but also highlights the ongoing need for innovation in kidney disease treatment to improve patient outcomes and quality of life.