SeaStar Medical's QUELIMMUNE, a groundbreaking medical device for 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 esteemed past recipients such as Janssen Pharmaceuticals and Merck & Co. Inc., underscoring the device's potential to address a critical unmet need in nephrology.
Acute kidney injury in children is a severe condition, with approximately 4,000 pediatric patients requiring continuous renal replacement therapy annually. The mortality rate for these cases ranges between 51-58%, and survivors often face long-term complications like chronic kidney disease. QUELIMMUNE, approved under a Humanitarian Device Exemption by the FDA in February 2024, targets the cytokine storm—a dysregulated immune response common in severe illnesses—aiming to reduce mortality and improve outcomes.
Clinical data from studies SCD-PED-01 and SCD-PED-02, published in Kidney Medicine, demonstrated QUELIMMUNE's safety and efficacy, showing a 77% reduction in mortality rates among treated pediatric patients and no dialysis dependency after 60 days. These findings represent a significant advancement in pediatric AKI treatment, offering hope for better survival rates and quality of life.
The NKF's recognition of QUELIMMUNE reflects its commitment to advancing nephrology care. Over its 75-year history, the foundation has played a pivotal role in improving kidney disease awareness, treatment, and policy, including advocating for the Medicare End-Stage Renal Disease benefit. SeaStar Medical's achievement with QUELIMMUNE aligns with the NKF's mission to accelerate innovation in kidney care, particularly for vulnerable populations like children with AKI.
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 initiative could further extend the device's impact, addressing AKI's high morbidity and mortality rates across age groups. The company's Breakthrough Device Designation for End-Stage Renal Disease therapy development hints at future advancements in kidney disease treatment.
Eric Schlorff, CEO of SeaStar Medical, expressed gratitude for the NKF's recognition, emphasizing the joy of hearing how QUELIMMUNE has saved children's lives. This award not only celebrates SeaStar Medical's innovation but also highlights the ongoing need for solutions in kidney disease treatment, a condition affecting over 35 million Americans, many unaware of their diagnosis.
