SeaStar Medical's QUELIMMUNE, a medical device designed to treat pediatric acute kidney injury resulting from sepsis, has received the 2025 Corporate Innovator Award from the National Kidney Foundation. This recognition places the company alongside previous distinguished recipients such as Janssen Pharmaceuticals and Merck & Co. Inc., highlighting the device's novel approach to a critical unmet medical need in nephrology. The award underscores the potential impact of QUELIMMUNE in a field where pediatric AKI carries a mortality rate of 51-58% among children requiring continuous renal replacement therapy.
The device functions by targeting the cytokine storm, a dysregulated immune response prevalent in severe illnesses, through integration with an existing continuous kidney replacement therapy circuit. Approved by the FDA in February 2024 under a Humanitarian Device Exemption, clinical data has shown promising results, including a 77% reduction in mortality rates among treated pediatric patients and no instances of dialysis dependency after 60 days. These outcomes are significant given the high mortality associated with the condition. More information on the National Kidney Foundation's initiatives and awards can be found at https://www.kidney.org.
Eric Schlorff, CEO of SeaStar Medical, expressed appreciation for the award, noting the profound impact of hearing how QUELIMMUNE has saved children's lives and prevented long-term dialysis. The company is now expanding its research to assess the device's effectiveness in adult AKI patients, with ongoing trials aiming to enroll 200 participants. This expansion could address a broader patient population, considering over 35 million adults in the U.S. are estimated to have kidney disease, often undiagnosed.
The National Kidney Foundation, founded in 1950, has been instrumental in advancing kidney disease treatment and patient care, with achievements such as establishing the Medicare End-Stage Renal Disease benefit and developing clinical practice guidelines that have improved outcomes nationwide. The Corporate Innovator Award reflects the foundation's commitment to innovation in nephrology. SeaStar Medical's work with QUELIMMUNE represents a critical advancement in tackling a widespread health challenge, potentially transforming treatment protocols for AKI across age groups.
