SeaStar Medical’s QUELIMMUNE, a medical device aimed at treating pediatric acute kidney injury (AKI) due to sepsis, has been recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation (NKF). This accolade underscores the device’s innovative approach to addressing a critical unmet need in nephrology, particularly in pediatric care where AKI leads to high mortality rates and long-term health complications.

The Corporate Innovator Award celebrates advancements in nephrology that tackle unmet medical needs or enhance existing treatments. QUELIMMUNE’s recognition places SeaStar Medical among esteemed past recipients such as Janssen Pharmaceuticals and Merck & Co. Inc., highlighting the device’s significance in the field. QUELIMMUNE operates by targeting the cytokine storm, a dysregulated immune response common in severe illnesses, thereby offering a novel treatment avenue for pediatric AKI patients.

Approved by the FDA under a Humanitarian Device Exemption in February 2024, QUELIMMUNE has demonstrated promising results, including a 77% reduction in mortality rates among treated pediatric patients and no instances of dialysis dependency after 60 days. These outcomes represent a significant leap forward in managing AKI, a condition that has long lacked effective treatments.

The National Kidney Foundation’s recognition of QUELIMMUNE not only honors SeaStar Medical’s contribution to nephrology but also aligns with the foundation’s 75-year mission to innovate kidney care and improve patient outcomes. With over 35 million adults in the U.S. estimated to have kidney disease, the development of treatments like QUELIMMUNE is critical in addressing the widespread impact of kidney-related conditions.

SeaStar Medical is currently expanding its research to evaluate QUELIMMUNE’s efficacy in adult AKI patients, furthering its potential to revolutionize kidney disease treatment across age groups. The company’s achievement reflects a shared commitment with the NKF to advance medical solutions that save lives and enhance the quality of care for kidney disease patients worldwide.

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