SeaStar Medical is making significant strides in treating acute kidney injury (AKI) with its innovative QUELIMMUNE therapy, recently approved for pediatric patients and currently expanding into adult treatment. The company's therapeutic device, granted a Humanitarian Device Exemption by the FDA in February 2024, has demonstrated remarkable clinical outcomes for children with AKI caused by sepsis.
Clinical data from two studies revealed a 77% survival rate for pediatric patients treated with QUELIMMUNE, with no device-related serious adverse events or infections. The therapy's potential extends beyond patient survival, as it could substantially reduce healthcare costs by eliminating dialysis dependency and shortening hospital stays.
Currently, five hospitals have adopted the QUELIMMUNE therapy, with SeaStar actively engaging more than a dozen medical centers in the approval process. The company is simultaneously pursuing adult AKI treatment, conducting a clinical trial evaluating the safety and efficacy of its therapy in 200 adult patients.
The potential market for adult AKI treatment is significant, estimated at $4.5 billion. SeaStar anticipates an interim analysis of the adult trial later this year, with potential treatment approval and launch possible in 2026. By addressing this critically underserved medical condition, SeaStar Medical is positioned to make a meaningful impact on patient outcomes and healthcare system efficiency.
