SeaStar Medical Announces First Pediatric Patient Treated In A Commercial Setting With Its FDA-Approved QUELIMMUNE Therapeutic Device
SeaStar Medical Announces First Pediatric Patient Treated In A Commercial Setting With Its FDA-Approved QUELIMMUNE Therapeutic Device
SeaStar Medical Holding Corporation (NASDAQ:ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA's approval of QUELIMMUNE.
SeaStar Medical Holding Corporation（納斯達克：ICU）（SeaStar Medical）報道了第一位在商業場景下使用其QUELIMMUNE進行治療的患者，這是一種獲得美國食品和藥物管理局（FDA）批准的、獲得專利的細胞導向性體外治療方法，用於治療10公斤或以上的小兒感染或感染狀態導致腎臟替代治療（KRT）的急性腎損傷（AKI）。隨着這一進展，該公司現已達到2024年8月20日FDA的開始患者治療的最後期限，這一期限已在FDA對QUELIMMUNE的批准中指定。