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（纳斯达克：ICU）（SeaStar Medical）报道了第一位在商业场景下使用其QUELIMMUNE进行治疗的患者，这是一种获得美国食品和药物管理局（FDA）批准的、获得专利的细胞导向性体外治疗方法，用于治疗10公斤或以上的小儿感染或感染状态导致肾脏替代治疗（KRT）的急性肾损伤（AKI）。随着这一进展，该公司现已达到2024年8月20日FDA的开始患者治疗的最后期限，这一期限已在FDA对QUELIMMUNE的批准中指定。