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First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical’s FDA-Approved QUELIMMUNE Therapeutic Device
DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports treatment of the first patient in a
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- 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. “This commercial milestone is highly gratifying to the SeaStar Medical team that has worked so hard to make QUELIMMUNE available to patients in need. Results from completed clinical trials show the potential of QUELIMMUNE to save the lives and decrease dialysis dependency of these severely ill children with AKI, and we are dedicated to ensuring widespread access to our therapeutic device,” said Eric Schlorff, CEO of SeaStar Medical. “We have now met the FDA’s requirement for a timely first treatment.” Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately 50%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis. Pooled analysis from two non-controlled clinical studies, one of which was funded by the FDA office of Orphan Products Development, showed that children with AKI weighing 10 kilograms or more requiring continuous KRT treated with QUELIMMUNE had a 77% survival rate with no dialysis dependency at 60 days, and had no device-related serious adverse events or device-related infections. About Acute Kidney Disease (AKI) AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as COVID-19, sepsis, severe trauma and surgery. In critically ill patients with AKI, a dysregulated immune response can lead to hyperinflammation, which may contribute to significant morbidity, including prolonged ICU stays, increased reliance on dialysis and mechanical ventilation, and higher hospital costs. Damage resulting from this dysregulated response in AKI can progress to other organs, such as the heart or liver. Multi-organ dysfu...