SeaStar Medical Holding Corporation (NASDAQ: ICU) shares sprinted Tuesday. The Denver-based SeaStar, a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the QUELIMMUNE therapy has been adopted for use by the nationally recognized Texas Children’s Hospital.
The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption application for pediatric patients with AKI due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy.
Clinical data from the FDA application and subsequently published in Kidney Medicine showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors at Day 60 after ICU discharge.
SeaStar Medical introduced its Selective Cytopheretic Device therapy under the brand name QUELIMMUNE to the pediatric market in mid-2024 based on the serious unmet need for organ-sparing and life-saving therapies in this patient population.
The SCD therapy is designed to be broadly applicable as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.
Shares in ICU zoomed nine cents, or 15.9%, to 64 cents.
