SeaStar Medical Finalizes QUELIMMUNE FDA Labeling Requirement

DENVER, Colo., Jul 03, 2024 ( SeaStar Medical Holding Corporation (Nasdaq:ICU) reported that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) agreed to the final labeling for QUELIMMUNE, SeaStar Medical’s Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).

Eric Schlorff, CEO of SeaStar Medical, commented, “We thank the FDA for diligently working through QUELIMMUNE’s labeling. We are now ready to make final changes to product labels for incorporation into the commercial kits.

“We expect to begin shipping this month and are excited to bring the potential lifesaving and quality-of-life benefits of QUELIMMUNE to critically ill children.”

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