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SeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device
DENVER, July 03, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, July 03, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical’s QUELIMMUNE™, the 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). “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,” said Eric Schlorff, SeaStar Medical CEO. “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.” Pediatric Acute Kidney InjuryQUELIMMUNE is approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Pediatric patients undergoing treatment with QUELIMMUNE are expected to require, on average, seven QUELIMMUNE daily therapies, with the disposable device being changed once every 24 hours. Only about half of patients in the pediatric ICU with AKI who require KRT survive, with those surviving being at risk of long-term, life-threatening conditions such as chronic kidney disease. A pooled analysis from two non-controlled studies (one of which was funded by the FDA Office of Orphan Products Development) showed that children weighing 10 kilograms or more with AKI requiring continuous KRT who were treated with QUELIMMUNE had a 77% survival rate, no dialysis dependency at day 60 and no device-related serious adverse events or device-related infections. The U.S. addressable population of about 4,000 children falls within the 8,000-patient HDE criteria. SeaStar Medical is also conducting a pivotal trial in adults with AKI who require continuous KRT. The appl...