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Quelimmune (SCD)

Pediatric Acute Kidney Injury (AKI) with sepsis/septic condition

ApprovedLaunched July 2024

Key Facts

Indication
Pediatric Acute Kidney Injury (AKI) with sepsis/septic condition
Phase
Approved
Status
Launched July 2024
Company

About SeaStar Medical

SeaStar Medical is on a mission to save lives by calming the cytokine storm, a destructive hyperinflammatory response that leads to organ failure in critically ill patients. The company has achieved its first FDA approval under a Humanitarian Device Exemption for its lead product, Quelimmune, to treat pediatric acute kidney injury, and has launched it commercially. With a robust pipeline backed by multiple FDA Breakthrough Device Designations, SeaStar is advancing its Selective Cytopheretic Device (SCD) technology into pivotal and feasibility studies for adult acute kidney injury, cardiorenal syndrome, and other severe inflammatory conditions.

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