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SCD (Adult)

Adult Acute Kidney Injury (AKI) requiring CRRT

Pivotal TrialNEUTRALIZE-AKI trial ongoingNCT05758077

Key Facts

Indication
Adult Acute Kidney Injury (AKI) requiring CRRT
Phase
Pivotal Trial
Status
NEUTRALIZE-AKI trial ongoing
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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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.

View full company profile

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.

View full company profile

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.

View full company profile

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.

View full company profile