SeaStar Medical Holding saw a 10% jump in shares, reaching $1.60 following the U.S. Food and Drug Administration's issuance of a Humanitarian Device Exemption Approval Order for its pediatric selective cytopheretic device.
Targeted Use for Children
The FDA's approval is specific to children weighing at least 10 kilograms who are suffering from acute kidney injury caused by sepsis or a septic condition necessitating kidney replacement therapy.
Introduction of Quelimmune Product Family
This marks SeaStar Medical's entry into the market with its new Quelimmune product family. The Quelimmune pediatric device has now received clearance for commercial marketing as a Humanitarian Use Device.
Anticipated Launch
SeaStar Medical's U.S. license and distribution partner, Nuwellis, is expected to launch Quelimmune for pediatric acute kidney injury in the near future. Subsequent to this initial launch, a comprehensive commercial program will be implemented.
Clinical Validation
The FDA's approval of the Quelimmune pediatric device stemmed from compelling clinical data indicating its safety and potential clinical benefits for critically ill children facing acute kidney injury with limited treatment alternatives.
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