By Chris Wack
SeaStar Medical Holding shares were up 13% to $1.15 after the company said the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research has issued an Approvable Letter for the company’s proprietary Selective Cytopheretic Device-Pediatric.
The stock hit its 52-week low of 16 cents on Sept. 11, and is down 91% in the past 12 months.
The letter is for approved use in children weighing 10 kilograms or more with acute kidney injury and sepsis or a septic condition requiring continuous kidney replacement therapy in the hospital intensive care unit.
The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption application.
The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization. SeaStar Medical intends to work with the FDA to complete these action items in the coming weeks and expects to commence commercialization of the device by the end of 2023 or the first quarter of 2024.
The device is a patented, cell-directed, extracorporeal device designed to be used as an adjunct therapy that selectively targets and transitions pro-inflammatory monocytes to promote reparative processes and reduce the acute inflammatory and damaging effects of activated neutrophils.
Write to Chris Wack at [email protected]
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