SeaStar Medical Holding, a leading medical technology company, has announced a significant development in its proprietary Selective Cytopheretic Device (SCD) for pediatric patients. The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research has issued an Approvable Letter for the device, causing a notable 13% increase in SeaStar Medical Holding shares, which are now valued at $1.15.
A Revolutionary Solution for Pediatric Patients
The powerful SCD-Pediatric has been approved for use in children weighing 10 kilograms or more who are suffering from acute kidney injury and sepsis or a septic condition that requires continuous kidney replacement therapy in the hospital intensive care unit. This groundbreaking device, with its patented design, promises to revolutionize the treatment of these debilitating conditions.
A Milestone in the FDA Approval Process
The issuance of the Approvable Letter by the FDA marks a significant milestone in the approval process of SeaStar Medical’s Humanitarian Device Exemption (HDE) application. This letter confirms that the company’s HDE application aligns with the necessary requirements for an Approval Order, outlining the remaining administrative steps that need to be completed before the HDE can be activated for commercialization. SeaStar Medical is fully dedicated to working closely with the FDA to address these action items efficiently.
The Path Towards Commercialization
With the cooperation of the FDA, SeaStar Medical aims to finalize the necessary steps in the coming weeks. As a result, they project that the SCD-Pediatric will be ready for commercialization by the end of 2023 or at the latest, by the first quarter of 2024. This timeline reaffirms SeaStar Medical’s commitment to bringing this innovative device to market as soon as possible, ensuring that young patients receive the care they urgently require.
Innovative Technology to Combat Inflammation
The SCD-Pediatric is an extracorporeal device with a patented design that selectively targets and transitions pro-inflammatory monocytes, enabling reparative processes and minimizing the acute inflammatory effects caused by activated neutrophils. This cutting-edge technology has the potential to significantly reduce the damaging impact of inflammation on young patients, improving their quality of life and overall outcomes.
For more information, please visit SeaStar Medical Holding’s website.
