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SeaStar Medical provides regulatory update regarding Selective Cytopheretic Device use in pediatric acute kidney injury under a Humanitarian Device Exemption

Written by | 4 Nov 2023 | Nephrology

SeaStar Medical Holding Corporation announces receipt of a correspondence from the FDA Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU).

The correspondence further indicates that an Approvable Letter, which is a standard part of CBER’s approval process, is expected to be issued within a month. The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval.

“The correspondence provides a clear path forward in making this much needed therapy accessible to critically ill children suffering with AKI and sepsis,” said Eric Schlorff, SeaStar Medical CEO. “Only about half of the children in the ICU with AKI requiring CKRT survive and those who do are at increased risk of long-term conditions such as chronic kidney disease. We understand the agency’s appropriate caution in these medically fragile septic patients whose care requires significant resources, and we appreciate the agency’s willingness to work collaboratively with SeaStar Medical and our advisors to review the HDE application, as well as its recognition of SCD as a therapy with probable benefit for these children. This is an important milestone for SeaStar Medical, and we intend to follow the regulatory path laid out by the FDA to commercialize SCD for this indication by the end of 2023.”

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