Medical technology company SeaStar Medical Holding Corporation (Nasdaq: ICU) announced on Monday that it has received an Approvable Letter from the FDA's Center for Biologics Evaluation and Research (CBER) for their Selective Cytopheretic Device Paediatric (SCD-PED).

This device is intended for paediatric patients weighing 10 kilograms or more who suffer from acute kidney injury (AKI) and sepsis or septic conditions necessitating continuous kidney replacement therapy (CKRT) in the ICU. The FDA's issuance of the Approvable Letter is a standard step in the Humanitarian Device Exemption (HDE) approval process, indicating that SeaStar Medical's HDE application aligns with the requirements for an Approval Order.

Remaining administrative tasks include revising product labeling and making minor adjustments to the post-approval study plan. SeaStar Medical is committed to collaborating with the FDA to complete these tasks in the near future. The company anticipates commencing SCD commercialization by the end of 2023 or the first quarter of 2024. The SCD is a patented extracorporeal device, designed as an adjunct therapy to target pro-inflammatory monocytes and reduce the damaging effects of activated neutrophils, ultimately promoting reparative processes.

Clinical studies, including SCD-PED-01 and SCD-PED-02, showed promising results with no device-related serious adverse events or infections, a 77% reduction in mortality rate, and no dialysis dependency at Day 60 in paediatric patients ≥10kg with AKI requiring CKRT. The SCD-PED-01 and PED-02 studies exhibited 75% and 83% reductions in mortality, respectively.