SeaStar Medical Holding Corporation announced that it has received a letter from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) regarding the Company's Humanitarian Device Exemption (HDE) application for its pediatric Selective Cytopheretic Device (SCD), which is designed to treat critically ill children with acute kidney injury (AKI) on continuous kidney replacement therapy (CKRT). In the letter, the FDA indicated that the application is not approvable in its current form but outlined specific guidance as to how the application may be amended and resubmitted successfully. The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CKRT and remove the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients.

Unlike pathogen removal and other blood-purification tools, the device works with hemofiltration systems to enable precise fluid and solute balance control to selectively target and transition pro-inflammatory monocytes to reparative and promote activated neutrophils to be less inflammatory. SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to focus on repair.

This unique immunomodulation approach may reverse injury and eliminate the need for CKRT going forward.