SeaStar Medical Holding Corporation announced receipt of a correspondence from the U.S. Food and Drug Administration?s (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 SCD 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. In the HDE regulatory approval process of SCD-PED for children with AKI and sepsis, the FDA considered clinical results showing safety and probable clinical benefit to these patients who have few treatment options. Pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02 showed that pediatric patients =10kg with AKI requiring CKRT treated with the SCD had no device-related serious adverse events or infections, a 77% reduction in mortality rate, and no dialysis dependency at Day 60.

The SCD-PED-01 (weight range =15 kg) and PED-02 (weight range =10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively. The Company believes the SCD could become the new standard of care for AKI patients requiring CKRT in the ICU and could also have significant benefit in additional indications where dysregulated immune processes are involved. Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs.

It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm. The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CKRT and disrupt 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.