FDA issues approvable letter for Selective Cytopheretic Device for pediatric patients

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). As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption (HDE) application. The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization. For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan. SeaStar Medical intends to work diligently with the FDA to complete these action items in the coming weeks and expects to commence commercialization of the SCD by the end of 2023 or the first quarter of 2024.

“We are well on our way to commercializing SeaStar Medical’s Selective Cytopheretic Device (SCD) in the first of what we believe will be multiple high-value indications where dysregulated inflammation plays a role,” said Eric Schlorff, SeaStar Medical Chief Executive Officer. “Our pivotal trial in critically ill adults with AKI is progressing well with the goal of the SCD becoming the standard of care for AKI in the ICU. In addition to adult AKI, we have recently received Breakthrough Device Designations for the SCD in both cardiorenal syndrome and hepatorenal syndrome, which should expedite the clinical development and regulatory review of the SCD for use in these indications.”

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. 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 greater then 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 greater than 15 kg) and greater than PED-02 (weight range greater than 10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

About Hyperinflammation 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 can result in multi-organ failure and even death. This is known as the cytokine storm.

.

About the Selective Cytopheretic Device :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 pro-inflammatory 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.