SeaStar Medical has submitted an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a pivotal study to evaluate the effectiveness of the CompanyÆs Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The SCD, the companyÆs innovative platform therapy, is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients. The therapy currently is delivered through continuous CKRT to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis.

The SCD received Breakthrough Device Designation by the FDA in May 2022. Approximately 6 million cases of adult AKI are diagnosed annually in the U.S. The SCD has demonstrated success in critically ill adult patients with AKI requiring CKRT, a condition with a high mortality rate. In the CompanyÆs previously completed pilot SCD 005 clinical study evaluating the safety and feasibility of the SCD in COVID-19 patients with AKI and/or acute respiratory distress syndrome (ARDS), patients experienced reductions in activated neutrophils and monocytes, which led to reduction in proinflammatory cytokines and improved clinical outcomes.

Based on the per-protocol minimum of four days of therapy, the mortality of treated patients was significantly lower (41%) than the contemporaneous control population that was treated under the current standard of care (81%). All patients received CKRT as the delivery vehicle for the therapy. The randomized, controlled study is expected to enroll 200 subjects, with a primary endpoint of a composite of 90-day mortality and dialysis dependency of SCD patients compared to the control group.

Details of the study design will be provided upon IDE approval by the FDA. The study is anticipated to begin in the first quarter of 2023 with interim results expected in the fourth quarter of 2023 and topline results and submission for Pre-market Approval (PMA) in the third quarter of 2024. In July 2022, SeaStar Medical announced it has submitted its application to the FDA for Humanitarian Device Exemption (HDE) for use of the Selective Cytopheretic Device (SCD) for critically ill children with AKI.

The HDE application submission to the FDA was based on findings from SeaStar MedicalÆs Pilot Study (NCT02820350) of pediatric patients with AKI which demonstrated that the SCD was safe for use in pediatric patients. The Company expects the FDA to complete its substantiative review of the HDE in the first quarter of 2023, with a commercial launch in the second quarter of 2023.