SeaStar Medical Holding Corp

SeaStar Medical is a commercial-stage healthcare company developing treatments for critically ill patients experiencing organ failure. The company's primary product is the Selective Cytopheretic Device ("SCD"), a device designed to neutralize over-active immune cells and stop cytokine storms that cause hyperinflammation. The SCD has potential applications for patients with acute and chronic kidney disease, cardiovascular disease, and other inflammatory conditions. On February 21, 2024, SeaStar Medical received Food and Drug Administration ("FDA") approval under a Humanitarian Device Exemption ("HDE") for its pediatric SCD therapy. This product, branded "QUELIMMUNE," is the only FDA-approved product for pediatric patients with acute kidney injury ("AKI") due to sepsis or a septic condition requiring kidney replacement therapy. The first commercial pediatric SCD was shipped in July 2024. The company is also conducting a pivotal clinical trial, "NEUTRALIZE-AKI," to evaluate the safety and efficacy of SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy ("CRRT"). Additionally, a feasibility study is underway for SCD therapy in adult patients with Cardiorenal Syndrome ("CRS") awaiting left ventricular assist device ("LVAD") implantation. The FDA has granted six Breakthrough Device Designations ("BDD") for the SCD therapy, covering multiple indications in adult patients, including AKI, CRS awaiting LVAD implantation, hepatorenal syndrome, end-stage renal disease ("ESRD"), and systemic inflammatory response during cardiac surgery.