SeaStar Medical Holding Corp

Unless the context otherwise requires, all references in this section to SeaStar Medical , the Company , we us or our refer to SeaStar Medical Holding Corporation and our consolidated subsidiaries following the Business Combination (as defined herein), other than certain historical information that refers to the business of SeaStar Medical, Inc. (the Predecessor ) prior to the consummation of the Business Combination. Overview We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. Our Selective Cytopheretic Device ( SCD ) is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. It has broad potential applications for patients suffering from both acute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases. We received Food and Drug Administration ( FDA ) approval on February 21, 2024, under a Humanitarian Device Exemption ( HDE ) for our pediatric SCD therapy. It is the only FDA approved product for use in pediatric patients with acute kidney injury ( AKI ) due to sepsis or a septic condition requiring kidney replacement therapy. We shipped our first commercial pediatric SCD ( QUELIMMUNE ) in July 2024.