SeaStar Medical Holding Corporation

SeaStar Medical Holding Corporation is a commercial-stage medical technology company headquartered in Denver, Colorado. The company's core business revolves around developing proprietary extracorporeal therapies designed to mitigate the effects of hyperinflammation on vital organs. Its mission is to transform treatments for critically ill patients facing organ failure and potential loss of life.

SeaStar Medical's primary product is its patented Selective Cytopheretic Device (SCD) therapy. The company's first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024 under a Humanitarian Device Exemption. QUELIMMUNE is specifically indicated for the treatment of life-threatening acute kidney injury (AKI) due to sepsis or septic conditions in critically ill pediatric patients requiring renal replacement therapy. The company is also advancing its SCD therapy through clinical trials for adult AKI patients (NEUTRALIZE-AKI pivotal trial) and exploring applications in other therapeutic areas such as cardiorenal syndrome, hepatorenal syndrome, and myocardial stunning in end-stage renal disease. The SCD therapy has been granted six FDA Breakthrough Device Designations across various indications.

Led by CEO Eric Schlorff, SeaStar Medical reported approximately $1.2 million in net revenue for the full year 2025. Recent developments include the completion of the FDA enrollment requirement for the QUELIMMUNE SAVE Surveillance Registry in March 2026 and the ongoing NEUTRALIZE-AKI pivotal trial for adult AKI, which has exceeded 50% enrollment. In February 2026, the FDA reduced the mandated target for the SAVE Registry from 300 to 50 patients based on initial data, and a health economic analysis projected significant cost savings with QUELIMMUNE in pediatric AKI. The company was also recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation. However, a class action complaint was filed in July 2024 alleging material misstatements or omissions, which led to a restatement of consolidated financial statements.