SeaStar Medical Holding Corporation Overview
Pro stress-test →SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The company's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 as the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients.
Strategic Profile
Pro stress-test →SeaStar's platform is based on the Selective Cytopheretic Device (SCD), which neutralizes over-active immune cells and stops cytokine storm-induced hyperinflammation, with development spanning acute kidney injury, cardiorenal syndrome, hepatorenal syndrome, and myocardial stunning in end-stage renal disease. The SCD therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling accelerated pathways to approval.
Competitive Landscape
Pro stress-test →SeaStar operates in the immunomodulation/critical care device market with limited direct competitors in the cytopheretic device space. Broader competitive pressures come from alternative sepsis/AKI management approaches, other critical care devices, and pharmaceutical interventions. The ultra-rare indication for QUELIMMUNE provides significant market protection, though adoption depends on clinical outcomes and reimbursement dynamics.
Industry Context
SeaStar Medical Holding Corporation operates in Medical Devices / Critical Care / Immunomodulation.
Key facts
Founded: 2007 · Headquarters: Denver, Colorado · Market cap: $10.46M