Category: Medical Literature

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. Our first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic-like condition in critically ill pediatric patients. Our Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. We are currently conducting a pivotal trial of our SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

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Category: Medical Literature

SCD Pilot Study

Early SCD Rationale