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FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition

Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults annually and contributes to nearly one in three in-hospital deaths DENVER, Oct. 07, 2026