SeaStar announces FDA breakthrough device designation for SCD in adult sepsis
Published in Immunology, Tools.
October 7, 2026
SeaStar Medical announced FDA Breakthrough Device Designation for its Selective Cytopheretic Device therapy to address hyperinflammation in adults with sepsis or a septic condition.
The SCD is designed to work with a continuous renal replacement therapy system and modulate activated inflammatory immune cells. The company plans to use a prespecified sepsis subgroup analysis from its ongoing NEUTRALIZE-AKI study to support further regulatory discussions.
The randomized pivotal study evaluates SCD in adults with acute kidney injury receiving continuous renal replacement therapy. Its primary endpoint combines mortality or dialysis dependence at 90 days, comparing SCD plus standard care with standard care alone.
The designation is intended to accelerate development and regulatory review; it is not approval for this adult sepsis indication. The announcement does not provide a new completed trial result demonstrating a survival benefit in that population. Clinical effectiveness and safety must be assessed through the ongoing evidence-generation program.