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ICU biotech catalysts & pipeline

SEASTAR MEDICAL HOLDING CORP · Data as of 2026-09-08

Upcoming catalysts

selective cytopheretic device — Topline data

Late 2026

Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026 and begin submission of relevant PMA modules to the FDA to facilitate the PMA review and approval process.
Source filing

SCD therapy — NDA/BLA submission

Late 2027

Completion of enrollment is anticipated around year end or into the first quarter of 2027, which would enable a PMA application to the FDA near the end of 2027, pending a positive outcome of the trial.
Source filing

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