ICU | Market Cap: $19.1M (07/13/26)
Industry:
Healthcare Equipment, Supplies, & Technology

DESCRIPTION

SeaStar Medical is a small commercial-stage medical device company with a single product platform: the Selective Cytopheretic Device (SCD), designed to treat critically ill patients suffering from hyperinflammation and organ failure. The SCD integrates into Continuous Renal Replacement Therapy (CRRT) circuits already present in ICUs, using a low-calcium environment to selectively deactivate the most overactive immune cells and return them to the patient in a less inflammatory state — a "catch-and-release" mechanism that calms the immune response without fully suppressing it. SeaStar's only commercial product today is QUELIMMUNE, an FDA-approved pediatric SCD therapy for critically ill children with acute kidney injury (AKI) due to sepsis requiring CRRT. SeaStar sells QUELIMMUNE directly to children's hospitals using a small internal sales force targeting the top 50 U.S. pediatric facilities. The business model is disposable-cartridge-based: hospitals pay per patient treatment, with each patient course consuming multiple units. Gross margins are high. The pediatric AKI market is small, so SeaStar's near-term commercial priority is largely foundational — the real growth opportunity lies in adult AKI, where SeaStar is running a 339-patient pivotal trial (NEUTRALIZE-AKI) with topline results expected in 2027. SeaStar also holds six FDA Breakthrough Device Designations covering additional indications including cardiorenal syndrome and end-stage renal disease, all addressable with the same SCD platform.

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