Here are the 10-K annual reports from SeaStar Medical Holding Corporation Warrant (ICUCW) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow ICUCW and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ICUCW filings page.
SeaStar Medical Holding Corporation is a commercial-stage healthcare company developing its Selective Cytopheretic Device (SCD) to treat life‑threatening hyperinflammatory conditions that drive acute and chronic organ failure. The SCD modulates over‑active neutrophils and monocytes via an extracorporeal membrane integrated into continuous renal replacement therapy systems.
In February 2024, the FDA approved the pediatric SCD therapy QUELIMMUNE under a Humanitarian Device Exemption for acute kidney injury due to sepsis, and commercial shipments began in July 2024. As of December 31, 2025, 10 hospitals had completed the required SAVE Surveillance Registry and purchased QUELIMMUNE, with early registry data in 21 patients showing no device‑related safety events and favorable 60‑ and 90‑day survival.
For adults, the pivotal NEUTRALIZE‑AKI trial in ICU patients with acute kidney injury on CRRT targets 339 subjects, with 181 enrolled as of March 21, 2026. The SCD platform has received multiple FDA Breakthrough Device Designations across acute kidney injury, cardiorenal and hepatorenal syndromes, end‑stage renal disease, and cardiac surgery–related systemic inflammation, supported by a patent estate of 17 U.S. and 29 foreign patents.