SeaStar Medical Holding Corp (NASDAQ: ICU) is a commercial-stage medical device company that develops and sells a Selective Cytopheretic Device (SCD) therapy targeting acute kidney injury (AKI) and related conditions in intensive care settings. Revenue comes from direct product sales of its FDA-approved pediatric SCD therapy, QUELIMMUNE, to hospitals and clinicians. QUELIMMUNE received FDA Humanitarian Device Exemption (HDE) approval in February 2024, and the company shipped its first commercial units in July 2024, recognizing $1.2 million in revenue for the year ended December 31, 2025, up from $0.1 million in the year ended December 31, 2024. The company operates at a significant loss, with a net loss of $12.2 million for the year ended December 31, 2025, and finances operations through equity and debt issuances. Manufacturing, distribution, and clinical trial execution rely on third-party vendors and contractors. SeaStar Medical is pursuing a pivotal study to support a PMA submission for adult AKI, an indication with an estimated 200,000 U.S. patients annually, and intends to expand SCD applications to additional indications over time.

Revenue model

Transactional product sales of the QUELIMMUNE SCD device to hospitals. Revenue was $1.234 million for the year ended December 31, 2025, versus $0.135 million for the year ended December 31, 2024. The company has not yet generated significant revenue from commercialized products and funds operations primarily through equity and debt issuances.

Products and services

QUELIMMUNE: an FDA HDE-approved pediatric SCD (Selective Cytopheretic Device) therapy for acute kidney injury in ICU patients, commercially launched in July 2024. An adult AKI SCD therapy is in pivotal clinical development targeting PMA submission. Additional pipeline indications include acute respiratory distress syndrome, chronic dialysis, cardiorenal syndrome, and hepatorenal syndrome.

Customers and end markets

Hospitals and clinicians treating pediatric ICU patients with acute kidney injury. The broader addressable market includes adult AKI patients, estimated at approximately 200,000 annually in the United States. Over 5 million ICU admissions occur in the U.S. each year, with approximately 50 to 60 percent of those patients experiencing AKI, per the company's 10-K filed 2026-03-25.

Value-chain role

Device developer and commercial-stage seller. Manufacturing, distribution, and clinical trial execution are outsourced to third-party vendors and contractors. The company's management team oversees these third parties but does not independently manufacture or distribute its products.

Geographic exposure

United States, based on regulatory filings and commercial operations described in the 10-K filed 2026-03-25. No international commercial operations are described in the filing excerpts.

Source: SEC 10-K, filed 2026-03-25

Industry: Surgical & Medical Instruments & Apparatus Peers: Abbott Laboratories Daxor Corp Strata Skin Sciences Inc Kewaunee Scientific Corp PetVivo Holdings Inc Precision Optics Corporation Inc Scientific Industries Inc VAPOTHERM INC