SeaStar Medical Holding Corp Overview
Pro stress-test →SeaStar Medical Holding Corporation develops and commercializes extracorporeal medical-device therapies for critically ill patients with organ failure driven by hyperinflammation. The company develops a proprietary platform therapy to reduce the consequences of hyperinflammation on vital organs in the United States. The company is at a critical commercialization inflection point with its first FDA-approved pediatric acute kidney injury therapy.
Strategic Profile
Pro stress-test →SeaStar received FDA Humanitarian Device Exemption (HDE) Approval for its Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for children with acute kidney injury due to sepsis, branded as Quelimmune and now commercially marketed as a Humanitarian Use Device. The company received dedicated ICD-10-PCS codes from CMS for its SCD therapy used in acute kidney injury requiring renal replacement therapy, taking effect October 1, 2026. SeaStar Medical estimates the adult AKI market is approximately $4.5 billion.
Competitive Landscape
Pro stress-test →SeaStar competes in the extracorporeal blood purification and organ support therapy space, with indirect competition from dialysis providers (DaVita, Fresenius Medical Care), ECMO/mechanical support device makers (Maquet, LivaNova), and emerging hyperinflammation therapies. The Quelimmune platform is differentiated as a selective cytopheresis device targeting sepsis-induced organ dysfunction, but market validation remains nascent and adoption depends on successful adult AKI indication expansion.
Industry Context
SeaStar Medical Holding Corp operates in Extracorporeal blood purification and organ support therapies.
Key facts
Founded: 2020 · Headquarters: Denver, US · Employees: N/A · Revenue: N/A · Market cap: $13.9M