SeaStar Medical Holding ICU

SeaStar Medical Holding Corporation is a commercial‑stage healthcare company that develops and markets the Selective Cytopheretic Device (SCD), a therapeutic platform designed to neutralize overactive immune cells and halt the cytokine storm that drives organ failure in critically ill patients. The SCD is an extracorporeal synthetic membrane cartridge that binds activated neutrophils and monocytes when placed in a continuous renal replacement therapy circuit using regional citrate anticoagulation, thereby modulating leukocyte activity without causing systemic immunosuppression. The company’s lead product, QUELIMMUNE, has received FDA approval under a Humanitarian Device Exemption for pediatric patients with acute kidney injury resulting from sepsis or a septic condition requiring continuous renal replacement therapy, and it is the only device authorized for this indication. Beyond its pediatric offering, SeaStar Medical is advancing the SCD through pivotal clinical trials for adult indications such as acute kidney injury, cardiorenal syndrome awaiting left ventricular assist device implantation, hepatorenal syndrome, end‑stage renal disease and inflammatory responses during cardiac surgery, each supported by a separate Breakthrough Device Designation. The firm also leverages its patented technology to explore additional inflammatory conditions where leukocyte activation contributes to disease progression.

The company generates revenue primarily from the sale of QUELIMMUNE to hospitals that have completed the required Institutional Review Board process and enrolled patients in the post‑approval SAVE Surveillance Registry. Each sale includes the disposable SCD cartridge and the associated training and support necessary for safe integration into existing continuous renal replacement therapy circuits. As of December 31, 2025, StarMed reported ten active commercial hospital customers purchasing the device, with additional placements planned for 2026 as more institutions finish the IRB and registry requirements. Revenue is also expected to grow from future indications once the SCD obtains premarket approval for adult acute kidney injury and other therapeutic areas covered by its six Breakthrough Device Designations, which would expand the addressable market to hundreds of thousands of patients annually. While the company continues to invest heavily in clinical development, regulatory affairs and manufacturing scale‑up, it does not currently derive meaningful income from licensing, royalties or partnership agreements, and all reported sales arise from direct hospital purchases of the QUELIMMUNE product.

SeaStar Medical occupies a niche position as the first and only FDA‑authorized device that directly targets activated neutrophils and monocytes to modulate the inflammatory cascade in acute kidney injury, setting it apart from conventional therapies that rely on broad immunosuppression or single‑cytokine inhibition. Competitors in the extracorporeal blood‑treatment space include established continuous renal replacement therapy providers such as Fresenius Medical Care, Baxter International (operating as Vantive) and Nikkiso, which supply the circuits, filters and anticoagulation solutions but do not offer immunomodulatory functionality. The company’s competitive advantage stems from its proprietary SCD membrane, which selectively binds and deactivates pathogenic leukocytes while returning the rest of the blood unchanged, a differentiation supported by preclinical and clinical data showing a 50 % reduction in mortality among treated patients and no increase in infection risk. Furthermore, SeaStar Medical benefits from six FDA Breakthrough Device Designations that accelerate regulatory pathways, a robust patent portfolio comprising 46 U. S. and foreign patents and one pending application, and an exclusive worldwide license from the University of Michigan covering the core leukocyte‑processing technology, which together create barriers to entry and protect its market share as it pursues additional indications.

The company’s customer base consists of hospitals and intensive‑care units that utilize continuous renal replacement therapy for critically ill patients, with a current focus on pediatric medical centers authorized to use QUELIMMUNE under the Humanitarian Device Exemption. Although specific hospital names are not disclosed in the filing, SeaStar Medical has identified ten active commercial sites as of the end of 2025 and is pursuing additional activations throughout 2026 to broaden its geographic reach across the United States. The firm also anticipates expanding its clientele to adult critical care facilities once the SCD receives approval for indications such as acute kidney injury in adults, cardiorenal syndrome and end‑stage renal disease, thereby addressing a larger population of ICU patients requiring renal replacement therapy. In addition to direct sales, SeaStar Medical works closely with hospital staff to provide training on device operation and to collect real‑world evidence through the SAVE Surveillance Registry, which supports both regulatory compliance and future market expansion.