DENVER — October 1, 2026
SeaStar Medical Holding Corporation announced that new ICD-10-PCS codes are now available for its Selective Cytopheretic Device (SCD) therapy in patients with acute kidney injury (AKI) requiring renal replacement therapy (RRT) in the inpatient hospital setting. The new coding framework is designed to support hospital billing, administrative reporting and clinical outcome tracking for SCD therapy, including QUELIMMUNE (SCD-PED). The newly assigned codes cover intermittent, prolonged intermittent and continuous selective cytopheresis procedures, providing hospitals with a standardized mechanism to document the use of the therapy. SeaStar Medical said the codes could help address previous coding limitations and support broader hospital adoption of its technology. The company also stated that the codes are broadly applicable to AKI patients requiring RRT, creating a framework that could support future SCD indications if additional uses are approved.
New ICD-10-PCS Codes Support Hospital Billing
The new ICD-10-PCS codes include 5A1D701 for intermittent urinary filtration with selective cytopheresis lasting less than six hours, 5A1D801 for prolonged intermittent treatment lasting six to 18 hours, and 5A1D901 for continuous treatment lasting more than 18 hours. ICD-10-PCS is the procedure coding system used by U.S. hospitals for inpatient procedures, including billing, reimbursement and statistical reporting. SeaStar Medical said the availability of dedicated procedure codes provides healthcare organizations with a clearer pathway for documenting and seeking payment when using its SCD therapy. The company expects the coding framework to simplify administrative processes for hospitals and support access to QUELIMMUNE, which is currently being commercialized for pediatric patients with AKI and sepsis or septic conditions who weigh at least 10 kilograms, are receiving antibiotics and are being treated in an intensive care unit with RRT. QUELIMMUNE received FDA approval in February 2024 under a Humanitarian Device Exemption.
QUELIMMUNE Uses Selective Cytopheresis Technology
The technology behind QUELIMMUNE is based on SeaStar Medical’s Selective Cytopheretic Device (SCD), a blood-treatment technology designed to modulate excessive inflammatory activity in critically ill patients. The company describes SCD therapy as a disease-modifying approach intended to target proinflammatory immune cells during continuous RRT and transition them toward a more reparative state. Unlike blood-purification approaches focused primarily on removing pathogens or other substances, the SCD is integrated with an existing continuous RRT hemofiltration system and is designed to influence inflammatory monocytes and activated neutrophils. SeaStar Medical is also evaluating the technology in a broader adult AKI population through the NEUTRALIZE-AKI pivotal trial, which is enrolling 339 adults with AKI in intensive care who require continuous RRT. The trial is designed to evaluate a composite endpoint of 90-day mortality or dialysis dependency, along with additional measures including mortality, ICU-free days and kidney outcomes.
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SeaStar Medical Advances Broader AKI Strategy
The new coding development comes as SeaStar Medical continues expanding the clinical and commercial framework surrounding its SCD platform. The company cited previous clinical data in which QUELIMMUNE-treated patients had a 77% survival rate, while early observations from the post-approval SAVE Registry showed survival rates of 76% at Days 28 and 60 and 71% at Day 90 among the first 21 pediatric patients evaluated. These findings are company-reported and remain distinct from evidence generated through randomized controlled trials. SeaStar Medical is now pursuing broader validation of SCD therapy through the ongoing NEUTRALIZE-AKI pivotal study in adults, while the newly available ICD-10-PCS codes establish an administrative and billing framework for AKI procedures involving selective cytopheresis. Together, the coding milestone, existing pediatric commercialization and ongoing adult clinical development represent key components of SeaStar Medical’s strategy to expand the use of SCD technology in critically ill patients with AKI and other conditions associated with severe hyperinflammation.
Source:SeaStar Medical, press release
