SeaStar Medical's SCD therapy receives CMS billing codes for AKI

SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that its Selective Cytopheretic Device (SCD) therapy has received dedicated ICD-10-PCS codes from the Centers for Medicare & Medicaid Services (CMS), according to a press release issued June 23, 2026.

The new codes enable administrative billing and statistical reporting for the SCD therapy in patients with acute kidney injury (AKI) requiring renal replacement therapy in the inpatient hospital setting. The codes are expected to take effect on October 1, 2026.

The coding assignment applies to SeaStar Medical's commercially available product, Quelimmune (SCD-PED), which was approved by the U.S. Food and Drug Administration in February 2024 under a Humanitarian Device Exemption for critically ill pediatric patients with AKI due to sepsis or a septic condition requiring renal replacement therapy.

Tim Varacek, Senior Vice President of Commercial and Business Operations at SeaStar Medical, said the codes "will ease the logistics for our existing Quelimmune customers," and noted the company estimates the adult AKI market is approximately $4.5 billion, which it characterizes as roughly 50 times larger than the pediatric market.

SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial evaluating the SCD therapy in 339 adult patients with AKI in the ICU receiving continuous renal replacement therapy. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency.

The SCD therapy has received Breakthrough Device Designation from the FDA for the treatment of immunomodulatory dysregulation in adult patients with AKI.

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