SeaStar Medical secures ICD-10-PCS codes for SCD therapy
SeaStar Medical Holding Corporation has secured dedicated ICD-10-PCS codes from the Centers for Medicare & Medicaid Services for its Selective Cytopheretic Device (SCD) therapy, enabling standardized billing for acute kidney injury treatment. The codes, effective October 1, 2026, are expected to ease logistics for existing QUELIMMUNE customers and support the potential launch of the therapy in the adult market, estimated at $4.5 billion. Clinical data shows a 77% survival rate for pediatric patients, with ongoing trials for adults.
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SeaStar Medical Holding Corporation has secured dedicated ICD-10-PCS codes from the Centers for Medicare & Medicaid Services for its Selective Cytopheretic Device (SCD) therapy. The assignment enables standardized administrative, billing, and statistical reporting for the use of the therapy in patients with acute kidney injury requiring renal replacement therapy in the inpatient hospital setting. The new codes are expected to take effect on October 1, 2026.
Tim Varacek, Senior Vice President of Commercial and Business Operations of SeaStar Medical, stated that universal billing codes will ease logistics for existing QUELIMMUNE customers. He noted that the development has significant implications for the potential launch of the SCD therapy in the adult acute kidney injury indication. The company estimates this market is approximately 50 times larger than the pediatric market, or about $4.5 billion.
The ICD-10-PCS codes provide hospitals with a specific mechanism to document and seek payment when using QUELIMMUNE. This addresses previous coding limitations that could hinder broader adoption. The codes also pave the way for billing of future potential SCD therapies requiring renal replacement therapy.
QUELIMMUNE (SCD-PED) therapy is commercialized for children with acute kidney injury and sepsis weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with renal replacement therapy. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from clinical trials showed a 77% survival rate for patients treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data.
Real-world data from the SAVE Registry, a post-approval surveillance registry, highlighted early experience with the therapy. Observations from the first 21 pediatric patients showed no device-related adverse events or infections. Preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90.
Key Clinical Data
| Metric | Result |
|---|---|
| Survival rate (QUELIMMUNE) | 77% |
| Reduction in loss of life | Approx. 50% |
| Normal kidney function at Day 60 | 87.5% of survivors |
| Survival rate (SAVE Registry) | 76% (Day 28/60), 71% (Day 90) |
SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of the SCD therapy in 339 adults with acute kidney injury in the ICU receiving continuous renal replacement therapy. The SCD therapy has been awarded Breakthrough Device Designation for the treatment of immunomodulatory dysregulation in adult patients with acute kidney injury.
What specific reimbursement rates will CMS assign to the new ICD-10-PCS codes, and how will they impact hospital profitability?
Will the positive pediatric real-world data from the SAVE Registry accelerate the FDA approval timeline for the adult indication?
How does SeaStar Medical plan to scale manufacturing and supply chain operations to meet the potential demand of the $4.5 billion adult market?
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