Announcement • Jun 23
Seastar Medical Announces New Icd-10-Pcs Codes for Its Scd Therapy for Acute Kidney Injury
SeaStar Medical Holding Corporation announced that its Selective Cytopheretic Device (SCD) therapy has received dedicated ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) codes from the Centers for Medicare & Medicaid Services (CMS). This assignment enables administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with acute kidney injury (AKI) requiring renal replacement therapy (RRT) in the inpatient hospital setting. A PCS code refers to the ICD-10-PCS developed and maintained by the CMS specifically for use in United States hospitals use to report inpatient procedures for billing, data tracking, and reimbursement purposes. The new codes provide hospitals with a clear, specific mechanism to document and seek payment when using QUELIMMUNE, addressing previous coding limitations that could hinder broader adoption. The new ICD-10-PCS codes are expected to take effect on October 1, 2026. The QUELIMMUNE (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. Real-world data published in the peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. SeaStar Medical’s SCD therapy has been awarded Breakthrough Device Designation for the treatment of immunomodulatory dysregulation in adult patients with AKI. AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.
