Study: Significant Savings Possible With SeaStar Medical’s QUELIMMUNE Therapy

SeaStar Medical Holding Corporation has released a health economic analysis that shows QUELIMMUNE therapy use for pediatric Acute Kidney Injury (AKI) treatment can significantly reduce hospitalization costs.

Published in the Journal of Medical Economics (IJME), the analysis estimates a cost savings of $69,146 per hospitalization with QUELIMMUNE therapy compared to standard continuous renal replacement therapy (CRRT). These projected savings are estimated to offset QUELIMMUNE therapy costs with a potential for institutions to incur no out-of-pocket expenses for six days (median duration) of pediatric AKI treatment.

“Data from the QUELIMMUNE clinical studies showed organ sparing and life-saving benefits for critically ill pediatric patients with AKI requiring CRRT,” SeaStar Medical Chief Medical Officer and study co-author Kevin Chung, M.D., said. “Our analysis shows that the QUELIMMUNE therapy may ‘pay for itself’ with the projected savings. Many of the most highly regarded children’s medical centers have already adopted the QUELIMMUNE therapy, including, most recently, a prominent pediatric hospital in Philadelphia. We believe this added economic benefit will support broader adoption of QUELIMMUNE therapy with a clear understanding of its beneficial implications in patient care.”

Highlights from the IJME publication include:

• A historical matched analysis of pediatric patients receiving CRRT without QUELIMMUNE from the Prospective Pediatric CRRT (ppCRRT) Registry found significantly better survival with QUELIMMUNE versus CRRT alone (adjusted odds ratio 13.4; P=0.01). Bayesian analysis indicated a 98% probability of higher survival odds with the QUELIMMUNE therapy, with a 22.4% predicted risk difference. There are no other approved selective therapies in the United States for pediatric patients with AKI due to sepsis on CRRT. These data were also previously published in 2024 in Kidney Medicine.
• Given the encouraging survival rates among critically ill children treated with the QUELIMMUNE therapy, the health economic study’s objective was to determine its financial impact to a healthcare system from an inpatient perspective by combining publicly available hospitalization cost data with non-cost clinical metrics derived from prior QUELIMMUNE studies and estimating the QUELIMMUNE therapy’s effect on inpatient hospital costs among a pediatric population receiving CRRT.
• Analysis of matched patient data sets to patients in the QUELIMMUNE studies (N=22) were derived from two pediatric patient registries: the Kid’s Inpatient Database (KID) Registry (N=106) and the ppCRRT Registry (N=210).
• Modeled hospitalization costs from the KID and ppCRRT cohorts were $457,092 and $389,451 respectively, versus a lower estimated cost of $320,304 for pediatric patients treated with the QUELIMMUNE therapy for a median of six days. Compared to the ppCRRT Registry cohort, the QUELIMMUNE therapy yields an estimated savings of $69,146 per hospitalization. The cost reduction is driven by two key metrics: reduced hospital length of stay of approximately three days and improved survival.

The U.S. Food and Drug Administration (FDA) approved QUELIMMUNE in 2024 under a Humanitarian Device Exemption for children with AKI due to sepsis or a septic condition who are on antibiotic therapy and require Renal Replacement Therapy (RRT). Clinical data from the FDA application, subsequently published in Kidney Medicine, showed a 77% survival rate in patients treated with QUELIMMUNE versus standard of care, representing a potential ~50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors at day 60 after QUELIMMUNE treatment.

SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of the SCD therapy in 200 patients with AKI in the ICU receiving CRRT. It has received FDA Breakthrough Device Designation for this indication and five others, including:

• Systemic inflammatory response in adult cardiac surgery
• Systemic inflammatory response in pediatric cardiac surgery to prevent post-operative adverse complications and outcomes
• Adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation
• End-stage renal disease (ESRD) requiring chronic dialysis
• Adult hepatorenal syndrome (HRS)

AKI is characterized by a sudden and temporary kidney function loss and can be caused by a various conditions such as sepsis, severe trauma, surgery, and COVID-19. 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 hyperinflammation can progress to other organs, such as the heart or liver, and potentially lead to multi-organ dysfunction or even failure. 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 QUELIMMUNE (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. QUELIMMUNE therapy is being commercialized for children (age 22 or younger) with AKI and sepsis or a septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy.

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 200 adults with AKI in the ICU receiving CRRT. 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 CRRT as the standard of care, compared with the control group receiving only CRRT 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. 

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 currently 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 renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life.

SeaStar Medical is a commercial-stage healthcare company transforming treatments for critically ill patients facing organ failure and potential loss of life. The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical’s first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. QUELIMMUNE is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring CRRT, a life-threatening condition with no effective treatment options that impacts more than 200,000 U.S. adults annually.