FDA Confirms QUELIMMUNE Pediatric Therapy Meets Post-Approval Study Requirements: 90-Day Survival 65.1% in Registry
Denver, Colorado-based SeaStar Medical Holding Corporation announced on November 3 that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE.
QUELIMMUNE (SCD-PED) is commercialized for children with acute kidney injury (AKI) and sepsis or a septic condition weighing 10 kilograms or more and aged 22 years or younger who are on antibiotics and being treated in the ICU with renal replacement therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption and is the only FDA-approved product for the ultra-rare condition of life-threatening AKI due to sepsis requiring RRT in critically ill pediatric patients.
Results from the SAVE Registry, presented in a late-breaking session at ASN Kidney Week 2026, showed 90-day survival of 65.1% for the 43 QUELIMMUNE patients versus 47.5% (P = 0.043) for 196 patients from clinically aligned cohorts in the Kids' Inpatient Database (KID), with statistically significant increases also seen for in-hospital and 60-day survival. The registry data showed no device-related adverse events. CEO Eric Schlorff said these children typically have about a 50% survival rate with traditional supportive care alone.
Chief Medical Officer Kevin Chung, MD, said many of the children are fighting sepsis and multi-organ failure at the same time, and that the registry provides crucial real-world evidence on safety and probable benefits. The company said FDA's decision now enables hospitals to employ the QUELIMMUNE therapy without the research infrastructure the SAVE Registry demanded, expanding access at medical centers that previously could not participate, while the company will continue to voluntarily enroll patients at centers that choose to take part.
The company noted that its Selective Cytopheretic Device (SCD) therapy is designed to neutralize over-activated immune cells and stop the destructive hyperinflammation that shuts down organ function, and that its NEUTRALIZE-AKI pivotal trial is evaluating the therapy in 339 adults with AKI in the ICU receiving continuous RRT. QUELIMMUNE was approved under the HDE based on safety and probable benefit; its effectiveness for this use has not been demonstrated, and adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia and thrombocytopenia.
(Source: SeaStar Medical)
Source: SeaStar Medical
Published by GSM · USA (original Chinese edition)
Photo: 血液透析机与治疗椅（QUELIMMUNE 配合肾脏替代治疗使用，同类设备示意）。图：Vitaliy Pospelov，CC BY-SA，经 Wikimedia Commons / A hemodialysis machine and treatment chair (renal replacement therapy equipment of the kind used alongside QUELIMMUNE). Photo: Vitaliy Pospelov, CC BY-SA, via Wikimedia Commons
