FDA Confirms SeaStar Medical Has Fulfilled the Post-Approval Study Requirements for QUELIMMUNE® for the Treatment of Sepsis-Associated Acute Kidney Injury (AKI) in Pediatric Patients
Key Highlights
- ➤FDA confirms SeaStar Medical fulfilled QUELIMMUNE post-approval study requirements
- ➤Hospitals can now use QUELIMMUNE without SAVE Registry research infrastructure
- ➤QUELIMMUNE patients posted 65.1% 90-day survival versus 47.5% for KID cohorts
- ➤SAVE Registry data showed no device-related adverse events
- ➤NEUTRALIZE-AKI pivotal trial is evaluating SCD therapy in 339 adults with AKI
Expert Statements
Eric Schlorff, CEO of SeaStar Medical
“We are grateful for this decision by FDA and believe it will enable us to expand the potential life-saving benefits of our QUELIMMUNE therapy to more critically ill children with life-threatening AKI.”
Eric Schlorff, CEO of SeaStar Medical
“These kids typically have about a 50% survival rate with traditional supportive care alone, and we believe this decision will be a win-win for patients, their families, health care providers, and the overall health care system.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“It is hard to describe how sick these children really are. Many are fighting sepsis and multi-organ failure at the same time.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“The SAVE Registry gives us crucial real-world evidence on both safety and probable benefits in these patients, and we are grateful to the pediatric teams and families who made it possible.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“We remain committed to collecting data wherever feasible, so that we keep learning how best to use QUELIMMUNE for the children who need it most.”
DENVER, Nov. 03, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today 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 (SAVE Registry) (link) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE.
“We are grateful for this decision by FDA and believe it will enable us to expand the potential life-saving benefits of our QUELIMMUNE therapy to more critically ill children with life-threatening AKI,” stated Eric Schlorff, CEO of SeaStar Medical. “These kids typically have about a 50% survival rate with traditional supportive care alone, and we believe this decision will be a win-win for patients, their families, health care providers, and the overall health care system.”
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