SeaStar Medical Reports Statistically Significant Survival Findings from Post-Approval QUELIMMUNE® SAVE Registry Analysis in Pediatric Sepsis-Associated AKI
Key Highlights
- ➤Day 90 survival 65.1% versus 47.4% for KID cohort; odds ratio 2.07
- ➤Hospital-discharge survival significantly higher for QUELIMMUNE cohort versus KID (P = 0.04)
- ➤QUELIMMUNE cohort mortality hazard estimates fell 34% to 40% versus KID
- ➤83% of eligible QUELIMMUNE survivors were RRT-independent at Day 90
- ➤No device-related adverse events occurred among SAVE registry patients
Expert Statements
Stuart Goldstein, MD, Director, Center for Acute Care Nephrology at Cincinnati Children’s and member of SeaStar Medical Scientific Advisory Board
“These real-world, post-approval data show a significant association with higher survival and a consistent safety profile in the QUELIMMUNE (SCD-PED)-treated patients with sepsis-associated AKI requiring CRRT with a broad range of clinical complexities,”
Stuart Goldstein, MD, Director, Center for Acute Care Nephrology at Cincinnati Children’s and member of SeaStar Medical Scientific Advisory Board
“The consistency of the survival signal across analyses support continued and further exploration of these and additional data that is forthcoming from new patients.”
Stuart Goldstein, MD, Director, Center for Acute Care Nephrology at Cincinnati Children’s and member of SeaStar Medical Scientific Advisory Board
“Given the urgency of this rare and life-threatening condition combined with no device-related adverse events, I believe there is a clear observed potential benefit from the SCD-PED therapy with a favorable safety profile.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“Selection as a late-breaker at ASN Kidney Week reflects the urgent need for better options for critically ill children with sepsis-associated AKI,”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“These real-world findings are consistent with our previous clinical results and the association with higher survival held across every analytic approach we applied.”
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical
“Sharing them with the nephrology community at its premier meeting is an important step toward making QUELIMMUNE therapy available to every child who may benefit.”
New late-breaking data presented today at ASN Kidney Week 2026
QUELIMMUNE (SCD-PED) treatment group demonstrates statistically significant higher survival in the primary analysis at Day 60, Day 90, and at hospital discharge versus comparator cohort
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