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SeaStar Medical Announces Completion of FDA Enrollment Requirement for SAVE Surveillance Registry Evaluating QUELIMMUNE Safety for Pediatric AKI

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  • SeaStar Medical Holding Corporation completed the required enrollment of 50 patients in the SAVE Registry, a Post-Approval Study mandated by the FDA to confirm QUELIMMUNE™ therapy safety for children with acute kidney injury due to sepsis.
  • The company plans to submit 28-day safety results from the full registry cohort to the FDA upon data analysis completion.
  • Early results from the registry published in Pediatric Nephrology indicate valuable clinical outcomes regarding the safety & probable benefit of QUELIMMUNE™ therapy.
  • Enrollment includes top-rated U.S. children's medical centers such as Children's Hospital of Philadelphia, Lurie Children's Hospital of Chicago, & Texas Children's Hospital.
  • QUELIMMUNE™ was approved by the FDA in February 2024 via a Humanitarian Device Exemption application for pediatric patients aged ≤22 years weighing ≥10 kg with AKI due to sepsis on Renal Replacement Therapy.
  • Clinical data published in Kidney Medicine showed a 77% survival rate for patients treated with QUELIMMUNE™ versus standard of care, representing an approximate 50% reduction in mortality compared to historical data.
  • Survivors in previous studies required no dialysis, & 87.5% had normal kidney function at Day 60 after ICU discharge.
  • SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contribution to pediatric AKI treatment.
  • The company is conducting the NEUTRALIZE-AKI pivotal trial evaluating the Selective Cytopheretic Device therapy in 339 adults with AKI receiving continuous renal replacement therapy.
  • The Selective Cytopheretic Device therapy targets destructive hyperinflammation by neutralizing over-active immune cells & is integrated with existing CRRT hemofiltration systems.
  • The SCD therapy holds Breakthrough Device Designation from the FDA for six therapeutic indications.