SeaStar reports approval for reduction in mandatory enrollment for SAVE registry

SeaStar Medical (ICU) announced the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients. This new 50-patient registry size will satisfy the post-approval surveillance requirement by the FDA as outlined in the original Humanitarian Device Exemption approval and indicates that FDA believes that continued device safety can be successfully shown with fewer patients than originally required. The SAVE Surveillance Registry is a Post-Approval Study that is designed to confirm the safety of the QUELIMMUNE therapy, which was approved in 2024 as a treatment for children with acute kidney injury and sepsis or a septic condition. To date, data from 32 pediatric patients have been entered into the SAVE Surveillance Registry. Preliminary results from the SAVE Surveillance Registry were recently presented at the 5th International Symposium on Acute Kidney Injury in Children. The SAVE Surveillance Registry presentation highlighted the role of QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury and sepsis requiring Renal Replacement Therapy. Data from the first 21 pediatric patients with AKI and sepsis requiring RRT showed zero device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine.