SeaStar Medical reports ‘positive’ results for QUELIMMUNE therapy in AKI

SeaStar Medical (ICU) announced “positive” preliminary results from the SAVE Surveillance Registry which is assessing the use of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury, AKI, and sepsis requiring Renal Replacement Therapy, RRT. Based on the data collected from the first 20 pediatric patients in the SAVE Surveillance Registry, there were no device related safety events with the QUELIMMUNE therapy and 75% of patients have survived through 28 days. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine. SeaStar also reported that additional analyses of the preliminary results of the SAVE Surveillance Registry are expected to mirror the clinical data that was submitted to the U.S. Food and Drug Administration to support the approval of QUELIMMUNE under a Humanitarian Device Exemption. These data, including additional 60-day and 90-day survival results, as well as dialysis dependence outcomes, will be submitted as an abstract later this summer to a prominent pediatric nephrology conference taking place in the fall.