SeaStar Medical Publishes QUELIMMUNE Clinical Data
SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology.The publication, co-authored by leading experts including Stuart Goldstein, Kelli Krallman, Meredith Harris, Rajit Basu, David Askenazi, Shina Menon, Matt Zinter, Steven Gorga, and H. David Humes, highlights early experience from the SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary 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 patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine. Additional analyses included survival of patients requiring extracorporeal membrane oxygenation and independence from renal replacement therapy for pediatric patients without a history of end-stage renal disease or a recent kidney transplant. The evaluation of five patients concomitantly treated with the QUELIMMUNE therapy and ECMO showed a 60% survival rate at Day 90. Among pediatric patient survivors without a history of end-stage renal disease or a recent kidney transplant, 75% (9 of 12) and 83% (10 of 12) were dialysis free at Day 28 and Day 90, respectively.
