SeaStar Medical announced positive preliminary results from its SAVE Surveillance Registry for its QUELIMMUNE therapy in critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis. The data from the first 20 patients showed no device-related safety issues and a 75% survival rate at 28 days, potentially exceeding the anticipated 50% reduction in mortality. These findings are expected to mirror data submitted to the FDA for QUELIMMUNE’s approval under a Humanitarian Device Exemption.
This news holds substantial promise for improving outcomes in critically ill pediatric patients. A 75% survival rate in this vulnerable population, often treated as a last resort, represents a significant advancement. The positive safety profile further strengthens the therapy’s potential to become a standard of care in this challenging clinical setting. This success could drive broader adoption of the therapy, particularly as further data are collected and analyzed.
The SAVE Surveillance Registry is collecting real-world evidence for up to 300 patients, tracking 90-day survival, dialysis dependency, and safety data. The initial results will be submitted to a pediatric nephrology conference this fall. SeaStar is also conducting the NEUTRALIZE-AKI pivotal trial to evaluate QUELIMMUNE in adults with AKI. The therapy has received FDA Breakthrough Device Designation for six indications, including AKI, systemic inflammatory response in cardiac surgery (adult and pediatric), adult cardiorenal syndrome, end-stage renal disease, and adult hepatorenal syndrome.
These initial findings offer significant hope for a vulnerable patient population. The continued data collection through the SAVE Surveillance Registry and the ongoing NEUTRALIZE-AKI trial will be critical for expanding QUELIMMUNE’s use and potentially revolutionizing the treatment of AKI and sepsis in both children and adults. The positive safety and efficacy data could position QUELIMMUNE as a crucial intervention for this life-threatening condition. Further positive results will likely attract more medical institutions to adopt the therapy and bolster SeaStar Medical’s position in the critical care market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
