SeaStar Medical completes FDA enrollment requirement for SAVE Registry

SeaStar Medical (ICU) announced that it has completed the required enrollment in the SAVE Registry, a Post-Approval Study, PAS, required by the FDA that is designed to confirm the safety of the Quelimmune therapy as a treatment for children with acute kidney injury due to sepsis or a septic condition requiring renal replacement therapy. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data.