SeaStar Medical Holding Corporation, a commercial-stage healthcare company, 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 (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT). 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.
“The early results from the SAVE Registry, as published recently in the prestigious, peer-reviewed journal Pediatric Nephrology, have provided valuable clinical outcomes data on both the safety and probable benefit of our QUELIMMUNE therapy,” stated Eric Schlorff, CEO of SeaStar Medical. “We look forward to evaluating the safety data from the full cohort of 50 patients and submitting that to the FDA in the coming months.”
“We also look forward to the further expansion of our customer base to children’s hospitals where the complexities of setting up and running a patient registry has hindered faster adoption of the QUELIMMUNE therapy,” stated Tim Varacek, Senior Vice President of Business and Commercial Operations. “There continues to be very strong interest in QUELIMMUNE adoption, and we are pleased that we have met the FDA’s registry enrollment requirements.”
The QUELIMMUNE therapy has been adopted by nationally recognised children’s medical centers in the United States. Participants in the SAVE Registry are listed on ClinicalTrials.gov and include the following top-rated children’s medical centers: Children’s of Alabama, Lucille Packard Children’s Hospital Stanford, UCSF Benioff Children’s, Children’s Hospital of Atlanta – Arthur M. Blank, Children’s Hospital of Atlanta – Scottish Rite, Lurie Children’s Hospital of Chicago, Cincinnati Children’s Medical Center, CS Mott Children’s Hospital, Cleveland Clinic Children’s Hospital, Children’s Hospital of Philadelphia, Children’s Medical Center Dallas, Cook Children’s Hospital, and Texas Children’s Hospital.
