SeaStar Medical has completed the required enrolment in the SAVE registry, a post-approval study (PAS) required by the US Food and Drug Administration (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 enrolment requirements.”
The patented technology behind Quelimmune is known as the selective cytopheretic device (SCD) therapy and has potential broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.
