SeaStar Medical has announced positive preliminary results from the SAVE surveillance registry which is assessing the use of the Quelimmune therapy in the treatment of critically ill paediatric patients with life-threatening acute kidney injury (AKI) and sepsis requiring renal replacement therapy (RRT).
Based on the data collected from the first 20 paediatric patients in the SAVE surveillance registry, there were no device related safety events with the Quelimmune therapy and 75% of patients have survived through 28 days. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine, SeaStar Medical says in a press release.
SeaStar also reported that additional analyses of the preliminary results of the SAVE Surveillance Registry are expected to mirror the clinical data that was submitted to the U.S. Food and Drug Administration (FDA) to support the approval of Quelimmune under a Humanitarian Device Exemption. These data, including additional 60-day and 90-day survival results, as well as dialysis dependence outcomes, will be submitted as an abstract later this summer to a prominent paediatric nephrology conference taking place in the fall.
“What is perhaps most remarkable about these data is that many of the patients who were treated with Quelimmune were incredibly sick, with most receiving this therapy as a last resort. It is likely that many of these patients would not have otherwise survived,” stated Kevin Chung, chief medical officer of SeaStar Medical. “The fact that they survived the immediate life-threatening period suggests that the Quelimmune therapy gave these kids a fighting chance.”
The SAVE surveillance registry is a real-world evidence surveillance programme that is designed to confirm safety and efficacy of the Quelimmune therapy. Medical institutions employing the Quelimmune therapy will continue to collect evidence for up to the first 300 patients treated with Quelimmune. Specific outcomes data will include 90-day survival and dialysis dependency along with safety data with plans to compare to an existing control group of similar illness severity. SeaStar Medical believes that initial results from the SAVE surveillance registry will support broader adoption of the Quelimmune therapy, inform payer discussions, and complement the company’s ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.
The patented technology behind Quelimmune is known as the selective cytopheretic device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life. SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial that is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the intensive care unit (ICU) receiving renal replacement therapy. It has received US Food and Drug Administration (FDA) breakthrough device designation for this indication and five others, including: systemic inflammatory response in adult cardiac surgery; systemic inflammatory response in paediatric cardiac surgery to prevent post-operative adverse complications and outcomes; adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation; end-stage renal disease (ESRD) requiring chronic dialysis; and, adult hepatorenal syndrome (HRS).
