SeaStar Medical Holding Corporation (NASDAQ:ICU) experienced a 4.8% stock decline on Monday following the publication of early post-approval clinical experience for its QUELIMMUNE therapy in pediatric patients.
The company reported the observations in the peer-reviewed journal Pediatric Nephrology, drawing on data from the SAVE Registry, a post-approval surveillance registry established to evaluate QUELIMMUNE in clinical use. The dataset covers the first 21 pediatric patients who presented with acute kidney injury (AKI) and sepsis and required renal replacement therapy.
According to the published report, there were no device-related adverse events observed among these initial patients. Survival outcomes in the cohort were reported as 76% at Day 28 and 76% at Day 60, and 71% at Day 90.
The company stated that these preliminary results are aligned with expectations to validate a 50% reduction in patient mortality at 60 days relative to historical data - an outcome the company says mirrors results seen in the registration study. The published observations reflect early, post-approval experience rather than final registry outcomes.
Regulatory interaction is reflected in a notable change to the SAVE Registry requirements. After reviewing the data from the first 21 patients, the U.S. Food and Drug Administration reduced the registry enrollment target from 300 patients to 50 patients. The therapy has already been taken up by several nationally recognized children’s medical centers in the United States.
Additional subgroup outcomes presented in the report included measures of renal independence among survivors without a prior history of end-stage renal disease or recent kidney transplant - 75% of those survivors were dialysis free at Day 28, and 83% were dialysis free at Day 90. A small subset of five patients who received both QUELIMMUNE therapy and extracorporeal membrane oxygenation (ECMO) showed a 60% survival rate at Day 90.
These findings come from early registry experience and represent initial clinical observations from a limited patient cohort. The SAVE Registry remains the post-approval vehicle for collecting additional data on QUELIMMUNE therapy in pediatric practice.