FDA grants Humanitarian Device Exemption approval to Selective Cytopheretic Device for pediatric acute kidney injury

This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

“This first regulatory approval is a major accomplishment for our company and, most importantly, it provides critically ill children with AKI access to a much-needed new therapy,” said Eric Schlorff, SeaStar Medical CEO. “Only about one-half of the children in the ICU with AKI requiring CKRT survive, and those who do are at increased risk of long-term conditions such as chronic kidney disease. In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.

“We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added. “We believe the HDE for children weighing as little as 10 kilograms – or roughly 22 pounds – acknowledges the proven life-saving capabilities of our device and addresses a critical unmet need for patients. We are working to make Quelimmune therapy the new standard of care for AKI requiring CKRT in the ICU and to demonstrate its benefit in the many indications where hyperinflammation and dysregulated inflammatory processes are involved.”

The initial commercial launch of Quelimmune for pediatric AKI is expected in the coming weeks by SeaStar Medical’s U.S. license and distribution partner Nuwellis, with a full commercial program to follow. Nuwellis has established strong relationships with pediatric nephrology and intensive care key opinion leaders across the U.S.

The FDA granted HDE approval to the Quelimmune pediatric device for AKI based upon clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02 showed that pediatric patients greater than 10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a 77% reduction in mortality rate, and no dialysis dependency at Day 60.

The SCD-PED-01 (weight range greater than 15 kg) and PED-02 (weight range greater than 10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively. These data were recently published in the journal Kidney Medicine. SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

See-

"Selective Cytopheretic Device Use in Continuous Kidney Replacement Therapy in Children: A Cohort Study With a Historical Comparator"-Stuart L. Goldstein, MD, Nicholas J. Ollberding, PhD, David J. Askenazi, MD MsPH, et al.,. Published: February 15, 2024.2024DOI:https://doi.org/10.1016/j.xkme.100792.