SeaStar Medical has received the humanitarian device exemption (HDE) approval order from the US Food and Drug Administration (FDA) for its Quelimmune device, a selective cytopheretic device (SCD) paediatric (SCD-PED).

Quelimmune is a patented cell-directed extracorporeal device. It uses immunomodulating technology to specifically target proinflammatory neutrophils and monocytes during continuous kidney replacement therapy (CKRT).

The FDA has approved the device for use in children of weight 10kgs or more with acute kidney injury (AKI) caused by sepsis or a septic condition requiring kidney replacement therapy (KRT).

The Quelimmune paediatric device is the first product in the company’s recently rebranded Quelimmune product family. It is now authorised for commercial marketing as a humanitarian use device (HUD).

According to SeaStar Medical, the FDA’s approval was based on clinical results that showed safety and potential clinical benefit to critically ill children with AKI who have few treatment alternatives.

The results combined data from two non-controlled studies, SCD-PED-01 and SCD-PED-02.

As per the findings, paediatric patients ≥10 kg with AKI requiring CKRT and treated with the Quelimmune paediatric device experienced a 77% reduction in mortality at Day 60.

The trials demonstrated no serious adverse events related to the device and no dependency on dialysis.

The investigational studies SCD-PED-01 and SCD-PED-02 showed reductions in mortality of 75% and 83%, respectively.

While investigating potential uses for this device, SeaStar Medical is presently concentrating on its NEUTRALIZE-AKI clinical study, which aims to assess Quelimmune treatment in the broader adult AKI population.

SeaStar Medical CEO Eric Schlorff said: “In clinical studies, Quelimmune for paediatric 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 paediatric use.

“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.”

SeaStar Medical’s US license and distribution partner Nuwellis is anticipated to introduce Quelimmune for juvenile AKI commercially in the upcoming weeks. A complete commercial programme will follow soon.