Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective cytopheretic device (SCD) for use in children with acute kidney injury (AKI).
The device, which was granted FDA breakthrough device designation in October 2023, is indicated for paediatric patients weighing 10kg or more with AKI, either due to sepsis or a septic condition requiring kidney replacement therapy (KRT).
An HDE is a marketing application for a humanitarian use device (HUD). It is used for products designed to treat diseases that affect small populations. As per FDA legislation, an HDE is exempt from the same effectiveness requirements of other regulatory pathways, though is subject to certain profit caps and use restrictions.
SeaStar’s SCD paediatric device, dubbed SCD-PED, can now be marketed as a HUD. It is the first product in the company’s Quelimmune line, the company said in a 21 February press release.
SeaStar’s CEO Eric Schlorff said: “[This approval] provides critically ill children with AKI access to a much-needed new therapy.”
Manufacturers with an HDE still need to demonstrate that the device’s benefits outweigh its risks. SeaStar submitted results from an FDA-funded Phase II SCD-PED-01 study (NCT02820350) and the SCD-PED-02 study (NCT04869787), both of which demonstrated that the target population had an average of 77% reduction in mortality rate. Participants were no longer dependent on dialysis at day 60 and did not experience any serious adverse events or device-related infections.
SeaStar is currently conducting its pivotal NEUTRALIZE-AKI clinical trial in the larger adult AKI population. The study (NCT05758077) is estimated to enrol up to 200 patients.
SeaStar expects to roll out the device in the coming weeks. The company has partnered with Nuwellis for licensing and distribution in the US.
SCD is a type of cell-directed extracorporeal therapy delivered via continuous kidney replacement therapy. It works by selectively targeting and neutralising neutrophils and monocytes – effector cells that play a key role in hyperinflammation. The neutralised cells are then returned to the body through the blood. Normally, the overactivity of the immune system can lead to organ damage and can even lead to multi-organ failure.
AKI is the sudden stopping of normal kidney function. There are no FDA-approved pharmacological therapies for the condition – though some compounds are in clinical trials such as CalciMedica’s Auxora for the treatment of AKI associated with acute hypoxemic respiratory failure (AHRF).
