Medical Device Network

SeaStar Medical builds enrolment in pivotal trial for AKI device

The company expects FDA approval for its extracorporeal therapy device under Humanitarian Device Exemption (HDE), with a commercial rollout slated for Q1 2024.

SeaStar Medical is progressing its pivotal trial evaluating the use of its Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI), with the company announcing that 12 patients have now been enrolled.

The NEUTRALISE-AKI pivotal clinical trial (NCT05758077) is expected to enrol up to 200 patients with AKI who require continuous kidney replacement therapy (CKRT).

SeaStar Medical’s chief medical officer Kevin Chung said that the company has enrolled five patients over the past six weeks, as well as activating additional clinical sites, according to a 28 December press release.

There are 30 study sites in the US expected for the trial, as per ClinicalTrials.gov. Five of these are currently in the recruiting stage. The trial enrolled its first patient in June 2023.

SCD is a type of cell-directed extracorporeal therapy delivered via CKRT. 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 back into 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.

SeaStar’s SCD device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in October 2023.

The company expects to receive FDA approval under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with AKI and sepsis. Children with a septic condition requiring continuous CKRT anytime within the next 30 to 45 days will also be indicated. In October 2023, the company received correspondence from the FDA signalling the device to be approvable under HDE.

The device’s rollout is expected in Q1 2024, according to SeaStar.

The NEUTRALISE-AKI study’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD. Patients receiving treatment with the SCD in addition to CKRT will be compared to patients in the control group only receiving CKRT standard of care. A subgroup analysis will also explore the potential effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.