SeaStar Medical announced that the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has approved the final labelling for Quelimmune.
Quelimmune is a selective cytopheretic device (SCD) for paediatric patients.
The patented extracorporeal device utilises immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous kidney replacement therapy (KRT).
The cell-directed device is integrated with KRT haemofiltration systems to target and guide proinflammatory monocytes towards a reparative state while promoting activated neutrophils.
The FDA agreed to the final labelling of the device under the Humanitarian Use Device (HUD) designation to market Quelimmune in the US market.
Quelimmune will used for the treatment of paediatric patients weighing 10kgs or more, suffering from acute kidney injury (AKI) and sepsis or septic conditions requiring KRT.
In February this year, the medical device company received the Humanitarian Device Exemption (HDE) FDA approval order for the selective cytopheretic device under the same indication.
Quelimmune has been approved under an HDE application after showing its safety and likely clinical benefit for critically ill children suffering from AKI.
A combined analysis of two non-controlled studies revealed that children weighing 10kgs or more who received continuous KRT and were treated with Quelimmune achieved a 77% survival rate at day 60.
These patients did not develop dialysis dependency by day 60, and there were no serious adverse events or infections related to the device.
SeaStar Medical CEO Eric Schlorff said: “We are now ready to make final changes to product labels for incorporation into the commercial kits.
“We expect to begin shipping this month and are excited to bring the potential lifesaving and quality-of-life benefits of Quelimmune to critically ill children.”
The selective cytopheretic device is currently being assessed for use on adults with AKI and other conditions.
SeaStar Medical is currently conducting the NEUTRALIZE-AKI study to evaluate the safety and effectiveness of the device in critically ill adults suffering from AKI and requiring continuous kidney replacement therapy.
The study will assess how treatment with selective cytopheretic device impacts a range of clinical outcomes in patients and evaluate the safety of Quelimmune’s usage from the start of treatment up to one year.
In April 2024, SeaStar Medical secured a $3.6m National Institutes of Health (NIH) grant award to study the device in adult patients with severe chronic heart failure.
