SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company, has announced that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has approved the final labeling for their QUELIMMUNE™ device.

This approval allows the therapeutic device to be marketed in the U.S. under the Humanitarian Use Device (HUD) designation for pediatric patients weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT).

“They appreciate the FDA’s diligent work on QUELIMMUNE’s labeling. We are now ready to finalize the product labels for incorporation into the commercial kits."

"Anticipate starting shipments this month and are eager to offer the potential lifesaving and quality-of-life benefits of QUELIMMUNE to critically ill children.”

Pediatric Acute Kidney Injury

QUELIMMUNE is approved under a Humanitarian Device Exemption (HDE) application, meeting criteria with clinical results demonstrating safety and probable clinical benefit for critically ill children with AKI who have limited treatment options.

Pediatric patients undergoing treatment with QUELIMMUNE are expected to require, on average, seven daily therapies, with the disposable device being changed every 24 hours.

Currently, only about half of pediatric ICU patients with AKI who require KRT survive, and those who do are at risk of long-term conditions such as chronic kidney disease.

A pooled analysis from two non-controlled studies (one funded by the FDA Office of Orphan Products Development) indicated that children weighing 10 kilograms or more with AKI requiring continuous KRT who were treated with QUELIMMUNE had a 77% survival rate, no dialysis dependency at day 60, and no device-related serious adverse events or infections.

The U.S. addressable population for this treatment is about 4,000 children, within the 8,000-patient HDE criteria.

SeaStar Medical is also conducting a pivotal trial in adults with AKI who require continuous KRT, a population of approximately 210,000 patients per year, about 50 times larger than the pediatric population.

About the Selective Cytopheretic Device (SCD)

The SCD is a patented, cell-directed extracorporeal device that uses immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous KRT, reducing the hyperinflammatory milieu, including the cytokine storm that leads to inflammation, organ failure, and potential death in critically ill patients.

Unlike pathogen removal and other blood-purification tools, the device is integrated with KRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and make activated neutrophils less inflammatory.

These cells are then returned to the body, signaling a reduction in the inflammatory environment and promoting repair. This unique immunomodulation approach may support long-term organ recovery and eliminate the need for future KRT, including dialysis.

 

Source: globenewswire.com

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