SeaStar and Nuwellis Ink Licensing Deal for Acute Kidney Injury Device

SeaStar Medical and Nuwellis have inked a U.S. licensing and distribution deal for SeaStar’s Selective Cytopheretic Device for treating children with acute kidney injury.

The device, which works with any continuous kidney replacement therapy system, targets pro-inflammatory neutrophils and monocytes to stop cytokine storms, a severe type of immune response that can lead to organ failure.

The companies expect the FDA to complete a review of their Humanitarian Device Exemption (HDE) application in the first quarter of 2023. The HDE pathway is for products that can treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States annually.

If approved, Nuwellis will market and distribute the device in the U.S. The financial terms of the deal were not disclosed.