FDA Grants Humanitarian Use Designation for Nativis System

The FDA granted the Nativis Voyager Pediatric system a Humanitarian Use Designation.

The device uses a proprietary ultra-low radio frequency energy (ulRFE) technology designed to treat medulloblastoma, a rare, high-grade glioma in children.

Nativis is a clinical-stage therapeutic device company that patented the ulRFE technology to regulate metabolic pathways on the molecular and genetic levels.

In 2017, Nativis entered into a license agreement for the development of the technology for the treatment of adults with glioblastoma multiforme in the Japanese market.