www.fdanews.com/articles/185692-fda-grants-humanitarian-use-designation-for-nativis-system
FDA Grants Humanitarian Use Designation for Nativis System
February 20, 2018
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.