FDA extends HUD to Nativis Voyager Pediatric System
Nativis, a clinical-stage therapeutic device company developing non-sterile, non-invasive, non-thermal treatments for cancers and other grave diseases asserted that it has received a notice from FDA wherein the FDA has granted a Humanitarian Use Designation (HUD) for Nativis Voyager Pediatric system.
In 2017, Nativis announced it had entered into an exclusive license agreement for the development and commercialization of Nativis’ proprietary ultra-low radio frequency energy (ulRFE) technology for the treatment of adults with glioblastoma multiforme (GBM) in the Japanese market with Teijin Limited.
Chris Rivera, Nativis President and Chief Executive Officer, made the announcement stating, “This is an important step for our company and a great start for 2018. A subsequent FDA approval for a Humanitarian Device Exemption will enable us to begin commercialization of the Voyager Pediatric in the U.S. to treat medulloblastoma as early as 4th quarter of 2018. More importantly, it will provide a potential treatment for children with brain cancer, where there is not currently a viable therapy on the market.”