February 20, 2018
FDA Grants Humanitarian Use Designation for Nativis Voyager® Pediatric System
New device designed to treat medulloblastoma, a rare, high-grade glioma in children
SEATTLE – February 20, 2018 – Nativis, Inc., a clinical-stage therapeutic device company developing non-sterile, non-invasive, non-thermal treatments for cancers and other serious diseases, announced it has received notice from the Food & Drug Administration (FDA) that the Nativis Voyager Pediatric system has been granted a Humanitarian Use Designation (HUD). This new device is designed to treat medulloblastoma, a rare, high-grade glioma in children.
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.”
Donna Morgan Murray, Chief Regulatory Officer for Nativis, stated, “The brain tumors that our new device targets are rare. However, the tumors are aggressive and uniformly fatal, and the Nativis Voyager Pediatric system might offer hope for children affected with these types of cancer.”
Michael Prados, M.D. of the Pacific Pediatric Neuro-Oncology Consortium and a leading researcher in pediatric brain cancer, is a member of the Nativis Scientific Advisory Board. Dr. Prados said, “I am excited and encouraged by the work Nativis has done in this field and we look forward to using the Nativis Voyager Pediatric system in our clinical studies.”
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, a comprehensive Japanese company expanding businesses in high-performance materials, pharmaceuticals, home healthcare, product converting and information technology.
About Nativis, Inc.
Founded in 2002 and headquartered in Seattle, Nativis is a clinical-stage therapeutic device company. Nativis has invented and patented a groundbreaking technology that utilizes precisely targeted ulRFE to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-sterile, non-invasive, non-thermal investigational device called the Nativis Voyager system. The company’s goal is to transform disease treatment on a global scale with ulRFE, which can potentially be applied to a wide range of medical conditions as well as to veterinary medicine and non-medical applications. Nativis’ initial focus is on the treatment of patients with brain cancer, who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Additional pre-clinical work is focused exploring new applications in oncology. Nativis Voyager ulRFE system for adults with GBM is an investigational medical device, limited by U.S. law to investigational use only.
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