April 18, 2018
FDA Grants Third Humanitarian Use Device Designation for Nativis Voyager® Pediatric System
New designation for device to treat ependymoma in children
SEATTLE – April 18, 2018 – Nativis, Inc., a clinical-stage therapeutic device company developing non-sterile, non-invasive and 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 Device (HUD) designation to treat ependymoma in children. Earlier this year, Nativis announced that the FDA granted HUD designations for the treatment of medulloblastoma and diffuse midline glioma in pediatric patients.
“This is another important step for our company,” said Chris Rivera, President and Chief Executive Officer of Nativis. “A subsequent FDA approval for a Humanitarian Device Exemption is expected that will enable us to begin commercialization of the Nativis Voyager® Pediatric system to treat ependymoma, as well as medulloblastoma and diffuse midline glioma, in the U.S. as early as fourth quarter of this year. We are on our way to providing a potential treatment for children with these aggressive and uniformly fatal conditions.”
“Medulloblastoma, diffuse midline glioma, and ependymoma are ultra-rare diseases in children,” said Donna Morgan Murray, Chief Regulatory Officer for Nativis. “It is gratifying that we have the potential to bring this new and unique treatment to children suffering from these devastating cancers.”
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 on 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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