Voyager Pediatric System Granted Humanitarian Use Designation

Nativis, Inc. announced this morning that its Voyager Pediatric system has been granted a Humanitarian Use Designation from the U.S. Food and Drug Administration (FDA).

The Voyager Pediatric system is a new device designed to treat medulloblastoma, a rare, high-grade glioma in pediatric patients. The Humanitarian Use designation is given to a medical device intended to benefit patients in the treatment or diagnosis of a disease of condition that affects or is manifested in less than 8,000 individuals in the United States per year.

At present, many patients with medulloblastoma can be treated with aggressive radiation therapy or chemotherapy. Cure rates are much lower, however, for patients in whom the tumor has disseminated or cannot be surgically removed.

“This is an important step for our company and a great start for 2018,” said Chris Rivera, Nativis President and Chief Executive Officer in a press release. “It will provide a potential treatment for children with brain cancer, where there is not currently a viable therapy on the market.”

Should Nativis receive FDA approval for a Humanitarian Device Exemption, the company will be able to begin commercialization of the Voyager Pediatric system in the U.S. to treat medulloblastoma as early as 4th quarter of 2018.

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.”

Medulloblastoma, often referred to as cerebellar neuroectodermal tumor (PNET), develops in the region of the brain at the base of the skull and has the potential to spread to other parts of the brain and to the spinal cord. Common symptoms include headaches, nausea and vomiting, issues with motor skills, fatigue, difficulties with walking and balance, and tilting the head to one side.

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.”

According to St. Jude Children’s Hosptial, between 250 and 500 children are found annually in the United States to have medulloblastoma, and most tumors of this kind are found in children younger than 16.

For more from the FDA, follow Rare Disease Report on Facebook and Twitter.