The FDA gave the green light for Helius Medical Technologies to begin enrolling patients in a clinical trial of its portable neuromodulation stimulator in patients with chronic balance disorders due to mild-to-moderate brain injury.
Helius said it plans to begin signing patient up in a few weeks. The study is slated to be conducted at medical centers in Portland, Ore., Orlando and Montreal, Newtown, Pa.-based Helius said.
"There has been little advancement over the years for the treatment of symptoms caused by TBI and we are excited to help patients who have tried many different therapies and have limited treatment options," CEO Phillipe Deschamps said in prepared remarks. "This pilot trial will guide next steps in the development of the PoNS."
The study is designed to evaluate the progress of patients who undergo treatment with PoNS after 5 weeks. The device, which delivers neurostimulation through the tongue, will be used in conjunction with physical therapy.
Helius is seeking to have PoNS approved in the U.S. for the treatment of balance disorders in patients with traumatic brain injuries. The company has also been testing the device in Canada for the treatment of gait and balance issues in patients with multiple sclerosis.
Last September, Helius announced a pilot study for PoNS at the University of Wisconsin-Madison.