Helius Medical Technologies has submitted its response to the U.S. Food and Drug Administration (FDA)’s request for more information about the company’s application for de novo classification and clearance of its portable neuromodulation stimulator (PoNS) device to help treat walking difficulties in people with multiple sclerosis (MS).
Helius submitted its request in August. In October the company announced the FDA had requested additional information and the application was placed on hold until the agency received the requested data.
“The Helius team is very excited to announce the timely submission of our response to the FDA’s request for additional information,” Dane Andreeff, interim president and CEO of Helius, said in a press release.
“Looking ahead, we expect that the FDA’s receipt of our response will enable the FDA to resume its review of our request for de novo classification and clearance,” Andreef added.
MS is characterized by a loss of neuronal function, leading to symptoms such as fatigue, numbness, muscle weakness, muscle spams, and balance problems — all of which make walking a challenge.
PoNS is a non-invasive medical device that is placed on top of the tongue and delivers mild electrical signals to the brainstem, a part of the brain that helps to control various bodily processes, including movement. Through these electrical signals, the device aims to increase neuroplasticity — the brain’s ability to “rewire itself” in response to new experiences.
The device is intended for use in combination with targeted functional therapy, such as physical or occupational therapy. By promoting neuroplasticity, the device is expected to improve rehabilitation.
“We remain committed to our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms as expeditiously as possible, and hope to receive the FDA’s decision on our request for de novo classification and clearance during the first half of this year,” Andreef said.
Helius’s request for de novo classification of the PoNS device means that the FDA would agree that no similar devices are legally marketed in the U.S., and that the controls provided are enough to assure the device’s safety and effectiveness. If the FDA issues a positive decision, the agency then would provide a risk-based classification to the new device and authorize its marketing.
The FDA granted breakthrough device designation to PoNS in May. The device recently was cleared in Canada to help treat walking difficulties in people with mild-to-moderate MS or traumatic brain injuries, in conjunction with physical therapy. It also is under review by Australia’s Therapeutic Goods Administration.
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