Benzinga | Oct 19, 2020 04:36PM EDT

Helius Medical Technologies Receives Request For Additional Information From FDA Related To Co.'s Request For De Novo Classification And Clearance Of The Portable Neuromodulation Stimulator

NEWTOWN, Pa., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) ("Helius" or the "Company"), a neurotech company focused on neurological wellness, today announced that it has received a request for additional information from the U.S. Food and Drug Administration (the "FDA" or "Agency") related to the Company's request for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS(tm)) device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis ("MS"), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.



During the substantive review phase of a request for de novo classification and clearance, FDA may request additional information in order to obtain information necessary for the Agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted.

Helius submitted its request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from MS on August 4, 2020, following the receipt of Breakthrough Designation by FDA in early May. The FDA's request for additional information was received approximately 75 days from the submission date, which is consistent with FDA's expected timing for review of a Breakthrough Designated product, such as the PoNS device. The FDA's request for additional information includes requests for additional analysis of clinical data and proposes certain labeling modifications.

"As we continue to work towards our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms, Helius is committed to preparing and submitting our response to the FDA's request for additional information as thoroughly and efficiently as possible, so that the Agency can resume its review process," said Dane Andreeff, Interim President and Chief Executive Officer of Helius. "Importantly, we believe the PoNS device's Breakthrough Designation status will provide Helius with the opportunity to work efficiently with the Agency as we address the request and plan our formal response."