2ndMar, 2020– Helius Medical Technologies, Inc. issued an announcement, which is summarized as follows：
On February 27, 2020, the Company submitted a Canadian Class II license amendment application for the treatment of gait deficit in patients with mild and moderate Multiple Sclerosis (“MS”). This is an important new clinical indication for the PoNS device, given the approximately 100,000 individuals living with MS in Canada. The Company believes this label expansion will significantly expand its addressable market opportunity in Canada to include a patient population that is motivated to pursue treatment options which may resolve or delay the progression of MS symptoms.
Based on the quality of the data included in its MS submission package to Health Canada, the Company is prioritizing the MS indication as the pathway to pursue for its first US clearance of the PoNS device. The Company believes the existing published data and clinical experience with use of the PoNS for the treatment of gait disorder in patients with mild and moderate MS are sufficient to demonstrate a favorable risk/benefit profile, as required for de novo clearance. The Company plans to submit to the FDA for this high unmet medical need in the second half of 2020.
The Company will continue to pursue its TBI indication with a new trial, called TBI-002, which will be used to support its new request for de novo classification and clearance of the PoNS device for the treatment of chronic balance deficit due to mild to moderate traumatic brain injury (“mmTBI”). The design of TBI-002 incorporates specific recommendations that the Company received from the FDA in January 2020. The Company expects the trial to cost $6 million and to begin enrollment in April 2020 and the Company is targeting submission to the FDA in the second quarter of 2021.
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