NEWTOWN, Pa., Sept. 27, 2018 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech aggregation focused on acoustic wellness, today appear its wholly endemic accessory NeuroHabilitation Corporation, submitted an appliance for a Class II Medical Accessory Authorization to Health Canada to bazaar its Portable Neuromodulation Stimulator (PoNS™), an investigational medical device.
“The Aggregation is admiring to abide our Class II Medical Accessory Authorization appliance to bazaar our PoNS Accessory as an accessory to concrete analysis for the analysis of abiding antithesis ataxia in patients with mild- to moderate-traumatic academician injury,” said Philippe Deschamps, Helius’ President, CEO and Chairman. “This accomplishment follows the contempo acquiescence of our appeal to the U.S. Food and Drug Administration for de novo allocation and 510(k) approval of our PoNS Device, which we appear via columnist absolution on September 4th.”
Mr. Deschamps continued: “In both the U.S. and Canada, Helius is focused on advancing our pre-regulatory approval activities, which includes the enactment of Clinical Experience Programs, and laying the background for the commercialization of our PoNS Analysis in anniversary market. We will additionally abide to accompany added authoritative clearances in assorted all-embracing markets, including Australia and Europe.”
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech aggregation focused on acoustic wellness. The Company’s purpose is to develop, authorization and access different and non-invasive belvedere technologies that amplify the brain’s adeptness to alleviate itself. The Company’s aboriginal artefact in development is the Portable Neuromodulation Stimulator (PoNS). For added information, appointment www.heliusmedical.com.
About the PoNS Accessory and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an investigational, non-invasive, medical device.
PoNS Analysis is the aboriginal and alone tongue-delivered neuromodulation actuality developed to amalgamate dispatch of cranial fretfulness with concrete and cerebral analysis to restore absent acoustic function. The Company’s trials investigating the PoNS in alarming academician abrasion are added absolutely discussed in the Company’s acknowledgment materials, including its Annual Report on Form 10-K and added filings with the United States Balance and Exchange Commission.
Cautionary Disclaimer Statement:
Certain statements in this account absolution are not based on absolute facts and aggregate advanced statements or advanced advice aural the acceptation of the U.S. Private Balance Litigation Reform Act of 1995 and Canadian balance laws.
All statements added than statements of absolute actuality included in this account absolution are advanced statements that absorb risks and uncertainties. Such advanced statements include, amid others, statements apropos the abeyant authoritative approval of the Company’s submissions to FDA and Health Canada.
Forward-looking statements are generally articular by agreement such as “believe”, “will”, “may”, “should”, “anticipate”, “expects”, “estimate”, “intend” and agnate expressions.
There can be no affirmation that such statements will prove to be authentic and absolute after-effects and approaching contest could alter materially from those advancing in such statements. Important factors that could account absolute after-effects to alter materially from the Company’s expectations accommodate the uncertainties associated with U.S. and Canadian regulatory acquiescence and approval processes, including the achievability that either the FDA or Health Canada may not acquisition the Company’s authoritative acquiescence acceptable to abutment clearance, the Company’s charge to accession added basic to accomplish its business objectives and added risks abundant from time to time in the filings fabricated by the Aggregation with balance regulators.
The clairvoyant is cautioned that assumptions acclimated in the alertness of any advanced statements may prove to be incorrect. Contest or affairs may account absolute after-effects to alter materially from those predicted, as a aftereffect of abundant accepted and alien risks, uncertainties, and added factors, abounding of which are above the ascendancy of the Company. The clairvoyant is cautioned not to abode disproportionate assurance on any advanced statement. Such information, although advised reasonable by administration at the time of preparation, may prove to be incorrect and absolute after-effects may alter materially from those anticipated. Advanced statements independent in this account absolution are especially able by this cautionary statement. Risks and uncertainties about the Company’s business are added absolutely discussed in the Company’s acknowledgment materials, including its Annual Report on Form 10-K for the year concluded December 31, 2017, its Quarterly Reports on Form 10-Q for the abode concluded March 31, 2018 and June 30, 2018 and its added filings with the United States Balance and Exchange Commission and the Canadian balance regulators and which can be acquired from either at www.sec.gov or www.sedar.com.
The advanced statements independent in this account absolution are fabricated as of the date of this account absolution and the Aggregation assumes no obligation to amend any advanced account or to amend the affidavit why absolute after-effects could alter from such statements except to the admeasurement appropriate by law.
The Toronto Stock Exchange has not advised and does not acquire albatross for the capability or accurateness of the agreeable of this account release.
Investor Relations Contact:
Westwicke Partners on account of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
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