NEWTOWN, Pa., Oct. 22, 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 subsidiary, NeuroHabilitation Corporation, accustomed allotment from Bloom Canada to bazaar its Portable Neuromodulation Stimulator (PoNS™), a chic II medical accessory in Canada. The Bloom Canada Medical Accessory Authorization certifies the PoNS Accessory meets all Canadian safety, effectiveness, and affection requirements. The Canadian Medical Accessory Authorization approval was preceded by the Company’s accomplishment of ISO 13485 Certification, the all-embracing accepted for medical accessory affection administration systems.
“The Aggregation is captivated to acquire accustomed Canadian authoritative approval to bazaar our PoNS Analysis as an accessory to concrete analysis for abiding antithesis arrears in patients with mild-to-moderate alarming academician abrasion (TBI),” said Philippe Deschamps, Helius’ President, CEO and Chairman. “Canada is one of the best admired healthcare markets in the apple and was accordingly able-bodied represented in our acknowledged TBI analytic trial. We are aflame to acquire this aboriginal authoritative acceptance on the allowances of our advance PoNS Treatment. We acknowledge Bloom Canada for its accelerated analysis and approval of our application. We attending avant-garde to accouterment our avant-garde analysis for this absolute aerial unmet medical charge to Canadians adversity from the abiding furnishings of TBI.”
Mr. Deschamps continued: “Earlier this month, we appear the conception of Heuro Canada, a new operating article formed as allotment of our cardinal accord with HealthTech Connex (HTC) to administer PoNS Analysis in Canada, already approval was obtained. Through Heuro Canada, we are alive agilely to body the requisite bartering and operating basement to activate alleviative patients now that we acquire accustomed authoritative approval for the PoNS Treatment. We acquire already accustomed the aboriginal two Heuro Canada neuroplasticity clinics which we apprehend to be operational in the fourth division of 2018 and we apprehend to activate alleviative patients in Canada in the aboriginal division of 2019.”
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 a Chic II Medical Accessory austere for bartering administration in Canada and an investigational, non-invasive, medical accessory currently beneath analysis by the United States Food and Drug Administration for approval to advance antithesis in patients afterward a mild-to-moderate alarming academician abrasion (mTBI) back accumulated with targeted concrete therapy. PoNS Analysis is the aboriginal and alone tongue-delivered neuromodulation analysis 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 avant-garde statements or avant-garde 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 avant-garde statements that absorb risks and uncertainties. Such avant-garde statements include, amid others, statements apropos the accepted timing for the Company’s Heuro Canada neuroplasticity clinics acceptable operational and the admission of analysis of patients in 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 achievability that Heuro clinics booty best to set up and accommodating application takes best than projected, the achievability that the accomplishment of bartering PoNS accessories takes best than projected, the accomplishing of the administration basement takes best than expected, 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 avant-garde 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 avant-garde 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. Avant-garde 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 avant-garde 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 avant-garde 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.
About HealthTech Connex, Inc.
HealthTech Connex, Inc. is a bloom technology aggregation alive to accommodate the convenance of analytic neuroscience through avant-garde technologies based on the accomplished affection science and innovation. Located in Surrey, British Columbia, Canada, it is one of the aboriginal companies to appear from the city’s Addition Boulevard, an active affiliation of health, business, college apprenticeship and government creating new bloom technologies to advance peoples’ lives. www.HealthTechConnex.com
Investor Relations Contact:
Westwicke Partners on account of Helius Medical Technologies, Inc.Mike Piccinino, [email protected]
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