NEWTOWN, Pa., Oct. 24, 2018 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech aggregation focused on acoustic wellness, today appear that its wholly endemic subsidiary, NeuroHabilitation Corporation, has partnered with Northwell Health’s Feinstein Institute for Medical Analysis in Manhasset, NY. This affiliation will accredit Helius to apparatus its added Analytic Experience Program (CEP) for its Portable Neuromodulation Stimulator (PoNS™) — an investigational medical accessory in the US currently beneath analysis for bazaar approval by the US Food & Drug Administration. PoNS is a accountant chic II medical accessory in Canada.
The CEP will be performed at three of Northwell Health’s analytic sites including North Shore University Hospital (NSUH) and Transitions of Long Island in Manhasset, NY and Southside Hospital in Bay Shore, NY.
CEPs are sponsored by Helius and implemented in affiliation with arch neurorehabilitation centers, including bookish and analysis institutions, hospital systems and high-volume absolute neurorehabilitation centers. CEPs accredit Helius to thoroughly investigate in the analytic setting, the PoNS analysis in patients adversity from abiding antithesis arrears due to mild- to moderate-traumatic academician abrasion (TBI).
“We are captivated to accomplice with NeuroHabilitation Corporation, as we attending to added analysis options for our patients who ache from TBI,” said Jamie Ullman, MD, Director of Neurotrauma at North Shore University Hospital and arch investigator of the Feinstein Institute study. “PoNS analysis is a able new technology which may enhance accretion afterwards TBI by amalgam argot dispatch with specialized concrete therapy.”
“Helius is admiring to advertise this important affiliation with the Feinstein Institute for Medical Research,” said Philippe Deschamps, Helius’ Chief Executive Officer. “Following our afresh appear CEP partnerships with Ohio State University Wexner Medical Center, our affiliation with the Feinstein Institute will accredit us to apparatus our added CEP, which we are advancing as allotment of our pre-regulatory approval activities for the investigational PoNS device.”
Mr. Deschamps continued: “By implementing CEPs, we aim to accomplish real-world analytic affirmation and admired bloom outcomes data, while architecture relationships with arch neurorehabilitation centers and key assessment leaders in the breadth of TBI. We attending advanced to alive with Dr. Ullman and the agents at all of the accommodating Northwell Bloom analytic sites included in this CEP affiliation to activate recruiting and enrolling patients for the PoNS Analysis in the fourth division of 2018.”
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 Feinstein Institute
The Feinstein Institute for Medical Analysis is the analysis arm of Northwell Health, the better healthcare provider in New York. Home to 50 analysis laboratories and to analytic analysis throughout dozens of hospitals and outpatient facilities, the Feinstein Institute includes 4,000 advisers and agents who are authoritative breakthroughs in atomic medicine, genetics, oncology, academician research, brainy health, autoimmunity, and bioelectronic anesthetic – a new acreage of science that has the abeyant to accommodate medicine. For added advice about how we empower acuteness and avant-garde discovery, appointment FeinsteinInstitute.org
About the PoNS Accessory and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an investigational, non-invasive, medical accessory in the US currently beneath analysis by the US Food & 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 is currently not commercially accessible in the US. PoNS is a accountant chic II medical accessory in Canada.
PoNS Analysis is the aboriginal and alone tongue-delivered neuromodulation that combines 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, the accepted timing of the company’s planned pre-submission affair with FDA and the accepted timing of the Company’s acquiescence authoritative approval of the PoNS device.
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 the FDA authoritative acquiescence and approval process, including the achievability that the FDA may not acquisition the Company’s authoritative acquiescence acceptable to abutment clearance, the action of negotiating with rehabilitation centers to apparatus CEPs, the ambiguity of the bloom outcomes abstracts to be generated by the CEPs, uncertainties associated with bartering application process, 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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