Full Press Release Details
Helius Medical Technologies Announces Clinical Device
Readiness for PoNS 4.0
Newtown, PA June 25 2015 - Helius Medical Technologies, Inc.
(CSE: HSM) (OTCQB: HSDT) ( Helius ) is pleased to announce that it has
successfully released the first clinical version of the Portable Neuromodulation
Stimulator (PoNS ) 4.0 device (see Figure 1 below). The PoNS 4.0 device is
manufactured by Ximedica LLC and will be used in Helius registrational clinical
trial, to investigate its safety and effectiveness for the treatment of balance
disorder caused by traumatic brain injury.
The PoNS 4.0 device represents the combined design and
engineering efforts of Helius and our valuable partner, Ximedica. Clinical
device readiness keeps Helius on track with our published timelines for trial
completion and submission to regulatory agencies for marketing approval, said
Helius CEO, Philippe Deschamps.
The Portable Neuromodulation Stimulator (PoNS) device is an
investigational medical device being studied for the treatment of neurological
symptoms caused by disease or trauma. The PoNS is currently being studied in the
United States and Canada for the treatment of balance disorder for subjects with
mild to moderate Traumatic Brain Injury (mTBI), and in Canada for the treatment
of gait and balance disorder for subjects with Multiple Sclerosis (MS).
The PoNS device is a non-invasive means for delivering
neurostimulation through the tongue. Researchers believe that use of the tongue
as a gateway to the brain may be one of the most natural, non-invasive and
direct ways to stimulate the brain. The tongue is anatomically unique, being
richly inervated by thousands of nerve fibers and interconnected to the
brainstem by two major cranial nerves.
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology company
focused on neurological wellness. HMT seeks to develop, license and acquire
unique and non-invasive platform technologies that amplify the brain s ability
to heal itself. HMT intends to file for U.S. Food and Drug Administration
clearance for the PoNS device. For more information, please visit www.heliusmedical.com. The contents of this website are
not, and should be deemed to be, incorporated by reference herein.
Ximedica is a full service ISO 13485-certified and
FDA-registered product development firm with an exclusive focus on medical
products. With more than 25 years of experience developing medical devices,
combination products and consumer healthcare, Ximedica s client base spans the
globe and ranges from start-ups to the world s largest medical device
manufacturers. Ximedica s mission is to create products that meet international
regulatory requirements and strategic business goals. For more information,
visit their website at http://www.ximedica.com. The contents of this website are
not, and should be deemed to be, incorporated by reference herein.
The Canadian Securities Exchange has not reviewed and does
not accept responsibility for the adequacy or accuracy of the content of this
Cautionary Disclaimer Statement:
This press release contains forward-looking statements relating
to the results of the Company s registrational clinical trial, planned future
commercial distribution, and other statements that are not historical facts.
Forward-looking statements are often identified by terms such as will , may ,
should , anticipate , expects and similar expressions. All statements other
than statements of historical fact, included in this release are forward-looking
statements that involve risks and uncertainties. There can be no assurance that
such statements will prove to be accurate and actual results and future events
could differ materially from those anticipated in such statements. Important
factors that could cause actual results to differ materially from the Company s
expectations include the failure to satisfy the conditions of the Securities and
Exchange Commission and the Canadian Securities Exchange, the success of the
Company s business plan, availability of funds, government regulations,
operating costs, the Company s ability to achieve revenues and other risks
detailed from time to time in the filings made by the Company with its
securities regulators.
The reader is cautioned that assumptions used in the
preparation of any forward-looking information may prove to be incorrect. Events
or circumstances may cause actual results to differ materially from those
predicted, as a result of numerous known and unknown risks, uncertainties, and
other factors, many of which are beyond the control of the Company. Many factors
may cause the Company s actual results to differ materially from any
forward-looking statement. The reader is cautioned not to place undue reliance
on any forward-looking information. Such information, although considered
reasonable by management at the time of preparation, may prove to be incorrect
and actual results may differ materially from those anticipated. Forward-looking
statements contained in this press release are expressly qualified by this
cautionary statement. The forward-looking statements contained in this press
release are made as of the date of this press release and the Company undertakes
no obligation to update or revise publicly this press release to reflect events
or circumstances after the date hereof, except as required by applicable law.