Newtown, PA / TheNewswire / August 7, 2015 - Helius Medical Technologies, Inc. (HSM:CNX) (HSDT) ("Helius" or the "Company") is please to provide the following corporate update in response to recent volatility in the Company's trading price.
Helius is developing a new and disruptive treatment for neurological symptoms of disease or trauma. Treatment of these symptoms represents one of the largest unmet medical needs in terms of both the multi-billion dollar cost to society as well as sheer patient numbers.
The Company's dedicated and experienced management team understands shareholder value is created by successfully navigating the path from innovation and development to clinical trials and, with success, regulatory approval and product launch into this large and underserved market.
On behalf of its shareholders, Helius is pursuing this market rationally and methodically, yet management is driven by a zeal and passion that can only occur when market success is paired with the alleviation of patient suffering.
The Company's successes to date are as follows, and its development milestones to come numerous.
Helius' key business milestones are:
-The completion of its design and manufacturing process for the clinical supply of the PoNSTM device.
-Completing the FDA pre-submission meetings with clear direction and approval of its clinical trial approach.
-Launching the Traumatic Brain Injury (TBI) registrational trial.
-Signing an exclusive and sole source contract with the Army for co-funding of the TBI clinical trial.
-Building its IP portfolio
The Company is pleased to report progress on all these milestones.
-Clinical supplies design and manufacturing is completed and the PoNSTM devices are available for the clinical trial.
-Earlier in the spring, the Company obtained registrational protocol approval from the FDA as well as designation as a non-significant risk device.
-All of the IRB approvals at the Company's three study sites (Montreal Neurofeedback Center, Portland Health Center, and Orlando Health) have been achieved and management expects to begin recruiting patients in August and completing the study in Q1, 2016 on time and on budget.
-The Company executed a contract with the US Army Medical Material Agency on July 3, 2015 for support in funding its TBI clinical trial.
-Helius has built a sizable IP portfolio with 4 issued patents covering the Major Medical Methods and the PoNSTM device itself.
For the balance of this year, Helius will also focus its attention on the early commercialization development including, branding, packaging and building a very sophisticated patient support system to ensure that patients' initial experiences are positive.
If cleared by the FDA, the PoNSTM device will be the first medical device cleared for the treatment of balance disorder associated with mild-to-moderate traumatic brain injury.
Despite the volatility of the markets, Helius remains on time and on budget for all of its key milestones. The Company thanks you for your continued support.
President & CEO
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology holding company focused on neurological wellness. HMT seeks to use 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(TM) device. For more information, please visit www.heliusmedical.com.
Cautionary Disclaimer Statement:
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
This news release contains forward-looking statements relating to the completion of multiple milestones leading into production of the PoNSTMdevice 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 Canadian Securities Exchange and other risks detailed from time to time in the filings made by the Company with securities regulations.
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. 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 news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
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