Newtown, PA – October 27, 2016 – Helius Medical Technologies, Inc. (TSX: HSM, OTCQB: HSDT) (“Helius” or the “Company”) announced today that its wholly owned subsidiary, NeuroHabilitation Corporation, has been assessed by Lloyd’s Register Quality Assurance Limited (LRQA) and recommended for ISO 13485 certification for its Portable Neuromodulation Stimulator (PoNS™), an investigational non-invasive device designed to deliver neurostimulation through the tongue. LRQA, an independent certifying agency, concluded that the company complies with the requirements of ISO 13485 for an integrated quality management system for medical devices across all functions of the business, from design and development to manufacturing and distribution.
Achievement of ISO 13485 certification constitutes an important regulatory milestone in the commercialization process for the company’s products. The ISO 13485 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.
“The ISO 13485 certification illustrates our commitment to quality, our ability to reach milestones required for product commercialization and, above all, our dedication to seeing PoNS™ Therapy through to approval,” said Helius CFO/COO, Joyce LaViscount.
With this certification, Helius will be proceeding with a CE Mark application in Europe, a Health Canada Medical Device License Application for Canada and a Therapeutic Goods Association application for Australia.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
About PoNS™ Therapy
The PoNS™ device is an investigational non-invasive method to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the investigational device with physiotherapy and is currently being evaluated in a pivotal, multicenter, clinical trial for the treatment of balance disorder in subjects with mild to moderate Traumatic Brain Injury (TBI). The PoNS ™ Therapy is also being evaluated in the treatment of symptoms related to other neurologic diseases including Multiple Sclerosis and Cerebral Palsy.
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Cautionary Disclaimer Statement:
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws (“forward-looking statements”).
All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, statements regarding ongoing or planned clinical research, expected future development timelines, regulatory approvals, business initiatives and objectives and use of proceeds from financings or other business initiatives.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions.
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 of the Company to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators.
The reader is cautioned that assumptions used in the preparation of any forward-looking statements 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 statement. 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. Risks and uncertainties about the Company’s business are more fully discussed in the Company’s disclosure materials, including the short form prospectus filed in connection with the Offering, its Annual Report on Form 10-K filed with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com.
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Brian Bapty, 604-652-3950
Becky Kern, 914-772-2310