A breakthrough in the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury
TORONTO, June 20, 2019 /CNW/ - Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) ("Helius" or the "Company"), a neurotech company focused on neurological wellness, will be hosting a scientific lecture at the fourth-annual Rehab Week, a global cross-disciplinary conference among engineers, researchers and clinicians in the field of rehabilitation technology. The lecture, which will be offered twice during Rehab week, will provide an overview of a new, non-invasive treatment option in Canada for those suffering from chronic balance deficit as a result of mild-to-moderate traumatic brain injury.
Approximately 350,000 people in Canada are living with a chronic balance deficit following a mild-to-moderate traumatic brain injury (mmTBI), and an estimated 13,000 new cases are reported annually. A recent publication revealed that, in Ontario alone, previously unreported/hidden health costs related to mild TBI is in excess of $110 million each year. Symptoms of mmTBI can negatively impact an individual's daily life, from difficulty walking to loss of balance and coordination. As a means to improve treatment of chronic balance deficit, Helius developed the Portable Neuromodulation Stimulator (PoNS™),* a device authorized for sale in Canada. The PoNS™ device delivers mild stimulation to nerves in the tongue, which connect to the brain. This stimulation, combined with targeted physiotherapy, is believed to promote neuroplasticity, which may provide functional improvements in balance and mobility.
"The challenge has been that with the current standard of care – rehabilitative physical therapy – as many as 40% of patients continue to experience balance issues," said Dr. Kim Skinner, Director of Physical Therapy at Helius and a former director of physical therapy and researcher at the University of Wisconsin. "PoNS is the first patented, non-invasive device designed to amplify the brain's powerful ability to heal itself. When used in conjunction with physical therapy, PoNS™ has the potential to help restore balance and gait for patients who have suffered mild-to-moderate traumatic brain injuries, including concussions."
Dr. Skinner, who worked with the lab team that developed PoNSTM, will provide insight into clinical trials which resulted in nearly 70% of patients experiencing significant improvements in their balance. In a 14 week long-term treatment trial, this benefit persisted for at least 12 weeks following the end of PoNS Treatment™.
"Helius has established a network of neuro-rehabilitation clinics in Canada that are authorized and trained to provide PoNS Treatment," said Phil Deschamps, CEO, Helius Medical Technologies. "Canadians who have chronic balance deficit previously had limited therapeutic options. With PoNSTM, there is now a new treatment available in Canada that may improve their balance and mobility."
For more information about PoNSTM, visit www.ponstreatment.ca.
Helius is a silver sponsor of Rehab Week, taking place June 24-28 at the Metro Toronto Convention Centre.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company's purpose is to develop, license and acquire unique and non-invasive platform technologies that may amplify the brain's ability to heal itself. The Company's first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.
*About the PoNS Device and PoNS Treatment™
The Portable Neuromodulation Stimulator (PoNS™) is a licensed class II, noninvasive, medical device in Canada intended for use as an acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is limited to prescription use. PoNS™ is an investigational medical device in the United States, the European Union ("EU"), and Australia ("AUS"), and it is currently under review for clearance by an EU Notified Body and the AUS Therapeutic Goods Administration. PoNS Treatment™ is currently not commercially available in the United States, the European Union or Australia.
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. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as "believe," "continue," "look forward," "will" and similar expressions. Such forward-looking statements include, among others, statements regarding the Company's future clinical and regulatory development plans for the PoNS device, including the planned physical therapy only study, and the potential regulatory clearance of the PoNS device.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the uncertainties associated with the regulation of commercially available medical devices in Canada, including Health Canada's ongoing assessment of post-market data, the initiation and enrollment process for the planned physical therapy only study, the clinical development, regulatory submission and approval process in the United States, the European Union and Australia, as well as the Company's capital requirements needed to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company's business described in the "Risk Factors" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
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SOURCE Helius Medical Technologies, Inc.
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