Traumatic brain injury (“TBI”) of varying severity can result in balance and movement disorders, for which the benefits of treatment with physical therapy has limits. NEWTOWN, Pa., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the formation of a Multiple Sclerosis (“MS”) Scientific Advisory Board. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. “80% of the people with MS that we queried indicated they wanted to have the opportunity to take part in research. “Their deep clinical expertise in treating individuals with gait issues due to Multiple Sclerosis and their knowledge of neurorehabilitation and other modalities to ‘prime the brain’ will be invaluable as we evaluate how to optimize the health economic and patient impact in the U.S.”.
Helius Medical Technologies is a neurotech company focused on neurological wellness.
He served in that capacity until leading the sale of the company to Thomas H. Lee Partners in 2010. The research project will focus on U.S.-based app users who agree to provide their information through an anonymous survey, which will be conducted either via email or an app notification. Through collaboration with distinguished research and production partners, Helius is developing and testing breakthrough technologies as potential treatments for neurological symptoms caused by disease or trauma.
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.
Importantly, Dane is dedicated to pursuing our objectives as an organization efficiently and effectively, and has elected to take no additional compensation in return for his service as Interim President and CEO. PoNS™ is currently not commercially available in the United States, the European Union or Australia. Current members of the Board of Directors, Dane C. Andreeff and Blane Walter, have been appointed to the respective positions of Interim President and CEO, effective August 23, 2020, and Chairman of the Board of Directors, effective August 23, 2020. Overall, these data indicate that TLNS delivered in conjunction with physical therapy may offer an integrative way to treat balance disorders after a mild-to-moderate TBI. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). Breakthrough builds privacy-focused applications that empower people living with chronic disease to gather and securely own their healthcare data, with the opportunity to share it to support research.
Important factors that could cause actual results to differ materially from the Company’s expectations include the impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements 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, 2019, Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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. Leading Multiple Sclerosis Experts to Inform U.S. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties.
It is also under premarket review by the AUS Therapeutic Goods Administration. We should continue to document these changes in future studies and are keen to see this treatment deployed to help a massive unmet clinical need.”, “I am thrilled that the body of scientific evidence showing the potential beneficial effects of our PoNS technology continues to grow,” added Dane Andreeff, Interim Chief Executive Officer of Helius. For more information, visit www.heliusmedical.com.
Mr. Walter has served as a member of Helius’ Board of Directors since December 2015. The presentation will be followed by a virtual breakout session. The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. It is also under premarket review by the AUS Therapeutic Goods Administration. Stock quotes by finanzen.net.
We look forward to leveraging his leadership skills, and experience in managing and advising businesses, as Helius pursues its next phase of growth.”, “During my tenure as a member of Helius’ Board, I have been consistently impressed with the potential of our PoNS technology and dedication our organization has shown to bringing it to the aid of patients suffering from the effects of chronic conditions like multiple sclerosis and traumatic brain injury,” said Dane C. Andreeff.
It is also under premarket review by the AUS Therapeutic Goods Administration. The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. In this study, a 9 patient subset of the original 43 patients published in “Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury” with balance issues received translingual neural stimulation (“TLNS”) with the PoNS device, in concert with physical therapy, and the effects on grey matter volume (“GMV”) in the brain were evaluated.
The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). Such forward-looking statements include, among others, statements regarding the Company’s future clinical and regulatory development plans for the PoNS device and the potential regulatory clearance of the PoNS device, the success of the Company’s planned study, business and commercialization initiatives and objectives, the potential receipt of regulatory clearance of the PoNS device in the United States, the European Union and Australia and the Company’s revenue guidance.
The MS Scientific Advisory Board’s initial goals will also include developing a new foundational scientific message, helping to validate the positive effects of neuromodulation in improved neurorehabilitative care, informing the development of the Company’s planned U.S. launch strategy to the MS community following the receipt of clearance and providing guidance on the Company’s reimbursement and market access strategies. “This is a really exciting partnership for Breakthrough and the MS community,” said Bazil Azmil, CEO of Breakthrough.
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