UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 24, 2020

HELIUS MEDICAL TECHNOLOGIES, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

DELAWARE

001-38445

36-4787690

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

642 Newtown Yardley Road, Suite 100

Newtown, PA

 

18940

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (215) 944-6100

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock

 

HSDT

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 

 


 

Item 7.01 Regulation FD Disclosure.

 

On March 24, 2020, Helius Medical Technologies, Inc. (the “Company”) posted an updated corporate presentation to its website at http://heliusmedical.com/index.php/investor-relations/overview, which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific references in such a filing.

 

Item 8.01 Other Events.

 

On March 24, 2020, the Company issued a press release announcing the expansion of the indication for use for its Portable Neuromodulation Stimulator (PoNSTM) device in Canada. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

 

Forward- Looking Statements

 

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, and Canadian securities laws, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.

 

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

 

 

 

99.1

 

Corporate Presentation.

99.2

 

Press Release, dated March 24, 2020.

 


1


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

HELIUS MEDICAL TECHNOLOGIES, INC.

 

 

 

 

Date: March 24, 2020

 

By:

/s/ Joyce LaViscount

 

 

 

Joyce LaViscount

 

 

 

Chief Financial Officer

 

2

SLIDE 1

A Revolution in Mind March 2020 Exhibit 99.1

SLIDE 2

Legal Disclaimers www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, including whether the results of our clinical trials will be sufficient to support an FDA, CE Mark or TGA approval of the PoNS™ device for marketing or whether the agencies may require that the Company conduct future clinical trials; future economic, competitive, reimbursement and regulatory conditions; new product introductions; ability to commercialize its PoNS Treatment™; demographic trends; the intellectual property landscape; financial market conditions; continued availability of capital and financing, including its ability to continue as a going concern; and future business decisions made by the Company and its competitors. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward looking statements include the risks described in the “Risk Factors” section of Company’s Annual Report on Form 10-K for the period ended December 31, 2019 and the Company’s Quarterly Report on From 10-Q for the period ended September 30, 2019, as well as those set forth from time to time in the Company’s other SEC filings, available at http://www.sec.gov. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Certain data in this presentation was obtained from various external sources. Neither the Company nor its affiliates, advisers or representatives have verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives make any representations as to the accuracy or completeness of that data or commits to update such data after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors. The Company’s first product, known as the Portable Neuromodulation Stimulator (“PoNS"TM), is an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy (“PoNS Treatment"TM) and indicated as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. It 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 the AUS Therapeutic Goods Administration. PoNS Treatment™ is not currently commercially available in the United States, the European Union or Australia. The Company has withdrawn its application from the EU marketing process due to uncertainty in Europe due to the switch from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the withdrawal of Lloyd’s Register Quality Assurance, the Company’s notified body, from the notified body business. The Company will reconsider submitting to the EU when conditions stabilize.

SLIDE 3

30+ years in the health sciences industry Former CEO at MediMedia Health Former President and CEO at GSW Worldwide (Division of inVentiv Health) Former Director of Neuroscience Marketing at Bristol-Myers Squibb Philippe Deschamps President, Chief Executive Officer & Chairman Dr. Jonathan Sackier Chief Medical Officer Joyce LaViscount Chief Financial Officer and Chief Operating Officer 17+ years in the medical devices industry Sales and Marketing Director, Boston Scientific Canada National Sales Manager, Canada Johnson & Johnson Former Media Relations and Marketing executive for Blue Jays & NHL Mark Leno VP, General Manager, Canadian Operations 30+ years in the health sciences industry Trained surgeon and pioneer of new medical technologies Has helped build several companies including medical technology, research and product- design and medical contract sales organizations 30+ years in the health sciences industry Accomplished pharmaceutical/healthcare public company CAO Former COO and CFO at MM Pharmaceutical Solutions Former Executive Director/Group Controller at Aptalis Pharmaceuticals Helius Leadership Team: Experienced Leadership With Healthcare and Commercialization Expertise www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 4

Strategic Vision PoNS Lifecycle Management +$10bn potential global market $10-15bn potential global market $1.5tn potential global market 2020 - 2023 +$10bn 2021 - 2027 2025 - 2030 $1.5tn(2) Wellness / Betterment Preventative and Personalized Medicine Human Performance Improvement Cognitive Maintenance / Enhancement, Balance and Mobility, Neuro Recovery, Fall Prevention Medical Applications TBI, MS, Stroke, Cerebral Palsy Helius Target Market $10-15bn(1) 1 Grandview Research Brain Health Supplements Market Size, Industry Report, 2019-2025 2 Global Wellness Economy Monitor – October 2018 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 5

The PoNS™ investigational medical device gently stimulates the surface of the tongue which excites the neural network flowing to the brain. This neural activity is believed to enable neuroplasticity which may restore lost function. Tongue Based Neuromodulation The neural network originating in the tongue flows to the brainstem, which is the body’s control center. The tongue’s dense nerve endings make it ideal for stimulation. A mild-to-moderate traumatic brain injury (“mmTBI”) damages the brain’s neural network and reduces its ability to effectively communicate with the body. To restore balance and function, the brain’s neural network needs to be “rewired” as this reestablishes the proper flow of neural impulses to the body. This “rewiring” is called neuroplasticity. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 6

Smart Device The PoNS™ is a smart device that tracks frequency, duration and intensity of use PoNS - One Smart Device Data Intelligence Capabilities Data captured is uploaded to the cloud for analysis, the results of which support treatment decisions and also provide compliance profiles for payer reimbursement opportunities www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Treatment Hypothesis Researchers believe that targeted physical therapy performed during neurostimulation may promote neural network changes including rebuilding and reorganization (neuroplasticity) thereby restoring communication with the body and improving functionality such as balance

SLIDE 7

Canada PoNS is an authorized class II medical device. The device is intended for use as a short term treatment (14 weeks) 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 intended for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. US Prioritizing using MS indication as the pathway to pursue for our first US clearance of the PoNS device based on: The quality of the data included in our MS submission package to Health Canada The existing published data Real-world evidence gathered in Canada High unmet medical need We plan to submit to the FDA for this high unmet medical need in the second half of 2020.   Regulatory Status www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 8

Study entry 2 wks lab 4 wks home 8 wks home 12 wks home Weeks DGI* Change *p < 0.05 **p < 0.01 *** p < 0.005 Clinically significant Two groups (10 each): “Active” PoNS + exercises Placebo PoNS + exercises Multiple Sclerosis Study – Mild and Moderate MS (EDSS score 3.5-6) Tyler et al. Journal of NeuroEngineering and Rehabilitation 2014, 11:79 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM All 10 subjects in the active treatment group experienced at least a 4 point improvement from baseline to Week 14 in DGI. only 3 of 10 (30%) subjects in the placebo control group experienced an improvement in DGI of at least 4 points from baseline to week 14. Mean DGI* 10 Active 10 Control *DGI = Dynamic Gait Index, a measure of the ability to walk

SLIDE 9

14 Data on file. Helius Medical Technologies Treatment outcomes for patients treated in Canada are captured in the company developed validated data capture system. 39 patients with MS were treated with PoNS in Canada between March 2019 and September 2019. Using all available data from the treated MS patients, the mean improvement from baseline to Week 14 in the FGA (functional gait assessment) was 4.53 (95% CI 3.35 to 5.72). Based on observed data, the median improvement was 5 points. 56.7% had an improvement at Week 14 greater than or equal to 4 points, the minimum detectable change. Given the safety profile to date, we believe these data support a positive benefit risk ratio in the real-world setting. Summary of Real-World Evidence in MS Patients Treated with PoNS in Canada www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 10

Pursuit of clearance for mmTBI indication: Our U.S. regulatory strategy initially focused on pursuing de novo classification and clearance of the PoNS device from the FDA for the treatment of chronic balance deficit due to mmTBI. FDA declined request for de novo classification in April 2019 In reaching its conclusion, the Agency noted: The risk profile of the device is well understood and acceptable FDA did not have sufficient information to discern the relative independent contributions of the PoNS™ device and physical therapy The FDA also noted that the Company could generate additional data to address its concerns and resubmit its application Regulatory Status – US (continued) www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 11

Designed new clinical protocol (“TBI-002”) intended to support a request for de novo classification of the PoNS device Based on the receipt of FDA’s final minutes from the pre-sub meeting Finalized our clinical protocol for a new trial, TBI-002 Multi-center, randomized trial in the U.S. and Canada consisting of 103 subjects with balance deficit due to mmTBI Primary end point will be a % responder analysis Patients will complete 10 weeks of treatment post randomization US Regulatory Strategy: mmTBI Indication www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 12

Real-world results of initial TBI patients consistent with Helius’ two RCTs in mmTBI: Patients demonstrated the same pattern of positive change over their course of treatment Majority of patients showed improvement in comfortable gait speed, a measure of their ability to walk, with meaningful clinical difference after treatment Focused on driving reimbursement by using health economic data to establish financial ROI for treatment Working with reimbursement specialists to formalize the reimbursement process by targeting multiple insurers Real-World Canadian Clinical Experience www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 13

Helius – Canadian Market Opportunity www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Multiple Sclerosis (“MS”) Helius’ target markets in Canada are expected to provide meaningful real world clinical experience in preparation for US launch Multiple Sclerosis (“MS”) Mild-to-Moderate Traumatic Brain Injury (“mmTBI”) 350,000 patients in Canada $9,500 CAD estimated revenue per patient per treatment $25mm CAD market opportunity 2020-2023 93,500 patients in Canada High urgency to treat Less price sensitive Very similar treatment protocol as mmTBI Specialty clinic system

SLIDE 14

Establish robust network of authorized Clinic locations to deploy PoNS 7 authorized Clinic locations established in 2019 7 additional locations in the first two months of 2020 It takes approximately 6 weeks for the first patients to be treated in a newly authorized clinic Submitted label expansion in MS on February 27, 2020 to Health Canada Gain KOL support through clinical experience programs (CEP) in Canada’s most respected Neuro Treatment Centers Clinical experience program through UHN Toronto at 3 private clinic locations with an opportunity to transition to commercial treatment centers Drive reimbursement by using health economic data to establish financial ROI for treatment Building Access, Credibility and Awareness while we Engage, Train and Authorize Canadian clinics to provide PoNS Treatment™ Commercializing PoNS Treatment™ in Canada Canadian Strategic Focus www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 15

Clinical Support for PoNS Treatment™: RCT Enrollment Criteria for Mild-to-Moderate TBI with Chronic Balance Deficit(1),(2) Safety and efficacy of PoNS Treatment™ demonstrated in two double-blind randomized controlled trials (RCTs): PoNS™ Registrational Trial in TBI (“TBI-001”) Long-Term Treatment Study in mmTBI Enrollment criteria included patients with persisting balance deficit, despite treatment with physical therapy (PT), the current standard of care Inclusion Criteria for Both Trials Aged 18-65 years at screening Balance disorder as a result of mmTBI ≥ 1-year since mmTBI Plateaued in recovery with current PT rehabilitation regimen Sensory Organization Test (SOT) score > 16 points below normal PT = physical therapy; SOT = Sensory Organization Test; TBI = traumatic brain injury. 1. Helius Medical Technologies data on file. Executive summary of TBI-001; 2. Tyler M, Skinner K, Prabhakaran V, Kaczmarek K, Danilov Y. Translingual neurostimulation for the treatment of chronic symptoms due to mild-to-moderate traumatic brain injury. Arch Rehabil Res Clin Transl.` www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 16

In patients with mmTBI, balance was significantly better at 2 Weeks, 14 Weeks and 26 Weeks 0 10 20 30 40 50 60 70 80 90 SOT Baseline Week 26 ∆ 29.8 ∆ 21.0 ∆ 33.8 Normal Range SOT Score Week 14 N=221 12-week washout period – no stimulation On average, patients with mmTBI improved from an impaired SOT score to normal SOT score in 14 weeks of treatment with HFP version of PoNS™ device On average, normal SOT score was maintained throughout the 12-week washout period for all patients Week 2 HFP+PT Clinical Support for PoNS Treatment™: Long-term Treatment Study in mmTBI Demonstrates Significant, Sustained Improvement Long-term Treatment Study in mmTBI Sensory Organization Test (SOT) Score Comparison 1 Patients treated with high frequency pulse (HFP) device. Low frequency pulse (LFP) data not shown since it was not statistically different from HFP. Archives of Rehabilitation Research and Clinical Translation (2019), doi: https://doi.org/10.1016/j.arrct.2019.100026. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 17

Balance Maintenance in Baby Boomers (78M people) Neurological Wellness (1 billion people) Human Performance Stroke (7M People; 795K new each year) Cerebral Palsy (764K People) Indication and Target Population - US* Potential for Future Development PoNS Treatment™ Additional Clinical Progress and Potential Opportunities www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Pilot Studies Completed * See reference slides for sources DTC Driven Consumer Device

SLIDE 18

Extensive IP Portfolio A Significant Barrier to Competitor Entry Exclusively licensed from inventors (4% royalty): 9 US Medical Method Patents Issued Patents expire between 2029 and 2031 Patents owned by Helius (no royalty): 29 US Patents Issued 41 Foreign Patents Issued Patents expire between 2026 and 2040 Helius Patents Transferred to China Medical System Holdings (CMS): 3 Chinese Design Patents Independent Verification of Patents and Freedom to Operate Opinion September 2017 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 19

Investor Contact: Mike Piccinino, CFA 443-213-0500 investorrelations@heliusmedical.com Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │Newtown, PA 18940 T: 215 944-6100 │E: investorrelations@heliusmedical.com │W: www.heliusmedical.com www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 20

References Slide 15-16: Clinical Support for PoNS Treatment™ Archives of Rehabilitation Research and Clinical Translation (2019), doi: https://doi.org/10.1016/j.arrct.2019.100026 Slide 19: Disease State Prevalence Multiple Sclerosis - http://www.nationalmssociety.org/About-the-Society/MS-Prevalence Cerebral Palsy: http://www.cerebralpalsy.org/about-cerebral-palsy/prevalence-and-incidence Stroke – http://www.strokeassociation.org/STROKEORG/LifeAfterStroke/Life-After-Stroke_UCM_308546_SubHomePage.jsp–https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_stroke.htm Grandview Research Brain Health Supplements Market Size, Industry Report, 2019-2025 Global Wellness Economy Monitor – October 2018 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 21

Appendix www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM

SLIDE 22

9 14 40 30 50 60 90 80 70 BASELINE 2 4 6 8 10 12 14 Weeks ACTIVE SHAM ROLLOVER SOT Composite Scores www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 P=.015 Relative to Baseline P= NS Relative to Baseline P=.001 Relative to Baseline 14 subjects, 7 non-stimulating PoNS Vs 7 active PoNS stimulation with concomitant physiotherapy Multiple Sclerosis Study Evaluating PoNS on Balance Deficit

SLIDE 23

fMRI Changes vs. Healthy Controls 26 Group A Active Arm Group B Placebo Arm Active ArmPlacebo ArmActive Arm Active ArmPlacebo Arm www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 P=.01 P=.02 P=.06

SLIDE 24

27 Working Memory fMRI Active Arm Placebo Arm Group A: Post PoNS™ device training fMRI shows significant increase in BOLD signal in the left DLPFC* (t=3.55, p=0.01), rACC** (t=3.057, p=0.02) and a trend for significance in the right DLPFC (t=2.3, p=0.06). Group B: Baseline as well as post- PoNS™ fMRI shows sub-threshold peaks in bilateral DLPFC* and rACC**. Paired-t tests comparing pre and post PoNS™ scans did not reveal any significant changes. 27 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM *dorsolateral prefrontal cortex (DLPFC) **rostral anterior cingulate cortex (rACC) Source: Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561

Exhibit 99.2

 

Helius Medical Technologies, Announces Authorization from Health Canada to Market the PoNS Device for the Treatment of Gait Deficit Due to Mild and Moderate Multiple Sclerosis (MS)

NEWTOWN, Pa. | March 24, 2020 - Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), today announced that its Canadian Class II license amendment application for the treatment of gait deficit in patients with mild and moderate symptoms from multiple sclerosis (“MS”) has received marketing authorization from Health Canada. Helius’ Portable Neuromodulation Stimulator (PoNS™) device is now authorized to be marketed for the short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy, in addition to the short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy.  

“We are very pleased to receive regulatory clearance to market our PoNS Treatment to the approximately 93,500 patients in Canada who suffer from MS,” said Philippe Deschamps, Chief Executive Officer of Helius. “Given the chronic and progressive nature of this potentially debilitating neurodegenerative disease, we feel that there is a strong clinical need for novel therapies such as our PoNS Treatment. We are proud to provide MS patients with a treatment option that has the potential to improve or restore their gait function, or in other words their ability to walk."

The PoNS treatment is available through authorized Treatment Centers throughout Canada.  For a list of the authorized treatment centers in Canada please visit www.ponstreatment.ca.  

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 amplify the brain’s ability to heal itself. The Company’s first product in development is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Treatment

The Portable Neuromodulation Stimulator (PoNS) is an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy and indicated as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.  The PoNS is an investigational medical device in the United States, the European Union, and Australia, and is currently under review for clearance by 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, 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.

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 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, 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.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.