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News Releases

NEWTOWN, Pa., June 05, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that management will participate in the Virtual Summer Summit, which is being held from June 9th-12th. Management will present on Tuesday, June 9th at 4:30 p.m. Eastern Time.

A live audio webcast of the presentation will be provided under the ‘Events’ section of the Helius Medical Technologies investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events. An archive of the webcast will be available for replay following the conference.

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 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 an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended 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 and indicated as a short term treatment (14 weeks) chronic balance deficit due to mild-to-moderate traumatic brain injury 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.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.

Mike Piccinino, CFA

investorrelations@heliusmedical.com


NEWTOWN, Pa., May 12, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation for its PoNS™ device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program.

“We are extremely pleased to receive this designation for our PoNS device,” said Philippe Deschamps, the Company’s CEO. “We look forward to working with FDA to process our application, with the ultimate goal of bringing our innovative technology to the aid of patients suffering with gait deficit due to MS-related symptoms, by providing them with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk.”

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with FDA’s mission to protect and promote public health.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.

It is important to note that Breakthrough Device Designation does not change the requirements for approval of an application for a marketing authorization under section 510(k) of the Food, Drug, and Cosmetic Act.

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 (PoNS™). 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 gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy and indicated as a short term treatment (14 weeks) chronic balance deficit due to mild-to-moderate traumatic brain injury 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 Form 10-Q for the quarter ended March 31, 2020 filed on May 11, 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.

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.

Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com

NEWTOWN, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported financial results for the quarter ended March 31, 2020.

First Quarter 2020 Financial Summary

  • Revenue of $0.2 million, compared to revenue of $0.7 million in first quarter of 2019.
    • Total revenue comprised of:
      • Product sales of $191 thousand, compared to product sales of $677 thousand in first quarter of 2019.
      • Fee and license revenue of $16 thousand, compared to no fee and license revenue in first quarter of 2019.
  • Operating loss of $4.0 million, compared to operating loss of $6.8 million in first quarter of 2019.
  • Net loss of $4.8 million, compared to net income of $1.3 million in first quarter of 2019.
  • As of March 31, 2020, the Company had cash of $4.4 million, compared to $5.5 million at December 31, 2019. The Company had no debt outstanding at March 31, 2020.
  • Net cash provided by financing activities during the three months ended March 31, 2020 was $2.7 million, which consisted of proceeds from the issuance of common stock in connection with the Company’s At The Market Offering Agreement (“ATM”) during the first quarter of 2020, and proceeds from the issuance of common stock and unregistered warrants in connection with Helius’ registered direct offering and concurrent private placement on March 20, 2020.

First Quarter and Recent Business Updates

  • On January 10, 2020, the Company announced that it received the Pioneer Technology Development Award for its development of the PoNS™ device.
  • On January 16, 2020, the Company announced that its fully owned subsidiary, Helius Medical Inc, entered into an agreement with the University Health Network to perform a clinical experience program to enable it, and three independent neurorehabilitation clinics in Canada, to evaluate Helius’ PoNS device, in conjunction with physical therapy, on patients with chronic balance deficit due to mmTBI in Canada.
  • On February 7, 2020, the Company announced the authorization of Clinic Medical Centre in Nanaimo, British Columbia, the eighth clinic to be authorized as a PoNS Treatment center in Canada.
  • On February 24, 2020, the Company announced that Helius CEO, Philippe Deschamps, had been invited to brief the U.S. Congress on the latest technologies, innovations and policies in clinical neuroscience at the 9th Annual Brain Mapping Foundation Congressional briefing at the U.S. Congress on February 25, 2020.
  • On March 2, 2020, the Company reported preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2019, provided an update on its commercial and regulatory activities and announced it has submitted a Canadian Class II license amendment application for the treatment of gait deficit in patients with mild and moderate Multiple Sclerosis.
  • On March 9, 2020, the Company provided details on five additional PoNS Treatment clinics that were recently authorized in the Greater Toronto Area and Southwestern Ontario.
  • On March 18, 2020, the Company entered into definitive agreements with healthcare focused institutional investors that provide for the purchase and sale of an aggregate of approximately 6.3 million shares of its Class A Common Stock and warrants, resulting in total gross proceeds of approximately $2.2 million.
  • On March 24, 2020, the Company 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”) was successful and that  Health Canada granted marketing authorization to the PoNS for the new MS indication.
  • On April 22, 2020, the Company announced the appointment of Jeffrey S. Mathiesen, CPA, to its Board of Directors, effective as of June 9, 2020. Upon his appointment, Mr. Mathiesen will serve as Chair of the Company’s Audit Committee.
  • On April 30, 2020, the Company announced that its registrational clinical trial, TBI-001, was published on April 29, 2020 in Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatment™ provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (“mmTBI”).

“We continued to make progress on our U.S. regulatory strategy during the first quarter of 2020, and while our pursuit of regulatory clearance for Multiple Sclerosis (“MS”) continued relatively unaffected by the COVID-19 pandemic, our regulatory activity may be adversely affected by Covid-19 going forward.” said Philippe Deschamps, Chief Executive Officer of Helius. “Based on the quality of the data included in our Health Canada application for an MS indication – including a statistically significant, peer-reviewed clinical trial and real-world treatment data from Canada – and the fact that more than 1 million patients suffer from MS in the U.S., we made the strategic decision to prioritize the MS indication as the pathway to pursue our first U.S. regulatory clearance. We are pleased with our pace of progress in pursuing our MS indication in the U.S., and continue to anticipate submitting a request for de novo classification for this indication in the second half of 2020. During the first quarter, we obtained marketing authorization from Health Canada in March for a new clinical indication to treat gait deficit in patients with mild and moderate symptoms from MS, significantly expanding our addressable patient population. Lastly, we finalized the design of new trial, TBI-002, to support our U.S. submission for an indication to treat chronic balance deficit due to mmTBI.  COVID-19 has temporarily halted clinical trial activity across the U.S. and Canada, we have thus put this project on hold for the foreseeable future until the clinical trial environment and financial conditions allow us to reengage this project.  

Mr. Deschamps continued: “During the first quarter, we also made important progress with respect our commercial strategy in Canada. We expanded our network of authorized clinics to a total of fourteen clinic locations and generated revenue of $0.2 million from sales of our PoNS device. While our performance during the first two months of 2020 was consistent with expectations, our business trends slowed materially in the last two weeks of March as a result of the disruption caused by the COVID-19 pandemic. Specifically, our authorized clinics in Canada suspended in-patient treatments and announced temporary closures in order to adhere to enacted mandates from the government in an effort to slow the spread of the virus. In response to COVID-19, we quickly implemented health and safety measures to protect our employees and enable them to operate remotely. We are closely monitoring the activities of the PoNS authorized clinics in Canada and continue to support their staff and patients during this difficult time.”

Mr. Deschamps continued: “Given the uncertainty surrounding the duration and impact of the COVID-19 pandemic on our financial and operating performance, we are withdrawing our full year 2020 outlook at this time. However, our team is executing efficiently to help mitigate the impact of this pandemic on our business and to continue pursuing the commercial and regulatory priorities we have outlined for this year. We are engaging virtually with new clinics, key opinion leaders and industry associations to raise awareness of our PoNS Treatment and our new clinical indication in MS. Most importantly, we remain confident in the potential of our PoNS technology and committed to expanding its access as effectively and efficiently as possible for the benefit of our patients and shareholders.”

First Quarter 2020 Financial Results

Total revenue for the first quarter of 2020 was $0.2 million, compared to $0.7 million in the first quarter of 2019. Product sales represented 92% of total revenue in the first quarter of 2020 compared to 100% of total revenue in the first quarter of 2019. Product sales in the first quarter of 2020 was generated through sales of the PoNS device pursuant to supply agreements with 14 neuroplasticity clinics in Canada. License and fee revenue represented 8% of total revenue in the first quarter of 2020, compared to 0% of total revenue in the first quarter of 2019.

Gross profit for the first quarter of 2020 was $0.1 million, compared to gross profit of $0.4 million in the first quarter of 2019. Operating expenses for the first quarter of 2020 decreased $3.2 million, or 43% year-over-year, to $4.1 million, compared to $7.3 million in the first quarter of 2019.

Operating loss for the first quarter of 2020 decreased $2.8 million, or 41%, to $4.0 million, compared to $6.8 million in the first quarter of 2019.

Total other expense for the first quarter of 2020 was $0.8 million, compared to $8.1 million of other income in the first quarter of 2019.  

Net loss for the first quarter of 2020 was $4.8 million, or $(0.15) per basic and diluted common share, compared to net income of $1.3 million, or $0.05 per basic common share and $(0.06) per diluted common share, in the first quarter of 2019. Weighted average shares used to compute basic net loss per common share were 31.0 million and 25.8 million for the first quarters of 2020 and 2019, respectively. Weighted average shares used to compute diluted net loss per common share were 31.0 million and 26.8 million for the first quarters of 2020 and 2019, respectively. 

Full Year 2020 Outlook

The Company is currently unable to estimate the duration and impact of the COVID-19 pandemic on its financial and operating results for the full year 2020. As a result, the Company is withdrawing its previously announced full year 2020 outlook, which was introduced on March 12, 2020.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on May 7, 2020 to discuss the results of the quarter and business outlook. Those who would like to participate may dial 877-407-2988 (201-389-0923 for international callers) and provide access code 13701495. A live webcast of the call will also be provided on the Events section of the Company's investor relations website at:

https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

For those unable to participate, a replay of the call will be available for two weeks at 877-660-6853 (201-612-7415 for international callers); access code 13698861. The webcast will be archived on the Events section of the Company’s investor relations website.

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 (PoNS™). 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 is 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 COVID-19 pandemic, including its impact on the Company, 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 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 the planned study, 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 years ended December 31, 2019 and December 31, 2018, its Quarterly Report on Form 10-Q for the quarter ended March 31, 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.

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.

Helius Medical Technologies, Inc.
Unaudited Consolidated Balance Sheets
(Except for share data, amounts in thousands)

  March 31, 2020  December 31, 2019 
ASSETS        
Current assets        
Cash $4,360  $5,459 
Accounts receivable, net  110   210 
Other receivables  124   364 
Inventory, net of reserve  594   598 
Prepaid expenses  687   610 
Total current assets  5,875   7,241 
Property and equipment, net  678   712 
Other assets        
Goodwill  686   1,242 
Intangible assets, net  687   582 
Operating lease right-of-use asset, net  517   552 
Other assets  18   18 
Total other assets  1,908   2,394 
TOTAL ASSETS $8,461  $10,347 
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities        
Accounts payable $1,111  $1,676 
Accrued liabilities  1,005   1,519 
Operating lease liability  180   172 
Derivative financial instruments     5 
Deferred revenue  321   430 
Total current liabilities  2,617   3,802 
Non-current liabilities        
Operating lease liability  417   465 
Deferred revenue  218   245 
TOTAL LIABILITIES  3,252   4,512 
Commitments and contingencies (Note 6)        
STOCKHOLDERS’ EQUITY        
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of March 31, 2020 and December 31, 2019      
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 38,041,666 and 30,718,554 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively  38   31 
Additional paid-in capital  114,967   111,479 
Accumulated other comprehensive loss  (266)  (902)
Accumulated deficit  (109,530)  (104,773)
TOTAL STOCKHOLDERS’ EQUITY  5,209   5,835 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $8,461  $10,347 
         

Helius Medical Technologies, Inc.
Unaudited Consolidated Statements of Operations and Comprehensive (Loss) Income
(Amounts in thousands except share and per share data)

  Three Months Ended 
  March 31, 
  2020  2019 
Revenue:        
Product sales, net $191  $677 
Fee revenue  9    
License revenue  7    
Total operating revenue  207   677 
Cost of sales:        
Cost of product sales  101   236 
Gross profit  106   441 
Operating expenses:        
Research and development  1,120   2,681 
Selling, general and administrative  2,862   4,581 
Amortization expense  126    
Total operating expenses  4,108   7,262 
Operating loss  (4,002)  (6,821)
Other income (expense):        
Other (expense) income  6   11 
Change in fair value of derivative financial instruments  4   8,289 
Foreign exchange gain (loss)  (765)  (155)
Total other (expense) income  (755)  8,145 
Net (loss) income  (4,757)  1,324 
Other comprehensive (loss) income:        
Foreign currency translation adjustments  636   (112)
Comprehensive (loss) income $(4,121) $1,212 
Net (loss) income per share        
Basic $(0.15) $0.05 
Diluted $(0.15) $(0.06)
Weighted average shares outstanding        
Basic  30,972,064   25,832,190 
Diluted  30,972,064   26,785,708 
         


Helius Medical Technologies, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(Amounts in thousands)

    
  March 31, 
  2020  2019 
Cash flows from operating activities:        
Net (loss) income $(4,757) $1,324 
Adjustments to reconcile net loss to net cash used in operating activities:        
Change in fair value of derivative financial instruments  (4)  (8,289)
Stock-based compensation expense  842   835 
Unrealized foreign exchange (gain) loss  738   176 
Depreciation expense  37   22 
Amortization expense  126    
Provision for doubtful accounts  139    
Intangible asset impairment  174    
Changes in operating assets and liabilities:        
Accounts receivable  (39)  (740)
Other receivables  240   (84)
Inventory  4   (339)
Prepaid expenses  (77)  95 
Other current assets     264 
Operating lease liability  (5)  (3)
Accounts payable  (626)  83 
Accrued liabilities  (459)  (144)
Deferred revenue  (84)   
Net cash used in operating activities  (3,751)  (6,800)
Cash flows from investing activities:        
Purchase of property and equipment  (3)  (161)
Internally developed software  (7)   
Net cash used in investing activities  (10)  (161)
Cash flows from financing activities:        
Proceeds from the issuances of common stock and warrants  2,992    
Share issuance costs  (340)  (52)
Proceeds from the exercise of stock options and warrants     92 
Net cash provided by financing activities  2,652   40 
Effect of foreign exchange rate changes on cash  10   (6)
Net (decrease) increase in cash  (1,099)  (6,927)
Cash at beginning of period  5,459   25,583 
Cash at end of period $4,360  $18,656 
         
CONTACT: Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
investorrelations@heliusmedical.com 

122 Subject, Multicenter, Double-Blind, Randomized, Clinical Trial Finds PoNS Treatment™ Provides Significant Improvement in Balance and Gait Deficits for Individuals Who Have Experienced a Mild-to-Moderate Traumatic Brain Injury

NEWTOWN, Pa., April 30, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its registrational clinical trial, TBI-001, was published on April 29, 2020 in Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatment™ provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (“mmTBI”).

This newly-published, 122 subject, multicenter, double-blind randomized clinical trial, found that the PoNS Treatment, which pairs translingual neurostimulation using the Portable Neuromodulation Stimulator (PoNS™) device with therapeutic activities, significantly improves balance and gait. Conducted by researchers at 7 clinical sites across the US and Canada, this trial, which was completed in 2017, is the second double-blind, randomized clinical trial to demonstrate the level of balance improvement  PoNS Treatment provides to patients suffering from chronic balance deficit as a result of a mild-to-moderate traumatic brain injury. For more information on the TBI-001 trial and its results, see the published journal article.

“Whether traumatic brain injuries are mild, moderate or severe, the devastating effects can last a lifetime,” said Philippe Deschamps, Chief Executive Officer of Helius Medical Technologies. “We are excited to announce the publication of this 122 subject, multicenter, double-blind, randomized, clinical trial in a peer-reviewed journal and believe that it provides important clinical support for the PoNS Treatment as new, novel, valuable treatment  option for patients suffering from the effects of mmTBI.”

The PoNS Treatment involves the use of the PoNS device in conjunction with therapeutic activities. The PoNS device sits on the surface of a patient’s tongue and delivers mild, gentle electrical impulses to the surface of the tongue. These impulses excite the neural network flowing to the brain. This neural activity, combined with therapeutic activities, is believed to enable “neuroplasticity” which may restore lost function. 

The TBI-001 trial evaluated subjects who had experienced a mild-to-moderate traumatic brain injury at least one year prior to receiving the PoNS Treatment and had reached a plateau in recovery (according to their healthcare providers) with physical therapy alone. Subjects used the PoNS device for 5 weeks in conjunction with therapeutic activities. At the end of the 5-week treatment program, patients demonstrated improved balance and gait. Researchers found that 67.2 percent of the pooled patient population who completed 5 weeks of PoNS Treatment experienced a clinically and statistically significant improvement in balance, as indicated in their mean SOT (Sensory Organizational Test) scores at 2 weeks and 5 weeks compared to baseline. Mean DGI (Dynamic Gait Index) scores were significantly increased from baseline at weeks 2 and 5.

Exploratory endpoints, such as the headache disability index, sleep quality index and quality of life measure index were also observed as part of the trial. While further analysis and research is needed, there was an indication of improvements in these exploratory endpoints. Demonstrated improvements in balance and gait, coupled with potential improvements in the exploratory endpoints, may allow treated individuals to experience improved quality of life.

Mr. Deschamps continued: “We are very encouraged by the results of the clinical trial. As a result of their improvements in balance and gait, many of our patients reported being able to perform independent self-care tasks, like dressing and showering, that were once beyond their reach prior to receiving PoNS Treatment.”

Katherine Webb, a patient enrolled in the study described her experience during the study. “It had been 4 and a half years since my injury when I first started the study. For those 4 and a half years, I had not been able to put one foot in tandem in front of the other and walk with my feet in a row without tipping or falling over due to loss of balance. It was early February of 2017, and with the device in my mouth, I walked the line. The Physiotherapist FaceTimed my husband and daughter who were flooded with tears as they watched. As a result of my improved balance throughout the study I experienced many more firsts since my TBI, like washing my hair without having to balance against the shower walls for stability,” said Katherine Webb.

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 a 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.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com

122 Subject, Multicenter, Double-Blind, Randomized, Clinical Trial Finds PoNS Treatment™ found Significant Improvement in Balance and Gait Deficits for Individuals Who Have Experienced a Mild-to-Moderate Traumatic Brain Injury

NEWTOWN, Pa., April 30, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its registrational clinical trial, TBI-001, was published on April 29, 2020 in Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatment™ provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (“mmTBI”).

This newly-published, 122 subject, multicenter, double-blind randomized clinical trial, found that the PoNS Treatment, which pairs translingual neurostimulation using the Portable Neuromodulation Stimulator (PoNS™) device with therapeutic activities, significantly improves balance and gait. Conducted by researchers at 7 clinical sites across the US and Canada, this trial, which was completed in 2017, is the second double-blind, randomized clinical trial to demonstrate the level of balance improvement  PoNS Treatment provides to patients suffering from chronic balance deficit as a result of a mild-to-moderate traumatic brain injury. For more information on the TBI-001 trial and its results, see the published journal article.

“Whether traumatic brain injuries are mild, moderate or severe, the devastating effects can last a lifetime,” said Philippe Deschamps, Chief Executive Officer of Helius Medical Technologies. “We are excited to announce the publication of this 122 subject, multicenter, double-blind, randomized, clinical trial in a peer-reviewed journal and believe that it provides important clinical support for the PoNS Treatment as new, novel, valuable treatment  option for patients suffering from the effects of mmTBI.”

The PoNS Treatment involves the use of the PoNS device in conjunction with therapeutic activities. The PoNS device sits on the surface of a patient’s tongue and delivers mild, gentle electrical impulses to the surface of the tongue. These impulses excite the neural network flowing to the brain. This neural activity, combined with therapeutic activities, is believed to enable “neuroplasticity” which may restore lost function. 

The TBI-001 trial evaluated subjects who had experienced a mild-to-moderate traumatic brain injury at least one year prior to receiving the PoNS Treatment and had reached a plateau in recovery (according to their healthcare providers) with physical therapy alone. Subjects used the PoNS device for 5 weeks in conjunction with therapeutic activities. At the end of the 5-week treatment program, patients demonstrated improved balance and gait. Researchers found that 67.2 percent of the pooled patient population who completed 5 weeks of PoNS Treatment experienced a clinically and statistically significant improvement in balance, as indicated in their mean SOT (Sensory Organizational Test) scores at 2 weeks and 5 weeks compared to baseline. Mean DGI (Dynamic Gait Index) scores were significantly increased from baseline at weeks 2 and 5.

Exploratory endpoints, such as the headache disability index, sleep quality index and quality of life measure index were also observed as part of the trial. While further analysis and research is needed, there was an indication of improvements in these exploratory endpoints. Demonstrated improvements in balance and gait, coupled with potential improvements in the exploratory endpoints, may allow treated individuals to experience improved quality of life.

Mr. Deschamps continued: “We are very encouraged by the results of the clinical trial. As a result of their improvements in balance and gait, many of our patients reported being able to perform independent self-care tasks, like dressing and showering, that were once beyond their reach prior to receiving PoNS Treatment.”

Katherine Webb, a patient enrolled in the study described her experience during the study. “It had been 4 and a half years since my injury when I first started the study. For those 4 and a half years, I had not been able to put one foot in tandem in front of the other and walk with my feet in a row without tipping or falling over due to loss of balance. It was early February of 2017, and with the device in my mouth, I walked the line. The Physiotherapist FaceTimed my husband and daughter who were flooded with tears as they watched. As a result of my improved balance throughout the study I experienced many more firsts since my TBI, like washing my hair without having to balance against the shower walls for stability,” said Katherine Webb.

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 a 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.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com