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News Releases

-- Total Q3 revenue up 80% over prior year --
-- Cash on hand expected to fund operations through 2023 --
-- Company to host call at 8:30am today --

NEWTOWN, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported financial results for the quarter ended September 30, 2022.

Third Quarter and Recent Business Updates

  • First full quarter of commercial availability of PoNS® in the U.S.
  • Introduced online, on-demand training module to standardize and streamline the training of physical therapists who wish to use PoNS Therapy to treat patients suffering gait impairment due to multiple sclerosis (MS).
  • Added MGH Institute of Health Professions (“Mass General”) and Oregon Health & Science University (“OHSU”) as Therapeutic Experience Program (TEP) centers of excellence joining Shepard Center in Atlanta and NYU Langone, who are already enrolling patients.
  • Closed an $18 million public offering, raising net proceeds of approximately $16.3 million.
  • Q3 2022 revenue increased by 80% to $196 thousand compared to $109 thousand in Q3 2021, and by 65% compared to Q2 2022.
  • $16.7 million of cash on hand to fund operations through 2023.

“It was the first full quarter of commercial sales and the market response to PoNS Therapy remains strong, as demonstrated by the quarter over quarter increase in US sales. The Patient Therapy Access Program we introduced in June has been well received, and a significant percentage of patients have used PTAP to access on-label PoNS Therapy at a reduced price. We also addressed another major impediment to access with our online training module which has allowed us to greatly accelerate the training of physical therapists. In the US, we have gone from less than half a dozen to close to 100 PTs trained over the past three months, with the large majority occurring since we kicked off the program. Because physical therapists can now receive PoNS Therapy training on-demand in three hours or less, instead of through an in-person, multi-day course, patients can have readily available access to PoNS trained therapists,” said Dane Andreeff, President and Chief Executive Officer of Helius.

“We also made progress with TEP, an important program that will help us gather information about the effectiveness of PoNS Therapy in a real-world environment. During the quarter, we began enrollment at the previously announced TEP locations and, more recently, added Mass General and OHSU as Centers of Excellence. We are energized by all the Company has accomplished in 2022 so far and, fortified by our recent equity raise, look forward to continuing the momentum into next year and beyond, bringing relief to as many patients as possible who suffer from gait impairment,” concluded Mr. Andreeff.

Third Quarter 2022 Financial Results

Total revenue for the third quarter of 2022 was $196 thousand, an increase of 80% compared to $109 thousand in the third quarter of 2021 and was comprised primarily of product sales in both periods. Product sales in the U.S. during the third quarter totaling $139 thousand more than doubled over the second quarter 2022 levels.

For the three months ended September 30, 2022, cost of sales was $101 thousand as compared to $86 thousand for the three months ended September 30, 2021. The increase was primarily attributable to overhead costs, including salaries and benefits of employees involved in management of the supply chain and, to a lesser extent, higher product sales in the current period. Gross profit for the third quarter of 2022 was $95 thousand, compared to gross profit of $23 thousand in the third quarter of 2021.

Operating expenses for the third quarter of 2022 increased to $4.9 million, compared to $4.4 million in the third quarter of 2021. The increase was primarily due to a net increase in stock-based compensation expense, including $1.2 million attributable to performance-based options that vested during current year quarter, partially offset by lower research and development costs following the U.S. commercial launch.

Operating loss for the third quarter of 2022 increased $0.5 million to a loss of $4.9 million, compared to an operating loss of $4.4 million in the third quarter of 2021.

Net loss was $1.0 million for the third quarter of 2022, compared to a net loss of $4.7 million, in the corresponding prior year period. The basic and diluted net loss per share for the third quarter 2022 was $0.12, compared to net loss per share of $2.01 in the third quarter 2021.

As of September 30, 2022, the Company had cash of $16.7 million, compared to $11.0 million at December 31, 2021. The Company had no debt outstanding at September 30, 2022.

Fourth Quarter and Near-Term Guidance

The Company currently expects fourth quarter revenue to be modestly above the third quarter levels, factoring in the timing required to pair patients with trained physical therapists. In addition, as we near the end of the fourth quarter, we may experience some patients delaying PoNS treatment until after the holidays, which could temper sales growth as we expand our U.S. market penetration. As we continue to build momentum and expand our sales coverage, the Company expects future quarterly revenue to continue increasing sequentially quarter over quarter throughout 2023 as the U.S. commercialization of PoNS develops.

Conference Call

As previously announced, management will host a conference call as follows:

Date:Monday, November 14, 2022
Time:8:30 AM ET
Register* (Audio Only):Click Here
Webcast:https://edge.media-server.com/mmc/p/k92nxahw

The webcast will be archived under the Newsroom section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promote neuroplasticity, improving the lives of people dealing with neurologic diseases.

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 Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy. For more information visit www.ponstherapy.com.

PoNS is also authorized for sale in Canada for two indications: (i) for use 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; and (ii) 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. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

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,” “expect,” “will,” “goal,” “aim to” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, including commercial activities for the PoNS device, projected revenue from sales of our products, progress of commercialization of the PoNS device in the U.S., the ability and timing of our customers’ ability to seek reimbursement for the PoNS device in the U.S., expectations for the Therapeutic Experience Program, clinical development plans, and product development activities.

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 uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the ability to find additional sources of funding, the impact of the COVID-19 pandemic, manufacturing, labor shortage and supply chain risks, the Company’s ability to train physical therapists in the supervision of the use of the PoNS treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, ongoing government regulation and other factors, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022 and June 30, 2022 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.

Investor Relations Contact:

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com


Helius Medical Technologies, Inc.

Unaudited Condensed Consolidated Statements of Operations
(Amounts in thousands except shares and per share data)

             
  Three Months Ended  Nine Months Ended
  September 30,  September 30, 
  2022  2021  2022  2021 
Revenue            
Product sales, net $195  $102  $497  $242 
Other revenue  1   7   8   22 
Total revenue  196   109   505   264 
Cost of revenue  101   86   313   169 
Gross profit  95   23   192   95 
Operating expenses            
Selling, general and administrative  3,393   2,859   8,673   9,800 
Research and development  751   1,489   3,468   4,182 
Amortization expense  47   48   141   153 
Goodwill impairment  757      757    
Total operating expenses  4,948   4,396   13,039   14,135 
Loss from operations  (4,853)  (4,373)  (12,847)  (14,040)
Nonoperating income (expense)            
Interest expense, net  (919)     (919)   
Change in fair value of derivative liability  5,489      5,489    
Foreign exchange (loss) gain  (747)  (314)  (910)  10 
Other income, net        1    
Nonoperating income (expense), net  3,823   (314)  3,661   10 
Loss before provision for income taxes  (1,030)  (4,687)  (9,186)  (14,030)
Provision for income taxes            
Net loss $(1,030) $(4,687) $(9,186) $(14,030)
Net loss per share            
Basic $(0.12) $(2.01) $(0.52) $(6.29)
Diluted $(0.12) $(2.01) $(0.52) $(6.29)
Weighted average number of common shares outstanding            
Basic  8,543,303   2,326,893   17,761,752   2,229,422 
Diluted  8,543,303   2,326,893   17,761,752   2,229,422 


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

       
  September 30, 2022 December 31, 2021
ASSETS      
Current assets      
Cash $16,658  $11,005 
Accounts receivable, net  21   66 
Other receivables  196   185 
Inventory, net  609   476 
Prepaid expenses and other current assets  733   862 
Total current assets  18,217   12,594 
Property and equipment, net  348   409 
Goodwill     763 
Intangible assets, net  178   333 
Operating lease right-of-use asset, net  116   3 
Total assets $18,859  $14,102 
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities      
Accounts payable $570  $1,069 
Accrued liabilities  551   1,433 
Operating lease liabilities  53   3 
Deferred revenue  26   148 
Total current liabilities  1,200   2,653 
Operating lease liabilities  70    
Deferred revenue  173   193 
Derivative liability  4,455    
Total liabilities  5,898   2,846 
STOCKHOLDERS’ EQUITY      
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 28,201,282 and
3,780,674 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
  28   4 
Additional paid-in capital  159,386   149,412 
Accumulated deficit  (146,221)  (137,035)
Accumulated other comprehensive loss  (232)  (1,125)
Total stockholders' equity  12,961   11,256 
Total liabilities and stockholders' equity $18,859  $14,102 

-- Fourth Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate impact of subjects’ adherence to PoNS® therapy for gait improvement in Multiple Sclerosis --

NEWTOWN, Pa., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the participation of Prue Plummer PhD, PT, Professor in the Department of Physical Therapy in the School of Health and Rehabilitation Sciences at the MGH Institute of Health Professions to its Therapeutic Experience Program (“TEP”). The MGH Institute of Health Professionals joins NYU Langone Health, the Shepherd Center, and Oregon Health & Science University as the fourth Center of Excellence in this company-sponsored open-label observational trial designed to evaluate the impact of subjects’ adherence to Portable Neuromodulation Stimulator (PoNS) therapy in patients with multiple sclerosis (“MS”).

“We are thrilled to have Dr. Plummer and the MGH Institute of Health Professions, one of the country’s preeminent health and rehabilitation institutions, as one of our Centers of Excellence for TEP,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. “The purpose of our Therapeutic Experience Program is to gain insight about the functional outcome of PoNS therapy used with MS by treating patients in a real-world environment. The TEP study will provide information about PoNS therapy to key opinion leaders in MS management, providing an opportunity for early adopters of the technology. We are enthusiastic about Dr. Plummer’s participation in the study and her contribution to bringing new therapeutic options to MS patients.”

“At our School of Health and Rehabilitation Sciences center, we are keenly interested in the ways injuries to the brain can affect a person’s ability to walk, and how neurological rehabilitation can help improve gait recovery,” said Dr. Prue Plummer, Professor of Physical Therapy at MGH Institute of Health Professions. “The majority of patients with MS develop progressive gait impairment, which can worsen over a lifetime, and participation in TEP is an important step in evaluating how PoNS therapy can improve gait function and potentially address this treatment gap.”

About MGH Institute of Health Professions

MGH Institute of Health Professions, a member of Mass General Brigham, was founded in 1977 by the Massachusetts General Hospital and counts more than 10,000 alumni. Celebrating our 45th year, we educate the next generation of health care leaders with a focus on quality, equal access, and utilizing inclusiveness in delivering healthcare. The MGH Institute’s mission - more critical than ever given the complexity of today’s healthcare systems – is carried out through academic programs in three schools: School of Nursing, School of Health and Rehabilitation Sciences, and School of Healthcare Leadership, with many programs top-ranked by U.S. News & World Report.

About the Therapeutic Experience Program

The Therapeutic Experience Program (“TEP”) is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis (“MS”) in a real-world clinical setting. The study will rate subjects’ adherence to PoNS therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome. The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.

The study will be conducted at ten to twelve Centers of Excellence across the United States, with an estimated four PoNS devices per site. Enrollment is expected to begin in the fourth quarter of 2022 and continue into 2023. A total of fifty to sixty patients with MS are expected to take part in the program.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. 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 Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy. For more information visit www.ponstherapy.com to learn more.

PoNS is also authorized for sale in Canada for two indications: (i) for use 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; and (ii) 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. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

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,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding expected enrollment, patient participation and other details of the TEP study and the ability of key opinion leaders in the management of MS to build their knowledge of PoNS® therapy and advise the broader medical community.

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 uncertainties associated with the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, 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.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com


-- Third Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS® therapy for gait improvement in Multiple Sclerosis --

NEWTOWN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the addition of Oregon Health & Science University (“OHSU”) to its Therapeutic Experience Program (TEP). This initiative will be led by Vijayshree Yadav, MD, MCR, FANA, FAAN, Professor of Neurology and OHSU Multiple Sclerosis Center Director. OHSU joins several other Centers of Excellence in this company-sponsored open-label observational trial designed to evaluate the impact of subjects’ adherence to Portable Neuromodulation Stimulator (PoNS) therapy in patients with multiple sclerosis (MS).

“The OHSU Multiple Sclerosis Center is one of the top programs in the country for the treatment and care of MS and we’re thrilled about the Center’s participation to our TEP. Dr. Yadav and her team are at the forefront of research in understanding and treating MS, and their involvement will go a long way in helping us understand the relationship between adherence to PoNS therapy and a meaningful therapeutic outcome,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer.

“With the availability of new technologies and therapies, it’s an exciting time in the research and treatment of MS. Studies have shown that the brain can make new connections after injury and rehabilitation can reduce functional disability, increasing a patient’s independence. A significant portion of MS patients suffer from gait deficit and PoNS therapy provides a unique opportunity to improve gait functionality and mobility. We’re excited to partner with Helius on this important initiative,” said Dr. Yadav.

About Oregon Health & Science University

Oregon Health & Science University is Oregon's only academic health center and distinguished nationally as a research university dedicated solely to advancing health sciences. OHSU focuses on discoveries to prevent and cure diseases, on education that prepares the health care and health science professionals of the future, and on patient care that incorporates the latest advances.

About the Therapeutic Experience Program

The Therapeutic Experience Program (“TEP”) is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis (“MS”) in a real-world clinical setting. The study will rate subjects’ adherence to PoNS therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome. The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.

The study will be conducted at ten to twelve Centers of Excellence across the United States, with an estimated four PoNS devices per site. Enrollment is expected to begin in the fourth quarter of 2022 and continue into 2023. A total of fifty to sixty patients with MS are expected to take part in the progra

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. 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 Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy. For more information visit www.ponstherapy.com to learn more.

PoNS is also authorized for sale in Canada for two indications: (i) for use 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; and (ii) 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. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gai

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,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding expected enrollment, patient participation and other details of the TEP study and the ability of key opinion leaders in the management of MS to build their knowledge of PoNS® therapy and advise the broader medical community.

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 uncertainties associated with the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, 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.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com


Physical Therapists Who Visit Booth 512 Can Sign Up for Free Online PoNS Therapy™ Training

NEWTOWN, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies (NASDAQ: HSDT) will showcase its innovative new Portable Neuromodulation Stimulator (PoNS®) at the 99th annual American Congress of Rehabilitation Medicine (ACRM) Conference, held November 8-11 in Chicago. Visitors to booth 512 will see the device and learn more about how it can improve gait deficiency in people with multiple sclerosis (MS).

PoNS works by delivering electrical impulses through nerve fibers on the tongue, stimulating the flow of millions of neural impulses to the brain structures that control gait. This creates a cascade of activity in the brain that – when combined with an exercise regimen supervised by a physical therapist – produces a neuromodulatory and neuroplastic effect that can have a significant impact on the independence and personal productivity of people with MS. (Results of this study can be found at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4017705/)

“The ACRM is committed to helping people live their fullest lives by improving, expanding and regaining mobility, and we’re excited to exhibit at the Conference because we share the same goals,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. “PoNS addresses a complication that’s very top-of-mind for people with MS: 70% of them report having difficulty walking, and of that group 70% identify gait deficit as the most challenging aspect of their disease.”

In addition to seeing the PoNS device in person, booth visitors can speak with key Helius team members, who can answer questions about PoNS and the accompanying PoNS Therapy regimen that maximizes its effectiveness. Physical therapists also will be able to sign up for free, online PoNS Therapy training.

“Rehabilitation professionals who work with people with MS, or are interested in the relationship between neuromodulation and gait, are invited to visit us at booth 512,” said Favit-Van Pelt. “But this is more than just a chance to see the device and talk, it’s an opportunity to take action: By signing up for training physical therapists are making themselves even more invaluable to their patients with MS.”

About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. 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 Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy. For more information visit www.ponstherapy.com.


NEWTOWN, Pa., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company will release its third quarter 2022 financial results on Monday, November 14, 2022, before the market opens.

Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer will host a conference call to discuss the results and provide an expanded business update regarding Helius’ progress and plans surrounding the U.S. commercialization of PoNS® as follows:

Date:Monday, November 14, 2022
  
Time:8:30 a.m. Eastern Time
  
Register* (Audio Only):Click Here
  
Webcast:https://edge.media-server.com/mmc/p/k92nxahw

The webcast will be archived under the Newsroom section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. 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 Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy. For more information visit www.ponstherapy.com to learn more.

Investor Relations Contact:

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com