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Helius Medical Technologies, Inc. (HSDT)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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15.97-0.33 (-2.02%)
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Neutralpattern detected
Previous Close16.30
Open16.35
Bid15.63 x 900
Ask16.48 x 800
Day's Range15.89 - 16.38
52 Week Range8.72 - 44.80
Volume19,075
Avg. Volume66,965
Market Cap23.841M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateNov 12, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est2.12
  • GlobeNewswire

    Helius Medical Technologies, Inc. Comments on the Centers for Medicare & Medicaid Services’ Announcement Regarding New Medicare Coverage Pathway for Breakthrough Medical Devices

    NEWTOWN, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare & Medicaid Services (“CMS”) on Tuesday, January 12, 2021. In the press release, CMS stated that it is finalizing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology, or “MCIT,” for Food and Drug Administration (“FDA”)-designated breakthrough medical devices. The MCIT rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and coverage would last for four years. Manufacturers will be able to opt-in to MCIT and choose a start date for coverage anytime within two years from the date of FDA market authorization. To be eligible for coverage through MCIT, the breakthrough device must be used for the FDA approved or cleared indication(s) for use. The press release can be accessed via the following link: https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f. “Helius is very pleased by CMS’ commitment to providing Medicare beneficiaries nation-wide with expedited access to new, FDA-designated breakthrough devices, like our PoNS device,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “If our request for de novo classification and clearance of the PoNS device is granted by the FDA, the new MCIT rule provides the opportunity to potentially obtain immediate, nation-wide Medicare coverage for four years following its commercial launch. We look forward to working with CMS to obtain more information and express our interest in MCIT, with the goal of providing the approximately 60 million Americans enrolled in Medicare with improved access to the PoNS device.” 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 (PoNSTM). For more information, visit www.heliusmedical.com. About the PoNS™ Device and PoNS Treatment™ The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ 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.Jack Powellinvestorrelations@heliusmedical.com 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,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the implementation of the new MCIT rule, the ability of the Company’s PoNS device to be covered by Medicare, the Company’s future growth and operational progress, clinical and regulatory development plans for the PoNS device, and potential regulatory clearance of the PoNS device, including expected timing for the FDA to resume its review of our request for de novo classification and clearance and expected timing for receipt of the FDA’s decision on such request. These statements involve substantial known and unknown risks and uncertainties. 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 MCIT rule, and the timing on when national Medicare coverage will be provided, whether such coverage would last for four years, whether the Company will be able to opt-in to such coverage, clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, uncertainties associated with future clinical trials and other development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.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.

  • GlobeNewswire

    Helius Medical Technologies, Inc. Regains Compliance with Nasdaq Listing Standards

    The Company’s Stock Will Continue to be Listed and Traded on The Nasdaq Stock Market NEWTOWN, Pa., Jan. 19, 2021 (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 received written notice from The Nasdaq Stock Market LLC that the Company’s minimum bid price deficiency has been cured, and that the Company is in compliance with all applicable listing standards. Accordingly, the scheduled hearing before the Hearings Panel to appeal the previous determination of non-compliance has been cancelled, and shares of the Company’s Class A common stock will continue to be listed and trade on The Nasdaq Capital Market under the ticker “HSDT.” 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 (PoNSTM). For more information, visit www.heliusmedical.com. About the PoNS™ Device and PoNS Treatment™ The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ 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.Jack Powellinvestorrelations@heliusmedical.com 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,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s ability to remain listed on The Nasdaq Capital Market, the Company’s regulatory development plans for the PoNS device, and potential regulatory clearance of the PoNS device, including expected timing for the FDA to resume its review of our request for de novo classification and clearance and expected timing for receipt of the FDA’s decision on such request. These statements involve substantial known and unknown risks and uncertainties. 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 ability to meet the continued listing requirements of The Nasdaq Capital Market, clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, uncertainties associated with future clinical trials and other development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.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. to Present at the Noble Capital Markets 17th Annual Small & Microcap Investor Conference
    GlobeNewswire

    Helius Medical Technologies, Inc. to Present at the Noble Capital Markets 17th Annual Small & Microcap Investor Conference

    NEWTOWN, Pa., Jan. 15, 2021 (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 Noble Capital Markets 17th Annual Small & Microcap Investor Conference, which is being held virtually from January 19th-20th. Management will present on Tuesday, January 19th at 11:15 a.m. Eastern Time. A live audio webcast of the conference presentation will be available on the Noble conference website following free registration: https://www.nobleconference.com/register/investor-guest. An archive of the webcast will be available following the conference under the ‘Events’ section of the Helius Medical Technologies investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events. 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 authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia. Investor Relations Contact: Westwicke on behalf of Helius Medical Technologies, Inc.Jack Powellinvestorrelations@heliusmedical.com