Helius Medical Technologies, Inc. Comments on the Centers for Medicare & Medicaid Services’ Announcement Regarding New Medi...
January 20 2021 - 7:05AM
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.
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