Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke
August 17 2021 - 7:05AM
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 from the U.S. Food and Drug Administration (“FDA”) for
its PoNS™ device with the proposed indication for use as a
temporary treatment of dynamic gait and balance deficits due to
symptoms from stroke, to be used as an adjunct to a supervised
therapeutic exercise program in patients 22 years of age and over.
“We are very pleased to announce the receipt of
Breakthrough Designation for our PoNS device to treat
stroke-induced gait and balance deficits,” said Helius CEO, Dane
Andreeff. “Strokes are a large and growing cause of long-term
disability in the United States. An estimated 7 million Americans
are living with stroke-related complications, and more than 80% of
stroke survivors are estimated to develop gait impairment.1”
Mr. Andreeff continued: “Obtaining Breakthrough
Designation represents an important milestone in our path to
providing this underserved patient population with a non-drug,
non-implantable treatment option that has the potential to
significantly improve their gait and balance, their ability to walk
and perform daily tasks. We look forward to building on this
achievement by utilizing the Breakthrough Devices Program to
facilitate our pursuit of U.S. regulatory clearance for treatment
of stroke-induced symptoms in close collaboration with the
FDA.”
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 the FDA’s mission to protect and promote public
health.
The Breakthrough Devices Program offers
manufacturers such as Helius 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.
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
including 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 innovative non-surgical device, inclusive of a controller and
mouthpiece, which delivers electrical stimulation to the surface of
the tongue to provide treatment of gait deficit. 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. It 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 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 Australia (“AUS”) and is
currently under premarket review by the AUS Therapeutic Goods
Administration.
Investor Relations Contact:
Westwicke on behalf of Helius Medical Technologies, Inc.Jack
Powell, Vice Presidentinvestorrelations@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,”
“will,” “goal,” “aim to,” “look forward” and similar expressions.
Such forward-looking statements include, among others, statements
regarding the Company’s regulatory plans and pursuit of U.S.
regulatory clearance for treatment of stroke-related symptoms.
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 future clinical trials and the
clinical development process, the product development process and
FDA regulatory submission review and approval process, other
development activities, 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, manufacturing and supply chain risks, potential
changes to the MCIT program resulting from the 60-day deferral of
the program implementation, 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, 2020, its Quarterly Report on Form 10-Q for the
quarter ended June 30, 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.
The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this
news release.
1 Carmen M. Cirstea. Gait Rehabilitation After Stroke, Should we
re-evaluate our practice? Stroke 2020;51(10):2892-94.
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