Helius Medical Technologies, Inc. Announces Launch of Patient Therapy Access Program for PoNS®
June 01 2022 - 7:05AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the
“Company”), a neurotech company focused on neurological wellness,
today announced the launch of its Patient Therapy Access Program
(“PTAP”), which will provide qualifying patients access to on-label
Portable Neuromodulation Stimulator (“PoNS”) Therapy at a
significantly reduced price. PoNS is indicated in the U.S. for use
as a short-term treatment of gait deficit in adults with
mild-to-moderate symptoms from multiple sclerosis (“MS”) and is
available by prescription only.
“In April, we announced that the first patients
in the United States had purchased the PoNS device on a cash pay
basis and begun treatment. We are also offering an opportunity for
MS patients to be treated with PoNS Therapy™ through our previously
announced Therapeutic Experience Program (“TEP”), gathering
important clinical evidence in a real-world environment while we
pursue reimbursement from third-party payers and CMS. Our goal is
to bring treatment to as many qualifying patients as possible and
we are proud to introduce our Patient Therapy Access Program for
potential first-time users,” stated Dane Andreeff, President and
Chief Executive Officer of Helius.
“With the proper prescription and a letter of
medical necessity, people struggling with MS in the U.S. will be
able to access PoNS Therapy at a greatly reduced price. We believe
this program will accelerate the adoption of PoNS Therapy and help
to establish PoNS as the standard of care for MS patients with gait
deficit. PTAP participants will also be invited to join Helius’s
upcoming registry program, which is designed to collect important
health economic information to establish the value of PoNS on key
therapeutic outcomes and will complement the data gleaned through
TEP,” concluded Mr. Andreeff.
The PTAP is currently available and expected to
run through December 31, 2022.
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.
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 scope and duration of PTAP, and patients’
ability to qualify for PTAP.
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, and ability to raise capital, 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 ContactLisa M. Wilson,
In-Site Communications, Inc.T: 212-452-2793E:
lwilson@insitecony.com
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