Helius Medical Technologies, Inc. Announces Third-Party Reimbursement for PoNS® from Major Insurance Carrier
May 29 2024 - 9:00AM
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the
“Company”), a neurotech company focused on delivering a novel
therapeutic neuromodulation approach for balance and gait deficits,
today announced the first third-party reimbursement from a major
insurance carrier for the Company’s Portable Neuromodulation
Stimulator (PoNS®) device.
“Securing widespread reimbursement for PoNS remains a top
priority for us, and we are thrilled to announce that we’ve
received our first third-party reimbursement for this innovative
device at the list price with a 7% rebate by a major insurance
carrier,” said Dane Andreeff, President and Chief Executive Officer
of Helius. “Following Centers for Medicare & Medicaid Services’
(CMS) establishment of unique Healthcare Common Procedure Coding
System codes for the PoNS mouthpiece and controller, we have been
actively negotiating reimbursement with third-party payers and for
patients covered by the Veterans Administration and the Department
of Defense through our recent partnership with Lovell Government
Services.”
“We believe this is yet another important milestone in
establishing the market pricing for PoNS as we continue to
negotiate with other third-party payers and CMS. In addition, we
are assisting several MS patients who have or are preparing to
submit claims with other third-party payers and look forward to
establishing reimbursement rates with those carriers as we move
forward,” concluded Andreeff.
The reimbursed rate, net of a 7% rebate, results in pricing of
$16,554 for the controller and $7,347 for the mouthpiece, exclusive
of rounding.
About Helius Medical Technologies,
Inc.
Helius Medical Technologies is a leading neurotech company in
the medical device field focused on neurologic deficits using an
orally applied technology platform that amplifies the brain’s
ability to engage physiologic compensatory mechanisms and promote
neuroplasticity, improving the lives of people dealing with
neurologic diseases. The Company’s first commercial product is the
Portable Neuromodulation Stimulator. For more information about the
PoNS® or Helius Medical Technologies, visit
www.heliusmedical.com.
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS)
is an innovative, non-implantable, orally applied therapy that
delivers neurostimulation through a mouthpiece connected to a
controller and it’s used, primarily at home, with physical
rehabilitation exercise, to improve balance and gait. The PoNS
device, which delivers mild electrical impulses to the tongue, 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.
PoNS has shown effectiveness in treating gait or
balance and a significant reduction in the risk of falling in
stroke patients in Canada, where it received authorization for sale
in three indications: (i) for use as a short-term treatment (14
weeks) of gait deficit due to mild and moderate symptoms from
stroke and is to be used in conjunction with physical therapy; (ii)
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 (iii)
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. For more information visit www.ponstherapy.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,” “expect,”
“continue,” “will,” “goal,” “aim” and similar expressions. Such
forward-looking statements include, among others, statements
regarding the Company’s ability to negotiate acceptable
reimbursement rates with additional third-party payers, the
potential for patients to submit additional claims with other
third-party payers, and the uses and effectiveness of PoNS and PoNS
Therapy.
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
Company’s ability to find additional sources of funding,
manufacturing, labor shortage and supply chain risks, including
risks related to manufacturing delays, the Company’s ability to
obtain national Medicare insurance coverage and negotiate
reimbursement with other third-party payers, the Company’s ability
to continue to build internal commercial infrastructure, secure
state distribution licenses, market awareness of the PoNS device,
future clinical trials and the clinical development process, the
product development process and the 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, 2023, 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
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