Helius Medical Technologies Announces DMEPOS Accreditation for PoNS
20 Juni 2023 - 1:05PM
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 that its Portable Neuromodulation Stimulator
(PoNS®) device has been awarded Durable Medical Equipment,
Prosthetics, Orthotics and Supplies (DMEPOS) accreditation by The
Compliance Team (TCT), which is authorized by the Centers for
Medicare & Medicaid Services (CMS) to accredit all DMEPOS
products and services. The accreditation certifies that Helius has
established processes that conform to TCT’s Exemplary Provider®
DMEPOS Quality Standards.
“We are thrilled that PoNS has been awarded DMEPOS
accreditation. Not only does the certification underscore our
commitment to quality and patient care, but it is also a crucial
part of our U.S. reimbursement strategy. Organizations that wish to
bill Medicare must have accreditation from an approved agency and
it’s become a standard with other funding sources as well,” said
Helius President and Chief Executive Officer Dane Andreeff.
“DMEPOS accreditation has particular relevance under the
proposed Transitional Coverage for Emerging Technologies (TCET)
legislation. If passed as currently proposed, companies with a
breakthrough designation could be covered by Medicare for up to
four years, allowing time to gather the necessary clinical data to
prove the efficacy of their products. PoNS has breakthrough
designations in both multiple sclerosis and stroke in the U.S. and
this certification establishes that Helius is an Exemplary
Provider® and our PoNS device has already met and exceeded CMS
quality standards,” concluded Andreeff.
TCT is a nationally recognized healthcare accreditation
organization that provides comprehensive accreditation and
certification services to healthcare providers in all fifty states.
TCT’s proprietary accreditation status is known as Exemplary
Provider Accreditation® and its industry-leading accreditation
model features healthcare’s first comprehensive set of plain
language, operations-driven quality standards with expert-led
implementation guidance.
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 promote neuroplasticity, improving the
lives of people dealing with neurologic diseases. The Company’s
first commercial product is the Portable Neuromodulation Stimulator
(PoNS®) device. 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-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.
PoNS is also authorized for sale in Canada for three
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; and (iii) for use as a
short-term treatment (14 weeks) of gait deficit due to mild and
moderate symptoms from stroke, 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 obtain reimbursement for the PoNS device, and
the potential for TCET to be approved.
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, disruptions in the banking system and
financial markets, lingering impacts of the COVID-19 pandemic, the
effect of macroeconomic conditions and the Company’s ability to
access capital markets, 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, availability of funds, manufacturing,
labor shortage and supply chain risks, our ability to maintain and
enforce our intellectual property rights, clinical trials and the
clinical development process, the product development process, the
regulatory submission review and approval process, our operating
costs and use of cash, and our ability to achieve significant
revenues, 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, 2022,
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: 212-452-2793E:
lwilson@insitecony.com
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