NanoVibronix Receives Reimbursement Approval from U.S. Centers for Medicare & Medicaid Services (CMS) for PainShield™
April 01 2020 - 8:00AM
NanoVibronix, Inc.,
(NASDAQ:
NAOV), a medical device company that produces the
PainShield® Surface Acoustic Wave (SAW) Portable Ultra Sonic
therapeutic device, today announced that the U.S. Centers for
Medicare and Medicaid Services (CMS) has approved its PainShield™
for reimbursement for Medicare beneficiaries on a national basis
effective January 2020.
“PainShield provides an effective alternative to
pharmaceuticals for pain management and can be used in a variety of
settings including the safety of a patient’s home, which has become
increasingly important in light of the coronavirus (COVID-19)
pandemic,” said Brian Murphy, CEO of NanoVibronix. “Receiving CMS
approval increases the number of providers who may prescribe
PainShield as a means for patients, particularly Medicare
beneficiaries who may be at a higher risk of infection, to manage
their pain while maintaining safe distances and reducing contact in
clinical settings. Obtaining this approval strengthens our
opportunities to secure private label partners in the United
States.”
The company was notified on March 30, 2020 that
its Medicare Enrollment Application was approved, and it is now an
approved Medicare Supplier for DME through the National Supplier
Clearinghouse, Palmetto-GBA as well as Noridian Administrative
Services, LLC, the two Medicare Administrative Contractors that
handle DME reimbursement nationwide.
PainShield is now available for Medicare
reimbursement on a national level under new HCPCS (Healthcare
Common Procedure Coding System) code K1004.
PainShield is an ultrasound device, consisting
of a reusable driver unit and a disposable patch, which contains a
proprietary therapeutic transducer. PainShield delivers a localized
ultrasound effect to treat pain and induce soft tissue healing in a
targeted area, while keeping the level of ultrasound energy at a
safe and consistent level. Its range of applications includes acute
and chronic pain resolution through its many mechanisms of action.
PainShield can be used by patients at home or work or in a clinical
setting and can be used even while the patient is sleeping. Patient
benefits include ease of application and use, faster recovery time,
high compliance, and increased safety and efficacy over existing
devices that rely on higher-frequency ultrasound.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical
device company headquartered in Elmsford, New York, with research
and development in Nesher, Israel, which is focused on developing
medical devices utilizing its proprietary and patented low
intensity surface acoustic wave (SAW) technology. This technology
allows for the creation of low-frequency ultrasound waves that can
be utilized for a variety of medical applications, including the
disruption of biofilms and bacteria colonization, as well as
providing pain relief. The devices can be administered at home
without the assistance of medical professionals. The Company’s
primary products include PainShield®, UroShield™ and WoundShield™.
Additional information about the Company is available at:
www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking
statements.” Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company’s control, and
cannot be predicted or quantified and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, risks and uncertainties associated with (i) the
geographic, social and economic impact of COVID-19 on the Company’s
ability to conduct its business and raise capital in the future
when needed, (ii) market acceptance of our existing and new
products or lengthy product delays in key markets; (iii) negative
or unreliable clinical trial results (iv) an inability to secure
regulatory approvals for the sale of our products, (v) intense
competition in the medical device industry from much larger,
multinational companies, (vi) product liability claims, (vii)
product malfunctions, (viii) our limited manufacturing capabilities
and reliance on subcontractors for assistance, (ix) insufficient or
inadequate reimbursement by governmental and other third party
payers for our products, ix) our efforts to successfully obtain and
maintain intellectual property protection covering our products,
which may not be successful, (xi) legislative or regulatory reform
of the healthcare system in both the U.S. and foreign
jurisdictions, (xii) our reliance on single suppliers for certain
product components, (xiii) the fact that we will need to raise
additional capital to meet our business requirements in the future
and that such capital may not be available, or may be costly,
dilutive or difficult to obtain and (xiv) the fact that we conduct
business in multiple foreign jurisdictions, exposing us to foreign
currency exchange rate fluctuations, logistical and communications
challenges, burdens and costs of compliance with foreign laws and
political and economic instability in each jurisdiction. More
detailed information about the Company and the risk factors that
may affect the realization of forward looking statements is set
forth in the Company’s filings with the Securities and Exchange
Commission (SEC), including the Company’s Annual Report on Form
10-K and its Quarterly Reports on Form 10-Q. Investors and security
holders are urged to read these documents free of charge on the
SEC’s web site at http://www.sec.gov. The Company assumes no
obligation to publicly update or revise its forward-looking
statements as a result of new information, future events or
otherwise.
Investor Contacts:Nanovibronix Incbmurphy@nanovibronix.com(630)
338-5022
Or:
Brett Maas, Managing Principal, Hayden IR,
LLCbrett@haydenir.com(646) 536-7331
SOURCE: NanoVibronix, Inc.
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