NanoVibronix Announces Expanded CMS Reimbursement Approval for PainShield
April 26 2021 - 9:00AM
NanoVibronix, Inc.,
(NASDAQ: NAOV), a medical device
company that produces the UroShield®, PainShield® and WoundShield®
Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic
Devices, today announced that the U.S. Centers for Medicare and
Medicaid Services (CMS) has expanded its reimbursement approval of
the company’s PainShield™ product by adding the device to its
Durable Medical Equipment (DME) schedule.
Effective immediately, PainShield is reimbursable as an
approved medical device under a unique reimbursement code assigned
by CMS for low frequency ultrasonic diathermy treatment
specifically for home use. The product is currently the only device
approved for reimbursement under the unique HCPCS code K1004, which
was established through the company’s efforts and work with CMS.
Visit here for additional
information.
“Receiving CMS approval for reimbursement under the DME
schedule is a breakthrough milestone in our efforts to fully
commercialize our PainShield product and reach the broader, more
traditional healthcare market,” stated Brian Murphy, CEO of
NanoVibronix. “This approval expands the original CMS approval to
include reimbursement as a device for the many millions of
beneficiaries enrolled in Medicare and paves the way for expanded
distribution by removing the limitations that we have been
operating under until now. We believe that demand has been building
due to providers anticipating the device being added to the
reimbursement schedule. We began experiencing an increase in orders
for the device almost immediately and are prepared to meet the
higher demand.”
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device
company headquartered in Elmsford, New York, with research and
development in Nesher, Israel, focused on developing medical
devices utilizing its patented low intensity surface acoustic wave
(SAW) technology. The proprietary technology allows for the
creation of low-frequency ultrasound waves that can be utilized for
a variety of medical applications, including for disruption of
biofilms and bacterial colonization, as well as for 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®, all of which are portable
devices suitable for administration at home without assistance of
medical professionals. Additional information about NanoVibronix 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; 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) 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 subcontractor assistance; (ix) insufficient or
inadequate reimbursements by governmental and/or other third party
payers for our products; (x) our ability to successfully obtain and
maintain intellectual property protection covering our products;
(xi) legislative or regulatory reform impacting the healthcare
system in the U.S. or in foreign jurisdictions; (xii) our reliance
on single suppliers for certain product components, (xiii) the need
to raise additional capital to meet our future business
requirements and obligations, given the fact that such capital may
not be available, or may be costly, dilutive or difficult to
obtain; (xiv) our conducting business in foreign jurisdictions
exposing us to additional challenges, such as, e.g., foreign
currency exchange rate fluctuations, logistical and communications
challenges, the burden and cost of compliance with foreign laws,
and political and/or economic instabilities in specific
jurisdictions; and (xv) market and other conditions. 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, except as
required by law.
Brett Maas
Hayden IR, LLC
646-536-7331
brett@haydenir.com
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From May 2024 to Jun 2024
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From Jun 2023 to Jun 2024