NanoVibronix Provides Update on Expanding Access to PainShield
January 18 2023 - 8:30AM
Business Wire
Receives Positive Interim Results of Lifecycle
Testing
Enactment of Federal ‘NOPAIN Act’ Could Be a
Catalyst
NanoVibronix, Inc. (NASDAQ: NAOV) (the “Company”), a
medical device company utilizing the Company's proprietary and
patented low intensity surface acoustic wave (SAW) technology,
today provided an update on the efforts to expand access to the
Company’s PainShield product.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230118005140/en/
PainShield Wearable Ultrasound Therapy
Device (Photo: Business Wire)
Brian Murphy, Chief Executive Officer of NanoVibronix, said, “We
continue to work closely with The Centers for Medicare &
Medicaid Services (“CMS”) to provide the required documentation for
potential reimbursement for PainShield, which we believe will make
the device much more readily available for those suffering from
chronic pain. We were notified in late September by CMS that
PainShield lacked sufficient life expectancy testing and therefore
denied reimbursement. We commissioned Carmel Labs in Israel to
conduct the testing. This week we received positive interim results
with regard to the ongoing lifecycle testing. We plan to submit the
results of the test to CMS to backfill our pending application and
provide additional evidence as requested.”
“Furthermore, we are highly encouraged by the attention the
‘NOPAIN Act1’ is garnering from a growing collation of professional
and medical organizations and the positive impact the potential
passing of the legislation could have on demand for our
PainShield,” added Murphy. “The NOPAIN Act is a bipartisan effort
to update federal guidelines that would expand access to non-opioid
pain management alternatives. Under current law, hospitals receive
the same payment from Medicare regardless of whether a physician
prescribes an opioid or a non-opioid.2 If enacted as proposed, the
legislation would direct CMS to provide separate Medicare
reimbursement for non-opioid treatments used to manage pain, which
we believe could provide a seismic increase in demand for products
such as our PainShield.”
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) market acceptance of our
existing and new products or lengthy product delays in key markets;
(ii) negative or unreliable clinical trial results; (iii) inability
to secure regulatory approvals for the sale of our products; (iv)
intense competition in the medical device industry from much
larger, multinational companies; (v) product liability claims; (vi)
product malfunctions; (vii) our limited manufacturing capabilities
and reliance on subcontractor assistance; (viii) insufficient or
inadequate reimbursements by governmental and/or other third party
payers for our products; (ix) our ability to successfully obtain
and maintain intellectual property protection covering our
products; (x) legislative or regulatory reform impacting the
healthcare system in the U.S. or in foreign jurisdictions; (xi) our
reliance on single suppliers for certain product components; (xii)
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; (xiii) 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 (xiv) 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.
_______________ 1 The Non-Opioids Prevent Addiction in the
Nation Act (“NOPAIN Act”) (S. 586/H.R. 3259) is a bill designed to
prevent opioid addiction before it starts by increasing the use of
non-opioid pain management approaches. 2 03-02-2021 NOPAIN One
Pager.pdf (senate.gov)
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version on businesswire.com: https://www.businesswire.com/news/home/20230118005140/en/
Investor Contacts:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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