NanoVibronix Receives Positive Final Results of Independent Lifecycle Testing of PainShield Prompted by Centers for Medicare and Medicaid Services (CMS)
March 28 2023 - 8:30AM
Business Wire
All functionalities proven to be within testing
performance criteria
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 announced
that independent life expectancy testing performed by Carmel Labs
in Israel confirm that its PainShield met all tested
functionalities.
Brian Murphy, Chief Executive Officer of NanoVibronix,
“Independent third-party testing results confirm that PainShield,
our non-opioid, ultrasound therapy device for pain, met the defined
testing parameters for lifecycle expectancy. We plan to submit the
results of the testing to the Centers for Medicare and Medicaid
Services (CMS) to backfill our pending application for Medicare
coverage.”
Murphy continued, “As you may recall, we were notified in
September of 2022 by CMS that PainShield lacked sufficient life
expectancy testing data, and therefore denied Medicare coverage. We
subsequently commissioned the testing services of an independent,
third party and received positive interim test results in January
of this year. Today, we are confirming the testing is complete and
the results were overwhelmingly positive. We believe these results
clear the way for us to move forward with securing approval from
CMS and ultimately making our device more widely available to those
who could benefit from its use.”
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.
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Investor Contacts: Brett Maas, Managing Principal, Hayden IR,
LLC brett@haydenir.com (646) 536-7331
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