NanoVibronix Announces PainGuard and UroGuard Approved by Health Canada as Licensed Medical Devices
March 30 2022 - 8:30AM
Business Wire
Increases Opportunity for Broader International
Distribution
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device
company that produces the UroShield® and PainShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
announced the Company’s PainGuard and UroGuard, offered as private
label products through Ideal Medical International Limited, have
been approved by Health Canada / Santé Canada as licensed medical
devices.
The license issued by Health Canada allows Ideal Medical
International Limited (“Ideal Medical”), one of the Company’s
international distribution partners, to market and sell the
Company’s PainGuard and UroGuard as licensed medical devices in
Canada.
“This license clears the way for our distribution partner, Ideal
Medical, to accelerate distribution of our products in Canada,
another catalyst for our potential future growth and international
expansion,” said Brian Murphy, CEO of NanoVibronix. “According to
the Canadian Pain Task Force1, nearly eight million, or one in four
Canadians aged 15 or older live with chronic pain. Our pain
management products are safe and effective alternative treatment to
prescription opioids, which have been the root cause of a number of
unintended consequences including overdose and death. Similarly,
there are millions of urinary catheters used in hospitals every
year, and our urology products can serve as protection against
urinary tract infections and the pain associated with the
catheters. We are eager to serve the Canadian market through Ideal
Medical and look forward to capitalizing on this new opportunity to
drive further growth.”
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 Company’s primary
products include PainShield® and UroShield®, 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 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.
1 Canadian Pain Task Force Report: October 2020
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Investor Contacts: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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