ELMSFORD, N.Y., Aug. 13, 2020 /PRNewswire/ -- NanoVibronix,
Inc., (NASDAQ: NAOV), a medical device company that produces the
UroShield®, PainShield® and WoundShield®, and WoundShield® Surface
Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today
announced that it has shipped its first orders of the new
UroShield® device to the United
Kingdom.
Contemporaneous with the fulfilment of new orders, the Company
has been engaged with the National Institute of Clinical Evidence
(NICE) on readying the new version of UroShield® for submission for
NICE Official Guidance. This important step is intended to
help accelerate market access to all NHS patients at risk of
catheter associated urinary tract infections (CAUTI). The Company
is also pursuing a similar registration process in Australia via the Therapeutic Goods
Administration (TGA), as well as other regulatory agencies.
"The global Covid-19 pandemic has reinforced the widely known
importance of preventing co-morbidity, which we believe may
complicate and compromise patients stricken with the Covid-19
virus," said Brian Murphy, CEO of
NanoVibronix. "UroShield has proven its effectiveness through
several randomized controlled trials to significantly reduce
Catheter Associated Urinary Tract Infection (CAUTI), one of the
leading factors associated with Hospital Acquired Infection and
increased hospital stays. We remain very excited about the
potential for this product to improve the lives of patients."
UroShield® is an ultrasound-based product that is designed to
prevent bacterial colonization and biofilm on indwelling urinary
catheters and increase antibiotic efficacy, ultimately reducing the
incidence of catheter-associated urinary tract infections (CAUTI).
UroShield® is also intended to decrease pain and discomfort
associated with urinary catheter 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) 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; and (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. 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.
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SOURCE NanoVibronix, Inc.