Independent Study Finds Significant Benefits Provided by NanoVibronix’s UroShield® Device
December 02 2020 - 7:54AM
Business Wire
Findings Submitted to National Institute for
Health and Care Excellence (NICE)
Physical and Mental Benefits of UroShield
Documented in Two-Year, Real-World Evaluation
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 positive findings from an
independent evaluation of its UroShield® device on patients who
have used the device for up to two years. The results have been
submitted to the National Institute for Health and Care Excellence
(NICE) for review and consideration.
“Findings from an independent study demonstrate significant
benefits of our UroShield device with patients reporting reductions
in blockages, catheter changes and use of bladder maintenance
solutions in addition to reductions in pain, fewer visits to
clinics and hospitals for emergency catheter changes,” stated Brian
Murphy, CEO of NanoVibronix. “As part of our ongoing engagement, we
submitted these findings to NICE as part of the process for
attaining ‘official guidance’ from the organization, an important
step in providing access to all NHS patients at risk of catheter
associated urinary tract infections. We believe that these findings
should also reinforce our efforts in the U.S. and other target
markets.”
An independent statistical analysis conducted by Coventry
University’s Assistant Professor, Ksenija Maravic da Silva,
reported statistically significant outcomes for the company’s
UroShield device. The findings demonstrated a reduced number of
urinary tract infections (UTIs), reduced instances of prescribed
antibiotics, reduced catheter blockages, reduced the need for
unplanned catheter changes and reduced pain reported as a result of
catheter associated complications. In addition, the study also
provided important insights into the lives of those using the
device including improvement of overall well-being, relating
specifically to decreased levels of worry and increased ability to
socialize. In addition, patient feedback on product improvements
were addressed and have been incorporated in the present
commercially available device.
“Tangentially, patients also reported an overall improvement in
their mental state, which was described as ‘priceless’ and ‘life
changing’ by study participants and their loved ones,” added
Murphy. “Beyond the physical health benefits, patients cited
improved sleep, higher levels of energy, increased confidence and
desire to socialize with family and friends. We remain committed to
full commercialization of our products, and the real-world findings
and testimonials from this study further substantiate what we
already know to be true about the efficacy of UroShield.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201202005146/en/
Investor Contacts:
NanoVibronix, Inc. bmurphy@nanovibronix.com (630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com (646) 536-7331
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