NanoVibronix Reports Schedule Published by NICE for Review of UroShield® Device
February 10 2021 - 8:00AM
Business Wire
Provides Milestones for Attaining NICE
Guidance, Including Addition of UroShield to the NHS Supply Chain;
Process Completion and Recommendation Expected in Q1 2022
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 that it has received documentation from
the National Institute for Health and Care Excellence (NICE) that
outlines the timeline for NICE’s review and recommendation of the
company’s UroShield device.
Publication of the approval schedule and timeline more clearly
codifies the process that the company believes will ultimately lead
to a positive recommendation of the device by NICE adoption by the
National Health Service (NHS) as a clinically effective and cost
saving medical device and addition of the device to the NHS Supply
Chain Catalogue. As an important element of this approval, funding
may also be provided by the NHS through the Medtech Funding
Mandate, demonstrating the NHS commitment to accelerate the uptake
of NICE-approved, cost-saving medical devices throughout the health
system, meaning patients will get access to these technologies
faster.
“Publication by NICE of its schedule for the review of the
independent study and its recommendation for UroShield is an
important step towards attaining ‘official guidance’ and ultimately
achieving adoption by NHS for use by all of its patients at risk of
catheter associated urinary tract infections,” stated Brian Murphy,
CEO of NanoVibronix. “Findings from the recent independent study
demonstrate statistically significant benefits and positive
outcomes from patients that use the medical device. We remain
committed to full commercialization of UroShield and are encouraged
by NICE’s addition of the study to its evidence-based medicine
documentation.”
The date for publication for rollout to the NHS is March, 2022,
coinciding with the NHS financial year, which begins on April 1st
and details of the UroShield review process are made available
online by NICE at
https://www.nice.org.uk/guidance/indevelopment/gid-mt560.
“NICE has achieved wide international impact, leading the way
for more evidence-based value assessment of medicines and medical
devices,” continued Murphy. “The NICE process for review,
recommendation and approval has helped global health systems and
clinicians to focus the practice of medicine where it matters most
from both a quality of patient care and cost effectiveness
perspective.”
As previously announced, the company submitted to NICE for
review, the findings from an independent evaluation of its
UroShield® device on patients who had used the device for up to two
years.. Clinical data from the study, conducted by Coventry
University’s Assistant Professor, Ksenija Maravic da Silva,
reported statistically significant outcomes for the device
including 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. 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.
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/20210210005196/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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