NanoVibronix Announces Interim Results of Clinical Study for UroShield
17 November 2022 - 12:30AM
Business Wire
Interim Results Indicate Beneficial Effects for
Patients
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device
company utilizing the Company's proprietary and patented low
intensity surface acoustic wave (SAW) technology, today announced
interim results of its U.K. clinical study for UroShield that is
being conducted by The University of Southampton and the National
Biofilms Innovation Centre.
Brian Murphy, CEO of NanoVibronix, stated, “We are encouraged by
the interim results we received from the Southampton quantitative
and qualitative study for UroShield. The results are positive and
are an important next step towards our expansion in the UK market
and securing permanent clearance from the FDA and ramping up
production for distribution in the U.S. We look forward to
receiving additional information when the study is published in
2023.”
Study: The Effect of Ultrasound on Urinary Catheter Biofilms and
Uropathogens
Initial results of the independent, real world patient study
suggest changes in the microbial population diversity following use
of the Uroshield, with potential beneficial effects on the urinary
and catheter microbiome. In addition to these analyses, most
patients using the Uroshield reported fewer catheter blockages and
infections, and other positive benefits.
The study was initiated in April 2021 for the purpose of filling
a gap in the Company’s clinical evidence and establishing
documentation required by the FDA for permanent 510K clearance. As
part of the preliminary clinical study, microbiological analyses of
urine and catheter samples pre- and post- use of Uroshield device
was carried out using a combination of culture, microscopy and
sequencing techniques.
For additional information about the study, please visit:
https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/the-effect-of-ultrasound-on-urinary-catheter-biofilms-and-uropathogens/
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®
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) 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221116005225/en/
Investor Contacts: Brett Maas, Managing Principal, Hayden IR,
LLC brett@haydenir.com (646) 536-7331
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From Apr 2024 to May 2024
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From May 2023 to May 2024