NanoVibronix Announces Encouraging Interim Results in Real World Patient Study of UroShield
December 07 2021 - 8:30AM
NanoVibronix, Inc., (NASDAQ: NAOV), a healthcare device company
that produces the UroShield® and PainShield® Surface Acoustic
Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced
positive interim results from an independent, real world patient
study of its UroShield at Southampton University Health Sciences.
Brian Murphy, CEO of Nanovibronix, stated, “Interim results and
observations from both the patient qualitative work and laboratory
analysis are highly encouraging and represent another important
step towards full commercialization of UroShield. Urine analysis is
demonstrating an approximate 1 log reduction in bacterial numbers
in most patients, a statistically significant outcome, indicating
that UroShield is reducing the bacterial load responsible for
colonizing a catheter which frequently leads to infection.
Qualitatively, participants are citing positive outcomes and
improved quality of life from using our UroShield device.”
The independent study, which was launched in the first half of
2021, was devised to evaluate how UroShield helps to reduce
infection by preventing bacteria colonisation and the buildup of
biofilms on long-term indwelling urinary catheters in real world
patients and to better understand the patient benefits and
experiences of using UroShield. The study consists of both
laboratory and patient studies and is nearing completion. At the
conclusion of the study, Southern Health will be able to purchase
the UroShield devices for all patients that want to continue using
the device and for additional patients in their care who have
indwelling catheters. The research team has reported strong
interest in the study from both the clinical teams and patients who
live with long term catheters. Full results of the study are
expected to be published in the second quarter of 2022.
According to Sandra Wilks, Director of Programmes Health (PGT)
at University of Southampton, “The UroShield study which is both
qualitative and quantitative, consisting of both laboratory and
patient studies is nearing completion. The independent research
team has experienced strong interest from the clinicians and
patients who live with long term catheters with 12 participants
already having consented to both the microbiology and device
testing with the remainder identified and about to commence.
Additional patients are completing the qualitative part of the
study which involves using the UroShield device for a minimum of 90
days with data collected every week. Analysis of Pathogenic
Bacteria Culture in the urine to date is demonstrating an
approximate 1 log reduction in bacterial numbers in most patients,
indicating that UroShield is reducing the bacterial load that is
responsible for colonising the catheter and causing infection. The
interim results and observations from both the patient qualitative
work and the laboratory analyses are very encouraging, with
participants providing positive comments about the effects of the
device and stating that it is improving their quality of life.”
UroShield™ is an ultrasound-based product that is designed to
prevent bacterial colonization and biofilm in urinary catheters,
increase antibiotic efficacy and decrease pain and discomfort
associated with urinary catheter use.
About Southern Health NHS Foundation Trust
Southern Health NHS Foundation Trust is one of the largest
providers of community health, specialist mental health and
learning disability services for people across the south of
England. They provide these services to 1.8 million people with a
skilled workforce of approximately 6,000 people operating from more
than 200 sites including community hospitals, health centres,
inpatient units and social care services.
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) 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.
Brett Maas, Managing Principal
Hayden IR, LLC
646-536-7331
brett@haydenir.com
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