NanoVibronix looks to expand use of its UroShield Due to the potential to impact comorbidities related to COVID-19 Crisis
March 27 2020 - 9:41AM
NanoVibronix, Inc.,
(NASDAQ:
NAOV), a medical device company that produces the
UroShield® Surface Acoustic Wave (SAW) Portable Ultra Sonic
therapeutic device which attaches to an indwelling catheter and has
been clinically proven to mitigate Catheter Associated Urinary
Tract Infection (CAUTI), as well as reducing pain and blockages,
today announced that it has reached out to regulatory agencies
around the world to inform them of the potential benefits for
greater use of the product on compromised patients. As a
result of the COVID-19 crisis, critically ill patients are at the
greatest risk, especially when compromised by comorbidities, such
as CAUTI. Additionally, with the existing and potential
burden this crisis has on the worldwide healthcare system, critical
patients may be displaced to lower acuity care settings.
UroShield has been proven to reduce the incidence of CAUTI and as a
result, has the potential to reduce readmissions into acute care
facilities.
According to the CDC, each year, 15-25% of hospitalized patients
and 5-10% (75,000-150,000) of nursing home residents will receive a
urinary catheter. Statistics show that 75% of hospital patients and
50% of nursing home patients will develop a catheter-associated
urinary tract infection (CAUTI). In fact, Urinary Tract Infections
(UTI) account for more than 40% of the Hospital Acquired Infections
(HAI). In addition, catheter acquired (symptomatic) UTIs are the
source for 20% of Healthcare Acquired Bacteremia in acute care and
50% in long term care facilities.
This has resulted in an increased morbidity (i.e., leading cause
of secondary blood stream infection with approx. 10% mortality) and
an estimated 13,000 attributable deaths annually. In addition to
the loss of life, these infections cost $400 to $500 million
annually for treatment. With the COVID-19 crisis, mortality
is much more likely when there are one or more comorbidities.
“Currently, we are aware of no other commercially available
urinary catheters or accessories that assist in prevention or
reduction of incidence of symptomatic UTI,” said Brian Murphy, CEO
of NanoVibronix. “The COVID-19 crisis has demonstrated the
importance of in-home and nursing home care for high-acuity
patients in an attempt to reduce inpatient care. We are also
sensitive to the needs of our hospitals to minimize the burden
placed on our healthcare system so severely taxed by this crisis.
We believe that our UroShield is a powerful tool for hospitals and
physicians to mitigate these costly and dangerous problems. Our
UroShield has been proven to be safe and effective and has
regulatory approvals outside the USA.”
The UroShield device is CE Marked and is currently marketed
outside USA (Europe and some Asian countries). In multiple
randomized clinical studies, UroShield has proven to minimize the
incidence of CAUTI and to alleviate the discomfort (such as
discomfort during insertion and removal of catheter, pain,
soreness, burning, itching and bladder spasms) associated with a
urinary catheter. We strongly believe that a device that can
effectively prevent “a serious disease or condition” far outweighs
the value of a device intended to “treat or diagnose” the same
“serious disease or condition”.
There is no assurance of broader adoption by regulators, but the
benefits certainly outweigh the risks.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company
headquartered in Elmsford, New York, with research and development
in Nesher, Israel, which is focused on developing medical devices
utilizing its proprietary and patented low intensity surface
acoustic wave (SAW) technology. This technology allows for the
creation of low-frequency ultrasound waves that can be utilized for
a variety of medical applications, including the disruption of
biofilms and bacteria colonization, as well as providing 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™. Additional
information about the Company 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 and 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) an 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 subcontractors for assistance, (viii) insufficient
or inadequate reimbursement by governmental and other third party
payers for our products, (ix) our efforts to successfully obtain
and maintain intellectual property protection covering our
products, which may not be successful, (x) legislative or
regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for
certain product components, (xii) the fact that we will need to
raise additional capital to meet our business requirements in the
future and that such capital may not be available, or may be
costly, dilutive or difficult to obtain and (xiii) the fact that we
conduct business in multiple foreign jurisdictions, exposing us to
foreign currency exchange rate fluctuations, logistical and
communications challenges, burdens and costs of compliance with
foreign laws and political and economic instability in each
jurisdiction. 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.
Investor Contacts:Nanovibronix Incbmurphy@nanovibronix.com(630)
338-5022
Or:
Brett Maas, Managing Principal, Hayden IR,
LLCbrett@haydenir.com(646) 536-7331
SOURCE: NanoVibronix, Inc.
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