ELMSFORD, N.Y., Sept. 22, 2020 /PRNewswire/ -- 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
the U.S. Food and Drug Administration ("FDA") has decided to
exercise its Enforcement Discretion to allow distribution of the
UroShield device in the United
States. According to the FDA, "UroShield® device can use
Intended Use Code (IUC) 081.006: Enforcement discretion per final
guidance, and FDA product code QMK (extracorporeal acoustic wave
generating accessory to urological indwelling catheter for use
during the COVID-19 pandemic)".
UroShield® is an ultrasound-based product that is designed to
prevent bacterial colonization and biofilm on indwelling urinary
catheters and increase antibiotic efficacy, ultimately reducing the
incidence of catheter-associated urinary tract infections
("CAUTI"). UroShield® is also intended to decrease pain and
discomfort associated with urinary catheter use.
Accordingly, the FDA's Enforcement Discretion clears the way for
import of UroShield to the U.S. during the Covid-19 pandemic,
immensely expanding the company's addressable market for the device
during this time period. The device is designed to aid in the
prevention of CAUTI incidence in patients requiring long-term
indwelling catheterization.
"The FDA continues its critical work to protect public health,
including expediting the review of medical devices that may be of
beneficial use during the COVID-19 pandemic," commented
Brian Murphy, CEO of NanoVibronix.
"After reviewing the body of scientific evidence that we presented,
the agency took decisive action to clear the way for patient access
to UroShield for the duration of the Covid-19 pandemic. The
evidence presented to the FDA on UroShield demonstrated decreases
in the risk of catheter-associated urinary tract infections and
related complications in patients using UroShield who required
long-term indwelling catheterization. Importantly, we are unaware
of any other commercially available device that can prevent
catheter-associated urinary tract infection incidence and achieve
results comparable to UroShield."
"Catheter-associated urinary tract infections are a greater risk
for critically ill patients and according to the Centers for
Disease Control and Prevention, urinary tract infections (UTI) are
the most common type of healthcare-associated infection reported"
continued Murphy. "Among UTIs acquired in the hospital,
approximately 75% are associated with a urinary catheter, and
between 15-25% of hospitalized patients receive urinary catheters
during their hospital stay. Approximately 40% of all hospital
acquired infections are attributable to CAUTI. Moreover, high rates
of catheter-associated urinary tract infections are observed in
high-risk nursing home and long-term care facility populations that
have been greatly impacted by COVID-19 and frequently with patients
who have one or more underlying conditions predisposing them to
more severe illnesses. Reducing the risk of these infections may
reduce catheter changes and prevent exposure to infectious diseases
such as COVID-19 by minimizing healthcare personnel or caregiver
interactions with patients."
"Hospitals are continually seeking opportunities to improve
patient care and quality performance metrics such as the number of
catheter-associated urinary tract infections," concluded Murphy.
"We believe that the FDA's enforcement discretion for UroShield
enables hospitals to be better equipped to improve CAUTI metrics
and provide patients with access to a device that can potentially
prevent the incidence of infections that further complicate care,
extend the duration of hospital stays or increase the risk of
readmission at a critical time for our healthcare system. UroShield
has been proven to be safe and cost-effective and has regulatory
approval in a number of countries around the globe. Introduction to
the U.S. market during the Covid-19 pandemic is a significant next
step in reaching a critical mass of healthcare facilities and
providers."
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, and include, among others, statements regarding the
completion of the public offering, the satisfaction of customary
closing conditions related to the public offering and the intended
use of net proceeds from the public offering; 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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SOURCE NanoVibronix, Inc.