Full Press Release Details
UroShield Receives U.S. Food and Drug Administration Authorization for Entry into the U.S.
Clears Path for Patient Access to UroShield Device for the duration of the Covid-19 pandemic; Significantly Expands Addressable
Market during this time period
N.Y., September 22, 2020 (PR NEWSWIRE) - 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)".
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.
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.
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."
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."
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:
press release contains "forward-looking statements."
Such statements may be preceded by the words "intends,"
"anticipates," "projects,"
"predicts," "estimates,"
"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.
Maas, Managing Principal, Hayden IR, LLC