NANOVIBRONIX RECEIVES REGISTRATION APPROVAL FOR PAINSHIELD FROM TGA AUSTRALIA
August 11 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 that the Therapeutic Goods
Administration (TGA), The Australian Regulatory body for
Therapeutic Devices, has granted approval for the Company’s
PainShield for use by patients in Australia.
This approval follows TGA’s recent approval of the Company’s
UroShield. As previously announced, the Company signed a
distribution agreement with DukeHill Healthcare Pty Ltd (DukeHill
HC) to distribute both UroShield® and PainShield® technologies in
Australia.
Brian Murphy, Chief Executive Officer of the Company, commented,
“This regulatory approval enables us to expand availability of
PainShield to Australia and follows closely after TGA’s approval of
UroShield just last month. We are positioned to serve beneficiaries
in this important market with a strong distribution partner in
DukeHill HC, an industry leader with proven distribution
capabilities in Australia.”
PainShield is an ultrasound device that delivers a localized
ultrasound effect to treat pain and induce soft tissue healing in a
targeted area, while keeping the level of ultrasound energy at a
safe and consistent level. Its range of applications includes acute
and chronic pain resolution through its many mechanisms of action.
The product has broad applications for sports injuries. PainShield
can be used by patients at home or work or in a clinical setting
and can be used even while the patient is sleeping. Patient
benefits include ease of application and use, faster recovery time,
high compliance, and increased safety and efficacy over existing
devices that rely on higher-frequency ultrasound.
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.
About DukeHill Healthcare Pty Ltd
DukeHill HC is a leader in advancing clinical education and has
a high level of clinical and technical expertise with a strong
focus on meeting the changing healthcare requirements in Australia.
DukeHill HC’s purpose is to address the needs of healthcare
professionals with the supply of quality, cost effective, minimally
invasive, and consumable devices which will enable clinicians to
obtain best practice outcomes for their patients.
For further information please contact Toni Hill.
DukeHill Healthcare Pty Ltd
Suite 34 Mezzanine Level
Offices First, Aspley Hypermarket
59 Albany Creek Road
Aspley, QLD, Australia 4034
1 300 622 636 / 07 3317 8362
uroshield@dukehillhealthcare.com.au
http://dukehillhealthcare.com.au
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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