NANOVIBRONIX ANNOUNCES PLAN TO EXPAND PRODUCT PORTFOLIO WITH INTRODUCTION OF PAINSHIELD RELIEF FOR OVER-THE-COUNTER (OTC) USE AND PLANS FOR FUTURE PRODUCT LAUNCH
August 16 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 it intends to enter the
Over-the-Counter (OTC) pain relief market with the introduction of
PainShield RELIEF™, a non-prescription ultrasound therapy device
that delivers fast pain relief for nerve and soft tissue damage.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc.,
commented, "Entering the OTC pain relief market with our newest
product in the PainShield family significantly expands our total
addressable market and opens up new opportunities for growth
through several additional revenue streams. Those suffering from
pain will have ready access to the device with no need for
clinician prescription. Plans are under way for an official launch
in the U.S. and select parts of the world and product reveal in the
coming months at a number of trade shows targeting a variety of
athletic interests including tennis and golf. We are targeting the
specific pain relief indications and the retail channels to address
them as an OTC alternative to less effective interventions. The
company expects widespread availability by early to mid-2022.”
The company has submitted its trademark application to the U.S.
Patent and Trademark Office (USPTO) for protection of the
PainShield RELIEF and expects to submit for clearance to the U.S.
Food and Drug Administration (FDA) in the very near term.
Murphy continued, “The pain relief market is flooded with
products that simply mask the pain versus providing proven pain
resolution. We believe the opportunities are endless with this
product. Our initial entry, as well as our next generation, which
is currently in development, are expected to be unique to the
market, as is Surface Acoustic Wave (Low Level, Low Frequency
Ultrasound) technology. Our entry into the OTC market will be
preceded by submission of the final results of our Lateral
Epicondylitis (Tennis Elbow) study.”
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.
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, 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.
Brett Maas, Managing Principal
Hayden IR, LLC
646-536-7331
brett@haydenir.com
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