NanoVibronix Announces Planned Launch of CBD Patch and Cream for PainShield® Designed to Amplify Therapeutic Effect
June 05 2019 - 8:30AM
NanoVibronix, Inc.,
(NASDAQ:
NAOV), a medical device company that produces the
PainShield® surface acoustic wave (SAW) device, which utilizes the
Company’s proprietary and patented low intensity, SAW ultrasound
technology, today announced that it is developing a cannabidiol
(CBD) patch and cream utilizing a proprietary and
nanoparticle-based infusion process. NanoVibronix intends to
make the CBD patch as well as similarly formulated CBD cream
available in combination with PainShield® as PainShield CBD™.
NanoVibronix intends to demonstrate that
coupling the infused patch and cream with PainShield® will increase
absorption and may provide sustained pain relief for up to 24
hours. The Company believes that this will be the first known
ultrasound-based pain relief product available in combination with
CBD, which can be used at home, and outside of a clinical setting,
as an opioid-alternative.
NanoVibronix is partnering with Saralex Group
Inc., which has successfully launched numerous regulated products
in both Canada and the European Union. Saralex plans to manage the
regulatory approval process and launch PainShield CBD™ in
these markets through highly-regarded e-commerce and retail
distribution channels.
“We are excited to announce that we will
commence development of an innovative CBD-infused patch and
companion cream for PainShield® in partnership with Saralex, who
bring more than 25 years of experience successfully launching new
products and navigating highly regulated markets,” said Brian
Murphy, CEO of NanoVibronix. “Combining PainShield® with
proprietary, nanoparticle-based CBD could provide a powerful
alternative to opioids by actually resolving, rather than masking,
pain. PainShield® has been shown in numerous clinical studies
to effectively resolve the source of pain by healing nerve and
tissue damage. By layering a proprietary CBD formulation to
the patch, we believe this product will offer further benefits,
including additional pain relief and anti-inflammatory properties
designed to accelerate the healing process.”
“PainShield® is a revolutionary product, with a
growing body of clinical evidence that supports mass adoption. By
applying the latest nanoscience to CBDs and combining the proven
benefits of PainShield®, we are in a position to deliver a
first-in-class product, expected to heal tissue and relieve pain,
providing an effective alternative to opioids,” commented Joe
Santos, President of Saralex. “The proprietary CBD formulation is
designed for maximum bio-availability due to the small molecule
size, which is intended to penetrate the central nervous system and
bypass the blood-brain barrier in order to maximize efficacy. We
are planning an aggressive product launch to drive market awareness
and consumer uptake.”
Most CBD infused topicals have a CBD molecule
size of 50 nanometers or considerably larger. High bioavailability
requires a very small molecule size in order to penetrate the
central nervous system and blood-brain barrier. PainShield CBD™ is
infused with an advanced nano-CBD formulation with a molecule size
of approximately 10 nanometers, which is much smaller than what is
regularly available in the market today. NanoVibronix believes this
formulation will provide the greatest bioavailability and,
therefore, the maximum delivery of potential pain relief.
NanoVibronix expects to launch PainShield CBD™
with Saralex into markets that have legalized or are in the process
of legalizing the sale of CBD-infused topicals, including Canada
and the European Union. Canada currently allows CBD sales on a
prescription-basis with regulatory changes expected in October 2019
that would allow CBD-infused topical sales without prescription.
CBD sales are currently permitted in almost all European
countries.
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 Contact:Crescendo
Communicationsnaov@crescendo-ir.com(212) 671-1021
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