NanoVibronix, Inc, (NASDAQ: NAOV), a medical device company
utilizing the Company's proprietary and patented low intensity
surface acoustic wave (SAW) technology, today provided the
following business update and letter to shareholders from its Chief
Executive Officer, Brian Murphy:
"It is my sincere pleasure to address you through this letter
and inform you of the progress, opportunities and potential of
NanoVibronix. I hope to use this letter as a means to highlight the
work we have done, but more importantly, the work we intend to do
to build upon our success.
As you may already be aware, I have worked in the medical device
and medical biologics industry for over 30 years. My background is
mostly commercialization of new technologies at various levels in
each organization, from sales to the executive level. Our Chairman,
Christopher Fashek, whom I have worked with for many years, also
has an extraordinarily successful history in commercializing new
and existing technologies. It is the collective honor of our team
to have been given the opportunity to serve in these roles, for a
company with such an effective and versatile Surface Acoustic Wave
(SAW) technology platform. We believe that both our existing
products and future innovations will serve the medical community
well and benefit patients suffering from chronic
conditions.
As 2021 comes to a close, I want to share an overview of recent
accomplishments, provide an update on current projects and convey
our expectations relative to several impactful issues.
Sales and Marketing Activities
Our sales and marketing initiatives, which are gaining traction,
are focused on three distinct initiatives related to product
adoption and commercialization
- Reimbursement
- Support of our existing sales network
- Developing a critical mass as validation of product
acceptance
We continue to seek category specific license partners where
there is a mutual benefit. The foundationally necessary
components viewed as essential, include retaining quality
personnel, product integrity, and product cost.
Our activities related to reimbursement continue to show
progress. The PainShield™ product earned a dedicated Medicare
reimbursement code (K1004) several months ago, and we continue to
work toward a reimbursement value. We have retained the law firm
Latham & Watkins to assist the company in this area.
Additionally, we recently announced our first contractual
agreement in the Workers’ Compensation arena. Our product is
a great adjunct to the services provided in this market, and we
intend to pursue additional agreements of this nature.
Covid-19 has limited our ability to present our technologies in
person as many professional exhibitions have been cancelled or
became virtual. We continue to look for opportunities to present
and look forward to onsite participation at expos and trade
conferences as soon as those opportunities are available.
Demand for our products continues to strengthen, which we
believe will soon be reflected in our financial results.
Supply Chain
Like most business, supply chain constraints are currently a
challenge for our business, but we are identifying alternative and
parllel sources for componentry, with the additional benefit of
improved economics sourcing. In addition to component alternatives,
we are also exploring contract manufacturing opportunities. While
we ended the third quarter with a backlog of orders, we expect to
be current with fulfillments by the end of Q4.
We have committed to a Q1 2022 delivery of a more significant
quantity than ever before.
Product Validation Research
The success of medical devices is reliant upon strong clinical
evidence, and we have been active in this area. Following the
succesful independent study published earlier this year, we are
completing an additional clinical study in the United Kingdom on
UroShield™ which we expect to be published next year. Additionally,
we recently released the final results of a randomized control
trial using PainShield™ to treat the pain and physical limitations
of Tennis Elbow (Lateral Epicondylitis). The tennis
elbow study achieved exceptional results using
PainShield™,reporting an incredible 92% effectiveness in resolving
the pain associated with Lateral Epicondylitis, solid proof of an
effective clinical application.
The UroShield™ is currently approved for sale in the United
States, Europe, Australasia and India and has been shown to
prevent Catheter Associated Urinary Tract Infection (CAUTI).
The PainShield™ is currently approved for sale in the United
States, Europe, Australasia and India, and is intended to treat and
resolve pain through the application of our proprietary, patented,
Surface Acoustic Wave (SAW) technology. We continue to
actively seek oppertunities to conduct further research and hope to
be able to update shortly.
New Product Development
We introducted two new products in the second half of this year,
PainShield Plus™ and PainShield Relief™. PainShield Plus has
already been shipped to customers and is performing well. We expect
PainShield Relief, our over-the-counter product, to be submitted
for 510K clearance by the end of November. We are awaiting
final testing of the product’s energy production technical
performance, which is on schedule to be completed by mid-November.
Once submitted to the Federal Drug Administration (FDA), we expect
a response within 90 days with a target release for clearance in Q1
2022.
Catalysts
There are several expected near-term catalysts for our business
including:
- Completion of NHS evaluation of UroShield. After a lengthy
clinical and economic NHS evaluation of UroShield, we expect NICE
Guidance to be completed in the next few months. Accordingly, we
are actively preparing for NHS adoption of UroShield in early
2022.
- Launch of PainShield Relief, our first non-prescription device
for the consumer market
- Launch of sales in Canada and the Middle East
- Granting of three additional patents by the end of 2021
- Continued growth and product adoption from our distributor
network
Balance Sheet
Our balance sheet remains strong with approximately $8.6 million
in cash and no debt, outside of the ordinary course of business
payables, as of September 30,2021 providing us with the financial
flexibility and capital to fund our growth initiatives, support
manufacuturing to deliver on an increasing level of orders and
invest in product development.
In Conclusion
Much has changed over the past year and many more changes and
improvements are planned. I believe the most significant change is
how rapidly we are advancing our product sales, despite the
headwinds caused by Covid-19. We have several significant“shots on
goal” and are always looking for the opportunity to add more. Any
one of these could singularly transform the company relative to our
profile today. While there is still much work to be done, be
assured that I am dedicated to a successful NanoVibronix.
I wish all of our shareholders Happy Holidays.”
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company
headquartered in Elmsford, NY with research and development in
Nesher, Israel, that is focused on developing medical devices
utilizing its proprietary and patented low intensity surface
acoustic wave technology. The company's 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, (ii) negative clinical trial results or lengthy
product delays in key markets, (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 raising 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.
Brett Maas
Managing Principal, Hayden IR, LLC
646-536-7331
brett@haydenir.com
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