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 in a letter to shareholders from its
Chief Executive Officer, Brian Murphy:
To Our Shareholders:
Today, I would like to provide you with an update on the
progress we are making towards scaling our business and unlocking
the full value of our products. We continue to believe that our
vision for a fully commercialized portfolio of distinct and
effective therapies will be realized. The long-term investment
thesis for our business remains unchanged despite elongated
regulatory approvals and near-term challenges we are working to
overcome.
Sales and Distribution
Currently, the majority of our sales, more than 90% for the
first nine months of 2022, are derived from our relationships with
outside distributors in the U.S. market.
In the Workers’ Compensation market, we continue to sign
additional contracts that increase access to our products and
streamline the claims and reimbursement processes for providers and
their patients. We attended the Workers’ Compensation Institute
(WCI) national conference in August. The WCI conference brings
together insurance companies, clinicians, key decision makers and
influencers. While at the conference we met with several
prospective TPA customers who have needs for pain resolution
products for their patients.
In our Veterans’ Administration sales channel, we continue to
improve penetration within the VA hospitals and facilities, which
we believe will lead to increased revenues starting in the fourth
quarter of this year. We have overcome early administrative
challenges that hindered orders. Our VA partner, Delta Medical,
continues to add resources and has intensified its efforts to serve
more patients. With broad clinician support, our products are
available in more than 100 veterans’ facilities across the U.S.
We hope to bolster our sales by adding international
distribution partners. On that front, we are currently in
negotiations with a European-based partner to assist us with
obtaining qualified distributors and potentially, private label
partners for sales of our UroShield product.
Operations
Significantly, we recently completed the transition of most of
our third-party manufacturing operations to Singapore and received
our first finished product in September. The shift of manufacturing
to Singapore reduces our risk to supply disruptions and
geopolitical instability and puts us in a stronger position to
scale our manufacturing and increase throughput as needed.
Advancement of Regulatory Approvals and Research
We continue to advance our efforts related to regulatory
approvals and research on multiple fronts.
PainShield was granted a dedicated reimbursement code (K1004) by
the Centers for Medicare and Medicaid (CMS) in 2021, which was an
initial step towards paving the way for many millions of
beneficiaries enrolled in Medicare to have access to our product.
Pricing was not established at that time, and our efforts to obtain
favorable pricing resulted in a denial, pending further testing of
the device’s life expectancy. Testing to gather life expectancy
data began in October, and we are preparing to demonstrate the life
expectancy in the next few months. We are hopeful of a positive
outcome that will allow us to secure pricing and remove the
barriers for distribution to beneficiaries under Medicare.
Similarly, approval of PainShield Plus by the U.S. Food and Drug
Administration (FDA) has been slower than we had hoped. Following
submission of a Special 510K application, the FDA has requested
clarifications and requested that we discontinue any new marketing
of our PainShield Plus products until we receive formal approval
that the devices meet the predicate product category
specifications. We are engaged with two separate engineering firms
to assist with the preparation of additional test data that was
requested by the FDA. This delay has hindered an increase in
purchasing volumes. Although, we continue to believe that upon
approval, this product will be back on track and increase our
revenue from certain channels.
Upon FDA approval of our PainShield Plus product, we expect to
submit PainShield Relief, our over-the-counter product, to the FDA,
pending a small-scale technical study. Given that this product
would be made available without a prescription, we believe that the
opportunities are vast. Not only should we be able to leverage our
sports injury research, but also allow consumer access to a
distinct and highly effective source of pain relief, at a
reasonable pricing structure.
Leveraging on our contract with the NHS Supply Chain, we
continue to make progress in attempting to prove the need and
viability of our UroShield product. The In Vivo study conducted by
Southampton University in the United Kingdom was recently
completed. Interim results are pending. We anticipate two
additional studies to be initiated in early 2023, one in the U.K.
and one in the U.S. The market opportunities for UroShield are
plentiful, and we expect contribution from this product will
increase over time as we continue with our marketing initiatives
and launch our ‘Gold Standard’ study.
Thank you for your continued support.
Kind regards,
Brian Murphy Chief Executive Officer
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) market acceptance of our
existing and new products or lengthy product delays in key markets;
(ii) negative or unreliable clinical trial results; (iii) 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 subcontractor assistance; (viii) insufficient or
inadequate reimbursements by governmental and/or other third party
payers for our products; (ix) our ability to successfully obtain
and maintain intellectual property protection covering our
products; (x) legislative or regulatory reform impacting the
healthcare system in the U.S. or in foreign jurisdictions; (xi) our
reliance on single suppliers for certain product components; (xii)
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; (xiii) 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 (xiv) 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221115005977/en/
Investor Contacts: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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