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:
We are making progress toward further commercialization and
efficiencies of our supply chain. We continue to grow our business
as exemplified by our 53% year-over-year growth in Q2. I can assure
you that our vision for a fully commercialized portfolio of
distinct and effective therapies and the investment thesis for our
business remain unchanged.
PainShield
Our PainShield family of products, which includes the original
PainShield MD, and pending clearance of PainShield MD Plus,
continues to comprise the majority of our business. There are a
number of work streams that are happening simultaneously to
increase distribution and get these products to those that can
benefit from them.
First, sales of PainShield MD to Veterans Administration (VA)
facilities are starting to increase, and we are encouraged by
increasing adoption. We have encountered a few administrative
challenges that have tamped down a more material increase in
orders. However, we are working diligently to overcome these ‘speed
bumps’ and are encouraged by the opportunities to further
strengthen this important revenue stream. Together with our VA
partner, Delta Medical, we are now ‘vendorized’ in over 100
Veterans facilities. In each of these facilities, many of the
clinicians support utilizing PainShield to address chronic pain and
prevention of opioids.
In May, we informed you that we submitted a 510(k) application
to the U.S. Food and Drug Administration (FDA) for our PainShield®
MD PLUS, a dual-actuator ultrasound pain therapy device. PainShield
Plus leverages the technology of its predicate device, PainShield
MD, to provide pain relief and treat soft tissue injuries. Since
that time, the FDA has requested clarifications, and we are working
to provide a timely response. We look forward to providing further
updates as we progress through the process with the FDA. Upon
approval, we believe that this product can help increase our
revenue, and we expect to have available inventory to meet the
expected demand.
PainShield Relief, our over-the-counter product, is ready for
submission to the FDA pending a small-scale technical study. Given
that this product will be made available without a prescription,
the opportunities are vast. Not only will we be able to leverage
our sports injury research, but also allow consumer access to a
distinct and highly effective source of pain relief.
We are continuing our efforts to gain approval from the Centers
for Medicare and Medicaid (CMS) to receive a reimbursement code for
our PainShield products. We presented to the HCPCS Work Group
earlier this summer and have provided the requested documentation.
There has been a high degree of communication and cooperation
between CMS and NanoVibronix, including a recent on-on-one
committee call. We are hopeful of receiving a positive Benefit
Category Determination and valuation.
In the Workers’ Compensation space, we are in advanced
discussions with another large workers’ compensation intermediary
to include PainShield. We expect this relationship can further
accelerate our penetration into the workers’ comp space as we exit
2022. Furthermore, we will be attending the Workers’ Compensation
Institute (WCI) national conference to meet with prospective
customers and network with professional to generate additional
sales leads. The WCI conference brings together insurance
companies, clinicians, key decision makers and influencers.
We believe that each of these workstreams is a key lever for
increasing units sold and accelerating our growth. Collectively, we
expect they will drive meaningful improvement to our top-line.
UroShield
The opportunities for UroShield remain 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.
The Randomized Control Trial (RCT) , which is currently in the
design stage, will soon initiate a contract with a Principal
Investigator. The study is intended to fill the gap in our clinical
evidence which will be required by the FDA for permanent 510K
clearance.
Earlier this year, we signed an international marketing, sales
and clinical management agreement with Medtech Solutions Group
(MTSG), a leader in the commercialization of healthcare
technologies, to help us commercialize UroShield and PainShield in
certain parts of Europe, Asia, Africa, South America and the Middle
East. Since that time, we are evaluating with several opportunities
that have been presented to our management team.
Our Australian distributor, DukeHill, launched an educational
webinar series for UroShield a few weeks ago to increase awareness
of the product and drive increased sales. It is our intent to
conduct additional webinars like this, to assist them in the
adoption of UroShield in Australia.
Operations
Earlier this summer, we announced our plans to shift the
majority of our third-party manufacturing operations to Singapore.
This transition is nearly completed, and we will benefit from
increased efficiencies while reducing our risk of supply
disruptions and geopolitical instability going forward. This move
also puts us in a stronger position to be able to scale our
manufacturing and increase throughput to meet increases in demand.
The first finished product is expected to be delivered in
September.
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) 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220818005573/en/
Investor Contact: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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