NanoVibronix, Inc., (NASDAQ: NAOV), a medical device
company that produces the UroShield®, PainShield® and WoundShield®
Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic
Devices, today issued a letter to shareholders from its Chief
Executive Officer, Brian Murphy, providing a review of the first
quarter 2023 and recent business developments.
To Our Shareholders:
NanoVibronix is committed to our strategic vision of
commercializing our distinct and effective therapies, which we
believe enable healthcare providers to treat patients in need, fill
a void in the market and have the potential to increase value for
our shareholders. We are focused on several areas, which we believe
will have a substantial impact on our growth and product adoption.
Our products continue to deliver impressive results with high
patient satisfaction.
Our ongoing efforts to obtain full approval from the Centers for
Medicare & Medicaid Services (“CMS”) with acceptable terms is
now in its fourth year. In the last cycle, our application for full
approval was not approved due to a lack of ‘life-cycle’ testing,
which was required by CMS. We immediately engaged an independent
testing laboratory, Carmel Labs, to conduct the testing. The
testing was intended to satisfy the requirement for a three-year
life expectancy with consideration to our patient use criteria. We
submitted the final report with our application to CMS in March
2023. The report provided the required information the regulatory
agency was seeking. As a result, CMS has invited NanoVibronix to a
public meeting to present our findings and to answer CMS’s
questions, which is scheduled to be held on June 1, 2023. We are
hopeful for a favorable outcome to this extraordinarily long and
laborious process. If successful, we expect such outcome will open
several opportunities that have stalled due to the lack of Medicare
reimbursement.
Reimbursement is currently approved in the Veterans Health
system and several Worker’s Compensation segments. Our sales
continue to grow in both segments, and we are in the process of
adding sales resources where we believe are appropriate.
We continue to make progress in two international markets where
full reimbursement is being considered. This, again, is expected to
significantly enhance our opportunities in these two key
markets.
We expect that two additional UroShield studies will be
initiated in 2023, one in the U.K. and one in the U.S. The market
opportunities for UroShield are plentiful, and as such, we are
hopeful that contribution from this product will increase over time
as we continue with our marketing initiatives and initiate our
‘Gold Standard’ study with a major U.S. university.
In the U.K., we continue to leverage our contract with NHS
Supply Chain. We continue to make progress towards communicating
the need and viability of our Uroshield product. Our new UK
distributor, Peak Medical, continues to aggressively pursue market
opportunities throughout the country.
Q1 Financial Results
We recorded revenues of $354,000 for the quarter ended March 31,
2023 with an operating loss of $1.1 million. We started to receive
orders for our Painshield Plus product in Q1. On our balance sheet
for the quarter ended March 31, 2023, we had $1.5 million of cash
and inventory in excess of $2.2 million.
A look ahead:
We remain focused on driving profitable growth by expanding and
increasing our distribution and licensing channels, nurturing
relationships with new and existing accounts and engaging consumers
through a variety of creative mediums. Today, we have initial
distribution agreements in place, a solid manufacturing partner and
the necessary working capital to meet existing and anticipated
demand.
We continue to negotiate for sector-specific private label
agreements. This strategy is intended to develop long lasting,
profitable, forecastable revenue. Covid-19 interupted our momentum,
but we believe that we are on track to aggressively push these
discussions forward.
In the near-term, we are primarily focused on achieving the
following milestones:
- Supplementing distribution in both VA and Worker’s Compensation
channels
- Identifying and initiating a U.S. contract manufacturer to
increase capacity with a parallel source to finished product
- Capitalizing on the new NHS supply contract through our UK
distributor
- Adding market segment specific distribution for PainShield in
the US
- Finalizing a private label partnership for PainShield in the
US
Thank you for your continued support. We are optimistic for a
promising 2023.
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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Investor Contacts: Brett Maas, Managing Principal, Hayden IR,
LLC brett@haydenir.com (646) 536-7331
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