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 its stockholders from its Chief
Executive Officer, Brian Murphy, providing a review of the second
quarter financials and recent business developments.
To Our Shareholders:
We are committed to our strategic vision of developing,
improving and 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
stockholder value. We are focused on several areas that we believe
will have a substantial impact on our growth and product adoption.
Many of those areas of focus have begun showing positive results,
as reflected in our most recent quarter’s financial results for the
quarter ended June 30, 2024. Our products continue to deliver
impressive outcomes with high patient satisfaction, with no
reportable adverse events. Moreover, we are investing in sales
improvement and long-term opportunities with all of our
products.
Q2 Financial Results
We recorded revenues of approximately $817,000 for the quarter
ended June 30, 2024, which is the largest amount of revenues we
have ever recorded in the second quarter of any fiscal year and
more than 2.5 times the revenue we generated for the same period in
2023. Compared to the quarter ended June 30, 2023, the loss from
operations was reduced by more than 30% to approximately
($674,000). We continue to generate increased revenues from the
Veterans’ Health System and Workers' Compensation market segments
and our dealer network even as we continue to reduce operating
costs. Our balance sheet remains strong, with approximately $2.2
million of cash and inventory of approximately $2.4 million as of
June 30, 2024.
Domestic update
We continue to make progress in several channels of domestic
sales and product adoption. Our Veterans' Affairs penetration
continues to improve in terms of the number of facilities served,
and we have added valuable sales resources in areas previously
uncovered by our current sales partner, Delta Medical.
Delta Medical was awarded a GSA grant that we believe will
provide for an accelerated uptick in product adoption within the
Veterans' Health facilities. The GSA contract became effective on
May 1, 2024, so we have yet to realize a full quarter impact. The
GSA contract is expected to have a positive impact on both sales
and adoption, as well as provide a significant competitive
advantage, and we are optimistic that we will see the effects of
the GSA in the second half of 2024. We are also optimistic about
our future sales growth within this important business sector.
Additionally, we continue to make progress in the Workers’
Compensation area of our business, from multiple sales channels.
Our Durable Medical Equipment (“DME”) exclusive distributor has
been steadily delivering and expanding its reach through the
addition of qualified and competent dealers, and we believe there
is significant upside potential in this area. We are gratified to
see the adoption of PainShield increase within both reimbursable
market segments and become the accepted product of choice for the
DME market. The PainShield product family is increasingly becoming
a recognizable and acceptable standard for pain relief and the
avoidance of opioids.
Reimbursement
Reimbursement is currently approved in the Veterans’ Health
System and several Workers' Compensation plans, Third Party
Administrators and insurance companies. Our revenues in these
markets have grown and continue to grow substantially. Through our
strategic, exclusive distributor partners for select markets, and
through our direct sales efforts, we are seeing growth every month.
The sales growth follows the payer and patient testimonials of
superior product efficacy, which is heavily scrutinized in these
markets. It is truly gratifying to witness the product loyalty and
increased adoption of PainShield.
Reimbursement for UroShield remains in effect for the Veterans'
Administration segment.
International update
We continue to make progress and generate additional sales in
the Australian and New Zealand markets. Full reimbursement for
UroShield is being considered in both markets, although the timing
is unknown at this point in time. If reimbursement is granted, we
believe there could be a significant increase in demand for our
urology products.
In the U.K., we continue to leverage our contract with the
National Health Services (“NHS”) Supply Chain and our supplies
reimbursement through the NHS Prescription Services’ Drug Tariff,
which became effective on November 1, 2023. We continue to make
progress with our UroShield product and have experienced more
interest since then. Our U.K. distributor, Peak Medical Limited,
continues to add to its inventory and is actively pursuing market
opportunities throughout the country.
Relative to the broader market in Europe, we are continuing our
evaluation with a significant urologic pharmaceutical company based
in Germany. Our previous announcement of the evaluation with
Apogepha Pharmaceutical, Inc. provides more detail, the link of
which can be found here. The synergy between the companies will
provide for a mutually beneficial opportunity. We expect to provide
updates regarding this matter in the near future.
Research
The University of Michigan will begin facilitating a gold
standard Randomized Control Trial (RCT) study on the efficacy and
patient satisfaction of patients utilizing UroShield. The research,
which is being led by the Center for Research and Innovations in
Special Populations (CRIISP), an experienced and highly
accomplished research team, will be conducted primarily with
nursing home residents and is aimed at studying the impact
UroShield may have on reducing urinary tract infections, catheter
blockages and pain and improving the quality of life of the
patients studied. The first phase of the study was originally
expected to include a validation pilot of up to 30 patients in
advance of the full study. The full study is expected to include
more than 300 patients. Reevaluating the pilot with the University
of Michigan team, we mutually believe we can achieve the desired
results of the pilot with just 20 patients, and at this time, we
have 15 patients enrolled. We look forward to receiving the
researchers’ conclusions on the pilot, and are hopeful of positive
outcomes for patients in the broader study.
Product development
We have been working on several exciting improvements to the
existing product portfolio as well as exploring new product
opportunities. The goals of the product development are to improve
the therapy, reduce costs and “future-proof” the componentry. The
“kick-off” for the project began on time and the development
process is progressing rapidly.
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
near-term demand.
We continue to negotiate for sector-specific private label
agreements. This strategy is intended to develop long-lasting,
profitable, forecastable revenue. COVID-19 interrupted our
momentum, but these discussions are moving forward.
In the near-term, we are primarily focused on achieving the
following milestones:
- Supplementing distribution to achieve broader geographic
coverage in both VA and Workers' Compensation channels
- Selection of UroShield distribution to key markets
- Adding market segment specific distribution for PainShield in
the U.S.
- Finalizing a private label partnership for PainShield in the
U.S.
- Expanding UroShield distribution throughout the world.
Thank you for your continued support. We remain optimistic and
motivated to deliver improved results for 2024.
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/20240821272005/en/
Investor Contact: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
NanoVibronix (NASDAQ:NAOV)
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