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 first quarter of
2024 and recent business developments.
To Our Stockholders:
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 and fill a void in the market, which has the potential to
increase value for our stockholders. We are focused on several
areas that we believe will have a substantial impact on our growth
and product adoption. Many of these areas of focus have begun
showing positive results, as reflected in our most recent quarterly
financial results. Our products continue to deliver impressive
results with high patient satisfaction, with no demonstrated
adverse events. We are also investing in sales improvement and
long-term opportunities with all of our products.
Q1 2024 Financial Results
We recorded revenues of approximately $921,000 for the quarter
ended March 31, 2024, which is the largest amount of revenue we
have ever recorded in the first quarter of any year, and a loss
from operations of approximately $568,000. We continue to generate
increased revenues from the Veterans’ Health System and worker’s
compensation market segments. Our balance sheet remains strong with
approximately $2.7 million of cash and inventory of approximately
$2.6 million.
Domestic Update
We continue to make progress in several channels of domestic
sales and product adoption. Our penetration into the Veterans
Affairs (“VA”) continues to improve both in facilities served as
well as adoption within those facilities. With our VA partner,
Delta Medical, LLC, we were awarded a General Services
Administration (“GSA”) grant that provides for an accelerated
uptake in product adoption within the Veterans Health facilities.
The GSA contract became effective on May 1, 2024. We expect this
contract to have a positive impact on both sales and adoption of
our products, as well as provide a significant competitive
advantage. I am highly optimistic about our sales growth within
this important business sector. Additionally, we continue to make
progress in the workers’ compensation area of our business, both on
a direct basis and through our Durable Medical Equipment (“DME”)
exclusive distributor. We are also gratified to see the increase in
the adoption of PainShield within both reimbursable market
segments. The PainShield product family is quickly becoming a
recognizable and acceptable standard for pain relief and the
avoidance of opioids.
We recently announced the addition of a distributor for our
UroShield within the VA system, CB Medical, LLC (“CB Medical”). VA
patients represent a significant opportunity for UroShield due to
increased lengths of stay at VA facilities and high acuity. CB
Medical is well positioned to establish a foothold in the VA with
our product that can benefit its patients.
Reimbursement
Reimbursement is currently approved in the Veterans’ Health
System and several worker’s compensation plans, third party
administrators and insurance companies. Our revenues in these
markets have, and continue to, grow substantially. Through our
strategic, exclusive distribution 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 that
illustrate superior product efficacy.
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
of a decision is unknown at this point in time. If reimbursement is
granted, we believe there would be a significant increase in demand
for our urology products in these markets.
In the United Kingdom 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
significant 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. Our fourth quarter
2023 sales in the U.K. surpassed the cuumulative total sales since
first introducing the product into 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. This link will
take you to the company’s press release. The synergy between the
two companies will provide for a mutually beneficial opportunity. A
decision on a path forward should be made in the very short
term.
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 will 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.
Patient enrollment for the pilot phase is currently underway. We
look forward to receiving the researchers’ conclusions and are
hopeful of positive outcomes for patients in the study.
UroShield is marketed under the U.S. Food and Drug
Administration’s (“FDA”) Enforcement Discretion, the intent of this
independent study is to support an application to the FDA for
permanent clearance. RCTs are considered the ‘gold standard’ in
clinical research, and we are pleased to be working with the team
at the University of Michigan.
Product development
We have been working on several exciting improvements to our
existing product portfolio, as well as exploring new product
opportunities. The goals of the product development are to improve
therapy, reduce costs and “future-proof” the componentry. The
“kick-off” for the product development project is scheduled for the
first week of June 2024.
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
we believe we have the necessary working capital to meet existing
and anticipated demand.
We continue to negotiate sector-specific private label
agreements. This strategy is intended to develop long lasting,
profitable, forecastable revenue. The COVID-19 pandemic 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 to achieve broader geographic
coverage in both VA and worker’s compensation channels;
- selection of UroShield distribution for key markets;
- adding market segment-specific distributions for PainShield in
the U.S.;
- finalizing a private label partnership for PainShield in the
U.S.; and
- expanding UroShield distribution in Europe and the U.S.
Thank you for your continued support. We remain very 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/20240516840704/en/
Investor Contacts: Brett Maas, Managing Principal, Hayden
IR, LLC brett@haydenir.com (646) 536-7331
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