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 year in review and
vision for 2021.
To Our Shareholders:
NanoVibronix is committed to our strategic vision of
commercializing our distinct and effective therapies which we
believe enable us to treat patients in need, fill a void in the
market, and have the potential to significantly increase value for
our shareholders. Through a challenging 2020, we have managed to
improve and expand our portfolio, strengthen our regulatory status,
and shore up our capital position. We enter 2021 a stronger company
in the areas of product portfolio, regulatory status, manufacturing
capacity and financial backing, poised to deliver growth in 2021 as
the macro environment improves.
2020 Year in Review:
NanoVibronix entered 2020 on a high note, with the initiation of
our new contract manufacturer providing greater capacity for
finished product, a newly designed portfolio, a private label
agreement, two licensing agreements executed, and much more. The
global pandemic temporarily dampened the optimistic start to the
beginning of 2020, and delayed much of what we had planned. We used
that time to further refine all aspects of our business in order to
be better prepared for the future … near and far. Here are some of
our accomplishments of 2020:
First and foremost, in late September, the FDA decided to
exercise its Enforcement Discretion to allow distribution of the
UroShield device in the United States during the COVID-19 pandemic.
This was the culmination of months of work and cooperation with the
FDA reviewers, who saw UroShield as a potential benefit to COVID-19
patients, and the risk associated with Catheter Associated Urinary
Tract Infection.
Another major milestone was achieved in December, when
NanoVibronix entered into a distribution agreement with Ultra Pain
Products, Inc, granting them the exclusive right to sell the
updated PainShield® products to and through distributors within the
DME sector. The exclusive arrangement is contingent upon meeting a
minimum of $7.8 million in product purchases over the next 3
years.
As mentioned above, NanoVibronix shored up our capital position
with three separate capital raises. Between August 27 and December
7, we raised approximately $11.2 million in gross proceeds and $9.6
million in net proceeds through three financings in which we sold
in aggregate approximately 15 million shares of our common stock at
an average price of $0.75 a share. It should also be noted that no
warrants were issued to investors in these offerings.
Other accomplishments and advances in 2020 included:
- Expanding our patent portfolio.
- Executing a license agreement for Canada and Turkey.
- Fulfilling our first private label commitment to Medisana.
- Receiving the coveted Plus X Award 2020 for PainShield/PT 100
device in the categories of high quality, design, ease of use and
functionality.
- Coventry University reported statistically significant outcomes
for the company’s UroShield device. These results were provided to
NICE in the United Kingdom.
- Obtaining regulatory approval in New Zealand and fulfilled an
initial order to a dominant distributor there.
- Identifying and initiating a US contract manufacturer,
resulting in a relationship which should increase capacity with a
parallel source to finished product.
A look ahead to 2021:
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, and a solid manufacturing partner
and the necessary working capital to meet existing demand. The
progress we made during 2020 gives us confidence that 2021 could be
a year of notable financial improvement.
We continue to negotiate with sector specific private label
agreements. This strategy is intended to develop a long lasting,
profitable, forecastable revenue. Covid interrupted our momentum,
but we believe that we are on track to aggressively push these
discussions forward. From a capital perspective, the capital raises
completed during 2020 allowed us to maintain our NASDAQ listing as
well as providing us sufficient capital for our operations for the
foreseeable future.
We are determined to improve shareholder value through our
commercialization efforts and management practices. With relevant
technologies which are now more cost efficient, clinically
effective, and aesthetically up to date, our future is bright.
Thank you for your support through a difficult year, and we look
forward to a promising 2021.
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®,
UroShield® and WoundShield®, all of 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, e.g., 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210119005188/en/
Investor Contacts: NanoVibronix, Inc. Brian Murphy
bmurphy@nanovibronix.com (630) 338-5022 Or: Brett Maas, Managing
Principal, Hayden IR, LLC brett@haydenir.com (646) 536-7331
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From Jun 2024 to Jul 2024
NanoVibronix (NASDAQ:NAOV)
Historical Stock Chart
From Jul 2023 to Jul 2024