Lays out key upcoming milestones for the
next 12 months
NanoVibronix, Inc, (NASDAQ: NAOV), a medical
device company utilizing the Company's proprietary and patented low
intensity surface acoustic wave (SAW) technology, today provided a
business update for the third quarter ended September 30, 2018.
Brian Murphy, Chief Executive Officer of NanoVibronix,
commented, "When I first joined NanoVibronix as CEO, the Company
had developed a potentially breakthrough technology, but lacked the
key ingredients for success. The past 12 months have been
transformational for the Company, as we have laid the foundation
for our commercial launch in each of the key verticals.
First, we completed a number of important trials that will be
important for expanded regulatory approvals and validation for
distributors as well as potential partners. We have a number
of additional trials planned that we expect to complete
near-term. Additionally, we have put in place the commercial
infrastructure necessary to support an aggressive launch.
Specifically, we have added a number of key hires to support our
global sales and marketing initiatives. We also added a
number of distributors in key markets. In the coming months,
we plan to announce a number of additional distributors in both the
domestic and international markets.
Looking ahead, we are seeking to accomplish a number of major
milestones that should help drive value for shareholders, as
outlined below:
UroShield:
- Publication of study in International Journal of Urology: Q4
2018
- Trial results compiled and expected 510(K) Class 2 filing to
FDA in 1Q 2019
- Target FDA approval of 510K in 3Q 2019
- Projected target US launch in 3-4Q 2019
- Submission for National Health System approval through rapid
review process in Q1 2019
- Targeted NHS approval in Q2 2019
- Adding additional domestic and international distributors
PainShield:
- Complete safety & usability studies for clearance without
prescription requirement: planned for Q1 2019
- Add additional domestic and international distributors
- License agreements with large scale providers
- License agreements with manufacturer
WoundShield
- Add additional domestic and international distributors
LungShield™ & RenooSkin™
- Active discussions with strategic partners
All products
- Streamlined manufacturing and outsourcing to reduce cost and
scale: planned for Q1 2019
Overall, we are building substantial clinical data supporting
the clinical efficacy of our devices. To-date, we have now
completed the following clinical studies for our UroShield
device:
- 56 patient randomized control trial in the U.S.
- 23 patient randomized control in the U.K.
- Economic impact study in the U.K.
- An in vitro study in the U.K. that is nearly complete
- 5 smaller completed studies covering 139 patients
We recently met with the FDA and expect to file a 510(K) Class 2
filing in the first quarter of 2019. Towards this end, we
have several smaller studies planned and underway we expect to
include in our submission, which we believe will help support our
application, including an animal model in sheep, a comparative
study of leachables from a urinary catheter with and without
UroShield attached, which is already underway, and a small study of
patients with neurogenic bladder dysfunction. Given our past
clinical data we are quite confident in our FDA submission and our
goal is to receive marketing clearance in the U.S. by the third
quarter of 2019, which we believe will be a major milestone for the
Company. In the meantime, we are in active discussions with a
number of potential partners in the U.S. and abroad, all of which
should help drive value for shareholders. To-date, we have
signed agreements with IMS Medical in the U.K., Instrumed Surgical
in Canada and Morulaa HealthTech in India.
Turning to PainShield, we have signed a distribution agreement
with Fabrication Enterprises in the U.S., Golfballs.com covering
both the U.S. and international markets, IMS Medical in the UK,
Morulaa HealthTech in India and M.D.S. Pharm Ltd. in Israel.
We are very pleased with the strong support we have witnessed from
both potential partners, as well as patients already using the
device, including a number of high-profile sports celebrities who
have publicly endorsed the product. We currently qualify for
reimbursement codes in the United States for clinical use only,
which require a prescription. We are currently conducting
additional safety and usability studies to secure clearance without
a prescription requirement, which we expect to complete by the
first quarter of 2019. We believe this will help to
dramatically expand the addressable market and remove a major
barrier to commercial adoption by consumers. Towards this end and
to satisfy the requirements of the FDA, we are completing a
usability study to reinforce ease of use for consumers, redesigning
the product, and revamping the user manuals and reference guides to
meet OTC and FDA requirements. We believe these initiatives
will help facilitate our approvals.
In terms of the supporting clinical data for PainShield, we
recently completed a double blinded, crossover trial across the US
for patients with trigeminal neuralgia, which is considered one of
the most chronically painful conditions and is associated with a
high suicide rate directly attributable to the condition. As
previously disclosed, this trial included 59 patients with a
diagnosis of unilateral trigeminal neuralgia; 30 in the active
treatment group and 29 in the control group. The treatment
group saw a 55.2% improvement in baseline scores vs 2.3% for
control group. The treatment group saw a 46.4% reduction in
breakthrough pain medication versus 1.5% for the control group. We
believe the results of this study are quite compelling, and our
plan is to have the final comprehensive data submitted for
publication in a leading industry journal.
Finally, we are moving forward with a number of
initiatives with WoundShield, LungShield™ and RenooSkin™. In
the meantime, we continue to carefully manage our expenses.
We have maintained a clean capital structure with sufficient cash
to accomplish our near-term goals and have no long-term debt.
Overall, we are making tremendous progress and look forward to
providing further updates to shareholders in the months ahead.”
The Company filed its Form 10-Q for the period ended September
30, 2018, with the Securities and Exchange Commission on November
14, 2018, which is available on the SEC’s website, www.sec.gov, or
the Company’s website, www.nanovibronix.com.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company
headquartered in Elmsford, New York with research and development
in Nesher, Israel, that is focused on developing medical devices
utilizing its proprietary and patented low intensity surface
acoustic wave technology. The company's technology allows for the
creation of low-frequency ultrasound waves that can be utilized for
a variety of medical applications, including the disruption of
biofilms and bacteria colonization, as well as providing 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. Additional
information about the company 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 and 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, (ii) negative clinical trial results or lengthy
product delays in key markets, (iii) an 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 subcontractors for assistance, (viii) insufficient or
inadequate reimbursement by governmental and other third party
payers for our products, (ix) our efforts to successfully obtain
and maintain intellectual property protection covering our
products, which may not be successful, (x) legislative or
regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for
certain product components, (xii) the fact that we will need to
raise additional capital to meet our business requirements in the
future and that such capital raising may be costly, dilutive or
difficult to obtain and (xiii) the fact that we conduct business in
multiple foreign jurisdictions, exposing us to foreign currency
exchange rate fluctuations, logistical and communications
challenges, burdens and costs of compliance with foreign laws and
political and economic instability in each jurisdiction. 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.
Investor Contact:Crescendo
Communicationsnaov@crescendo-ir.com212-671-1021
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