SUBJECT
TO COMPLETION, DATED
MAY 13, 2019
PROSPECTUS
NanoVibronix,
Inc.
$15,000,000
Common
Stock
Preferred
Stock
Warrants
Units
We
may offer and sell from time to time, in one or more series or issuances and on terms that we will determine at the time of the
offering, any combination of the securities described in this prospectus, up to an aggregate amount of $15,000,000.
We
will provide specific terms of any offering in a supplement to this prospectus. Any prospectus supplement may also add, update,
or change information contained in this prospectus. You should carefully read this prospectus and the applicable prospectus supplement
as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before you purchase any of
the securities offered hereby.
These
securities may be offered and sold in the same offering or in separate offerings; to or through underwriters, dealers, and agents;
or directly to purchasers. The names of any underwriters, dealers, or agents involved in the sale of our securities, their compensation
and any over-allotment options held by them will be described in the applicable prospectus supplement. See “Plan of Distribution.”
Our
common stock is listed on the Nasdaq Capital Market under the symbol “NAOV.” On May 10, 2019, the last reported sale
price of our common stock as reported on the Nasdaq Capital Market was $ 3.20 per share. We recommend
that you obtain current market quotations for our common stock prior to making an investment decision. We will provide information
in any applicable prospectus supplement regarding any listing of securities other than shares of our common stock on any securities
exchange.
As
of May 10, 2019, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float, was
approximately
$12,835,917,
which was calculated based on 4,011,224 shares of our outstanding
common stock held by non-affiliates and a price of $3.20 per share, the last reported sale price for our common stock on May
10, 2019. We have not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during the 12 calendar months
prior to and including the date of this prospectus.
You
should carefully read this prospectus, any prospectus supplement relating to any specific offering of securities, and all information
incorporated by reference herein and therein.
Investing
in our securities involves a high degree of risk. These risks are discussed in this prospectus under “Risk Factors”
beginning on page 9 and in the documents incorporated by reference into this prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is May , 2019
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission using a “shelf”
registration process. Under this shelf process, we may, from time to time, sell any combination of the securities described in
this prospectus in one or more offerings up to a total amount of $15,000,000.
This
prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide
a prospectus supplement that will contain specific information about the terms of that offering. The prospectus supplement may
also add to, update or change information contained in the prospectus and, accordingly, to the extent inconsistent, information
in this prospectus is superseded by the information in the prospectus supplement.
The
prospectus supplement to be attached to the front of this prospectus may describe, as applicable: the terms of the securities
offered; the public offering price; the price paid for the securities; net proceeds; and the other specific terms related to the
offering of the securities.
You
should only rely on the information contained or incorporated by reference in this prospectus and any prospectus supplement or
issuer free writing prospectus relating to a particular offering. No person has been authorized to give any information or make
any representations in connection with this offering other than those contained or incorporated by reference in this prospectus,
any accompanying prospectus supplement and any related issuer free writing prospectus in connection with the offering described
herein and therein, and, if given or made, such information or representations must not be relied upon as having been authorized
by us. Neither this prospectus nor any prospectus supplement nor any related issuer free writing prospectus shall constitute an
offer to sell or a solicitation of an offer to buy offered securities in any jurisdiction in which it is unlawful for such person
to make such an offering or solicitation. This prospectus does not contain all of the information included in the registration
statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement,
including its exhibits.
You
should read the entire prospectus and any prospectus supplement and any related issuer free writing prospectus, as well as the
documents incorporated by reference into this prospectus or any prospectus supplement or any related issuer free writing prospectus,
before making an investment decision. Neither the delivery of this prospectus or any prospectus supplement or any issuer free
writing prospectus nor any sale made hereunder shall under any circumstances imply that the information contained or incorporated
by reference herein or in any prospectus supplement or issuer free writing prospectus is correct as of any date subsequent to
the date hereof or of such prospectus supplement or issuer free writing prospectus, as applicable. You should assume that the
information appearing in this prospectus, any prospectus supplement or any document incorporated by reference is accurate only
as of the date of the applicable documents, regardless of the time of delivery of this prospectus or any sale of securities. Our
business, financial condition, results of operations and prospects may have changed since that date.
PROSPECTUS
SUMMARY
This
summary provides an overview of selected information contained elsewhere or incorporated by reference in this prospectus and does
not contain all of the information you should consider before investing in our securities. You should carefully read the prospectus,
the information incorporated by reference and the registration statement of which this prospectus is a part in their entirety
before investing in our securities, including the information discussed under “Risk Factors” in this prospectus and
the documents incorporated by reference and our financial statements and related notes that are incorporated by reference in this
prospectus. As used in this prospectus, unless the context otherwise indicates, the terms “we,” “our,”
“us,” or “the Company” refer to NanoVibronix, Inc., a Delaware corporation, and its subsidiaries taken
as a whole.
Overview
We
were organized as a Delaware corporation in October 2003. Through our wholly-owned subsidiary, NanoVibronix Ltd., a private company
incorporated under the laws of the State of Israel, we focus on noninvasive biological response-activating devices that target
biofilm prevention, wound healing and pain therapy and can be administered at home, without the assistance of medical professionals.
Our primary products, which are in various stages of clinical and market development, currently consist of:
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UroShield™,
an ultrasound-based product that is designed to prevent bacterial colonization and biofilm
in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated
with urinary catheter use.
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PainShield™,
a patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint
contractures by delivering a localized ultrasound effect to treat pain and induce soft
tissue healing in a targeted area; and
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WoundShield™,
a patch-based therapeutic ultrasound device intended to facilitate tissue regeneration
and wound healing by using ultrasound to increase local capillary perfusion and tissue
oxygenation.
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Each
of our PainShield, UroShield, and WoundShield products employs a small, disposable transducer that transmits low frequency, low
intensity ultrasound acoustic waves that seek to repair and regenerate tissue, musculoskeletal and vascular structures, and decrease
biofilm formation on urinary catheters and associated urinary tract infections. Through their size, effectiveness and ease of
use, these products are intended to eliminate the need for technicians and medical personnel to manually administer ultrasound
treatment through large transducers, thereby promoting patient independence and enabling more cost-effective home-based care.
PainShield
is currently cleared for marketing in the United States by the U.S. Food and Drug Administration although to date there has not
been a significant sales and marketing effort. All three of our products have CE Mark approval in the European Union, and a certificate
allowing us to sell PainShield, UroShield and WoundShield in Israel. We are able to sell PainShield, UroShield and WoundShield
in India and Ecuador based on our CE Mark. We have consummated sales of PainShield and UroShield in the relevant markets, although
to date sales have been minimal; WoundShield has not generated significant revenue to date. Outside of the United States we generally
apply, through our distributor, for approval in a particular country for a particular product only when we have a distributor
in place with respect to such product.
In
the United States, PainShield requires a prescription from a licensed healthcare practitioner. If U.S. Food and Drug Administration
clearance is obtained, we anticipate that WoundShield and UroShield will require a prescription from a licensed healthcare practitioner
in the United States. We anticipate that UroShield will be sold directly to health care facilities and therefore will not require
a prescription for these venues. However, in other countries in which we sell PainShield, UroShield, and WoundShield, such products
are eligible for sale without a prescription. We are working toward a new PainShield 510(k) submission which would potentially
remove the requirement for a prescription.
In
addition to the need to obtain regulatory approvals, we anticipate that sales volumes and prices of our UroShield, PainShield,
and WoundShield products will depend in large part on the availability of insurance coverage and reimbursement from third party
payers. Third party payers include governmental programs such as Medicare and Medicaid in the United States, private insurance
plans and workers’ compensation plans. We do not currently have reimbursement codes for use of WoundShield in any of the
markets in which we have regulatory authority to sell WoundShield. Of the markets in which we have regulatory authority to sell
PainShield, we have reimbursement codes in the United States (i.e., CPT codes) for clinical use only, but do not have such reimbursement
codes for at-home use of the product, although the product is marketed and sold for such use. With respect to UroShield, which
may be used in a clinical and home setting, we do not currently have reimbursement codes in any of the markets in which we have
regulatory authority to sell UroShield. We anticipate that we will begin to seek reimbursement codes for use of our products in
the markets in which we have regulatory authority to sell such products; however, additional clinical data will be required in
order to obtain such reimbursement codes. Our current ongoing research and planned research may facilitate our ability to obtain
reimbursement codes and there is no guarantee that we will be successful in obtaining such codes quickly, or at all. We have engaged
a reimbursement expert, Redemption Revenue Cycle Solutions, LLC, to help facilitate private insurance reimbursement.
We
have completed six separate clinical studies with UroShield that together evaluated approximately 194 patients with urinary catheters.
In patients where the UroShield product was used there were no serious adverse events reported, while a variety of clinical beneficial
observations were seen including: catheter biofilm reduction, reduction in catheter associated pain, reduction in urinary tract
infections, and a significant decrease in bacteriuria rates. We recently completed a double blind clinical trial for UroShield
in the United States. The results of the study, entitled “The Effect of Surface Acoustic Waves on Bacterial Load and Preventing
Catheter-Associated Urinary Tract Infections (CAUTI) in Long Term Indwelling Catheters,” were published in the December
2018 issue of Medical & Surgical Urology, a peer-reviewed journal in the field of urology. In the study, 55 patients in a
skilled nursing facility chain treated with long term indwelling catheters were evaluated. There was a significant difference
between the treated group and the placebo group in the number of colony forming units (“CFU”) present upon evaluation,
as well as on the number of treated urinary tract infections (“UTI”), and the effect lasted beyond the time of active
treatment. The study concluded that the UroShield™ device was shown to be effective in significantly reducing the number
of CFUs in patients with indwelling catheters. The study also concluded that the UroShield™ device was shown to be effective
in reducing the number of treated UTIs in this patient population, and surface acoustic waves in the form of the UroShield™
device is an effective tool in the prevention of catheter-associated UTI and while further evaluation is encouraged, can be safely
utilized with a high likelihood of success. In July 2017, we engaged Idonea Solutions, Inc., an FDA consultant, to assist in our
efforts to obtain 510(K) clearance. If we are successful, we intend to pursue obtaining reimbursement codes and to target completion
of partnerships with leading catheter product companies for sales and marketing efforts in the United States. The Company has
entered into recent distribution partnerships for UroShield in the United States, U.K., Switzerland, Israel and India.
In
addition, we are currently ramping up our clinical development and marketing efforts in North America with respect to PainShield.
In February 2018, we completed a clinical trial to evaluate the effect of PainShield in patients with trigeminal neuralgia. The
double blinded, crossover trial was conducted across the United States and included 59 patients with a diagnosis of unilateral
trigeminal neuralgia. Among the 59 patients, 30 were in the active treatment group and 29 were in the control group. The values
which were assessed include Visual Analog Scale (“VAS”) pain score, both baseline prior to trial and VAS pain score
at the end of the study. The study also assessed breakthrough medications per week at the start of the trial and breakthrough
medications per week at the end of the trial, with a particular focus on the use of opioids. Breakthrough medications are used
for chronic pain directly related to the pre-existing trigeminal neuralgia condition.
There
was a significant difference in the outcomes of the two groups relative to pain, quality of life, and breakthrough medications
taken, which was directly correlated to pain experienced during treatment. Specifically, the control group saw an improvement
in baseline scores of 2.3% versus the treatment group, which saw a 55.2% improvement in baseline scores. Additionally, the control
group saw a reduction in breakthrough pain medication of 1.5% versus the treatment group, which saw a 46.4% reduction in breakthrough
pain medication.
The Company is beginning
a study which is intended to assess the PainShield’s ability to effectively treat Lateral Epicondylitis (Tennis Elbow).
This is a double blinded, randomized control trial. The study in ongoing, but intended to enroll 24 patients.
The Company has entered
into recent distribution partnerships for PainShield in the United States, Israel, India, Italy, United Kingdom, and Switzerland.
WoundShield
has been evaluated in two published clinical studies done to-date that suggest improved localized blood flow and oxygenation,
and improved topical oxygen saturation (Morykwas M, “Oxygen Therapy with Surface Acoustic Waveform Sonication,” European
Wound Management Association 2011; Covington S, “Ultrasound-Mediated Oxygen Delivery to Lower Extremity Wounds,” Wounds
2012; 24(8))). We supplied devices for these studies but had no further involvement with them. We are pursuing licensing opportunities
to develop commercial markets for the WoundShield product.
Business
Model
All
of our products consist of a reusable controller device and a disposable component, or transducer. The controllers have a life
expectancy of up to three years, while the disposable transducer has a life expectancy of up to a month and must be replaced to
provide the intended therapy. The components are purchased by either the distributor or end user for use in any of the intended
applications. Once the controller is purchased by the end user, recurring revenue will be realized by purchases of replacement
transducers to the extent that the end user continues treatment with our product.
Our products are intended
to be distributed both by independent distributors as well as by potential licensees. Distributor cost is discounted to account
for their intended margins, based upon purchase volumes and/or periodic purchase commitments, with the disposable transducer sold
and distributed in the same fashion. We currently have an established distributor network and are implementing certain criteria
within such network to ensure the appropriate assignment of a distributor or licensee. We also intend to add additional distributors
to our network.
Ultrasound
Technology and Our Products
As
noted above, our primary products are based on the use of low frequency ultrasound, which delivers energy through mechanical vibrations
in the form of sound waves. Ultrasound has long been used in physical therapy, physical medicine, rehabilitation and sports medicine.
Our proprietary technology
consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces
with a radius of up to 10 centimeters beyond the transducer. This technology allows us to treat wounds by implanting our transducers
into a small, portable self-adhering acoustic patch, thereby eliminating the need for technicians and medical personnel to manually
administer ultrasound therapy, which should reduce the cost of therapy. Moreover, we believe that, based upon the body of evidence,
the delivery of ultrasound through our portable devices is equal to or more effective than existing competitive products, as our
technology is better positioned to target the affected areas of the body.
While
there are currently a number of products on the market that treat pain through ultrasound therapy, we believe that our products
differentiate themselves because they are portable, without the requirement to be plugged into an outlet and they have a frequency
of 100kHz (in contrast to other devices, which have a frequency of 1MHz), which means our products do not produce heat that can
damage tissue. Our products can therefore (i) be self-administered by the patient without the need to be moved about the treated
area by the patient or a clinician, (ii) be applied for a significantly longer period without the risk of tissue damage and (iii)
do not require the use of gel. We are aware of one competitive product with similar ultrasound technology, the SAM® Sport4
by a company called Zetroz Systems LLC, aka ZetrOz, Inc. However, it is our belief that this product does not generate surface
acoustic waves as our products do, the treatment area is generally limited to that of the transducer’s diameter, the use
of transmission gel is still required and the transducer thickness is significantly greater than ours (approximately 1.5cm). To
our knowledge, the device only provides a battery life of 4 hours and is continuous therapy versus intermittent therapy. We are
also aware of a small clinical study, for which results were reported in August 2013, in which the SAM® Sport4 showed positive
results in the treatment of venous ulcers, a type of chronic wound.
Research has further
shown that ultrasound therapy has resulted in increased collagen repair (Da Cunha A, Parizotto NA, Vidal BC, “The effect
of therapeutic ultrasound on repair of the achilles tendon (tendo calcaneus) of the rat”, Ultrasound Med. Biol. 2001 December;
27(12):1691-6), improved resolution of inflammation (Young SR, Dyson M, “Macrophage responsiveness to therapeutic ultrasound”,
Ultrasound Med. Biol. 1990; 16(8):809-16) and increased tissue healing (Young SR, Dyson M, “Effect of therapeutic ultrasound
on the healing of full-thickness excised skin lesions”, Ultrasonics. 1990 May; 28(3):175-80), which are all important factors
in the wound healing process. Furthermore, research has shown that ultrasound therapy can contribute to increased membrane permeability
(Sundaram J, Mellein BR, Mitragotri S, “An experimental and theoretical analysis of ultrasound-induced permeabilization
of cell membranes,” Biophys. J. 2003 May; 84(5):3087-101) and accelerated fibrinolysis, a process that prevents blood clots
from growing and becoming problematic (Harpaz D, “Ultrasound enhancement of thrombolytic therapy: observations and mechanisms”,
Int. J. Cardiovasc Intervent. 2000 June; 3(2):81-89), which collectively improve the tissue regeneration process and healing of
wounds. Sonophoresis, a process that increases the absorption of semisolid topical compounds, including medications, into the
skin, is an additional significant effect of ultrasound therapy (Tezel A, Paliwal S, Shen Z, Mitragotri S, “Low-frequency
ultrasound as a transcutaneous immunization adjuvant”, Vaccine 2005 May 31; 23(29):3800-7).
In general, ultrasound
offers the benefits cited above by increasing local blood circulation, increasing vascular wall permeability, promoting protein
secretion, promoting enzymatic reactions, accelerating nitric oxide production, promoting angiogenesis (the formation of new blood
vessels from pre-existing vessels) and promoting fibroblast proliferation (fibroblasts are a type of cell that play a critical
role in wound healing). We believe that the body of evidence, and the positive therapeutic effect that ultrasound has for various
indications, potentially provides for future product development opportunities for us.
Our proprietary technology
consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces
with a radius of up to 10 centimeters beyond the transducer. This technology allows us to treat wounds by implanting our transducers
into a small, portable self-adhering acoustic patch, thereby eliminating the need for technicians and medical personnel to manually
administer ultrasound therapy, which should reduce the cost of therapy. Moreover, we believe that, based upon the body of evidence,
the delivery of ultrasound through our portable devices is equal to or more effective than existing competitive products, as our
technology is better positioned to target the affected areas of the body.
While
there are currently a number of products on the market that treat pain through ultrasound therapy, we believe that our products
differentiate themselves because they are portable, without the requirement to be plugged into an outlet and they operate with
a frequency of 100kHz (in contrast to other devices, which have a frequency of 1MHz), which means our products do not produce
heat that can damage tissue. Our products can therefore (i) be self-administered by the patient without the need to be moved about
the treated area by the patient or a clinician, (ii) be applied for a significantly longer period without the risk of tissue damage
and (iii) do not require the use of gel. We are aware of one competitive product with similar ultrasound technology, the SAM®
Sport4 by a company called Zetroz Systems LLC, aka ZetrOz, Inc. However, it is our belief that this product does not generate
surface acoustic waves as our products do, the treatment area is generally limited to that of the transducer’s diameter,
the use of transmission gel is still required and the transducer thickness is significantly greater than ours (approximately 1.5cm).
To our knowledge, the device only provides a battery life of four hours and is continuous therapy versus intermittent therapy.
We are also aware of a small clinical study, for which results were reported in August 2013, in which the SAM® Sport4 showed
positive results in the treatment of venous ulcers, a type of chronic wound.
In a comparison of a
traditional ultrasound device and our portable ultrasound patch-based device, the bulk wave conventional ultrasound machines with
handheld transducers distribute the energy deeply into the body, as shown above in diagram (A) on the left. In comparison, our
device distributes the energy on the surface, as shown in diagram (B), thereby meaningfully increasing the treatment area. Our
transducers may also be incorporated into treatment patches, including patches that are designed to deliver medicine and other
compounds through the skin. The generation and delivery of low frequency ultrasound over a period of time to a specific area has
been termed “targeted slow-release ultrasound”. We believe that this delivery method of ultrasound may be comparable
to that of slow release medication in the pharmaceutical industry. This “targeted slow-release” capability is intended
to allow for more frequent targeting of the intended treatment area and thus may result in a more effective therapeutic response.
Micro
Vibrations Technology and Our Products
It is well established
that increasing blood flow to the wound and peri-wound area helps accelerate the healing of ischemic wounds. Micro-vibrations
applied on the skin tissue increase local blood flow and oxygen delivery to the wound area and stimulate angiogenesis and growth
factors that are helpful for the wound healing process. Vibration therapy has been found to stimulate blood flow due to mechanical
stresses of endothelial cells resulting in increased production of nitric oxide and vasodilation, as well as increase soft tissue
and skin circulation. (Maloney-Hinds et al., “The Role of Nitric Oxide in Skin Blood Flow Increases due to vibration in
healthy adults and adults with type 2 diabetes,” School of Medicine, Loma Linda University. Ca. Diabetes Technology &
Therapeutics, 2009 p. 39-43). In addition, micro vibrations induce skin surface nerve axon reflex and type IIa muscle fibers contraction
rates, resulting in vasodilation (Nakagami et al., “Effect of vibration on skin blood flow in an in vivo microcirculatory
model”, The University of Tokyo, Bio-Science Trends 2007; 1 (3): 161-166). Ten minutes of vibration therapy with laser doppler
revealed a consistent increase in water content of the upper dermis (TJ Ryan et al., “The effect of mechanical forces (vibration
or external compression) on the dermal water content of the upper dermis and epidermis, assessed by high frequency ultrasound”,
Oxford Wound Healing Institute, Journal of Tissue Viability, 2001. In another study, mean blood flow increase was higher in the
vibration group than the placebo group. Improvements in local blood flow may be beneficial in the therapeutic alleviation of pain
or other symptoms resulting from acute or chronic injuries (C. Button et al., “The effect of multidirectional mechanical
vibration on peripheral circulation of humans”, University of Otago New Zealand, Clinical Physiology and functional Imaging,
2007 27, p211-216). A study on the effect of whole body vibration on lower extremity skin blood flow suggests, that short duration
vibration alone significantly increases lower extremity skin blood flow, doubling skin blood for a minimum of 10 minutes following
treatment (Lohman et al., “The effect of whole body vibration on lower extremity skin blood flow in normal subjects”,
Department of Physical Therapy, Loma Linda university, USA, Med Sci Monit, 2007; 13(2) 71-76). Vibration has also been shown to
stimulate angiogenesis and growth factors such as vascular endothelial growth factor (Suhr F et al., “Effects of short-term
vibration and hypoxia during high intensity cycling exercise on circulating level of angiogenic regulators in humans”, J
Appl Physiol, 2007, 103:474-483,. Yue Z. et al., “On the cardiovascular effects of whole-body vibration I. Longitudinal
effects: hydrodynamic analysis”, Studies Appl Math, 2007, 119:95-109). Of import with respect to diabetic wounds, in which
a prolonged inflammatory phase occurs, vibration vasodilation has generated an indirect anti-inflammatory action, mainly by suppression
of nuclear factor-kβ, the key gene for inflammatory mediators (Sackner, M.A., “Nitric Oxide is released into circulation
with whole-body, periodic acceleration”, Chest 2005;127;30-39).
Urinary
catheter usage is associated with pain and discomfort caused by the friction between the catheter surface and the urethral tissue.
Generally, this friction is treated by applying lubricating gels and low friction catheter coatings. These methods are effective
for a short term during the catheter insertion as the lubricating gel is quickly absorbed into the surrounding tissue and loses
its effect and the catheter coatings lose their lubricity within a few days, as the coating is covered by a thin film of mucous.
Our
UroShield product provides vibrations along the surface of the urinary catheter that is in contact with urethral tissue. We believe
that these vibrations create a continuous acoustic lubrication effect along the surface of the indwelling catheter that is in
contact with the surrounding tissue, thus reducing catheter-tissue contact time, which may lessen trauma from urethra abrasion
and adhesion. We have also shown in animals and in humans that the micro-vibration technology can reduce the level of biofilm
formation on urinary catheters.
Market for UroShield
Approximately 25% of
patients who are admitted to a hospital will have an indwelling catheter at some point during their stay and 7% of nursing home
residents are managed by long term catheterization.
Catheter acquired urinary
tract infection (CAUTI) is the most common nosocomial infection in hospitals and nursing homes, representing over 40% of all hospital-acquired
infections (HAIs) and 20% of intensive care unit HAIs (Maki, P and Tambyah, D. Engineering Out the Risk for Infection with Urinary
Catheters., Emerging Infectious Diseases., Vol. 7, No. 2, March–April 2001). In addition, CAUTIs are the source for approximately
20% of healthcare acquired bacteremia in acute care and 50% in long-term care facilities (Nicolle, Lindsay E. “Catheter
Associated Urinary Tract Infections.” Antimicrobial Resistance and Infection Control 3 (2014). The risk of acquiring CAUTI
depends on the method and duration of catheterization and patient susceptibility. Patients requiring a urinary catheter have a
daily risk of approximately five percent of developing bacteriuria and approximately 25% of patients develop nosocomial bacteriuria
or candiduria over one week (Maki, P and Tambyah, D. Engineering Out the Risk for Infection with Urinary Catheters., Emerging
Infectious Diseases., Vol. 7, No. 2, March–April 2001). Virtually all patients requiring indwelling urinary catheters for
longer than a month become bacteriuric.
CAUTI occurs because
urethral catheters inoculate organisms into the bladder and promote colonization by providing a surface for bacterial adhesion
and causing mucosal irritation. The presence of a urinary catheter is the most important risk factor for bacteriuria. Once a catheter
is placed, the daily incidence of bacteriuria is 3-10%. Between 10% and 30% of patients who undergo short-term catheterization
(i.e., 2-4 days) develop bacteriuria and are asymptomatic. Between 90% and 100% of patients who undergo long-term catheterization
develop bacteriuria. About 80% of nosocomial UTIs are related to urethral catheterization; only 5-10% are related to genitourinary
manipulation. (John L. Brusch, Catheter-Related Urinary Tract Infection, Medscape, August 18, 2015).
According to a report
by Zion Market Research, the global catheter market totaled approximately $26.6 billion in 2015 and is estimated to grow at a
CAGR of 9.7% through 2021. In the United States there are 25 million Foley catheters sold annually and there are 75 million catheters
sold elsewhere yielding a total global Foley catheter market of 100 million units worldwide. The cost to treat a simple CAUTI
has been estimated at $675 per case, and the cost of treating bacteremia has been estimated at $3,800 per case, yielding a total
healthcare burden of $830 million per year. While there are currently both antibiotic and silver coated catheters in the market,
they often sell for approximately $10 above the non-antimicrobial equivalent.
In addition, as of October
1, 2008, Medicare stopped authorizing its payment to hospitals in which patients have developed a catheter-associated urinary
tract infection that was not present on admission. This provides hospitals in the United States with a substantial financial incentive
to reduce the occurrence of such infections through the use of products such as UroShield, which help prevent infections hospitals
would otherwise have to treat without reimbursement. In addition, it has been noted that the Centers for Medicare & Medicaid
Services may fine hospitals in the future when their patients develop CAUTI, which will likely increase the incentive of hospitals
to invest in technologies that may prevent this complication (Brown J, et al. “Never Events: Not Every Hospital-Acquired
Infection Is Preventable, Clinical Infectious Diseases, 2009, 49 (5)). Markets for Our Products.
Market for PainShield
Pain-related complaints
are one of the most common reasons patients seek treatment from physicians (Prince V, “Pain Management in Patients with
Substance-Use Disorders,” Pain Management, PSAP-VII, Chronic Illnesses). According to Landro L, “New Ways to Treat
Pain: Tricking the Brain, Blocking the Nerves in Patients When all Else Has Failed,” Wall Street Journal, May 11, 2010,
approximately 26% of adult Americans, or approximately 76.5 million people, suffer from chronic pain. The National Center for
Health Statistics has estimated that approximately 54% of the adult population experiences musculoskeletal pain. Studies have
shown that low-frequency ultrasound treatment has yielded positive results for a variety of indications, including tendon injuries
and short-term pain relief (Warden SJ, “A new direction for ultrasound therapy in sports medicine,” Sports Med. 2003;
33 (2):95-107), chronic low back pain (Ansari NN, Ebadi S, Talebian S, Naghdi S, Mazaheri H, Olyaei G, Jalaie SA, “Randomized,
single blind placebo controlled clinical trial on the effect of continuous ultrasound on low back pain,” Electromyogr Clin
Neurophysiol. 2006 Nov; 46(6):329-36) and sinusitis (Ansari NN, Naghdi S, Farhadi M, Jalaie S, “A preliminary study into
the effect of low-intensity pulsed ultrasound on chronic maxillary and frontal sinusitis,” Physiother Theory Pract. 2007
Jul-Aug; 23(4):211-8). We believe that PainShield’s technology, portability and ease of use may result in it becoming an
attractive product in the pain management and therapy field.
Market for Wound-Healing Devices
The global wound care
device market totaled approximately $24 billion in 2015 and it is expected to grow at a CAGR of 6.7% during 2016-2022 (as reported
by P&S Global Research in January 2017). According to the Global Report on Diabetes produced by the World Health Organization
in 2016, globally, an estimated 422 million adults were living with diabetes in 2014, compared to 108 million in 1980. According
to a report entitled “Advances in Wound Closure Technology” by Frost and Sullivan (2005), foot complexities are the
most frequent causes for patients with diabetes to get hospitalized, with complications usually starting with the formation of
skin ulcers. In addition, according to the American Burn Association, approximately 486,000 patients received medical treatment
annually for burn injuries in 2016 in the United States. There are also policy-based factors that may increase the size of the
wound care market. We anticipate that reimbursement decisions with respect to hospital acquired wounds may create a large market
opportunity for wound care products, including WoundShield. Furthermore, in 2009, the Centers for Medicare and Medicaid Services
announced that they would stop reimbursements for treatment of certain complications that they believed were preventable with
proper care. One such complication was surgical site infections after certain elective procedures, including some orthopedic surgeries
and bariatric surgery. We believe that such developments incentivize medical care providers to invest in reducing the risk of
infection through the use of wound care products, including WoundShield.
Corporate
Information
We
were organized in the State of Delaware on October 20, 2003. Our principal executive offices are located at 525 Executive Boulevard,
Elmsford, New York 10523. Our telephone number is (914) 233-3004. Our website address is www.nanovibronix.com. Information accessed
through our website is not incorporated into this prospectus and is not a part of this prospectus.
The
Securities We May Offer
We
may offer up to $15,000,000 of common stock, preferred stock, warrants and/or units in one or more offerings and in any combination.
This prospectus provides you with a general description of the securities we may offer. A prospectus supplement, which we will
provide each time we offer securities, will describe the specific amounts, prices and terms of these securities.
Common
Stock
We
may issue shares of our common stock from time to time. The holders of common stock are entitled to one vote per share. Our certificate
of incorporation does not provide for cumulative voting. All of our directors hold office for one-year terms until the election
and qualification of their successors. The holders of our common stock are entitled to receive ratably such dividends, if any,
as may be declared by the board of directors out of legally available funds. Upon liquidation, dissolution or winding-up, the
holders of our common stock are entitled to share ratably in all assets that are legally available for distribution. The holders
of our common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges
of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of any series of preferred
stock, which may be designated solely by action of the board of directors and issued in the future.
Preferred
Stock
We
may issue shares of our preferred stock from time to time, in one or more series. Our board of directors will determine the rights,
preferences, privileges and restrictions of the preferred stock, including dividend rights, conversion rights, voting rights,
terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation
of such series, without any further vote or action by stockholders. Convertible preferred stock will be convertible into our common
stock or exchangeable for our other securities. Conversion may be mandatory or at your option or both and would be at prescribed
conversion rates.
If
we sell any series of preferred stock under this prospectus and applicable prospectus supplements, we will fix the rights, preferences,
privileges and restrictions of the preferred stock of such series in the certificate of designation relating to that series. We
will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from
reports that we file with the Securities and Exchange Commission, the form of any certificate of designation that describes the
terms of the series of preferred stock we are offering before the issuance of the related series of preferred stock. We urge you
to read the applicable prospectus supplement related to the series of preferred stock being offered, as well as the complete certificate
of designation that contains the terms of the applicable series of preferred stock.
Warrants
We
may issue warrants for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently
or together with common stock or preferred stock, and the warrants may be attached to or separate from these securities. We will
evidence each series of warrants by warrant certificates that we will issue under a separate agreement. We may enter into warrant
agreements with a bank or trust company that we select to be our warrant agent. We will indicate the name and address of the warrant
agent in the applicable prospectus supplement relating to a particular series of warrants.
In
this prospectus, we have summarized certain general features of the warrants. We urge you, however, to read the applicable prospectus
supplement related to the particular series of warrants being offered, as well as the warrant agreements and warrant certificates
that contain the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part,
or will incorporate by reference from reports that we file with the Securities and Exchange Commission, the form of warrant agreement
or warrant certificate containing the terms of the warrants we are offering before the issuance of the warrants.
Units
We
may issue units consisting of common stock, preferred stock and/or warrants for the purchase of common stock or preferred stock
in one or more series. In this prospectus, we have summarized certain general features of the units. We urge you, however, to
read the applicable prospectus supplement related to the series of units being offered, as well as the unit agreements that contain
the terms of the units. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate
by reference reports that we file with the Securities and Exchange Commission, the form of unit agreement and any supplemental
agreements that describe the terms of the series of units we are offering before the issuance of the related series of units.
RISK
FACTORS
An
investment in our securities involves a high degree of risk. The prospectus supplement applicable to each offering of our securities
will contain a discussion of the risks applicable to an investment in our securities. Before deciding whether to invest in our
securities, you should carefully consider the specific factors discussed under the heading “Risk Factors” in the applicable
prospectus supplement, together with all of the other information contained or incorporated by reference in the prospectus supplement
or appearing or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions
discussed under Item 1A, “Risk Factors,” in our most recent Annual Report on Form 10-K or any updates in our Quarterly
Reports on Form 10-Q, together with all other information appearing in or incorporated by reference into this prospectus or the
applicable prospectus supplement, before deciding whether to purchase any securities being offered. If any of these risks actually
occurs, our business, business prospects, financial condition or results of operations could be seriously harmed. This could cause
the trading price of our common stock to decline, resulting in a loss of all or part of your investment. Please also read carefully
the section below entitled “Special Note Regarding Forward-Looking Statements.”
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement
contain “forward-looking statements,” which include information relating to future events, future financial performance,
strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,”
“would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”
“future,” “intends,” “plans,” “believes,” “estimates,” and similar
expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not
be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance
or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our
management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties
that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements. Important factors that could cause such differences include, but are not limited to:
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Our ability to continue
as a going concern.
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Our ability to regain
compliance with the listing standards of the Nasdaq Capital Market.
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The timing of clinical
studies and eventual U.S. Food and Drug Administration approval of WoundShield™ and our other product candidates.
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Regulatory actions that could adversely affect
the price of or demand for our approved products.
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Market acceptance of existing and new products.
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Favorable or unfavorable
decisions about our products from government regulators, insurance companies or other third-party payers.
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Our ability to regain
compliance with the continued listing requirements of the Nasdaq Capital Market and the risk that our common stock will be
delisted if we cannot do so.
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Our intellectual property portfolio.
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Our ability to recruit and retain qualified
regulatory and research and development personnel.
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Unforeseen changes in healthcare reimbursement
for any of our approved products.
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Lack of financial resources to adequately support
our operations.
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Difficulties in maintaining commercial scale
manufacturing capacity and capability.
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Our ability to generate internal growth.
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Changes in our relationship with key collaborators.
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Changes in the market valuation or earnings
of our competitors or companies viewed as similar to us.
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Our failure to comply with regulatory guidelines.
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Uncertainty in industry demand and patient wellness
behavior.
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General
economic conditions and market conditions in the medical device industry.
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Future
sales of large blocks of our common stock, which may adversely impact our stock price.
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Depth
of the trading market in our common stock.
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You
should read this prospectus, the applicable prospectus supplement and any related free-writing prospectus and the documents incorporated
by reference in this prospectus with the understanding that our actual future results, levels of activity, performance and events
and circumstances may be materially different from what we expect. The forward-looking statements contained or incorporated by
reference in this prospectus or any prospectus supplement are expressly qualified in their entirety by this cautionary statement.
We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the
date on which any such statement is made or to reflect the occurrence of unanticipated events.
USE
OF PROCEEDS
Unless
we specify another use in the applicable prospectus supplement, we will use the net proceeds from the sale of the securities offered
by us for general corporate purposes, including funding of our development programs, commercial planning and sales and marketing
expenses, general and administrative expenses and working capital.
Investors
are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of
our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing
of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount
of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this
offering for other purposes.
From
time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing
allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change
in the use of proceeds include:
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a
change in development plan or strategy;
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the
addition of new products or applications;
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delays
or difficulties with our clinical trials;
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negative
results from our clinical trials;
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difficulty
obtaining U.S. Food and Drug Administration approval;
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failure
to achieve sales as anticipated; and
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the
availability of other sources of cash including cash flow from operations and new bank debt financing arrangements, if any.
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Pending
other uses, we intend to invest the proceeds to us in investment-grade, interest-bearing securities such as money market funds,
certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether
the proceeds invested will yield a favorable, or any, return.
DESCRIPTION
OF CAPITAL STOCK
The
following description of common stock and preferred stock summarizes the material terms and provisions of the common stock and
preferred stock that we may offer under this prospectus, but is not complete. For the complete terms of our common stock and preferred
stock, please refer to our amended and restated certificate of incorporation, as amended, any certificates of designation for
our preferred stock, and our amended and restated bylaws, as may be amended from time to time. While the terms we have summarized
below will apply generally to any future common stock or preferred stock that we may offer, we will describe the specific terms
of any series of preferred stock in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement,
the terms of any preferred stock we offer under that prospectus supplement may differ from the terms we describe below.
We
have authorized 25,000,000 shares of capital stock, par value $0.001 per share, of which 20,000,000 are shares of common
stock and 5,000,000 are shares of “blank check” preferred stock. On May 10, 2019, there were 4,101,064 shares
of common stock, 2,733,142 shares of our Series C Convertible Preferred Stock (“Series C Preferred Stock”) issued
and outstanding, and 304 shares of our Series D Convertible Preferred Stock (“Series D Preferred Stock”) issued
and outstanding. We currently have 3,000,000 shares of preferred stock designated as Series C Preferred Stock and 506 shares
of preferred stock designated as Series D Preferred Stock. The authorized and unissued shares of common stock and the
authorized and undesignated shares of preferred stock are available for issuance without further action by our stockholders,
unless such action is required by applicable law or the rules of any stock exchange on which our securities may be listed.
Unless approval of our stockholders is so required, our board of directors does not intend to seek stockholder approval for
the issuance and sale of our common stock or preferred stock.
Common
Stock
The
holders of common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative voting.
All of our directors hold office for one-year terms until the election and qualification of their successors. The holders of our
common stock are entitled to receive ratably such dividends, if any, as may be declared by the board of directors out of legally
available funds. Upon liquidation, dissolution or winding-up, the holders of our common stock are entitled to share ratably in
all assets that are legally available for distribution. The holders of our common stock have no preemptive, subscription, redemption
or conversion rights. The rights, preferences and privileges of holders of our common stock are subject to, and may be adversely
affected by, the rights of the holders of any series of preferred stock, which may be designated solely by action of the board
of directors and issued in the future.
The
transfer agent and registrar for our common stock is VStock Transfer, LLC. The transfer agent’s address is 18 Lafayette
Place, Woodmere, New York 11598. Our common stock is listed on the Nasdaq Capital Market under the symbol “NAOV.”
Preferred
Stock
The
board of directors is authorized, subject to any limitations prescribed by law, without further vote or action by the stockholders,
to issue from time to time shares of preferred stock in one or more series. Each such series of preferred stock shall have such
number of shares, designations, preferences, voting powers, qualifications, and special or relative rights or privileges as shall
be determined by the board of directors, which may include, among others, dividend rights, voting rights, liquidation preferences,
conversion rights and preemptive rights. Issuance of preferred stock by our board of directors may result in such shares having
dividend and/or liquidation preferences senior to the rights of the holders of our common stock and could dilute the voting rights
of the holders of our common stock.
Prior
to the issuance of shares of each series of preferred stock, the board of directors is required by the Delaware General Corporation
Law and our certificate of incorporation to adopt resolutions and file a certificate of designation with the Secretary of State
of the State of Delaware. The certificate of designation fixes for each class or series the designations, powers, preferences,
rights, qualifications, limitations and restrictions, including, but not limited to, some or all of the following:
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the
number of shares constituting that series and the distinctive designation of that series, which number may be increased or
decreased (but not below the number of shares then outstanding) from time to time by action of the board of directors;
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the
dividend rate and the manner and frequency of payment of dividends on the shares of that series, whether dividends will be
cumulative, and, if so, from which date;
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whether
that series will have voting rights, in addition to any voting rights provided by law, and, if so, the terms of such voting
rights;
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whether
that series will have conversion privileges, and, if so, the terms and conditions of such conversion, including provision
for adjustment of the conversion rate in such events as the board of directors may determine;
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whether
or not the shares of that series will be redeemable, and, if so, the terms and conditions of such redemption;
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whether
that series will have a sinking fund for the redemption or purchase of shares of that series, and, if so, the terms and amount
of such sinking fund;
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whether
or not the shares of the series will have priority over or be on a parity with or be junior to the shares of any other series
or class in any respect;
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the
rights of the shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the
corporation, and the relative rights or priority, if any, of payment of shares of that series; and
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any
other relative rights, preferences and limitations of that series.
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Once
designated by our board of directors, each series of preferred stock may have specific financial and other terms that will be
described in a prospectus supplement. The description of the preferred stock that is set forth in any prospectus supplement is
not complete without reference to the documents that govern the preferred stock. These include our certificate of incorporation
and any certificates of designation that our board of directors may adopt.
All
shares of preferred stock offered hereby will, when issued, be fully paid and nonassessable, including shares of preferred stock
issued upon the exercise of preferred stock warrants or subscription rights, if any.
Although
our board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of preferred
stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt.
Delaware
Anti-Takeover Law, Provisions of our Certificate of Incorporation and Bylaws
Delaware
Anti-Takeover Law
We
are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
after the date of the transaction in which the person became an interested stockholder, unless:
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prior
to the date of the transaction, the board of directors of the corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an interested stockholder;
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the
interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares outstanding (i) shares owned by persons who are directors and also
officers and (ii) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially
whether shares held subject to the plan will be tendered in a tender or exchange offer; or
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on
or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual
or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding
voting stock which is not owned by the interested stockholder.
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Section
203 defines a business combination to include:
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any
merger or consolidation involving the corporation and the interested stockholder;
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any
sale, transfer, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;
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subject
to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder; or
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the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
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In
general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of
the outstanding voting stock of the corporation and any entity or person affiliated with, or controlling, or controlled by, the
entity or person. The term “owner” is broadly defined to include any person that, individually, with or through that
person’s affiliates or associates, among other things, beneficially owns the stock, or has the right to acquire the stock,
whether or not the right is immediately exercisable, under any agreement or understanding or upon the exercise of warrants or
options or otherwise or has the right to vote the stock under any agreement or understanding, or has an agreement or understanding
with the beneficial owner of the stock for the purpose of acquiring, holding, voting or disposing of the stock.
The
restrictions in Section 203 do not apply to corporations that have elected, in the manner provided in Section 203, not to be subject
to Section 203 of the Delaware General Corporation Law or, with certain exceptions, which do not have a class of voting stock
that is listed on a national securities exchange or held of record by more than 2,000 stockholders. Our certificate of incorporation
and bylaws do not opt out of Section 203.
Section
203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage
attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price
above the prevailing market price.
Certificate
of Incorporation and Bylaws
Provisions
of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in
our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their
shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions
could adversely affect the price of our common stock. Among other things, our certificate of incorporation and bylaws:
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permit
our board of directors to issue up to 5,000,000 shares of preferred stock, without further action by the stockholders, with
any rights, preferences and privileges as they may designate, including the right to approve an acquisition or other change
in control;
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provide
that the authorized number of directors may be changed only by resolution of a majority of the total number of authorized
directors whether or not there exist any vacancies in previously authorized directorships (the “Whole Board”);
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provide
that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative
vote of a majority of directors then in office, even if less than a quorum;
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do
not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common stock entitled
to vote in any election of directors to elect all of the directors standing for election, if they should so choose);
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provide
that special meetings of our stockholders may be called only by a resolution adopted by a majority of the Whole Board; and
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set
forth an advance notice procedure with regard to the nomination, other than by or at the direction of our board of directors,
of candidates for election as directors and with regard to business to be brought before a meeting of stockholders.
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DESCRIPTION
OF WARRANTS
As
of May 10, 2019, there were 2,685,271 shares of common stock that may be issued upon exercise of outstanding
warrants.
We
may issue warrants for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently
or together with common stock or preferred stock, and the warrants may be attached to or separate from these securities.
We
will evidence each series of warrants by warrant certificates that we may issue under a separate agreement. We may enter into
a warrant agreement with a warrant agent. Each warrant agent may be a bank that we select which has its principal office in the
United States. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent
in the applicable prospectus supplement relating to a particular series of warrants.
We
will describe in the applicable prospectus supplement the terms of the series of warrants, including:
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the
offering price and aggregate number of warrants offered;
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if
applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such security;
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if
applicable, the date on and after which the warrants and the related securities will be separately transferable;
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in
the case of warrants to purchase common stock or preferred stock, the number or amount of shares of common stock or preferred
stock, as the case may be, purchasable upon the exercise of one warrant and the price at which and currency in which these
shares may be purchased upon such exercise;
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the
manner of exercise of the warrants, including any cashless exercise rights;
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the
warrant agreement under which the warrants will be issued;
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the
effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants;
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anti-dilution
provisions of the warrants, if any;
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the
terms of any rights to redeem or call the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the
dates on which the right to exercise the warrants will commence and expire or, if the warrants are not continuously exercisable
during that period, the specific date or dates on which the warrants will be exercisable;
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the
manner in which the warrant agreement and warrants may be modified;
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the
identities of the warrant agent and any calculation or other agent for the warrants;
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federal
income tax consequences of holding or exercising the warrants;
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the
terms of the securities issuable upon exercise of the warrants;
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any
securities exchange or quotation system on which the warrants or any securities deliverable upon exercise of the warrants
may be listed or quoted; and
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any
other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including, in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any,
or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to 5:00 P.M. eastern time, the close of business, on the expiration
date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required exercise price by the methods provided in the applicable prospectus supplement.
We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information
that the holder of the warrant will be required to deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants.
Enforceability
of Rights By Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action the holder’s right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance
with their terms.
Warrant
Agreement Will Not Be Qualified Under Trust Indenture Act
No
warrant agreement will be qualified as an indenture, and no warrant agent will be required to qualify as a trustee, under the
Trust Indenture Act. Therefore, holders of warrants issued under a warrant agreement will not have the protection of the Trust
Indenture Act with respect to their warrants.
Governing
Law
Unless
we provide otherwise in the applicable prospectus supplement, each warrant agreement and any warrants issued under the warrant
agreements will be governed by New York law.
DESCRIPTION
OF UNITS
We
may issue units comprised of one or more of the other securities described in this prospectus or any prospectus supplement in
any combination. Each unit will be issued so that the holder of the unit is also the holder, with the rights and obligations of
a holder, of each security included in the unit. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at any time or at any times before a specified date or upon the
occurrence of a specified event or occurrence.
The
applicable prospectus supplement will describe:
|
●
|
the
designation and the terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
|
|
●
|
any
unit agreement under which the units will be issued;
|
|
●
|
any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units;
and
|
|
●
|
whether
the units will be issued in fully registered or global form.
|
PLAN
OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus to or through underwriters, through dealers, through agents,
or directly to one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe
the terms of the offering of the securities, including:
|
●
|
the
name or names of any underwriters, if any, and if required, any dealers or agents;
|
|
●
|
the
purchase price of the securities and the proceeds we will receive from the sale;
|
|
●
|
any
underwriting discounts and other items constituting underwriters’ compensation;
|
|
●
|
any
discounts or concessions allowed or reallowed or paid to dealers; and
|
|
●
|
any
securities exchange or market on which the securities may be listed or traded.
|
We
may distribute the securities from time to time in one or more transactions at:
|
●
|
a
fixed price or prices, which may be changed;
|
|
●
|
market
prices prevailing at the time of sale, directly by us or through a designated agent;
|
|
●
|
prices
related to such prevailing market prices; or
|
Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name
of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation
of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated.
If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may
be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or
at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed
or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations
of the underwriters to purchase the offered securities will be subject to conditions precedent, and the underwriters will be obligated
to purchase all of the offered securities, if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering
price, with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms
of any over-allotment option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to
be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified
in a prospectus supplement.
We
may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, any agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by institutional investors to purchase securities from us at the public
offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation
of these contracts in the prospectus supplement.
In
connection with the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers
of the securities for whom they act as agents, in the form of discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions
from the underwriters or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that
participate in the distribution of the securities, and any institutional investors or others that purchase securities directly
for the purpose of resale or distribution, may be deemed to be underwriters, and any discounts or commissions received by them
from us and any profit on the resale of the common stock by them may be deemed to be underwriting discounts and commissions under
the Securities Act of 1933, as amended.
We
may provide agents, underwriters and other purchasers with indemnification against particular civil liabilities, including liabilities
under the Securities Act of 1933, as amended, or contribution with respect to payments that the agents, underwriters or other
purchasers may make with respect to such liabilities. Agents and underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
To
facilitate the public offering of a series of securities, persons participating in the offering may engage in transactions that
stabilize, maintain, or otherwise affect the market price of the securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating in the offering of more securities than have been sold to them
by us. In addition, those persons may stabilize or maintain the price of the securities by bidding for or purchasing securities
in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters or dealers participating in
any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The
effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might
otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make no representation
or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on
the price of our securities.
Unless
otherwise specified in the applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will be
eligible for listing on the Nasdaq Capital Market, subject to official notice of issuance. Any underwriters to whom securities
are sold by us for public offering and sale may make a market in the securities, but such underwriters will not be obligated to
do so and may discontinue any market making at any time without notice.
In
order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will
be sold in those states only through registered or licensed brokers or dealers. In addition, in some states securities may not
be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or
qualification requirement is available and complied with.
LEGAL
MATTERS
The validity of the securities offered
by this prospectus will be passed upon by Troutman Sanders LLP, New York, New York.
EXPERTS
The consolidated financial statements
of the Company and its subsidiary as of December 31, 2018 and for the year then ended, included in the Annual Report on Form 10-K/A
for the year ended December 31, 2018 and incorporated in this Prospectus by reference, have been so incorporated in reliance on
the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as
described in Note 1 to the financial statements) of Marcum LLP, an independent registered public accounting firm, given on the
authority of said firm as experts in auditing and accounting.
The consolidated financial statements
of the Company and its subsidiary as of December 31, 2017 and for the year then ended, included in the Annual Report on Form 10-K/A
for the year ended December 31, 2018 and incorporated in this Prospectus by reference, have been so incorporated in reliance on
the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as
described in Note 1 to the financial statements) of Kost Forer Gabbay & Kasierer, an independent registered public accounting
firm and a member of Ernst & Young Global, given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and in accordance therewith
file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission.
The Securities and Exchange Commission maintains a website that contains reports, proxy and information statements and other information
regarding registrants that file electronically with the Securities and Exchange Commission. The address of the Securities and
Exchange Commission’s website is www.sec.gov.
We
make available free of charge on or through our website at www.nanovibronix.com, our Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material
with or otherwise furnish it to the Securities and Exchange Commission.
We
have filed with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended,
relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional
relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration
statement. You can obtain a copy of the registration statement for free at www.sec.gov. The registration statement and the documents
referred to below under “Incorporation of Certain Information By Reference” are also available on our website, www.nanovibronix.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
Securities and Exchange Commission allows us to “incorporate by reference” the information we have filed with it,
which means that we can disclose important information to you by referring you to those documents. The information we incorporate
by reference is an important part of this prospectus, and later information that we file with the Securities and Exchange Commission
will automatically update and supersede this information. We incorporate by reference the documents listed below and any future
documents (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Securities and Exchange
Commission pursuant to Sections l3(a), l3(c), 14 or l5(d) of the Securities Exchange Act of 1934, as amended, subsequent to the
date of this prospectus and prior to the termination of the offering:
|
●
|
Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the Securities and Exchange Commission
on April 15, 2019 as amended by Amendment No. 1 to our Annual Report on Form 10-K for the fiscal year ended December 31,
2018, filed with the Securities and Exchange Commission on May 13, 2019;
|
|
●
|
Our definitive Proxy Statement on Schedule
14A, filed with the Securities and Exchange Commission on April 30, 2019;
|
|
●
|
Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 5, 2019;
|
|
●
|
Our Current Report on Form 8-K, filed with the Securities and Exchange
Commission on February 22, 2019;
|
|
●
|
Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on March 19, 2019; and
|
|
●
|
Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on April 4, 2019.
|
|
●
|
The description of our common stock, which is contained in our registration
statement on Form 8-A, filed with the Securities and Exchange Commission on October 19, 2017, as updated or amended in any
amendment or report filed for such purpose.
|
All
filings filed by us pursuant to the Securities Exchange Act of 1934, as amended, after the date of the initial filing of this
registration statement and prior to the effectiveness of such registration statement (excluding information furnished pursuant
to Items 2.02 and 7.01 of Form 8-K) shall also be deemed to be incorporated by reference into the prospectus.
You
should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone else
to provide you with different information. Any statement contained in a document incorporated by reference into this prospectus
will be deemed to be modified or superseded for the purposes of this prospectus to the extent that a later statement contained
in this prospectus or in any other document incorporated by reference into this prospectus modifies or supersedes the earlier
statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part
of this prospectus. You should not assume that the information in this prospectus is accurate as of any date other than the date
of this prospectus or the date of the documents incorporated by reference in this prospectus.
We
will provide without charge to each person to whom a copy of this prospectus is delivered, upon written or oral request, a copy
of any or all of the reports or documents that have been incorporated by reference in this prospectus but not delivered with this
prospectus (other than an exhibit to these filings, unless we have specifically incorporated that exhibit by reference in this
prospectus). Any such request should be addressed to us at: 525 Executive Boulevard, Elmsford, New York 10523, Attention: Stephen
Brown, Chief Financial Officer, or made by phone at (914) 233-3004. You may also access the documents incorporated by reference
in this prospectus through our website at www.nanovibronix.com. Except for the specific incorporated documents listed above, no
information available on or through our website shall be deemed to be incorporated in this prospectus or the registration statement
of which it forms a part.
$15,000,000
COMMON
STOCK
PREFERRED
STOCK
WARRANTS
UNITS
PROSPECTUS
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
|
Item
14.
|
Other
Expenses of Issuance and Distribution.
|
The
fees and expenses payable by us in connection with this registration statement are estimated as follows:
Securities
and Exchange Commission Registration Fee
|
|
$
|
1,818
|
|
Accounting
Fees and Expenses
|
|
|
15,000
|
|
Legal
Fees and Expenses
|
|
|
20,000
|
|
Printing
Fees and Expenses
|
|
|
—
|
|
Transfer
Agent Fees and Expenses
|
|
|
3,000
|
|
Miscellaneous
Fees and Expenses
|
|
|
5,000
|
|
Total
|
|
$
|
44,818
|
|
|
Item
15.
|
Indemnification
of Directors and Officers.
|
Section
145 of the General Corporation Law of the State of Delaware provides, in general, that a corporation incorporated under the laws
of the State of Delaware, as we are, may indemnify any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding (other than a derivative action by or in the right of the corporation)
by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving
at the request of the corporation as a director, officer, employee or agent of another enterprise, against expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection
with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be
in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable
cause to believe such person’s conduct was unlawful. In the case of a derivative action, a Delaware corporation may indemnify
any such person against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection
with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably
believed to be in or not opposed to the best interests of the corporation, except that no indemnification will be made in respect
of any claim, issue or matter as to which such person will have been adjudged to be liable to the corporation unless and only
to the extent that the Court of Chancery of the State of Delaware or any other court in which such action was brought determines
such person is fairly and reasonably entitled to indemnity for such expenses.
Our
certificate of incorporation and bylaws provide that we will indemnify our directors, officers, employees and agents to the extent
and in the manner permitted by the provisions of the General Corporation Law of the State of Delaware, as amended from time to
time, subject to any permissible expansion or limitation of such indemnification, as may be set forth in any stockholders’
or directors’ resolution or by contract. Any repeal or modification of these provisions approved by our stockholders will
be prospective only and will not adversely affect any limitation on the liability of any of our directors or officers existing
as of the time of such repeal or modification.
We
are also permitted to apply for insurance on behalf of any director, officer, employee or other agent for liability arising out
of his actions, whether or not the General Corporation Law of the State of Delaware would permit indemnification.
*
To be filed as an exhibit to a Current Report of the registrant on Form 8-K or other document to be incorporated herein by reference.
**
Filed herewith.
*** Previously filed
The
undersigned registrant hereby undertakes:
|
(a)
(1)
|
To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
|
(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low
or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
|
|
(iii)
|
To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
|
provided,
however,
that the undertakings set forth in paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information
required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the
Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part
of the registration statement.
|
(2)
|
That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
|
|
(3)
|
To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
|
|
(4)
|
That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
|
(i)
|
If
the registrant is relying on Rule 430B (§230.430B of this chapter):
|
|
(A)
|
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
|
|
|
|
|
(B)
|
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the
issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration
statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
Provided, however
, that no statement
made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated
or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such effective date.
|
|
(ii)
|
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance
on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such date of first use.
|
|
(5)
|
That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
|
|
(i)
|
Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
|
|
(ii)
|
Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
|
|
(iii)
|
The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
|
|
|
|
|
(iv)
|
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
(b)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that
in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful
defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy
as expressed in the Act and will be governed by the final adjudication of such issue.
(d)
The undersigned registrant hereby undertakes that:
|
(1)
|
For
purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the
registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
|
|
(2)
|
For
the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form
of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Elmsford, State of New York, on May 13, 2019.
|
NANOVIBRONIX,
INC.
|
|
|
|
|
By:
|
/s/
Brian Murphy
|
|
Name:
Brian Murphy
|
|
Title:
Chief Executive Officer
|
Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature
|
|
Title
|
|
Date
|
/s/ Brian Murphy
|
|
Chief Executive Officer and Director
|
|
May 13, 2019
|
Brian Murphy
|
|
(principal executive officer)
|
|
|
|
|
|
|
|
/s/
Stephen
Brown
|
|
Chief Financial Officer
|
|
May 13, 2019
|
Stephen Brown
|
|
(principal financial and accounting officer)
|
|
|
|
|
|
|
|
*
|
|
Chairman of the Board of Directors
|
|
May 13, 2019
|
Christopher Fashek
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
May 13, 2019
|
Martin Goldstein
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
May 13, 2019
|
Harold Jacob, M.D.
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
May 13, 2019
|
Michael Ferguson
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
May 13, 2019
|
Thomas R. Mika
|
|
|
|
|
* By:
|
/s/ Brian Murphy
|
|
|
|
May 13, 2019
|
|
Brian Murphy
|
|
|
|
|
|
Attorney-in Fact
|
|
|
|
|
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