Item 1A. Risk Factors
item
1a. risk factors
Risks
Related to Our Business, Operations and Financial Condition
The
COVID-19 pandemic has adversely affected, and will continue to adversely affect, our business, financial condition, liquidity
and results of operations.
The
COVID-19 pandemic has resulted in a widespread health crisis that has adversely affected businesses, economies and financial markets
worldwide, placed constraints on the operations of businesses, decreased consumer mobility and activity, and caused significant
economic volatility in the United States, Israel and international capital markets. Our business has been affected in various
ways, as discussed below, including in our operations, and we cannot predict the length and severity of the pandemic or its effects
on us and our customers. We have followed guidance by the U.S. and Israeli governments and the other local governments in which
we operate to protect our employees and our operations during the pandemic and have implemented a remote environment for certain
of our employees, and, as a result, may experience inefficiencies in our employees’ ability to collaborate. We have also
experienced difficulty in our efforts to recruit and hire qualified personnel during this time. In addition, the COVID-19 pandemic
has caused an economic recession, high unemployment rates and other disruptions, both in the United States, Israel and the rest
of the world. Any of these impacts, including the prolonged continuation of these impacts, could adversely affect our business.
We
cannot predict the other potential impacts of the COVID-19 pandemic on our business or operations, and there is no guarantee that
any near-term trends in our results of operations will continue, particularly if the COVID-19 pandemic and the adverse consequences
thereof continue for a long period of time. Additional waves of infections, a continuation of the current environment, or any
further adverse impacts caused by the COVID-19 pandemic could further deteriorate employment rates and the economy, detrimentally
affecting our consumer base and divert consumers’ discretionary income to other uses, including for essential items. These
events could adversely impact our cash flows, results of operations and financial conditions and heighten many of the other risks
described in these “Risk Factors.”
Our
reliance on third-party suppliers for most of the components of our products could harm our ability to meet demand for our products
in a timely and cost-effective manner.
Though
we attempt to ensure the availability of more than one supplier for each important component in any product that we commission,
the number of suppliers engaged in the provision of miniature video sensors which are suitable for our Complementary Metal Oxide
Semiconductor (“CMOS”) technology products is very limited, and therefore in some cases we engage with a single supplier,
which may result in our dependency on such supplier. This is the case regarding sensors for the CMOS type technology that is produced
by a single supplier in the United States. As we do not have a contract in place with this supplier, there is no contractual commitment
on the part of such supplier for any set quantity of such sensors. The loss of our sole supplier in providing us with miniature
sensors for our CMOS technology products, and our inability or delay in finding a suitable replacement supplier, could significantly
affect our business, financial condition, results of operations and reputation.
Because
of ScoutCam’s limited operating history, we may not be able to successfully operate our business or execute our business
plan.
Given
the limited operating history of ScoutCam, it is hard to evaluate our proposed business and prospects. Our proposed business operations
will be subject to numerous risks, uncertainties, expenses and difficulties associated with early-stage enterprises. Such risks
include, but are not limited to, the following:
●
the
absence of a lengthy operating history;
●
insufficient
capital to fully realize our operating plan;
●
expected
continual losses for the foreseeable future;
●
operating
in multiple currencies;
●
our
ability to anticipate and adapt to a developing market(s);
●
acceptance
of our products by the medical community and consumers;
●
acceptance
of our products by the non-medical community and consumers;
●
limited
marketing experience;
●
a
competitive environment characterized by well-established and well-capitalized competitors;
●
the
ability to identify, attract and retain qualified personnel; and
●
operating
in an environment that is highly regulated by a number of agencies.
Furthermore,
we have a history of losses, and we may not be able to generate sufficient revenues to achieve and sustain profitability, and
as a result, there is substantial doubt about our ability to continue as a going concern following the fiscal year ended December
31, 2020.
Because
we are subject to these risks, evaluating our business may be difficult, our business strategy may be unsuccessful and we may
be unable to address such risks in a cost-effective manner, if at all. If we are unable to successfully address these risks our
business could be harmed.
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Our
commercial success depends upon the degree of market acceptance by the medical community as well as by other prospect markets
and industries.
Our
current business model is that of a business-to-business approach, or B2B, in which we seek to identify target businesses interested
in integrating our technology, or commissioning individual projects using our technology. Any product that we commission or that
is brought to the market may or may not gain market acceptance by prospect customers. The commercial success of our technologies,
commissioned products and any future product that we may develop depends in part on the medical community as well as other industries
for various use cases, depending on the acceptance by such industries of our commissioned products as a useful and cost-effective
solution compared to current technologies. To date, we have not yet commenced proactive market penetration in other industries,
with the exception of the biomedical sector. If our technology or any future product that we may develop does not achieve an adequate
level of acceptance, or does not garner significant commercial appeal, we may not generate significant revenue and may not become
profitable. The degree of market acceptance will depend on a number of factors, including:
●
the
cost, safety, efficacy/performance, and convenience of our technology and any commissioned product and any future product
that we may develop in relation to alternative products;
●
the
ability of third parties to enter into relationships with us without violating their existing agreements;
●
the
effectiveness of our sales and marketing efforts;
●
the
strength of marketing and distribution support for, and timing of market introduction of, competing technology and products;
and
●
publicity
concerning our technology or commissioned products or competing technology and products.
Our
efforts to penetrate industries and educate the marketplace on the benefits of our technology, and reasons to seek the commissioning
of products based on our technology, may require significant resources and may never be successful. Such efforts to educate the
marketplace may require more resources than are required by conventional technologies.
We
expect to face significant competition. If we cannot successfully compete with new or existing technologies or future developed
products, our marketing and sales will suffer and we may never be profitable.
We
expect to compete against existing technologies and proven products in different industries. In addition, some of these competitors,
either alone or together with their collaborative partners, operate larger research and development programs than we do, and may
have substantially greater financial resources than we do, as well as significantly greater experience in obtaining applicable
regulatory approvals applicable to the commercialization of our technologies and future products.
If
we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships with business
targets and third parties to perform these services, we may not be successful in commercializing our products and technology.
Given
that we are currently a B2B company, our business is reliant on our ability to successfully attract potential business targets.
Furthermore, we have a limited sales and marketing infrastructure and have limited experience in the sale, marketing or distribution
of our technologies beyond the B2B model. To achieve commercial success for our technologies or any future developed product,
we will need to establish a sales and marketing infrastructure or to out-license such future products.
In
the future, we may consider building a focused sales and marketing infrastructure to market any future developed products and
potentially other product in the United States or elsewhere in the world. Similarly, we may consider evolving our business model
in the future and adopting a business-to-consumer approach, or B2C. There are risks involved with establishing our own sales,
marketing and distribution capabilities. For example, recruiting and training a sales force could be expensive and time consuming
and could delay any product launch. This may be costly, and our investment would be lost if we cannot retain or reposition our
sales and marketing personnel.
Factors
that may inhibit our efforts to commercialize any future products on our own include:
●
our
inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
●
the
inability of sales personnel to obtain access to potential customers;
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●
the
lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to
companies with more extensive product lines; and
●
unforeseen
costs and expenses associated with creating an independent sales and marketing organization.
If
we are unable to establish our own sales, marketing and distribution capabilities or enter into successful arrangements with third
parties to perform these services, our revenues and our profitability may be materially adversely affected.
In
addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our products
inside or outside of the United States or may be unable to do so on terms that are favorable to us. We likely will have little
control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our
products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or
in collaboration with third parties, we will not be successful in commercializing our technologies or any future products we may
develop.
We
depend on the success of micro ScoutCam ™ for our revenue, which could impair our ability to achieve profitability.
We
plan to derive most of our future revenue from the development services of our imaging equipment and our flagship micro ScoutCam ™
and through the engagement with target businesses that are interested in the commissioning of certain products using our
technology. Our future growth and success is largely dependent on the successful commercialization of the micro ScoutCam ™
technology. If we are unable to achieve increased commercial acceptance of the micro ScoutCam ™ technology,
or experience a decrease in the utilization of our product line or procedure volume, our revenue would be adversely affected.
We
may be subject to product liability claims, product actions, including product recalls, and other field or regulatory actions
that could be expensive, divert management’s attention and harm our business.
Our
business exposes us to potential liability risks, product actions and other field or regulatory actions that are inherent in the
manufacturing, marketing and sale of medical device products that we may have commissioned for a target business. We may be held
liable if such products cause injury or death or is found otherwise unsuitable or defective during usage. Our products incorporate
mechanical and electrical parts, complex computer software and other sophisticated components, any of which can contain errors
or failures. Complex computer software is particularly vulnerable to errors and failures, especially when first introduced. In
addition, new products or enhancements to our existing products may contain undetected errors or performance problems that, despite
testing, are discovered only after installation.
If
any of our commissioned products are defective, whether due to design or manufacturing defects, improper use of the product, or
other reasons, we may voluntarily or involuntarily undertake an action to remove, repair, or replace the product at our expense.
In some circumstances we will be required to notify regulatory authorities of an action pursuant to a product failure.
We
may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
Our
cash balance as of December 31, 2020 was $3.4 million. We may require additional funding to fund and grow our operations and to
develop certain products. There can be no assurance that financing will be available in amounts or on terms acceptable to us,
if at all. In the event we required additional capital, the inability to obtain additional capital will restrict our ability to
grow and may reduce our ability to continue to conduct business operations. If we require and are unable to obtain additional
financing, we will likely be required to curtail our development plans. In that event, current stockholders would likely experience
a loss of most or all of their investment. Additional funding that we do obtain may be dilutive to the interests of existing stockholders.
Our
failure to effectively manage growth could impair our business.
Our
business strategy contemplates a period of rapid growth which may put a strain on our administrative and operational resources,
and our funding requirements. Our ability to effectively manage growth will require us to successfully expand the capabilities
of our operational and management systems, and to attract, train, manage, and retain qualified personnel. There can be no assurance
that we will be able to do so, particularly if losses continue and we are unable to obtain sufficient financing. If we are unable
to appropriately manage growth, our business, prospects, financial condition, and results of operations could be adversely affected.
12
We
may not be able to manage our strategic partners effectively.
Our
growth strategy may include strategic partners. The process to bring on, train and assist strategic partners is time-consuming
and costly. We expect to expend significant resources to undertake business, financial and legal due diligence on both existing
and potential partners, and there is no guarantee that these will be successful in ultimately increasing our business.
Failure
to manage our partners effectively may affect our success in executing our business plan and may adversely affect our business,
financial condition and results of operation. We may not realize the anticipated benefits of any or all partnerships, or may not
realize them in the time frame expected.
We
may not have sufficient manufacturing capabilities to satisfy any growing demand for our commissioned products. We may be unable
to control the availability or cost of producing such products.
Our
current manufacturing capabilities may not reach the required production levels necessary in order to meet growing demands for
any products we may commission or future products we may develop. While we do intend to purchase a manufacturing facility in Israel
in the future, such an engagement has not yet materialized and it is not clear at what point the Company will execute such an
acquisition. In the interim, and prior to the purchase of a manufacturing facility by the Company, there can be no assurance that
our commissioned products can be manufactured at our desired commercial quantities, in compliance with our requirements and at
an acceptable cost. Any such failure could delay or prevent us from shipping said products and marketing our technologies in accordance
with our target growth strategies.
Testing
of our technologies potential applications for our products will be required and there is no assurance of regulatory approval.
The
effect of government regulation and the need for approval may delay marketing of our technologies and future potentially developed
products for a considerable period of time, impose costly procedures upon our activities and provide an advantage to larger companies
that compete with us. There can be no assurance that regulatory approval for any products developed by us will be granted on a
timely basis or at all. Any such delay in obtaining, or failure to obtain, such approvals would materially and adversely affect
the marketing of any contemplated products and the ability to earn product revenue. Further, regulation of manufacturing facilities
by state, local, and other authorities is subject to change. Any additional regulation could result in limitations or restrictions
on our ability to utilize any of our technologies, thereby adversely affecting our operations. Various federal and foreign statutes
and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of food products.
The process of obtaining these approvals and the subsequent compliance with appropriate U.S. and foreign statutes and regulations
are time-consuming and require the expenditure of substantial resources. In addition, these requirements and processes vary widely
from country to country.
Our
suppliers may not be able to always supply components or products to us on a timely basis and on favorable terms, and as a result,
our dependency on third party suppliers can adversely affect our revenue.
We
will rely on our third-party suppliers for components and depend on obtaining adequate supplies of quality components on a timely
basis with favorable terms to manufacture our commissioned products. Some of those components that we sell are provided to us
by a limited number of suppliers. We will be subject to disruptions in our operations if our sole or limited supply contract manufacturers
decrease or stop production of components or do not produce components and products of sufficient quantity. Alternative sources
for our components will not always be available. Many of our components are manufactured overseas, so they have long lead times,
and events such as local disruptions, natural disasters or political conflict may cause unexpected interruptions to the supply
of our products or components.
It
is our intention, as mentioned in the use of proceeds, to allocate financial resources to improve our inventory management, including
establishing an inventory buffer of components appropriate to our business. However, we cannot assure that our attempt will be
successful or that product or component shortages will not occur in the future. If we cannot supply commissioned products or future
potentially developed products due to a lack of components, or are unable to utilize other components in a timely manner, our
business will be significantly harmed. If inventory shortages continue, they could be expected to have a material and adverse
effect on our future revenues and ability to effectively project future sales and operating results.
13
We
rely on highly skilled personnel, and, if we are unable to attract, retain or motivate qualified personnel, we may not be able
to operate our business effectively.
Our
success depends in large part on continued employment of senior management and key personnel who can effectively operate our business,
as well as our ability to attract and retain skilled employees. Competition for highly skilled management, technical, research
and development and other employees is intense and we may not be able to attract or retain highly qualified personnel in the future.
In making employment decisions, particularly in the job candidates often consider the value of the equity awards they would receive
in connection with their employment. Our long-term incentive programs may not be attractive enough or perform sufficiently to
attract or retain qualified personnel.
If
any of our employees leaves us, and we fail to effectively manage a transition to new personnel, or if we fail to attract and
retain qualified and experienced professionals on acceptable terms, our business, financial condition and results of operations
could be adversely affected.
Our
success also depends on our having highly trained financial, technical, recruiting, sales and marketing personnel. We will need
to continue to hire additional personnel as our business grows. A shortage in the number of people with these skills or our failure
to attract them to our company could impede our ability to increase revenues from our existing technology and services, ensure
full compliance with international and federal regulations, or launch new product offerings and would have an adverse effect on
our business and financial results.
We
may have difficulty in entering into and maintaining strategic alliances with third parties.
We
have entered into, and we may continue to enter into, strategic alliances with third parties to gain access to new and innovative
technologies and markets. These parties are often large, established companies. Negotiating and performing under these arrangements
involves significant time and expense, and we may not have sufficient resources to devote to our strategic alliances, particularly
those with companies that have significantly greater financial and other resources than we do. The anticipated benefits of these
arrangements may never materialize, and performing under these arrangements may adversely affect our results of operations.
We
may not be able to obtain patents or other intellectual property rights necessary to protect our proprietary technology and business.
We
may seek to patent concepts, components, processes, designs and methods, and other inventions and technologies that we consider
to have commercial value or that will likely give us a technological advantage. Despite devoting resources to the research and
development of proprietary technology, we may not be able to develop technology that is patentable or protectable. Patents may
not be issued in connection with pending patent applications, and claims allowed may not be sufficient to allow them to use the
inventions that they create exclusively. Furthermore, any patents issued could be challenged, re-examined, held invalid or unenforceable
or circumvented and may not provide sufficient protection or a competitive advantage. In addition, despite efforts to protect
and maintain patents, competitors and other third parties may be able to design around their patents or develop products similar
to our work products that are not within the scope of their patents. Finally, patents provide certain statutory protection only
for a limited period of time that varies depending on the jurisdiction and type of patent.
Prosecution
and protection of the rights sought in patent applications and patents can be costly and uncertain, often involve complex legal
and factual issues and consume significant time and resources. In addition, the breadth of claims allowed in our patents, their
enforceability and our ability to protect and maintain them cannot be predicted with any certainty. The laws of certain countries
may not protect intellectual property rights to the same extent as the laws of the United States. Even if our patents are held
to be valid and enforceable in a certain jurisdiction, any legal proceedings that we may initiate against third parties to enforce
such patents will likely be expensive, take significant time and divert management’s attention from other business matters.
We cannot assure that any of our issued patents or pending patent applications provide any protectable, maintainable or enforceable
rights or competitive advantages to us.
In
addition to patents, we will rely on a combination of copyrights, trademarks, trade secrets and other related laws and confidentiality
procedures and contractual provisions to protect, maintain and enforce our proprietary technology and intellectual property rights
in the United States and other countries. However, our ability to protect our brands by registering certain trademarks may be
limited. In addition, while we will generally enter into confidentiality and nondisclosure agreements with our employees, consultants,
contract manufacturers, distributors and resellers and with others to attempt to limit access to and distribution of our proprietary
and confidential information, it is possible that:
●
misappropriation
of our proprietary and confidential information, including technology, will nevertheless occur;
●
our
confidentiality agreements will not be honored or may be rendered unenforceable;
14
●
third
parties will independently develop equivalent, superior or competitive technology or products;
●
disputes
will arise with our current or future strategic licensees, customers or others concerning the ownership, validity, enforceability,
use, patentability or registrability of intellectual property; or
●
unauthorized
disclosure of our know-how, trade secrets or other proprietary or confidential information will occur.
We
cannot assure that we will be successful in protecting, maintaining or enforcing our intellectual property rights. If we are unsuccessful
in protecting, maintaining or enforcing our intellectual property rights, then our business, operating results and financial condition
could be materially adversely affected, which could
●
adversely
affect our reputation with customers;
●
be
time-consuming and expensive to evaluate and defend;
●
cause
product shipment delays or stoppages;
●
divert
management’s attention and resources;
●
subject
us to significant liabilities and damages;
●
require
us to enter into royalty or licensing agreements; or
●
require
us to cease certain activities, including the sale of products.
If
it is determined that we have infringed, violated or are infringing or violating a patent or other intellectual property right
of any other person or if we are found liable in respect of any other related claim, then, in addition to being liable for potentially
substantial damages, we may be prohibited from developing, using, distributing, selling or commercializing certain of our technologies
unless we obtain a license from the holder of the patent or other intellectual property right. We cannot assure that we will be
able to obtain any such license on a timely basis or on commercially favorable terms, or that any such licenses will be available,
or that workarounds will be feasible and cost-efficient. If we do not obtain such a license or find a cost-efficient workaround,
our business, operating results and financial condition could be materially adversely affected and we could be required to cease
related business operations in some markets and restructure our business to focus on our continuing operations in other markets.
We
may be unable to keep pace with changes in technology as our business and market strategy evolves.
We
will need to respond to technological advances in a cost-effective and timely manner in order to remain competitive. The need
to respond to technological changes may require us to make substantial, unanticipated expenditures. There can be no assurance
that we will be able to respond successfully to technological change.
Risks
Related to Our Common Stock
Trading
on the OTC Markets is volatile, sporadic and often thin, which could depress the market price of our common stock and make it
difficult for our stockholders to resell their common stock.
Our
common stock is quoted on the OTCQB tier of the OTC Markets. Trading in securities quoted on the OTC Markets is often thin and
characterized by wide fluctuations in trading prices, due to many factors, some of which may have little to do with our operations
or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operating performance.
Moreover, the OTC Markets is not a stock exchange, and trading of securities on the OTC Markets is often more sporadic than the
trading of securities listed on a stock exchange like NASDAQ or the NYSE. Our common stock has a history of thin trading. During
the 52-week period ended December 31, 2020, trades were only reported on 103 trading days. These factors may result in
investors having difficulty reselling any shares of our common stock.
Because
we were a “shell company,” Rule 144 is unavailable until one year has elapsed from the date that we have filed “Form
10 information” with the SEC, including current financial statements.
Rule
144 provides, as indicated above, that sales of securities of a former shell company may only be made once the applicable waiting
period has terminated and only if appropriate current information is available by the company and that it has filed all relevant
periodic reports that it is required to file. Rule 144 will be unavailable to holders of restricted securities until one year
has elapsed from the date that we filed “Form 10 information” (as defined in Rule 144) with the SEC along with audited
financial statements. Once we become current, no assurance can be made that the Company will be able to remain current with its
reports. In addition to the above, because we voluntarily file SEC reports with the SEC, following the one (1) year period discussed
above, holders will not be permitted to rely on Rule 144 for sales of our shares, unless and until such time as we are mandatorily
required under SEC laws, rules and regulations to file periodic reports with the SEC.
15
The
market price of our Common Stock may be highly volatile and such volatility could cause you to lose some or all of your investment.
The
market price of our common stock, par value $0.001 per share, or Common Stock, may fluctuate significantly in response to numerous
factors, some of which are beyond our control, such as:
●
the
announcement of new products or product enhancements by us or our competitors;
●
developments
concerning intellectual property rights;
●
changes
in legal, regulatory, and enforcement frameworks impacting our technology or the application of our technology;
●
variations
in our and our competitors’ results of operations;
●
fluctuations
in earnings estimates or recommendations by securities analysts, if our Common Stock is covered by analysts;
●
the
results of product liability or intellectual property lawsuits;
●
future
issuances of Common Stock or other securities;
●
the
addition or departure of key personnel;
●
announcements
by us or our competitors of acquisitions, investments or strategic alliances; and
●
general
market conditions and other factors, including factors unrelated to our operating performance.
Further,
the general stock market has recently experienced price and volume fluctuations. The volatility of our Common Stock could be further
exacerbated due to low trading volume. Continued market fluctuations could result in extreme volatility in the price of our Common
Stock, which could cause a decline in the value of our Common Stock and the loss of some or all of our investors’ investment.
Sales of shares of our Common Stock could also depress the then price of our shares.
An
investor’s ability to trade our common stock may be limited by trading volume.
The
Company’s shares are currently quoted on the OTCQB under the symbol “SCTC.” An active trading market for our
common stock has not developed, and may not develop, on the OTCQB. During the period subsequent to our upgrade from the OTC Pink
Market to the OTCQB, which occurred on September 14, 2020 and until December 31, 2020, trades were only reported on 46
trading days. A limited trading volume may prevent our shareholders from selling shares at such times or in such amounts as
they may otherwise desire.
Because
our Common Stock may be a “penny stock,” it may be more difficult for investors to sell shares of our Common Stock,
and the market price of our Common Stock may be adversely affected.
Our
Common Stock may be a “penny stock” if, among other things, the stock price is below $5.00 per share, it is not listed
on a national securities exchange, or it has not met certain net tangible asset or average revenue requirements. Broker-dealers
who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC.
This risk-disclosure document provides information about penny stocks and the nature and level of risks involved in investing
in the penny-stock market. A broker must also give a purchaser, orally or in writing, bid and offer quotations and information
regarding broker and salesperson compensation, make a written determination that the penny stock is a suitable investment for
the purchaser and obtain the purchaser’s written agreement to the purchase. Broker-dealers must also provide customers that
hold penny stock in their accounts with such broker-dealer a monthly statement containing price and market information relating
to the penny stock. If a penny stock is sold to an investor in violation of the penny stock rules, the investor may be able to
cancel its purchase and get their money back.
If
applicable, the penny stock rules may make it difficult for stockholders to sell their shares of our Common Stock. Because of
the rules and restrictions applicable to a penny stock, there is less trading in penny stocks and the market price of our Common
Stock may be adversely affected. Also, many brokers choose not to participate in penny stock transactions. Accordingly, stockholders
may not always be able to resell their shares of our Common Stock publicly at times and prices that they feel are appropriate.
Compliance
with the reporting requirements of federal securities laws can be expensive.
We
are a public reporting company in the United States, and accordingly, subject to the information and reporting requirements of
the Exchange Act and other federal securities laws. The costs of preparing and filing annual and quarterly reports and other information
with the SEC and furnishing audited reports to stockholders are substantial. Failure to comply with the applicable securities
laws could result in private or governmental legal action against us or our officers and directors, which could have a detrimental
impact on our business and financials, the value of our stock, and the ability of stockholders to resell their stock.
16
Our
investors’ ownership in the Company may be diluted in the future.
In
the future, we may issue additional authorized but previously unissued equity securities, resulting in the dilution of ownership
interests of our present stockholders. For instance, pursuant to that certain Securities Exchange Agreement by and between Intellisense
and Medigus, dated September 16, 2019, if ScoutCam achieves US$33.0 million in sales in the aggregate within the first three years
following December 30, 2019, the consummation date of such agreement, we will issue shares of Common Stock to Medigus representing
10% of our issued and outstanding share capital as of December 30, 2019. Similarly, we may issue a substantial number of shares
of Common Stock or other securities convertible into or exercisable for Common Stock in connection with capital raising activity,
hiring or retaining employees, future acquisitions, raising additional capital in the future to fund our operations, and other
business purposes. We expect to authorize in the future a substantial number of shares of our Common Stock for issuance under
a stock option or similar plan, and may issue equity awards to management, employees and other eligible persons. Additional shares
of Common Stock issued by us in the future will dilute an investor’s investment in the Company. In addition, we may seek
stockholder approval to increase the amount of the Company’s authorized stock, which would create the potential for further
dilution of current investors.
Directors,
executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they
may make decisions that our stockholders do not consider to be in their best interests.
As
of March 28, 2021, our directors, executive officers, principal stockholders and affiliated entities may be deemed to beneficially
own, in the aggregate, approximately 67.54% of our outstanding voting securities as of the date hereof. As a result,
if some or all of such parties acted together, they would have the ability to exert substantial influence over the election of
our board of directors and the outcome of issues requiring approval by our stockholders. This concentration of ownership may also
have the effect of delaying or preventing a change in control of the Company that may be favored by other stockholders. This could
prevent transactions in which stockholders might otherwise recover a premium for their shares over current market prices. This
concentration of ownership and influence in management and board decision-making could also harm the price of our capital stock
by, among other things, discouraging a potential acquirer from seeking to acquire shares of our capital stock (whether by making
a tender offer or otherwise) or otherwise attempting to obtain control of our Company.
17
Risks
Related to our Operations in Israel
Political,
economic and military instability in Israel may impede our ability to operate and harm our financial results.
Our
offices and management team are located in Israel. Accordingly, political, economic, and military conditions in Israel and the
surrounding region may directly affect our business and operations. In recent years, Israel has been engaged in sporadic armed
conflicts with Hamas, an Islamist terrorist group that controls the Gaza Strip, with Hezbollah, an Islamist terrorist group that
controls large portions of southern Lebanon, and with Iranian-backed military forces in Syria. In addition, Iran has threatened
to attack Israel and may be developing nuclear weapons. Some of these hostilities were accompanied by missiles being fired from
the Gaza Strip against civilian targets in various parts of Israel, including areas in which our employees and some of our consultants
are located, and negatively affected business conditions in Israel. Any hostilities involving Israel or the interruption or curtailment
of trade between Israel and its trading partners could adversely affect our operations and results of operations.
Our
commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism. Although the
Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of
war, we cannot assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages.
Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability
in the region would likely negatively affect business conditions and could harm our results of operations.
Further,
in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict
business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on
our operating results, financial condition or the expansion of our business. A campaign of boycotts, divestment and sanctions
has been undertaken against Israel, which could also adversely impact our business.
In
addition, many Israeli citizens are obligated to perform several days, and in some cases more, of annual military reserve duty
each year until they reach the age of 40 (or older, for reservists who are military officers or who have certain occupations)
and, in the event of a military conflict, may be called to active duty. In response to increases in terrorist activity, there
have been periods of significant call-ups of military reservists. It is possible that there will be military reserve duty call-ups
in the future. Our operations could be disrupted by such call-ups, which may include the call-up of members of our management.
Such disruption could materially adversely affect our business, prospects, financial condition and results of operations.
Exchange
rate fluctuations between foreign currencies and the U.S. Dollar may negatively affect our earnings.
Our
reporting and functional currency is the U.S. dollar. Our revenues are currently primarily payable in U.S. dollars and we expect
our future revenues to be denominated primarily in U.S. dollars. However, certain amount of our expenses are in NIS and as a result,
we are exposed to the currency fluctuation risks relating to the recording of our expenses in U.S. dollars. We may, in the future,
decide to enter into currency hedging transactions. These measures, however, may not adequately protect us from material adverse
effects.
18
We
may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could
result in litigation and adversely affect our business.
A
significant portion of ScoutCam’s intellectual property has been developed by ScoutCam’s employees in the course of
their employment for us. Under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee in the
course and as a result of or arising from his or her employment with a company are regarded as “service inventions,”
which belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention
rights. The Patent Law also provides that if there is no such agreement between an employer and an employee, the Israeli Compensation
and Royalties Committee, or the Committee, a body constituted under the Patent Law, will determine whether the employee is entitled
to remuneration for his inventions. Recent case law clarifies that the right to receive consideration for “service inventions”
can be waived by the employee and that in certain circumstances, such waiver does not necessarily have to be explicit. The Committee
will examine, on a case-by-case basis, the general contractual framework between the parties, using interpretation rules of the
general Israeli contract laws. Further, the Committee has not yet determined one specific formula for calculating this remuneration
(but rather uses the criteria specified in the Patent Law). Although we generally enter into assignment-of-invention agreements
with our employees pursuant to which such individuals assign to us all rights to any inventions created in the scope of their
employment or engagement with us, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence
of such claims, we could be required to pay additional remuneration or royalties to our current and/or former employees, or be
forced to litigate such claims, which could negatively affect our business.
Item
1b. unresolved staff comments
Not
applicable.
Item
2. properties
We
do not own property and currently lease our principal corporate office, which is located at Omer Industrial Park, No. 7A P.O.
Box 3030, Omer 8496500. We believe our leased office sufficiently meets our current needs.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.