Item 1A. Risk Factors
item
1a. risk factors
Risk
Factor Summary
Below
is a summary of the principal factors that make an investment in the Company speculative or risky. This summary does not address all
of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can
be found below, after this summary, and should be carefully considered.
Risks
Related to Our Business, Operations and Financial Condition
●
We
have had a limited operating history and may not be able to successfully operate our business or execute our business plan.
●
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.
●
We
may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
●
We
have a single customer that accounts for a substantial portion of our revenues, and our business would be harmed
were we to lose this customer.
●
If
we fail to effectively manage growth, our business could be impaired.
●
Our
commercial success depends upon the degree of market acceptance by prospective markets and industries.
●
Weakened
global economic conditions may harm our industry, business and results of operations.
12
Risk
Related to Third Parties
●
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.
●
We
may not be able to manage our strategic partners effectively.
●
We
may not have sufficient manufacturing capabilities to satisfy any growing demand for our products. We may be unable to control the
availability or cost of producing such products.
Risks
Related to Competition
●
We
expect to face competition in the future. 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.
●
If
we fail to comply with anti-bribery, anti-corruption and anti-money laundering laws, we could be subject to penalties and other adverse
consequences.
Risks
Related to Intellectual Property
●
We
may not be able to obtain all possible patents or other intellectual property rights necessary to protect our proprietary technology
and business.
●
We
may not be successful in enforcing our intellectual property rights against third parties.
●
We
may be subject to infringement claims and other litigation, which could adversely affect our business.
●
Governmental
regulation of non-practicing patent holders may adversely affect our business.
General
Risk Factors Related to Our Business
●
Our
business and operations may suffer in the event of computer system failures, cyber-attacks, or deficiencies in our cyber-security.
●
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.
●
Testing
of our technologies potential applications for our products will be required and there is no assurance of regulatory approval.
●
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
data and information systems and network infrastructure may be subject to hacking or other cybersecurity threats.
●
We
incorporate artificial intelligence, or AI, into some of our products. This technology is new and developing and may present both
compliance and reputational risks.
Risks
Related to Our Common Stock
●
If
the ownership of our Common Stock continues to be highly concentrated, it may prevent you and other minority stockholders from influencing
significant corporate decisions and may result in conflicts of interest.
●
Future
resales of Common Stock may cause the market price of our Common Stock to drop significantly, even if our business is doing well.
●
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.
●
Anti-takeover
provisions contained in our articles and bylaws, as well as provisions of Nevada law, could impair a takeover attempt.
●
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.
●
Our
Common Stock is currently a “penny stock,” which imposes additional sales practice requirements on broker-dealers that
sell such securities.
●
Compliance
with the reporting requirements of federal securities laws can be expensive.
●
Our
investors’ ownership in the Company may be diluted in the future.
●
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.
●
We
do not anticipate paying any cash dividends in the foreseeable future.
13
Risks
Related to our Operations in Israel
●
We
are subject to the risks of political, economic, health, and military instability in countries outside the United States in which
we operate.
●
Conditions
in Israel, including the October 7, 2023 attack by Hamas and other terrorist organizations and Israel’s war against them, if
escalated, could negatively affect our operations.
●
Other
instances of political, economic, or military instability in Israel, if escalated, could impede our ability to operate and harm our
financial results.
●
It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
●
Exchange
rate fluctuations between foreign currencies and the U.S. Dollar may negatively affect our earnings.
●
Certain
technology developed and used by us received Israeli government grants for certain research and development activities. The terms
of those grants require us to satisfy specified conditions in addition to repayment of the grants upon certain events.
●
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.
Certain
factors may have a material adverse effect on our business, financial condition, and results of operations. You should carefully consider
the following risks, together with all of the other information contained in this Annual Report on Form 10-K, including the sections
titled “Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and our financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. Any of
the following risks could materially and adversely affect our business, strategies, prospects, financial condition, results of operations,
and cash flows. In such case, the market price of our common stock could decline. Our business, prospects, financial condition, or results
of operations could also be harmed by risks and uncertainties not currently known to us or that we currently do not believe are material.
Risks
Related to Our Business, Operations and Financial Condition
We
have had a limited operating history and may not be able to successfully operate our business or execute our business plan.
Given
our limited operating history, 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;
●
potential
for ongoing operating losses;
●
operating
in multiple currencies;
●
our
ability to anticipate and adapt to a developing market(s);
●
acceptance
of our products by the medical and industrial (I4.0) markets and consumers;
●
introducing
innovation to conservative industries;
●
development
risks and implementation of new software and algorithm for AI and cloud utilization;
●
insufficient
capital to fully realize our operating plan;
●
a
competitive environment;
●
the
ability to identify, attract, and retain qualified personnel; and
●
operating
in an environment that is highly regulated by a number of agencies.
14
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. We have not earned a profit in any full fiscal year since our inception,
and we cannot be certain as to when or if we will achieve or maintain profitability. If we are unable to successfully address these risks
our business could be harmed.
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 as 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 developed products and potentially other
products in the United States or elsewhere in the world. 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:
●
we
have not recruited adequate numbers of effective sales and marketing personnel;
●
the
challenge of sales personnel to obtain access to potential customers;
●
the
lack of complementary products to be offered by sales personnel or lack of product-market fit, 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, we will not be successful in commercializing our technologies or any future products we may develop, and our
revenues and profitability may be materially adversely affected.
We
may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
Our
cash and short-term deposit balance as of December 31, 2023 was $17 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 require additional capital, the inability to obtain such 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 may be dilutive to the interests of existing stockholders.
15
We
have a single customer that accounts for a substantial portion of our revenues , and our business
would be harmed were we to lose this customer.
We
currently have one major customer, a leading Fortune 500 multinational healthcare corporation, which accounted for approximately 98%
and 81% of our revenues for 2023 and 2022, respectively, and is expected to generate most of our forecasted revenue in the near term.
Were we to lose this customer, our revenues would decline significantly, and our business would be harmed.
If
we fail to effectively manage growth, our business could be impaired.
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.
Our
commercial success depends upon the degree of market acceptance by such prospective markets and industries as defense and aviation, as
well as by the medical community.
Our
current business model is that of a B2B approach 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 prospective customers. The commercial success of our technologies, current 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 products as a useful and cost-effective solution compared to current technologies. During 2022, we commenced
proactive market penetration into industries other than the biomedical sector, such as the defense and aviation industries. 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, perceived value and convenience of our technology and any current or future product that we may
develop;
●
the
ability of third parties to enter into relationships with us;
●
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 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.
Weakened
global economic conditions may harm our industry, business and results of operations.
Our
overall performance depends in part on worldwide economic conditions. Global financial developments and downturns seemingly unrelated
to us or may harm us. The United States and other key international economies have been affected from time to time by falling demand
for a variety of goods and services, restricted credit, reduced liquidity, reduced corporate profitability, volatility in credit, equity
and foreign exchange markets, bankruptcies, inflation and overall uncertainty with respect to the economy, including with respect to
tariff and trade issues. Weak economic conditions or the perception thereof, or significant uncertainty regarding the stability of financial
markets related to stock market volatility, inflation, recession, changes in tariffs, trade agreements, or governmental fiscal, monetary
and tax policies, among others, could adversely impact our business, financial condition and operating results.
16
More
recently, inflation rates in the U.S. have been higher than in previous years, which may result in decreased demand for our products
and services, increases in our operating costs including our labor costs, constrained credit and liquidity, reduced government spending
and volatility in financial markets. The Federal Reserve has raised, and may again raise, interest rates in response to concerns over
inflation risk. Increases in interest rates on credit and debt that would increase the cost of any borrowing that we may make from time
to time and could impact our ability to access the capital markets. Increases in interest rates, especially if coupled with reduced government
spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks.
In an inflationary environment, we may be unable to raise the sales prices of our products at or above the rate at which our costs increase,
which could reduce our profit margins and have a material adverse effect on our financial results and net income. We also may experience
lower than expected sales and potential adverse impacts on our competitive position if there is a decrease in consumer spending or a
negative reaction to our pricing. A reduction in our revenue would be detrimental to our profitability and financial condition and could
also have an adverse impact on our future growth.
Risk
Related to Third Parties
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.
We
rely on our third-party suppliers to obtain an adequate supply of quality components on a timely basis with favorable terms to manufacture
our 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 or quality. Alternative sources for our components will not always be available.
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 CMOS technology mainly in the medical domain
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 are produced by a single supplier in the United States. As we do not
have a direct general 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 mainly
in the medical domain, and our inability or delay in finding a suitable replacement supplier, could negatively affect our business, financial
condition, results of operations, and reputation.
We
are also subject to other risks inherent in the manufacturing of our products and their supply chain, including industrial accidents,
natural disasters (including as a result of climate change), environmental events, strikes, and other labor disputes, capacity constraints,
disruptions in material or packaging supplies, as well as global shortages, disruptions in supply chain or information technology, loss
or impairment of key manufacturing sites or suppliers, product quality control, safety, increase in commodity prices and energy costs,
licensing requirements and other regulatory issues, as well as other external factors over which we have no control. If such an event
were to occur, it could have an adverse effect on our business, financial condition, and results of operations.
In
addition, if we cannot supply current 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 occur, 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.
We
may not be able to manage our strategic partners effectively.
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.
17
Failure
to manage our current partners effectively or enter into new strategic alliances 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 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. There can be no assurance that our 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.
Risks
Related to Competition
We
expect to face competition in the future. 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 regulatory approvals applicable
to the commercialization of relevant competitive technologies and future products.
If
we fail to comply with anti-bribery, anti-corruption and anti-money laundering laws, we could be subject to penalties and other adverse
consequences.
We
are subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, Chapter 9 (sub-chapter 5) of the Israeli Penal Law, 5737-1977, and
the Israeli Prohibition on Money Laundering Law, 5760-2000, collectively, the Israeli Anti-Corruption Laws, and the UK Bribery Act 2010,
or UK Bribery Act, and other anticorruption, anti-bribery and anti-money laundering laws in the jurisdictions in which we do business,
both domestic and abroad. These laws generally prohibit us and our employees from improperly influencing government officials or commercial
parties in order to obtain or retain business, direct business to any person or gain any advantage. The FCPA, the Israeli Anti-Corruption
Laws, the UK Bribery Act, and other applicable anti-bribery and anti-corruption laws also may hold us liable for acts of corruption and
bribery committed by our third-party business partners, representatives and agents. In addition, we leverage third parties to sell our
products and conduct our business abroad. We and our third-party business partners, representatives and agents may have direct or indirect
interactions with officials and employees of government agencies or state-owned or affiliated entities and we may be held liable for
the corrupt or other illegal activities of these third-party business partners and intermediaries, our employees, representatives, contractors,
channel partners and agents, even if we do not explicitly authorize such activities. These laws also require that we keep accurate books
and records and maintain internal controls and compliance procedures designed to prevent any such actions. While we have policies and
procedures to address compliance with such laws, we cannot provide complete assurance that our employees and agents will not take actions
in violation of our policies or applicable law, for which we may be ultimately held responsible. Our potential exposure for violating
these laws increases as our international presence expands and we increase sales and operations in foreign jurisdictions. Any violation
of the FCPA, the Israeli Anti-Corruption Laws, the UK Bribery Act, or other applicable anti-bribery, anti-corruption laws and anti-money
laundering laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant legal fees,
loss of export privileges, severe criminal or civil sanctions or suspension or debarment from U.S. government contracts, substantial
diversion of management’s attention, a decline in the market price of our Common Stock or overall adverse consequences to our reputation
and business, all of which may have an adverse effect on our results of operations and financial condition.
18
Risks
Related to Intellectual Property
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, lengthy, 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 plan to 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;
●
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
may not be successful in enforcing our intellectual property rights against third parties.
Unlicensed
copying and use of our intellectual property or infringement of our intellectual property rights may result in the loss of revenue to
us and cause us other harm. We seek diligently to enforce our intellectual property rights. Although we devote significant resources
to developing and protecting our technologies and evaluating potential competitors of our technologies for infringement of our intellectual
property rights, these infringements may nonetheless go undetected or may arise in the future. In the ordinary course of business, we
encounter companies that we suspect are infringing on our intellectual property rights. When we encounter a company that we suspect is
infringing our intellectual property rights, we may try to analyze their products and/or try to negotiate a license arrangement with
such party. If we try and are unable to negotiate a license or secure the agreement of such alleged infringing party to cease its activities,
we must make decisions as to how best to enforce our intellectual property rights.
19
The
process of negotiating a license with a third party can be lengthy and may take months or even years in some circumstances. Even if we
are successful in securing a license agreement, there can be no assurance that our technologies will be used in a product that is ultimately
brought to market, achieves commercial acceptance or results in significant royalties to us. We generally incur expense prior to entering
into our license agreements, generating a license fee, and establishing a royalty stream from each customer. We may incur costs in any
particular period before any associated revenue stream begins, if at all. Further, it is possible that third parties who we believe are
infringing our intellectual property rights are unwilling to license our intellectual property from us on terms we can accept, or at
all.
If
we cannot persuade a third party who we believe is infringing our technology to enter into a license with us, we may be required to consider
other alternatives to enforce our rights, including commencing litigation. The decision to commence litigation over infringement of a
patent is complex and may lead to several risks to us, including the following, among others:
●
the
time, significant expense and distraction to management of managing such litigation;
●
the
uncertainty of litigation and its potential outcomes;
●
the
possibility that in the course of such litigation, the defendant may challenge the validity of our patents, which could result in
a re-examination or post grant review of our patents and the possibility that our patents may be limited in scope or invalidated
altogether;
●
the
potential that the defendant may successfully persuade a court that their technology or products do not infringe our intellectual
property rights;
●
the
impact of such litigation on other licensing relationships we have or seek to establish, including the timing of renewing or entering
into such relationships, as applicable, as well as the terms of such relationships; and
●
adverse
publicity to us or harm to relationships we have with customers or others.
Also,
enforcement of patent protection throughout the world is generally established on a country-by-country basis and we may not have as much
success enforcing our patents in foreign jurisdictions as in the United States. Further, in some instances, certain foreign governmental
entities that might infringe our intellectual property rights may enjoy sovereign immunity from such claims. Consequently, effective
protection of our intellectual property rights may be unavailable or limited.
Defendants
in any litigation we consider commencing may have substantially greater financial and management resources necessary to manage litigation
than we have. Further, such potential defendants may also have their own substantial patent portfolio. Patent litigation can endure for
years and result in millions of dollars of expenses. If our counterparties in such litigation have substantially greater resources than
we have, we may not be able to withstand the time, expense, or distraction of the litigation, even though we may have a better litigation
position than such counterparties. In such instances we may not recover the expenses of litigation, and we may be required to enter into
settlement agreements that would be adverse to us or our intellectual property portfolio.
The
foregoing and other factors may cause us not to file or continue litigation against alleged infringers of our intellectual property rights,
or may cause us not to file for, or pursue, patent protection for our inventive technology, in certain jurisdictions. Our failure to
seek to enforce our intellectual property rights may weaken our ability to enforce our intellectual property in the future or make our
efforts to license our intellectual property rights more difficult.
If
we fail to protect our intellectual property rights adequately, if there are adverse changes in applicable laws, or if we become involved
in litigation relating to our intellectual property rights or the intellectual property rights of others, our business could be seriously
harmed. In such cases, the value ascribed to our intellectual property could diminish, we may incur significant legal expenses that could
harm our results of operations, and our patents or other intellectual property rights may be limited or invalidated. Any of the foregoing
could have a negative effect on the value of our Common Stock.
20
We
may be subject to infringement claims and other litigation, which could adversely affect our business.
As
more companies engage in business activities relating to predictive maintenance solutions, and develop corresponding intellectual property
rights, it is increasingly likely that claims may arise which assert that some of our products or services infringe upon other parties’
intellectual property rights. These claims could subject us to costly litigation and divert management resources. These claims may require
us to pay significant damages, cease production of infringing products, terminate our use of infringing technology, or develop non-infringing
technologies. In these circumstances, continued use of our technology may require that we acquire licenses to the intellectual property
that is the subject of the alleged infringement, and we might not be able to obtain these licenses on commercially reasonable terms or
at all. Our use of protected technology may result in liability that could threaten our continued operation.
Some
of the contracts with our customers include indemnity and similar provisions regarding our non-infringement of third-party intellectual
property rights. As deployment of our technology increases, and more companies enter our markets, the likelihood of a third-party lawsuit
resulting from these provisions increases. If an infringement arose in a context governed by such a contract, we may have to refund to
our customer amounts already paid to us or pay significant damages, or we may be sued by the party whose intellectual property has allegedly
been infringed upon.
Governmental
regulation of non-practicing patent holders may adversely affect our business.
Governmental
policymakers and commercial participants have proposed reforming U.S. patent laws and regulations in a manner that may limit a patent-holder’s
ability to enforce its patents against others to the extent that the holder is not practicing the subject matter of the patent at issue.
The U.S. International Trade Commission has also recently taken certain actions that have been viewed as unfavorable to patentees seeking
recourse in this forum. While we cannot predict what form any new patent reform laws or regulations may ultimately take, or what impact
they may have on our business, any laws or regulations that restrict our ability to enforce our patent rights against third parties could
have a material adverse effect on our business.
General
Risk Factors Related to Our Business
Our
business and operations may suffer in the event of computer system failures, cyber-attacks, or deficiencies in our cyber-security.
Security
incidents involving our information technology systems and those of third parties on which we rely have occurred in the past, such as
phishing attacks, although none of these incidents have been material to our business. Such security incidents may occur in the future.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable
to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks
or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside
our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer
hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted
attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations,
it could result in a material disruption of our product development programs. To the extent that any disruption or security breach was
to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information,
we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates
could be delayed. We face an increasingly difficult challenge to attract and retain highly qualified security personnel to assist us
in combatting these security threats.
21
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 devices, or any other products that we may develop for a target business. We may be held liable if such
products cause injury or death or are 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 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
cannot ensure that provisions in our customer contracts will be legally sufficient to protect us if we are subjected to legal action.
In addition, our errors and omissions and product liability insurance coverage may not be completely adequate, may not continue to be
available on reasonable terms or in sufficient amounts to cover one or more large claims, or the insurer may disclaim coverage as to
some types of future claims. The successful assertion of any large claim against us could seriously harm our business. Even if not successful,
these claims may result in significant legal and other costs, be a distraction to our management and harm our reputation.
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 compliance 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 we will be able to achieve regulatory compliance for any of our products. Any such
delay in achieving such regulatory compliance 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 our products. The process of compliance with relevant 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.
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. Our long-term incentive
programs may not be attractive enough or perform sufficiently to attract or retain qualified personnel.
If
a significant portion of our employees leaves us, we might 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, R&D, 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.
Further,
the volatility of our stock price may make our equity compensation less attractive to current and potential employees.
22
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.
Our
data and information systems and network infrastructure may be subject to hacking or other cybersecurity threats. If our security measures
are breached and an unauthorized party obtains access to our proprietary business information, our information systems may be perceived
as being insecure, which could harm our business and reputation and our proprietary business information could be misappropriated, which
could have an adverse effect on our business and results of operations.
Our
Company stores and transmits its proprietary information on its computer systems. Despite our security measures, our information systems
and network infrastructure may be vulnerable to cyber-attacks or could be breached due to an employee error or other disruption that
could result in unauthorized disclosure of sensitive information that has the potential to significantly interfere with our business
operations. Breaches of our security measures could expose us to a risk of loss or misuse of this information, litigation and potential
liability. Since techniques used to obtain unauthorized access or to sabotage information systems change frequently and generally are
not recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventive measures
in advance of such an attack on our systems. In addition, we use third party vendors to store our proprietary information who use cyber
or “cloud” storage of information as part of their service or product offerings, and despite our attempts to validate the
security of such services, our proprietary information may be misappropriated by other parties. In the event of an actual or perceived
breach of our security, or the security of one of our vendors, the market perception of the effectiveness of our security measures could
be harmed and we could suffer damage to our reputation or our business. Additionally, misappropriation of our proprietary business information
could prove competitively harmful to our business. For a description of our cybersecurity risk management and strategy, see Item 1C.
Cybersecurity.
We
incorporate artificial intelligence, or AI, into some of our products. This technology is new and developing and may present both compliance
and reputational risks.
Because
we develop our own algorithms and learning capabilities in the artificial intelligence (“AI”) capabilities that we incorporate
into some of our products, and because the software solutions we create, implement, and maintain are often critical to some of our potential
customers’ platforms, we may experience some system and service failures, schedule or delivery delays and other problems in connection
with our AI work. If we experience these problems, we may lose revenue due to adverse customer reactions, including postponement, cancellation
or failure to renew contracts; be required to provide additional services to a customer at no charge; receive negative publicity, which
could damage our reputation and adversely affect our ability to attract or retain customers; and suffer legal action for substantial
damages.
Risks
Related to Our Common Stock
If
the ownership of our Common Stock continues to be highly concentrated, it may prevent you and other minority stockholders from influencing
significant corporate decisions and may result in conflicts of interest.
Mr.
Arkin, who beneficially owns approximately 55.60% of our Common Stock, holds approximately 44.57% of the current voting power in our
Company and may exercise warrants and options which could increase his voting power to 55.60%. As a result, Mr. Arkin will likely control
any action requiring a stockholder vote, including: the election of directors; mergers, consolidations and acquisitions; the sale of
all or substantially all of our assets and other decisions affecting our capital structure; the amendment of our amended and restated
certificate of incorporation and our amended and restated bylaws; and our winding up and dissolution. This concentration of ownership
may delay, deter or prevent acts that would be favored by our other stockholders. The interests of Mr. Arkin may not always coincide
with our interests or the interests of our other stockholders. This concentration of ownership may also have the effect of delaying,
preventing or deterring a change in control of our Company. Also, Mr. Arkin may seek to cause us to take courses of action that, in his
judgment, could enhance his investment in our Company, but which might involve risks to our other stockholders or adversely affect us
or our other stockholders. As a result, the market price of our Common Stock could decline or stockholders might not receive a premium
over the then-current market price of our Common Stock upon a change in control. In addition, this concentration of share ownership may
adversely affect the trading price of our Common Stock because investors may perceive disadvantages in owning shares in a company with
significant stockholders.
If
we ever list on Nasdaq, we may be considered a “controlled company” within the meaning of Nasdaq rules and, as a result,
may rely on exemptions from certain corporate governance requirements that provide protection to stockholders of other companies.
As
a result of the concentration of voting power described above, we may be considered a “controlled company”, for example by
Nasdaq if we ever list on The Nasdaq Stock Market, which we do not expect to be able to do, if ever, until after we file our Annual Report
on Form 10-K for the fiscal year ended December 31, 2023 in March or April 2024, at the earliest. Under these rules, a listed company
of which more than 50% of the voting power is held by an individual, group or another company is a “controlled company” and
may elect not to comply with certain corporate governance requirements, including: the requirement that a majority of our board of directors
consist of “independent directors” as defined under the rules of Nasdaq; the requirement that we have a compensation committee
that is composed entirely of directors who meet the Nasdaq independence standards for compensation committee members; and the requirement
that our director nominations be made, or recommended to our full board of directors, by our independent directors or by a nominations
committee that consists entirely of independent directors.
Although
no decision has been made about whether or not to rely on such exemptions, if we do rely on any or all of these exemptions, you may not
have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
23
Future
resales of Common Stock may cause the market price of our Common Stock to drop significantly, even if our business is doing well.
Sales
of a substantial number of shares of our Common Stock in the public market could occur at any time, including by Mr. Moshe Arkin, our
largest shareholder, and other significant shareholders. These sales, or the perception in the market that such sales can occur, could
reduce the market price of our Common Stock and increase the volatility in the market price of our Common Stock. Further, the sale of
a substantial portion of shares of our Common Stock could result in a change of control, which could impact the market price and liquidity
of 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 currently 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. Although in June 2021 we filed an application with The Nasdaq Stock
Market to list our Common Stock, we did not complete the process and do not expect to be able to do so, if ever, until after we file
our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 in March or April 2024, at the earliest. Our Common Stock
has a history of thin trading. During the 52-week period ended February 29, 2024, trades were only reported on 78 trading days. These
factors may result in investors having difficulty reselling any shares of our Common Stock .
Anti-takeover
provisions contained in our articles and bylaws, as well as provisions of Nevada law, could impair a takeover attempt.
Our
amended and restated articles of incorporation and bylaws currently contain provisions that, together with Nevada law, could have the
effect of rendering more difficult or discouraging an acquisition deemed undesirable by our board of directors. Our corporate governance
documents presently include provisions such as providing for a “staggered” board of directors in which only one-third (1/3)
of the directors can be elected in any year, and limiting the liability of, and providing indemnifications to, our directors and officers.
These provisions, alone or together, could delay hostile takeovers and changes in control of our Company or changes in our management.
As
a Nevada corporation, we may also become subject to the provisions of Nevada Revised Statutes Sections 78.378 through 78.3793, which
prohibit an acquirer, under certain circumstances, from voting shares of a corporation’s stock after crossing specific threshold
ownership percentages, unless the acquirer obtains the approval of the stockholders of the issuer corporation. The first such threshold
is the acquisition of at least one-fifth, but less than one-third of the outstanding voting power of the issuer. We may become subject
to the above referenced Statutes if we have 200 or more stockholders of record, at least 100 of whom are residents of the State of Nevada
and do business in the State of Nevada directly or through an affiliated corporation.
Any
provision of our amended and restated articles of incorporation, our bylaws or Nevada law that has the effect of delaying or deterring
a change in control of our Company could limit the opportunity for our stockholders to receive a premium for their shares of our Common
Stock and could also affect the price that some investors are willing to pay for our Common Stock.
24
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 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;
●
current
or anticipated impact of military conflict, including the conflict between Russia and Ukraine, Israel’s war or conflicts with
Hamas or Lebanon, terrorism or other geopolitical events;
●
sanctions
imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely
impact the financial markets and the global economy, and any economic countermeasures by affected countries and others could exacerbate
market and economic instability; and
●
general
market conditions and other events or factors, many of which are beyond our control.
In
addition, the stock market has experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and other
life sciences company stocks. The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate
to the operating performance of the companies represented by the stock. In the past, securities class action litigation has often been
initiated against companies following periods of volatility in their stock price. This type of litigation could result in substantial
costs and divert our management’s attention and resources and could also require us to make substantial payments to satisfy judgments
or to settle litigation.
Our
Common Stock is currently a “penny stock,” which imposes additional sales practice requirements on broker-dealers that sell
such securities.
The
SEC has adopted regulations which generally define so-called “penny stocks” to be an equity security that has a market price
less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. Our Common Stock is currently
a “penny stock” and is subject to Rule 15g-9 under the Securities Exchange Act of 1934, or the Penny Stock Rule. This rule
imposes additional sales practice requirements on broker-dealers that sell such securities to persons other than established customers
and “accredited investors” (generally, individuals with a net worth in excess of $1,000,000 or annual incomes exceeding $200,000,
or $300,000 together with their spouses). For transactions covered by Rule 15g-9, a broker-dealer must make a special suitability determination
for the purchaser and have received the purchaser’s written consent to the transaction prior to sale. As a result, this rule may
affect the ability of broker-dealers to sell our securities and may affect the ability of purchasers to sell any of our securities in
the secondary market, thus possibly making it more difficult for us to raise additional capital.
For
any transaction involving a penny stock, unless exempt, the rules require delivery, prior to any transaction in penny stock, of a disclosure
schedule required by the SEC relating to the penny stock market. Disclosure is also required to be made about sales commissions payable
to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements are
required to be sent disclosing recent price information for the penny stock held in the account and information on the limited market
in penny stock.
25
There
can be no assurance that our Common Stock will qualify for exemption from the Penny Stock Rule. Even if our Common Stock were exempt
from the Penny Stock Rule, we would remain subject to Section 15(b)(6) of the Securities Exchange Act of 1934, or the Exchange Act, which
gives the SEC the authority to restrict any person from participating in a distribution of penny stock, if the SEC finds that such a
restriction would be in the public interest.
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.
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. We have in the past and may continue to 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 26, 2024, our directors, executive officers, principal stockholders, and affiliated entities may be deemed to beneficially
own, in the aggregate, approximately 84.11% of our outstanding voting securities. 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.
We
do not anticipate paying any cash dividends in the foreseeable future.
We
have never declared or paid cash dividends, and we do not anticipate paying cash dividends in the foreseeable future. Therefore, you
should not rely on an investment in our Common Stock as a source for any future dividend income. Our board of directors has complete
discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount,
and form of future dividends, if any, will depend on our future results of operations and cash flow, our capital requirements and surplus,
the amount of distributions, if any, received by us from our wholly-owned subsidiary Odysight.ai Ltd., our financial condition, contractual
restrictions, and other factors deemed relevant by our board of directors.
26
Risks
Related to our Operations in Israel
We
are subject to the risks of political, economic, health, and military instability in countries outside the United States in which we
operate.
Some
of our products are produced in Israel, India, China, and other countries which are particularly subject to risks of political, economic,
health, and military instability. This instability could result in wars, riots, nationalization of industry, currency fluctuations, and
labor unrest or unavailability. These conditions could have an adverse impact on our ability to manufacture, ship, and operate in these
regions and, depending on the extent and severity of these conditions, could result in a reduction in customer orders and sales to certain
regions and end-markets and materially and adversely affect our overall financial condition and operating results. We have principal
manufacturing facilities and operations located in Israel. Accordingly, our business will be directly influenced by the political, economic,
and military conditions affecting Israel at any given time.
Conditions
in Israel, including the October 7, 2023 attack by Hamas and other terrorist organizations and Israel’s war against them, if escalated,
could negatively affect our operations.
Our
offices and management team are located in Israel. Accordingly, our business and operations may be affected by economic, political, geopolitical
and military conditions in Israel. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred
between Israel and its neighboring countries and Muslim based terrorist organizations active in the region. These conflicts have involved
missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which from time to time have
negatively affected business conditions in Israel.
On
October 7, 2023, the Hamas organization launched a series of deadly terror attacks on civilian and military targets skirting the Gaza
Strip in the southern part of Israel and fired rockets on many of the communities in southern and central Israel. Following the attack,
Israel’s security cabinet declared war and commenced a military campaign in Gaza against Hamas. Since the outbreak of the war,
the Hezbollah terrorist organization has regularly fired rockets into northern Israel, other terrorist organizations have done so from
western Iraq and the Houthis terrorist organization operating out of Yemen has fired various projectiles and drones against commercial
shipping vessels in the Gulf of Aden and Red Sea. Moreover, these conditions may escalate in the future into a greater regional conflict.
The
war has led to consequences and restrictions with respect to the Israeli economy, including a significant call-up of military reservists,
most of whom have been released from such service as of the date of this Annual Report. However, to date the war has not had a material
adverse effect on our business. While our executive offices are located in Omer and Ramat Gan, Israel, neither of our sites is located
near Israel’s relevant borders where the main impact of the war has been felt. Nevertheless, we have experienced some minor disruptions
to our routine work, including some difficulties in traveling outside of Israel in the first month of the war and occasional rocket fire
on municipalities where our offices are located, requiring our employees to take temporarily shelter for a few minutes at a time in on-site
safe rooms. In addition, several of our employees, including company officers such as our CEO Yehu Ofer, were called up to military reserve
duty, with many such call-ups having since lapsed. As of the date of this Annual Report, Mr. Ofer is subject to military reserve duty
a few days a month. We have taken various measures to mitigate the effects of the war, including adopting work-from-home measures, increased
employee overtime and third-party outsourcing where needed, and reviewing our business continuity plan.
In
case of material escalation of current conditions or the outbreak of a greater regional conflict, it is possible that there will be further
military reserve duty call-ups, which may negatively affect our business due to a shortage of skilled labor and loss of institutional
knowledge. Were such an escalation to occur, the steps we have taken to mitigate the effects of the war may not be sufficient to prevent
material adverse impacts our business, financial condition and results of operations. In addition, although the intensive flight hours
flown by all Israeli Air Force platforms as a result of the war has caused an increase of interest in our technology from Israeli government
agencies and R&D programs, we may not be successful in turning these expressions of interest into orders for our products.
27
It
is currently not possible to predict the duration or severity of the ongoing war or its effects on our business, operations and financial
conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources
and availability of supply and hamper our ability to raise additional funds or sell our securities, among other possible negative effects.
Other
instances of political, economic or military instability in Israel, if escalated, could impede our ability to operate and harm our financial
results.
In
addition to the ongoing war with Hamas, other political, economic, and military conditions in Israel and the surrounding region may directly
affect our business and operations. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred
between Israel and its neighboring countries. We have never experienced any material interruption in our operations attributable to these
factors, in spite of several Middle East crises. A change in the security and political situation in Israel and in the economy could
have a material adverse effect on our business, operating results, and financial condition.
In
recent years, Israel has been subject to certain political instability and an increased number of elections were held. Actual or perceived
political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely
affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects. Changes in the
Israeli economy could make it more difficult for us to operate our business and could have a material adverse effect on our business,
reputation, financial condition, results of operation and cash flow.
In
the beginning of 2023, the newly formed government commenced a legislative process to effect changes in the Israeli legal system. Certain
financial, legal, and commercial organizations and entities have claimed that such changes will weaken the Israeli legal system and,
as a result, could lead to negative impact on the economic and financial conditions of the State of Israel. At this stage, where most
of the proposed legislation has not become effective and its scope is not fully determined, we cannot assess the likelihood of the legislation
going into effect or the possible impact of these changes.
In
addition to Hamas, Israel is engaged in sporadic armed conflicts 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 have been accompanied by missiles being fired from Lebanon against civilian targets in various
parts of Israel, including areas in which some of our employees and consultants may be located, and negatively affected business conditions
in Israel. The global shipping industry is also experiencing disruptions due attacks by Houthi militants from Yemen on commercial shipping
in the Gulf of Aden and Red Sea, which has caused the rerouting of shipping away from the Suez Canal. 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 conflict 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 and may do so in the future as a result of the war with Hamas or for other reasons.
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.
28
Many
Israeli citizens are also 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. As has been the case with the ongoing war with Hamas, 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 additional 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.
It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
It
may be difficult to acquire jurisdiction and enforce liabilities against any of our officers and directors who are based in Israel. It
may not be possible for United States investors to enforce their legal rights, to effect service of process upon our directors or officers
or to enforce judgments of United States courts predicated upon civil liabilities and criminal penalties of our directors and officers
under federal securities laws. Moreover, we have been advised that Israel does not have treaties providing for the reciprocal recognition
and enforcement of judgments of courts with the United States. Further, it is unclear if extradition treaties now in effect between the
United States and Israel would permit effective enforcement of criminal penalties of the federal securities laws. Even if an Israeli
court agrees to hear a claim, it may determine that the Israeli law, and not U.S. law, is applicable to the claim. Further, if U.S. law
is found to be applicable, certain content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly
process, and certain matters of procedure would still be governed by the Israeli law. Consequently, you may be effectively prevented
from pursuing remedies under U.S. federal and state securities laws against us or any of our non-U.S. directors or officers.
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, some of our expenses are in New Israeli Shekels (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.
Exchange
rate movements have impacted and may continue to impact our consolidated revenues and operating results. It is particularly difficult
to forecast exchange rate movements and unanticipated currency fluctuations have affected and could continue to affect our financial
results and cause our results to differ from investor expectations or our own guidance in any future periods. Volatility in exchange
rates and global financial markets is expected to continue due to the ongoing global political and economic uncertainty.
Certain
technology developed and used by us received Israeli government grants for certain research and development activities. The terms of
those grants require us to satisfy specified conditions in addition to repayment of the grants upon certain events.
The
research and development efforts that contributed to certain technology used by us was financed in part through grants from the Israel
Innovation Authority (“IIA”) to Medigus, which was subsequently transferred to Odysight.ai (for more information about such
agreements, refer to – “CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS” below). The terms of such grants require
Odysight.ai to comply with the requirements of the Innovation Law. When a company develops know-how, technology or products using IIA
grants, the terms of these grants and the Innovation Law restrict the transfer outside of Israel of such know-how, and the manufacturing
or manufacturing rights of such products, technologies or know-how, without the prior approval of the IIA. Therefore, if aspects of our
technologies are deemed to have been developed with IIA funding, the discretionary approval of an IIA committee would be required for
any transfer to third parties outside of Israel of know-how or manufacturing or manufacturing rights related to those aspects of such
technologies. We may not receive those approvals. Furthermore, the IIA may impose certain conditions on any arrangement under which it
permits us to transfer technology or development out of Israel.
29
The
transfer of IIA-supported technology or know-how or manufacturing or manufacturing rights related to aspects of such technologies outside
of Israel may involve the payment of significant penalties and other amounts, depending upon the value of the transferred technology
or know-how, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions
and requirements for payment may impair our ability to sell our technology assets outside of Israel or to outsource or transfer development
or manufacturing activities with respect to any product or technology outside of Israel. Furthermore, the consideration available to
our shareholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such
as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.
The
Company has applied for and been awarded an additional IIA-funded grant, to support and enhance the Company’s production capabilities.
Subject to successfully achieving certain predetermined milestones, the Company will receive a maximum grant amount of NIS 1 million.
The grant shall subject the Company to certain restrictions on transfer of manufacturing rights and know-how outside of Israel and will
require royalty payments on revenues derived from sales of the products developed from the IIA funding.
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 our intellectual property has been developed by our 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.