What changed in this filing

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Item 1A. Risk Factors

2023-03-28 compared with 2022-03-30 · 288 added, 198 removed, 505 unchanged (49% of the section changed)

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failure to effectively manage growth could impair our business.

commercial success depends upon the degree of market acceptance by the medical community as well as by other prospective markets

and industries.

COVID-19 pandemic has adversely affected, and may continue to adversely affect, our business, financial condition, liquidity and

results of operations.

commercial success depends upon the degree of market acceptance by prospective markets and industries.

global economic conditions may harm our industry, business and results of operations.

continuing effects of the COVID-19 pandemic are highly unpredictable and could be significant, and the duration and extent to which

this will impact our future results of operations and overall financial performance remains uncertain.

Related to Third Parties

reliance on third-party suppliers for most of the components of our products, including miniature video sensors which are suitable

for our CMOS technology products mainly in the medical domain, could harm our ability to meet demand for our products in a timely

and cost-effective manner.

may not be able to manage our strategic partners effectively.

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.

reliance on third-party suppliers for most of the components of our products, including miniature video sensors could harm our ability

to meet demand for our products in a timely and cost-effective manner.

may not be able to manage our strategic partners.

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.

Related to Competition

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.

customers may develop the capabilities of our solution in-house, which would significantly reduce the demand for our products.

expect to face some competition possibly from our customer.

If we cannot successfully compete there might be adverse effect on the

to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.

Related to Intellectual Property

may not be able to obtain patents or other intellectual property rights necessary to protect our proprietary technology and business.

may not be able to obtain all possible patents or other intellectual property rights necessary

to protect our proprietary technology and business.

may not be successful in enforcing our intellectual property rights against third parties.

may be subject to infringement claims and other litigation, which could adversely affect our business.

regulation of non-practicing patent holders may adversely affect our business.

Risk Factors Related to Our Business

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operate our business effectively.

may be unable to keep pace with changes in technology as our business and market strategy evolves.

Related to this Offering and Our Common Stock

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Related to our Operations in Israel

are subject to the risks of political, economic, health, and military instability in countries outside the United States in which

economic and military instability in Israel may impede our ability to operate and harm our financial results.

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absence of a lengthy operating history;

continual losses for the foreseeable future;

potential for ongoing operating losses;

in multiple currencies;

ability to anticipate and adapt to a developing market(s);

of our products by the medical and industrial (I4.0) markets (and the non-medical community) and consumers;

marketing experience;

experience in developing and implementing full platform solutions including AI and cloud;

of our products by the medical and industrial (I4.0) markets and consumers;

innovation to conservative industries;

risks and implementation of new software and algorithm for AI and cloud utilization;

capital to fully realize our operating plan;

competitive environment characterized by well-established and well-capitalized competitors;

competitive environment;

ability to identify, attract, and retain qualified personnel;

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to address such risks in a cost-effective manner, if at all.

If we are unable to successfully address these risks our business could

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.

we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships with business targets

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sales and marketing infrastructure or to out-license such future products.

the future, we may consider building a focused sales and marketing infrastructure to market any future 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.

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.

that may inhibit our efforts to commercialize any future products on our own include:

inability to recruit, train, and retain adequate numbers of effective sales and marketing personnel;

inability of sales personnel to obtain access to potential customers;

have not recruited adequate numbers of effective sales and marketing personnel;

challenge of sales personnel to obtain access to potential customers;

lack of complementary products to be offered by sales personnel or lack of product-market fit, which may put us at a competitive

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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.

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.

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.

may require substantial additional funding, which may not be available to us on acceptable terms, or at all.

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growth, our business, prospects, financial condition, and results of operations could be adversely affected.

commercial success depends upon the degree of market acceptance by the medical community as well as by other prospective markets and

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.

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.

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

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the acceptance by such industries of our commissioned products as a useful and cost-effective solution compared to current technologies.

During 2021, we commenced proactive market penetration into industries other than 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:

During 2022, we commenced proactive market penetration into industries other than the biomedical sector, such as the defense and aviation

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:

cost, safety, efficacy/performance, perceived value and convenience of our technology and any commissioned product and any future

product that we may develop in relation to alternative products;

ability of third parties to enter into relationships with us without violating their existing agreements;

ability of third parties to enter into relationships with us;

effectiveness of our sales and marketing efforts;

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may require more resources than are required by conventional technologies.

COVID-19 pandemic has adversely affected, and may continue to adversely affect, our business, financial condition, liquidity and results

of operations.

date, the COVID-19 pandemic has not had a material effect on our operations.

However, the measures adopted to contain and mitigate the

effects of the COVID-19 pandemic, including stay-at-home, business closure, social distancing, capsuled labor, and other restrictive

orders, and the resulting changes in consumer behaviors, have disrupted our normal operations and impacted our employees and suppliers.

We expect these disruptions and impacts to continue.

In addition, certain of our suppliers experienced delays and shut-downs due to the

COVID-19 pandemic and we have experienced supply chain disruptions due to multiple factors, such as fulfillment center disruption and

limited shipping capacity.

This has led to abnormally high transportation delays and shipping costs, which has increased our cost of

Further, the continuation of the COVID-19 pandemic has led to increased operational and cybersecurity risks, including those

related to a number of our employees working remotely.

These risks include, among others, increased demand on our information technology

resources and systems, the increased risk of phishing, and other cybersecurity attacks as cybercriminals try to exploit an increased

number of points of possible attack, such as laptops and mobile devices, both of which are now being used in increased numbers.

to effectively manage these increased operational and cybersecurity demands and risks, including to timely identify, appropriately respond

to, and remediate cybersecurity attacks and other security incidents, may materially adversely affect our results of operations and the

ability to conduct our business.

the continued spread of COVID-19, including the emergence of COVID-19 variants, such as the recent Delta and Omicron variants, and the

resultant personal, economic and governmental reactions, we may have to take additional actions in the future that could adversely affect

our business, financial condition, and results of operations, including a return to a fully remote workforce.

changes could negatively impact our operations, sales, and marketing in particular, which could have longer-term effects on our sales

pipeline, or create operational or other challenges as our workforce remains predominantly remote, any of which could adversely affect

our business, financial condition, and results of operations.

In addition, our management team has spent, and will likely continue to

spend, significant time, attention, and resources monitoring the COVID-19 pandemic and associated global economic uncertainty and seeking

to manage its effects on our business and workforce.

The degree to which COVID-19 will affect our business, financial condition, and

results of operations will depend on future developments that are highly uncertain and cannot currently be predicted.

These developments

include, but are not limited to, the duration, extent, impact and severity of the COVID-19 pandemic in different geographies, the effectiveness

of our transition from work-from-home arrangements to a gradual return to our offices, actions taken to contain the COVID-19 pandemic,

the long-term efficacy, global availability and acceptance of vaccines, related restrictions on economic activity and domestic and international

trade, and the extent of the impact of these and other factors on our employees, suppliers, and customers.

The COVID-19 pandemic and

related restrictions could limit supplier and distributors’ ability to continue to operate (limiting their abilities to obtain

inventory, generate sales, ship and dispatch orders, or make timely payments to us).

It could disrupt or delay the ability of employees

to work because they become sick or are required to care for those who become sick or for dependents for whom external care is not available.

In addition, the COVID-19 pandemic may also result in reduced consumer spending and adverse or uncertain economic conditions globally,

which in turn may impact our revenue.

global economic conditions may harm our industry, business and results of operations.

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.

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.

continuing effects of the COVID-19 pandemic are highly unpredictable and could be significant, and the duration and extent to which this

will impact our future results of operations and overall financial performance remains uncertain.

The extent to which the COVID-19 pandemic ultimately impacts our business

will depend on future developments, which are highly uncertain and cannot be predicted, such as the duration of future outbreaks, including

current and subsequent variants of COVID-19, travel restrictions and social distancing in Israel, the United States and other countries,

business closures or business disruptions, and the effectiveness of actions taken in Israel, the United States and other countries to

contain and treat the disease and to address its impact, including on financial markets or otherwise.

These measures have impacted, and

may further impact, our suppliers and other business partners from conducting business activities as usual (including, without limitation,

the availability and pricing of materials, manufacturing and delivery efforts, clinical trials and other aspects that may affect our business)

for an unknown period of time.

In addition, we, our suppliers and other business partners may experience significant impairments of business

activities due to operational shutdowns or suspensions that may be requested or mandated by national or local governmental authorities

or self-imposed by us, our suppliers or other business partners.

Related to Third Parties

reliance on third-party suppliers for most of the components of our products, including miniature video sensors which are suitable for

our CMOS technology products mainly in the medical domain, could harm our ability to meet demand for our products in a timely and cost-effective

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.

rely on our third-party suppliers to obtain an adequate supply of quality components on a timely basis with favorable terms to manufacture

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is the case regarding sensors for the CMOS type technology that are produced by a single supplier in the United States.

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 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.

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.

are also subject to other risks inherent in the manufacturing of our products and their supply chain, including industrial accidents,

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were to occur, it could have an adverse effect on our business, financial condition, and results of operations.

In addition, we may experience

interruptions with our suppliers and other supply chain disruptions as a result of the COVID-19 pandemic, or any other international

In recent months, global supply chain disruptions have slowed receipt of some of our supplies and delayed some of our deliveries,

although as yet not materially, and increased some of our product costs.

Although such cost increases have been fully covered by our

customers to date, there is no assurance that this will continue in the future.

addition, if we cannot supply commissioned products or future potentially developed products due to a lack of components or are unable

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Related to Competition

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.

expect to face 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.

expect to compete against existing technologies and proven products in different industries.

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to the commercialization of relevant competitive technologies and future products.

customers may develop the capabilities of our solution in-house, which would significantly reduce the demand for our products.

customers may develop the capabilities to manufacture solutions in-house that are currently satisfied by our solutions.

our customers, or future customers, develop such capacities, our potential for profitability may be significantly reduced.

to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.

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or pending patent applications provide any protectable, maintainable, or enforceable rights or competitive advantages to us.

addition to patents, we will rely on a combination of copyrights, trademarks, trade secrets, and other related laws and confidentiality

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

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disclosure of our know-how, trade secrets, or other proprietary or confidential information will occur.

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:

affect our reputation with customers;

time-consuming and expensive to evaluate and defend;

product shipment delays or stoppages;

management’s attention and resources;

us to significant liabilities and damages;

us to enter into royalty or licensing agreements;

us to cease certain activities, including the sale of products.

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.

may not be successful in enforcing our intellectual property rights against third parties.

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

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.

process of negotiating a license with a third party can be lengthy, and may take months or even years in some circumstances.

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.

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.

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:

time, significant expense and distraction to management of managing such litigation;

uncertainty of litigation and its potential outcomes;

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

potential that the defendant may successfully persuade a court that their technology or products do not infringe our intellectual

property rights;

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;

publicity to us or harm to relationships we have with customers or others.

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.

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.

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.

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

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.

may be subject to infringement claims and other litigation, which could adversely affect our business.

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

Our use of protected technology may result in liability that could threaten our continued operation.

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.

regulation of non-practicing patent holders may adversely affect our business.

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.

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.

Risk Factors Related to Our Business

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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.

may be subject to product liability claims, product actions, including product recalls, and other field or regulatory actions that could

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vary widely from country to country.

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.

rely on highly skilled personnel as a result of the high-tech applications we utilize, and if we are unable to attract, retain, or motivate

qualified personnel, we may not be able to operate our business effectively.

success depends in large part on continued employment of senior management and key personnel who can effectively operate our business,

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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, 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.

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

Our long-term incentive

programs may not be attractive enough or perform sufficiently to attract or retain qualified personnel.

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.

the volatility of our stock price may make our equity compensation less attractive to current and potential employees.

success also depends on our having highly trained financial, technical, R&D, sales, and marketing personnel.

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reselling any shares of our common stock .

law and provisions in our amended and restated articles of incorporation and amended and restated bylaws could make a merger, tender

offer or proxy contest difficult, thereby depressing the market price of our common stock.

provisions of Nevada law may prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage

attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above

the prevailing market price.

In addition, our amended and restated articles of incorporation and amended and restated bylaws contain

provisions that may make the acquisition of the Company more difficult, including the following:

board of directors is classified into three classes of directors with staggered three-year terms;

special meeting of our stockholders may only be called by either our chairman of the board or a majority of our board of directors;

notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting

of stockholders.

provisions, alone or together, could discourage, delay or prevent a transaction involving a change in control of the Company.

These provisions

could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause us

to take other corporate actions they desire, any of which, under certain circumstances, 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.

Anti-takeover

provisions contained in our articles and bylaws, as well as provisions of Nevada law, could impair a takeover attempt.

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.

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.

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.

market price of our common stock may be highly volatile and such volatility could cause you to lose some or all of your investment.

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with the reporting requirements of federal securities laws can be expensive.

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.

are a public reporting company in the United States, and accordingly, subject to the information and reporting requirements of the Securities

Exchange Act of 1934 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.

investors’ ownership in the Company may be diluted in the future.

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of our present stockholders.

For instance, pursuant to the Securities Exchange Agreement by and between Intellisense and Medigus, dated

September 16, 2019, if ScoutCam achieves $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,

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.

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decisions that our stockholders do not consider to be in their best interests.

of March 28, 2022, our directors, executive officers, principal stockholders, and affiliated entities may be deemed to beneficially own,

in the aggregate, approximately 76.43% 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.

As of March 28, 2023, our directors,

executive officers, principal stockholders, and affiliated entities may be deemed to beneficially own, in the aggregate, approximately

84.40% 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.

do not anticipate paying any cash dividends in the foreseeable future.

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Related to our Operations in Israel

are subject to the risks of political, economic, health, and military instability in countries outside the United States in which we

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.

economic and military instability in Israel may impede our ability to operate and harm our financial results.

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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

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.

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, including wars.

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.

recent years, Israel has been subject to certain political instability and 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.

Israel is still

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.

commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism.

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affect our business, prospects, financial condition, and results of operations.

the beginning of 2023, the newly formed government commenced a legislative process to effect changes in the Israeli legal system.

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 the

proposed legislation has not become effective, and its scope is not fully determined, we cannot assess the possible impacts of these

changes and their likelihood.

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.

may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.

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future revenues to be denominated primarily in U.S.

However, some 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.

We may, in the future, decide to enter into

currency hedging transactions.

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.

We may, in the future,

decide to enter into currency hedging transactions.

These measures, however, may not adequately protect us from material adverse effects.

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 political and economic uncertainty globally

technology developed and used by us received Israeli government grants for certain research and development activities.

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in litigation and adversely affect our business.

significant portion of ScoutCam’s intellectual property has been developed by ScoutCam’s employees in the course of their

significant portion of our intellectual property has been developed by our employees in the course of their

employment for us.

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unresolved staff comments

do not own property and currently lease our principal corporate office, which is located at Omer Industrial Park, No.

7A and 3B, P.O.

Box 3030, Omer, Israel 8496500.

We believe our leased office sufficiently meets our current needs.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors