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Item 1A. Risk Factors

2026-02-27 compared with 2025-02-19 · 894 added, 995 removed, 838 unchanged (69% of the section changed)

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our business plan, and the price at which our Common Stock is quoted on the OTC Pink Market.

Many of these events are outside of our

Many of these events are outside of our control.

The risks described below are not the only ones facing our Company.

Additional risks not presently known to us or that we currently

believe are immaterial may also impair our business operations.

If any of these risks actually occur, our business, financial condition

or results of operation may be materially adversely affected.

In such case investors in our securities could lose all or part of their

Additional risks not presently known to us or that we currently believe

are immaterial may also impair our business operations.

If any of these risks actually occur, our business, financial condition or results

of operation may be materially adversely affected.

In such case investors in our securities could lose all or part of their investment.

Risks Related to Our Capital Requirements and Financing

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have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order to continue as a going

In its report dated February

19, 2025, Barzily & Co., our independent registered public accounting firm, expressed substantial doubt about our ability to continue

we must raise additional capital to fund our operations in order to continue as a going concern.

In its report dated February 27, 2026, Barzily & Co., our independent registered public accounting firm, expressed substantial doubt about our ability to continue

as a going concern as we have suffered recurring losses from operations and have insufficient liquidity to fund our future operations.

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war against them, may affect our operations.

Because our wholly-owned

subsidiary is incorporated under the laws of the state of Israel, all of our operations are conducted in Israel, and all of our employees

and management personnel are located in Israel, our business and operations are directly 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 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 have negatively affected business

conditions in Israel.

Because our wholly-owned subsidiary

is incorporated under the laws of the State of Israel, all of our operations are conducted in Israel, and all of our employees and management

personnel are located in Israel, our business and operations are directly affected by economic, political, geopolitical and military conditions

Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring

countries and 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 have negatively affected business conditions in Israel.

In October 2023, Hamas terrorists

infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.

also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza

Strip and in other areas within the State of Israel.

Following the attack, Israel’s security cabinet declared war against Hamas

and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks.

the clash between Israel and Hezbollah in Lebanon may escalate in the future into a greater regional conflict.

also launched extensive rocket attacks on Israeli population, industrial centers located along Israel’s border with the Gaza Strip

and in other areas within the State of Israel.

Following the attack, Israel’s security cabinet declared war against Hamas and a

military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks.

While a ceasefire

was reached between Israel and Hamas in October 2025, the situation remains volatile.

In addition, since the commencement

of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization)

and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and

In October 2024, Israel began limited ground operations against Hezbollah in Lebanon, and in November 2024, a ceasefire was brokered

between Israel and Hezbollah.

In addition, in April 2024 and October 2024, Iran launched direct attacks on Israel involving hundreds of

drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons.

In June 2025,

in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly

targeting military and nuclear infrastructure inside Iran, aimed at disrupting Iran’s capacity to coordinate or launch further hostilities

against Israel, as well as to degrade its nuclear program.

In response, Iran launched multiple waves of drones and ballistic missiles

at Israeli cities.

While most of these attacks were intercepted, several caused civilian casualties and damage to infrastructure.

Israeli military has since conducted additional operations against Iranian assets.

While a ceasefire was reached between Israel and Iran

in June 2025 after 12 days of hostilities, the situation remains volatile.

A broader regional conflict involving additional state and

non-state actors remains a significant risk.

Iran is also believed to have a strong influence among extremist groups in the region, such

as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq.

These situations

may potentially escalate in the future to more violent events which may affect Israel and us.

Additionally, Yemeni rebel group, the Houthis,

launched series of attacks on global shipping routes in the Red Sea, causing disruptions of supply chain.

Such clashes may escalate in

the future into a greater regional conflict.

Any hostilities involving

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The conflict situation in Israel could cause situations where medical product certifying or auditing bodies could not be able

to visit manufacturing facilities of our subcontractors in Israel in order to review our certifications or clearances, thus possibly

leading to temporary suspensions or even cancellations of our product clearances or certifications.

The conflict situation in Israel

could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform

their commitments under those agreements pursuant to force majeure provisions in such agreements.

to visit manufacturing facilities of our subcontractors in Israel in order to review our certifications or clearances, thus possibly leading

to temporary suspensions or even cancellations of our product clearances or certifications.

The conflict situation in Israel could also

result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments

under those agreements pursuant to force majeure provisions in such agreements.

There have been travel advisories

imposed as related to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be

imposed as related to travel to Israel, and restrictions on travel, or delays and disruptions as related to imports and exports may be

imposed in the future.

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agencies, which in turn would have a material adverse impact on our ability to commercialize our product candidates.

The Israel Defense Force

(the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions.

The Israel Defense Force (the

“IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions.

Several employees

of our vendors are subject to military service in the IDF and have been and may be called to serve.

It is possible that there will be

further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional

of our vendors are subject to military service in the IDF and have been or may be called to serve.

It is possible that there will be further

military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional

knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party

outsourcing, for example, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash

outsourcing, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.

It is currently not possible

to predict the duration or severity of the ongoing conflict or its effects on our business, operations and financial conditions.

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 others.

Our operations and

financial performance depend on global and regional economic conditions.

Inflation, fluctuations in currency exchange rates, changes

in consumer confidence and demand, and weakness in general economic conditions and threats, or actual recessions, could materially affect

our business, results of operations, and financial condition.

Macroeconomic conditions

impact consumer confidence and discretionary spending, which could adversely affect demand for any products we bring to market.

spending habits are affected by, among other things, inflation, fluctuations in currency exchange rates, weakness in general economic

conditions, threats or actual recessions, pandemics, wars and military actions, levels of employment, wages, debt obligations, discretionary

income, interest rates, volatility in capital, and consumer confidence and perceptions of current and future economic conditions.

and uncertainty can, among other things, reduce or shift spending away from elective treatments and procedures, drive patients to purchase

conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources and availability of

supplies and hamper our ability to raise additional funds or sell our securities, among others.

Our operations and financial

performance depend on global and regional economic conditions.

Inflation, fluctuations in currency exchange rates, changes in consumer

confidence and demand, and weakness in general economic conditions and threats, or actual recessions, could materially affect our business,

results of operations, and financial condition.

Macroeconomic conditions impact

consumer confidence and discretionary spending, which could adversely affect demand for any products we bring to market.

Consumer spending

habits are affected by, among other things, inflation, fluctuations in currency exchange rates, weakness in general economic conditions,

threats or actual recessions, pandemics, wars and military actions, levels of employment, wages, debt obligations, discretionary income,

interest rates, volatility in capital, and consumer confidence and perceptions of current and future economic conditions.

uncertainty can, among other things, reduce or shift spending away from elective treatments and procedures, drive patients to purchase

orthodontic treatments that may cost less than our treatment options, result in a decrease in the number of overall orthodontic and dental

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Further, decreased demand

for dental services can cause dentists and labs to postpone investments in capital equipment, such as intraoral scanners and CAD/CAM

equipment and software.

The recent declines in, or uncertain economic outlooks for, the U.S., European and certain other international

economies has and may continue to adversely affect consumer and dental practice spending.

The increase in the cost of fuel and energy,

food and other essential items along with climbing interest rates could reduce consumers’ disposable income, resulting in less

discretionary spending for products like ours.

Decreases in disposable income and discretionary spending or change in consumer confidence

and spending habits may adversely affect our revenues and operating results.

for dental services can cause dentists and labs to postpone investments in capital equipment, such as intraoral scanners and CAD/CAM equipment

and software.

The recent declines in, or uncertain economic outlooks for, the U.S., European and certain other international economies

has and may continue to adversely affect consumer and dental practice spending.

The increase in the cost of fuel and energy, food and

other essential items along with climbing interest rates could reduce consumers’ disposable income, resulting in less discretionary

spending for products like ours.

Decreases in disposable income and discretionary spending or change in consumer confidence and spending

habits may adversely affect our revenues and operating results.

Inflation continues to adversely

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Our business could be impacted by major

public health issues, including pandemics such as the spread of COVID-19.

Major public health issues,

including pandemics could in the future materially affect our business due to their impact on the global economy and regional economies,

public health issues, including future pandemics.

Major public health

issues, including pandemics, could in the future materially affect our business due to their impact on the global economy and regional economies,

demand for consumer products, the imposition or removal of public safety measures.

Public health concerns may also limit the movement

of products between regions, disrupt or delay supply chains and sales and distribution channels, resulting in interruptions of the supply

The emergence of another pandemic, epidemic or infectious disease outbreak,

and any required or voluntary actions to help limit the spread of illness, could impact our ability to carry out our business and may

materially adversely impact global economic conditions, our business, financial condition and results of operations.

The extent to which

a future pandemic, an epidemic or an infectious disease outbreak impacts our business will depend on future developments, which are highly

uncertain and cannot be predicted at this time, and include the duration, severity and scope and the actions taken to contain or treat

such pandemic, epidemic or outbreak.

Public health concerns may also limit the

movement of products between regions, disrupt or delay supply chains and sales and distribution channels, resulting in interruptions

of the supply of products.

The emergence of another pandemic,

epidemic or infectious disease outbreak, and any required or voluntary actions to help limit the spread of illness, could impact our ability

to carry out our business and may materially adversely impact global economic conditions, our business, financial condition and results

of operations.

The extent to which a future pandemic, an epidemic or an infectious disease outbreak impacts our business will depend on

future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope and

the actions taken to contain or treat such pandemic, epidemic or outbreak.

Our business could be impacted by political

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Political events, trade and

other international disputes, wars, and terrorism can lead to unexpected tariffs or trade restrictions, which could adversely impact

our business.

other international disputes, wars, and terrorism can lead to unexpected tariffs or trade restrictions, which could adversely impact our

Tariffs could increase the cost of our products and the components and raw materials to make them.

Once we begin marketing

our products, these increased costs could adversely impact our gross margin and make our products less competitive or reduce demand.

Countries could also adopt other measures, such as controls on imports or exports of goods, technology or data, that could adversely

impact our operations and supply chain and limit our ability to offer products and services.

These measures could require us to take

various actions, including changing suppliers or restructuring business relationships.

Complying with new or changed trade restrictions

is expensive, time-consuming and disruptive to our operations.

Such restrictions can be announced with little or no advance notice and

we may be unable to effectively mitigate the adverse impacts of such measures.

If disputes and conflicts escalate in the future, actions

by governments in response could be significantly more severe and restrictive and could materially affect our business.

Once we begin marketing our

products, these increased costs could adversely impact our gross margin and make our products less competitive or reduce demand.

could also adopt other measures, such as controls on imports or exports of goods, technology or data, that could adversely impact our

operations and supply chain and limit our ability to offer products and services.

These measures could require us to take various actions,

including changing suppliers or restructuring business relationships.

Complying with new or changed trade restrictions is expensive, time-consuming

and disruptive to our operations.

Such restrictions can be announced with little or no advance notice and we may be unable to effectively

mitigate the adverse impacts of such measures.

If disputes and conflicts escalate in the future, actions by governments in response could

be significantly more severe and restrictive and could materially affect our business.

Political unrest, threats,

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a significant portion of our research and development activities is located in Israel.

If there is a natural disaster in the region,

our employees could be impacted, our research could be lost, and our ability to create treatment plans, respond to customer inquiries

or manufacture and ship our aligners or intraoral scanners could be compromised, which could result in our future customers experiencing

significant product and services delays.

If there is a natural disaster in the region, our

employees could be impacted, our research could be lost, and our ability to create treatment plans, respond to customer inquiries or manufacture

and ship our aligners or intraoral scanners could be compromised, which could result in our future customers experiencing significant

product and services delays.

The effects of climate change

on regional and global economies could change the supply, demand or availability of sources of energy or other resources material to

our products and operations and affect the availability or cost of natural resources and goods and services on which we and our suppliers

on regional and global economies could change the supply, demand or availability of sources of energy or other resources material to our

products and operations and affect the availability or cost of natural resources and goods and services on which we and our suppliers

Business and Industry Risks

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cannot be certain of our future profitability.

We have incurred net operating losses since inception.

For the years ended

December 31, 2024 and 2023, we incurred net losses of $5.8 million and $3.6 million, respectively.

From inception through the present,

we have spent significant funds in organizational and start up activities, to recruit key managers and employees, to develop our Platform,

and for research and development.

We have incurred net operating

losses since inception.

For the years ended December 31, 2025 and 2024, we incurred net losses of $2.5 million and $5.8 million, respectively.

From inception through the present, we have spent significant funds in organizational and start up activities, to recruit key managers

and employees, to develop our Platform, and for research and development.

We expect to continue incurring

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may require us to raise additional capital over the next few years.

We may consume available resources more rapidly than anticipated

and we may not be able to raise additional funds when needed or on acceptable terms.

We may consume available resources more rapidly than anticipated and

we may not be able to raise additional funds when needed or on acceptable terms.

If we raise additional funds through further issuances

of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities

we issue could have rights, preferences, and privileges superior to those of holders of our common stock.

of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we

issue could have rights, preferences, and privileges superior to those of holders of our Common Stock.

In connection with the Private

Placement, we granted the Private Placement Investors a right to participate in future financings, until the second anniversary of the

closing of the Private Placement, that involve the issuance of our common stock or common stock equivalents for cash consideration.

the Securities Purchase Agreement entered into in connection with the Private Placement (the “Securities Purchase Agreement”)

contains “most favored nation” provisions, which may require future amendments to the terms of the Private Placement to give

Private Placement Investors the benefit of more favorable terms governing certain future issuances of our common stock or common stock

Such participation right and “most favored nation” provisions may restrict our ability to secure future financings

unless the Private Placement Investors waive their right to participate, the persons providing such financing accept the participation

of the Private Placement Investors or the Private Placement Investors waive their rights under “most favored nation” provisions,

respectively.

If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability

to continue to pursue our business objectives and to respond to business opportunities, challenges, or unforeseen circumstances could

be significantly limited, and our business, operating results, financial condition, and prospects could be materially adversely affected.

Placement (as defined herein) that closed in August 2023, we granted the Private Placement Investors a right to participate in future

financings, until the second anniversary of the closing of the Private Placement, that involve the issuance of our Common Stock or Common

Stock equivalents for cash consideration.

Further, the Securities Purchase Agreement entered into in connection with the Private Placement

(the “Securities Purchase Agreement”) contains “most favored nation” provisions, which may require future amendments

to the terms of the Private Placement to give Private Placement Investors the benefit of more favorable terms governing certain future

issuances of our Common Stock or Common Stock equivalents.

Such participation right and “most favored nation” provisions may

restrict our ability to secure future financings unless the Private Placement Investors waive their right to participate, the persons

providing such financing accept the participation of the Private Placement Investors or the Private Placement Investors waive their rights

under “most favored nation” provisions, respectively.

If we are unable to obtain adequate financing or financing on terms

satisfactory to us, when we require it, our ability to continue to pursue our business objectives and to respond to business opportunities,

challenges, or unforeseen circumstances could be significantly limited, and our business, operating results, financial condition, and

prospects could be materially adversely affected.

We will depend on the acceptance of teledentistry

and a demand for correcting tooth alignment.

Continued and widespread

market acceptance of teledentistry by consumers is critical to our future success.

Delivery of our Platform via a teledentistry model

will represent a change from traditional orthodontic treatment, which requires in person visits, and consumers may be reluctant to accept

this model or may not find it preferable to traditional treatment.

In addition, consumers may not respond to our direct marketing campaigns,

or we may be unsuccessful in reaching our target audience, particularly in foreign jurisdictions where our advertising may be more heavily

If consumers prove unwilling to adopt our teledentistry model as rapidly or in the numbers that we anticipate, our operating

results could be materially harmed.

Consumer spending habits

are affected by, among other things, prevailing economic conditions, inflationary factors, levels of employment, salaries and wage

rates, consumer confidence, and consumer perception of economic conditions.

In many markets, dental and orthodontic reimbursement is

largely out of pocket for the consumer and, as result, utilization rates can vary significantly depending on economic growth.

general slowdown in the U.S.

economy and certain international economies may result in, among other things, a decrease in the number

of overall orthodontic case starts, a reduction in consumer spending on elective or higher value procedures, or a reduction in

demand for dental and orthodontic services generally, each of which would have an adverse effect on our sales, if any, and operating

Inflation and weakness in the global economy result in a challenging environment for selling dental and orthodontic

technologies.

If there is a reduction in consumer demand for orthodontic treatment generally, or if consumers choose to use a

competitive product rather than our Platform for any reason, our business, results of operations, and financial condition could be

materially harmed.

Continued and widespread market

acceptance of teledentistry by consumers is critical to our future success.

Delivery of our Platform via a teledentistry model will represent

a change from traditional orthodontic treatment, which requires in person visits, and consumers may be reluctant to accept this model

or may not find it preferable to traditional treatment.

In addition, consumers may not respond to our direct marketing campaigns, or we

may be unsuccessful in reaching our target audience, particularly in foreign jurisdictions where our advertising may be more heavily regulated.

If consumers prove unwilling to adopt our teledentistry model as rapidly or in the numbers that we anticipate, our operating results could

be materially harmed.

Consumer spending habits are

affected by, among other things, prevailing economic conditions, inflationary factors, levels of employment, salaries and wage rates,

consumer confidence, and consumer perception of economic conditions.

In many markets, dental and orthodontic reimbursement is largely

out of pocket for the consumer and, as result, utilization rates can vary significantly depending on economic growth.

A general slowdown

economy and certain international economies may result in, among other things, a decrease in the number of overall orthodontic

case starts, a reduction in consumer spending on elective or higher value procedures, or a reduction in demand for dental and orthodontic

services generally, each of which would have an adverse effect on our sales, if any, and operating results.

Inflation and weakness in

the global economy result in a challenging environment for selling dental and orthodontic technologies.

If there is a reduction in consumer

demand for orthodontic treatment generally, or if consumers choose to use a competitive product rather than our Platform for any reason,

our business, results of operations, and financial condition could be materially harmed.

Adverse changes in, or interpretations

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is dependent, in part, on current laws, rules, and regulations governing remote healthcare and the practice of dentistry.

in laws, rules, regulations, or their interpretations are inconsistent with our current business model, we would need to adapt our business

If changes in

laws, rules, regulations, or their interpretations are inconsistent with our current business model, we would need to adapt our business

model accordingly, and our operations in certain jurisdictions may be disrupted, which could have a material adverse effect on our business,

results of operations, and financial condition.

Our net revenues will depend primarily

on our Platform and any decline in sales or average selling price of our Platform may adversely affect net revenues, gross margin and

Our net revenues will be

largely dependent on sales of our Platform, making widespread acceptance of our Platform by dental professionals and consumers critical

to our future success.

Our net revenues will depend primarily on

our Platform and any decline in sales or average selling price of our Platform may adversely affect net revenues, gross margin and net

Our net revenues will be largely

dependent on sales of our Platform, making widespread acceptance of our Platform by dental professionals and consumers critical to our

future success.

Our operating results could be harmed if:

professionals experience a reduction in consumer demand for orthodontic services;

are unwilling to adopt system treatment offered by our Platform as rapidly or in the volumes we anticipate and at the prices offered;

professionals choose to continue using wires and brackets or competitive products rather than our Platform or the rates at which they

utilize our Platform fail to increase or increase as rapidly as anticipated after we commence sales;

the average selling price of our products declines after we commence sales.

dental professionals experience a reduction in consumer demand for orthodontic services;

consumers are unwilling to adopt system treatment offered by our Platform as rapidly or in the volumes we anticipate and at the prices offered;

dental professionals choose to continue using wires and brackets or competitive products rather than our Platform or the rates at which they utilize our Platform fail to increase or increase as rapidly as anticipated after we commence sales;

if the average selling price of our products declines after we commence sales.

The average selling prices

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for our Platform may be adversely affected in the future after we commence sales if:

introduce new or change existing promotions, general or volume-based discount programs, product or services bundles, or consumer rebate

● participation

in any promotions or programs unexpectedly increases or decreases or drives demand in unexpected and material ways;

geographic, channel, or product mix shifts to lower priced products or to products that have a higher percentage of deferred revenue;

decrease prices on one or more products or services in response to increasing competitive pricing pressures;

introduce new or change existing products or services, or modify how we market or sell any of our new or existing products or services;

used in the calculation of deferred revenue differ from actual average selling prices.

we introduce new or change existing promotions, general or volume-based discount programs, product or services bundles, or consumer rebate programs;

participation in any promotions or programs unexpectedly increases or decreases or drives demand in unexpected and material ways;

our geographic, channel, or product mix shifts to lower priced products or to products that have a higher percentage of deferred revenue;

we decrease prices on one or more products or services in response to increasing competitive pricing pressures;

we introduce new or change existing products or services, or modify how we market or sell any of our new or existing products or services;

estimates used in the calculation of deferred revenue differ from actual average selling prices.

If our average selling prices

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We expect to compete with

a handful of large aligner companies including Align Technologies, Dentsply Sirona, 3M™ Clarity™ Aligners, and Straumann

We expect some additional competition from other teledentistry solutions, and from new entrants into the orthodontic supply or

clear aligner markets.

Some of these competitors may have greater resources as well as the ability to leverage existing channels in the

dental market to compete directly with us.

a handful of large aligner companies including Align Technologies, Dentsply Sirona, 3M™ Clarity™ Aligners, and Straumann Group.

We expect some additional competition from other teledentistry solutions, and from new entrants into the orthodontic supply or clear aligner

Some of these competitors may have greater resources as well as the ability to leverage existing channels in the dental market

to compete directly with us.

In addition, we may also face future competition from companies that introduce new technologies.

We may be unable to compete with these competitors, and one or more of these competitors may render our technology obsolete or economically

unattractive.

unable to compete with these competitors, and one or more of these competitors may render our technology obsolete or economically unattractive.

Our business model depends on being able

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statements in support of, or lend support to events or causes which may be perceived by a portion of society negatively, our sponsorships

or support of these entities or individuals may be questioned, boycotts of our products announced, and our reputation may be harmed,

any of which could have a material effect on our gross margin and business overall.

or support of these entities or individuals may be questioned, boycotts of our products announced, and our reputation may be harmed, any

of which could have a material effect on our gross margin and business overall.

In addition, various countries

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of new products and services.

We intend to continually improve and enhance our Platform and/or develop

and introduce new products and services in order to maintain or increase our sales.

The success of new or enhanced products and services

may depend on a number of factors, including anticipating and effectively addressing consumer preferences and demand, the success of our

sales and marketing efforts, innovation and timely and successful research and development, obtaining necessary regulatory clearances,

anticipating and responding to competing products and technological innovations, adequately protecting our intellectual property rights,

effective forecasting and management of product demand, effective management of manufacturing and supply costs, and the quality of our

There can be no assurance that we will be able to successfully develop and introduce new or enhanced products and services.

Even if new or enhanced products and services are successfully introduced, they may not rapidly gain market share and acceptance.

We intend to continually improve

and enhance our Platform and/or develop and introduce new products and services in order to maintain or increase our sales.

of new or enhanced products and services may depend on a number of factors, including anticipating and effectively addressing consumer

preferences and demand, the success of our sales and marketing efforts, innovation and timely and successful research and development,

obtaining necessary regulatory clearances, anticipating and responding to competing products and technological innovations, adequately

protecting our intellectual property rights, effective forecasting and management of product demand, effective management of manufacturing

and supply costs, and the quality of our products.

There can be no assurance that we will be able to successfully develop and introduce

new or enhanced products and services.

Even if new or enhanced products and services are successfully introduced, they may not rapidly

gain market share and acceptance.

The development of new products

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of new and enhanced products and services, including delays in obtaining any necessary regulatory clearances.

Unanticipated problems

in developing products and services could also divert substantial research and development resources, which may impair our ability to

develop new products and services and enhancements of existing products and services, and could substantially increase our costs.

new or enhanced product and service introductions are delayed or not successful, we may not be able to achieve an acceptable return,

if any, on our research and development efforts, and our business may be adversely affected.

Even if we successfully innovate and develop

new or enhanced products and services, we may incur substantial costs in doing so and our profitability may suffer.

Unanticipated problems in

developing products and services could also divert substantial research and development resources, which may impair our ability to develop

new products and services and enhancements of existing products and services, and could substantially increase our costs.

If new or enhanced

product and service introductions are delayed or not successful, we may not be able to achieve an acceptable return, if any, on our research

and development efforts, and our business may be adversely affected.

Even if we successfully innovate and develop new or enhanced products

and services, we may incur substantial costs in doing so and our profitability may suffer.

Any failure in our ability

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or prolonged business disruptions, whether internal or at key suppliers, could harm our business and results of operations, result in

material losses, seriously harm our development efforts and future revenues, profitability and financial condition, adversely affect

our competitive position, increase our costs and expenses, and require substantial expenditures and recovery time in order to fully resume

material losses, seriously harm our development efforts and future revenues, profitability and financial condition, adversely affect our

competitive position, increase our costs and expenses, and require substantial expenditures and recovery time in order to fully resume

When business disruptions

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systems and operations, and automating processes needed for long term efficiencies.

Any such failure could have a material impact on

our business, operations and prospects.

Any such failure could have a material impact on our

business, operations and prospects.

Our products and information technology

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or interruption from a variety of sources.

To effectively manage and improve our operations, our IT systems and applications require

an ongoing commitment of significant expenditures and resources to maintain, protect, upgrade, enhance and restore existing systems and

develop new systems to keep pace with continuing changes in information processing technology, evolving industry and regulatory standards,

increasingly sophisticated cyber threats, and changing consumer preferences.

Failure to adequately protect and maintain the integrity

of our products and IT systems may result in a material effect on our financial position, results of operations and cash flows.

To effectively manage and improve our operations, our IT systems and applications require an

ongoing commitment of significant expenditures and resources to maintain, protect, upgrade, enhance and restore existing systems and develop

new systems to keep pace with continuing changes in information processing technology, evolving industry and regulatory standards, increasingly

sophisticated cyber threats, and changing consumer preferences.

Failure to adequately protect and maintain the integrity of our products

and IT systems may result in a material effect on our financial position, results of operations and cash flows.

We plan to continuously upgrade

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first introduced or when new versions are released.

Additionally, the third-party software integrated into or interoperable with our

products and services will routinely reach end of life, and as a consequence, may be exposed to additional vulnerabilities, including

increased security risks, errors and malfunctions that may be irreparable or difficult to repair.

The discovery of a defect, error or

security vulnerability in our products, software applications or IT systems, incompatibility with future customers’ computer operating

systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems may cause

adverse consequences, including:

delay or loss of revenues, significant remediation costs, delay in market acceptance, loss of data,

disclosure of financial, health or other personal information of any customers or patients, product recalls, damage to our reputation,

or increased service costs, any of which could have a material effect on our business, financial condition or results of our operations

and the operations of our potential customers or our business partners.

Additionally, the third-party software integrated into or interoperable with our products

and services will routinely reach end of life, and as a consequence, may be exposed to additional vulnerabilities, including increased

security risks, errors and malfunctions that may be irreparable or difficult to repair.

The discovery of a defect, error or security vulnerability

in our products, software applications or IT systems, incompatibility with future customers’ computer operating systems and hardware

configurations with a new release or upgraded version or the failure of our products or primary IT systems may cause adverse consequences,

delay or loss of revenues, significant remediation costs, delay in market acceptance, loss of data, disclosure of financial,

health or other personal information of any customers or patients, product recalls, damage to our reputation, or increased service costs,

any of which could have a material effect on our business, financial condition or results of our operations and the operations of our

potential customers or our business partners.

Our success depends on key executive personnel,

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personnel, our business and prospects could be materially and adversely affected.

In addition, since the research and development of

the Platform is mainly performed by outsourced third party vendors, although we could transfer the materials to other vendors, an interruption

In addition, since the research and development of the

Platform is mainly performed by outsourced third party vendors, although we could transfer the materials to other vendors, an interruption

of service could materially and adversely affect us.

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The orthodontics industry

is inundated with new products and services which demand the attention of practitioners, who do not have adequate time or motivation

to explore new treatments for their patients or business opportunities of their practices.

Additionally,

facilitating seamless leadership transitions for key positions is a critical factor in sustaining the culture and maintaining the

success of our organization.

is inundated with new products and services which demand the attention of practitioners, who do not have adequate time or motivation to

explore new treatments for their patients or business opportunities of their practices.

Additionally, facilitating

seamless leadership transitions for key positions is a critical factor in sustaining the culture and maintaining the success of our organization.

If our succession planning efforts are not effective, it could adversely impact our business.

continue to assess the key personnel that we believe are essential to our long-term success, as future organizational changes could

also cause our employee attrition rate to increase.

If we fail to effectively manage any organizational or strategic changes, our

financial condition, results of operations, and reputation, as well as our ability to successfully attract, motivate and retain key

employees, could be harmed.

We continue to assess the key personnel

that we believe are essential to our long-term success, as future organizational changes could also cause our employee attrition rate

If we fail to effectively manage any organizational or strategic changes, our financial condition, results of operations,

and reputation, as well as our ability to successfully attract, motivate and retain key employees, could be harmed.

Legal, Regulatory and Compliance Risks

Complying with regulations enforced by

FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties.

Our products (including the

currently cleared version, as well as the next generation Platform for which we have not yet submitted the requisite 510(k) application

to FDA) are considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S.

countries in which we intend to sell our products.

Compliance with these rigorous regulations will affect capital expenditures, earnings

and our competitive position.

These regulations vary from country to country but cover, among other things, the following activities

with respect to medical devices:

development and manufacturing;

labeling, content and language of instructions for use and storage;

storage and safety;

sales and distribution;

clearance and approval;

keeping procedures;

● advertising

and promotion;

and field safety corrective actions;

● post-market

surveillance;

● post-market

approval studies;

import and export.

The regulations to which

we are subject are complex.

Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher

than anticipated costs, or lower than anticipated sales.

Our failure to comply with applicable regulatory requirements could result in

enforcement action by FDA or state agencies, which may include any of the following sanctions:

letters, fines, injunctions, consent decrees, and civil penalties;

replacement, refunds, recall, or seizure of our products;

restrictions or partial suspension or total shutdown of production;

our requests for 510(k) clearance or pre-market approval of new products, new intended uses, or modifications to existing products;

● withdrawing

clearance or pre-market approvals that have already been granted;

Complying with regulations enforced by FDA

and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties.

Our products (both the first

generation Aerodentis system and the recently cleared ZSmile Platform) (including the currently cleared version, as well as the next generation

Platform for which we have not yet submitted the requisite 510(k) application to FDA) are considered medical devices and, accordingly,

are subject to rigorous regulation by government agencies in the U.S.

and other countries in which we intend to sell our products.

with these rigorous regulations will affect capital expenditures, earnings and our competitive position.

These regulations vary from country

to country but cover, among other things, the following activities with respect to medical devices:

design, development and manufacturing;

testing, labeling, content and language of instructions for use and storage;

product storage and safety;

marketing, sales and distribution;

pre-market clearance and approval;

record keeping procedures;

advertising and promotion;

recalls and field safety corrective actions;

post-market surveillance;

post-market approval studies;

product import and export.

The regulations to which we

are subject are complex.

Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than

anticipated costs, or lower than anticipated sales.

Our failure to comply with applicable regulatory requirements could result in enforcement

action by FDA or state agencies, which may include any of the following sanctions:

warning letters, fines, injunctions, consent decrees, and civil penalties;

repair, replacement, refunds, recall, or seizure of our products;

operating restrictions or partial suspension or total shutdown of production;

refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses, or modifications to existing products;

withdrawing clearance or pre-market approvals that have already been granted;

criminal prosecution.

If any of these events were

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We may not receive the necessary authorizations

to market our Platform or any future new products, and any failure to timely do so may adversely affect our ability to grow our business.

Before we can sell a new

medical device in the U.S., or market a new use of, new claim for, or significant modification to a legally marketed device, we must

first obtain either FDA 510(k) clearance or approval, unless an exemption applies.

In the 510(k) clearance process, before a device may

be marketed, the applicant must submit a premarket notification to FDA under Section 510(k) of the FD&C Act, and FDA must determine

that a proposed device is “substantially equivalent” to a legally-marketed “predicate” device.

To be “substantially

equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological

characteristics as the predicate device or have different technological characteristics, not raise different questions of safety or effectiveness

than the predicate device, and be as safe and as effective as the predicate device.

The 510(k) clearance process can be expensive and

uncertain and can take from three to 12 months, but may last significantly longer.

Clinical data may be required in connection with an

application for 510(k) clearance.

Furthermore, even if we are granted regulatory clearances or approvals, they may include limitations

on the indications for use or intended uses of the device, which may limit the market for the device.

Our first generation Aerodentis

System is a Class II medical device, which was cleared by FDA for commercialization in the U.S.

pursuant to the 510(k) notification process

for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

We are preparing to apply for 510(k)

clearance for the updated version of the currently cleared device.

Such updated Platform contains new and/or different components than

the original device, which is why a new 510(k) clearance is required prior to marketing the Platform in the U.S.

We have not yet filed

a 510(k) submission for the Platform, and it has, thus, not been found by the FDA to be substantially equivalent to the first generation

Aerodentis System.

FDA can delay, limit, or

deny 510(k) clearance, or other approval or reclassification, of a device for many reasons, including:

may be unable to demonstrate to FDA’s satisfaction that the products or modifications are substantially equivalent to a proposed

predicate device or safe and effective for their intended uses;

be unable to demonstrate that the clinical and other benefits of the device outweigh the risks;

the applicable

regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers.

to market any future new products, and any failure to timely do so may adversely affect our ability to grow our business.

Before we can sell a new medical

device in the U.S., or market a new use of, new claim for, or significant modification to a legally marketed device, we must first obtain

either FDA 510(k) clearance or approval, unless an exemption applies.

In the 510(k) clearance process, before a device may be marketed,

the applicant must submit a premarket notification to FDA under Section 510(k) of the FD&C Act, and FDA must determine that a proposed

device is “substantially equivalent” to a legally-marketed “predicate” device.

To be “substantially equivalent,”

the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as

the predicate device or have different technological characteristics, not raise different questions of safety or effectiveness than the

predicate device, and be as safe and as effective as the predicate device.

The 510(k) clearance process can be expensive and uncertain

and can take from three to 12 months, but may last significantly longer.

Clinical data may be required in connection with an application

for 510(k) clearance.

Furthermore, even if we are granted regulatory clearances or approvals, they may include limitations on the indications

for use or intended uses of the device, which may limit the market for the device.

Both our first generation

Aerodentis system and the recently cleared ZSmile Platform are classified as Class II medical devices, which were cleared by FDA for commercialization

pursuant to the 510(k) notification process for movement and alignment of teeth during orthodontic treatment of malocclusion

in April 2020 and February 2026, respectively.

FDA can delay, limit, or deny

510(k) clearance, or other approval or reclassification, of a device for many reasons, including:

we may be unable to demonstrate to FDA’s satisfaction that the products or modifications are substantially equivalent to a proposed predicate device or safe and effective for their intended uses;

we may be unable to demonstrate that the clinical and other benefits of the device outweigh the risks;

the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers.

Any delay or failure to obtain

necessary regulatory clearances or approvals could harm our business.

Once cleared for marketing in the U.S., if ever, to the extent

we decide to market the Platform for any additional indications for use and/or make any material modifications to any element of the

device and/or the manufacturing or distribution thereof in the future, an additional 510(k) submission, and FDA clearance thereof, will

Once cleared for marketing in the U.S., if ever, to the extent we

decide to market the Platform for any additional indications for use and/or make any material modifications to any element of the device

and/or the manufacturing or distribution thereof in the future, an additional 510(k) submission, and FDA clearance thereof, will be required.

In addition, FDA may change

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our current marketing authorizations.

We received our European

CE mark and ISO/MDSAP certification in 2019.

In light of our ISO/MDSAP certification, we believe that we are in substantial compliance

with applicable E.U.

We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to

market and sell our products.

The time required to obtain registrations or approvals, if required by other countries, may be longer than

that required for FDA clearance, and requirements for such registrations, clearances, or approvals may significantly differ from FDA

requirements.

If we modify our products, we may need to apply for additional regulatory approvals before we are permitted to sell the

modified product.

In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that

we have received.

If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable

product in that country.

We received our European CE

mark and ISO/MDSAP certification in 2019.

In light of our ISO/MDSAP certification, we believe that we are in substantial compliance with

applicable E.U.

We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market

and sell our products.

The time required to obtain registrations or approvals, if required by other countries, may be longer than that

required for FDA clearance, and requirements for such registrations, clearances, or approvals may significantly differ from FDA requirements.

If we modify our products, we may need to apply for additional regulatory approvals before we are permitted to sell the modified product.

In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we have received.

If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that

Failure to comply with these

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require new 510(k) clearance or other marketing authorizations.

Once a medical device is

permitted to be legally marketed in the U.S.

pursuant to a 510(k) clearance, a manufacturer may be required to notify FDA of certain

modifications to the device.

Manufacturers determine in the first instance whether a change to a product requires a new premarket submission,

but FDA may review any manufacturer’s decision.

Once a medical device is permitted

to be legally marketed in the U.S.

pursuant to a 510(k) clearance, a manufacturer may be required to notify FDA of certain modifications

to the device.

Manufacturers determine in the first instance whether a change to a product requires a new premarket submission, but FDA

may review any manufacturer’s decision.

While our first generation

Aerodentis System has received 510(k) clearance in 2020, we are preparing to apply for 510(k) clearance for the updated components of

our Platform, which must, then, be found by the FDA to be substantially equivalent to the Aerodentis System and, thus, may not be lawfully

marketed in the U.S.

until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated

Although the development of our Platform has been carefully monitored and documented by professionals who are experienced in

the FDA clearance process, there is no assurance that the FDA will agree that our Platform is substantially equivalent to the Aerodentis

System and allow our Platform to be marketed in the United States.

The FDA may determine that the device is not substantially equivalent

and require a PMA or, more likely, a de novo reclassification, and/or require further information, such as additional test data,

including data from clinical studies, before it is able to make a determination regarding substantial equivalence.

By requesting additional

information, the FDA can delay market introduction of our Platform.

Delays in receipt of or failure to receive any necessary 510(k) clearance,

de novo classification, or PMA, or the imposition of stringent restrictions for our Platform could have a material adverse effect on

our business, results of operations and financial condition.

In the future, we may make

other modifications to our products, including our Platform, and determine, based on our review of the applicable FDA regulations and

guidance, that in certain instances new 510(k) clearances or other premarket submissions are not required.

If FDA disagrees with our

determinations, we may be subject to a wide range of enforcement actions, including, for example, a warning letter, among other consequences,

after which we will likely have to cease marketing the applicable modified product and/or to recall distributed units of such modified

product until we obtain the requisite clearance or approval.

Aerodentis System and ZSmile Platform received 510(k) clearance in 2020 and 2026, respectively, we may in the future make other modifications

to our products, including our Platform, and determine, based on our review of the applicable FDA regulations and guidance, that in certain

instances new 510(k) clearances or other premarket submissions are not required.

If FDA disagrees with our determinations, we may be subject

to a wide range of enforcement actions, including, for example, a warning letter, among other consequences, after which we will likely

have to cease marketing the applicable modified product and/or to recall distributed units of such modified product until we obtain the

requisite clearance or approval.

Our products must be manufactured in accordance

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other regulatory enforcement actions if we fail to comply with these regulations.

The methods used in, and

the facilities used for, the manufacture of our products must comply with FDA’s Quality System Regulation which is a complex regulatory

The methods used in, and the

facilities used for, the manufacture of our products must comply with FDA’s Quality System Regulation which is a complex regulatory

scheme that covers the procedures and documentation of, among other requirements, the design, testing, validation, verification, complaint

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There have been several proposed

changes in the United States at the federal and state level for comprehensive reforms regarding the payment for, the availability of

and reimbursement for healthcare services.

changes in the United States at the federal and state level for comprehensive reforms regarding the payment for, the availability of and

reimbursement for healthcare services.

These proposals have ranged from fundamentally changing federal and state healthcare reimbursement

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to existing programs.

One example, among countless others, is the Patient Protection and Affordable Care (the “Affordable Care

Act”) which was the most significant Federal healthcare reform law enacted in the U.S.

One example, among countless others, is the Patient Protection and Affordable Care (the “Affordable Care Act”)

which was the most significant Federal healthcare reform law enacted in the U.S.

in recent history.

The Affordable Care Act

has undergone substantial challenges and changes since its enactment in 2010, and numerous other federal healthcare reform legislation,

executive orders, and judicial rulings have been implemented in the years since, most of which have been or are aimed at lowering healthcare

costs in the U.S.

To the extent any such reform measures or any future initiatives reduce reimbursement or coverage eligibility or amount(s)

for our Platform and/or any future products we may market in the U.S.

The Affordable Care Act has undergone

substantial challenges and changes since its enactment in 2010, and numerous other federal healthcare reform legislation, executive orders,

and judicial rulings have been implemented in the years since, most of which have been or are aimed at lowering healthcare costs in the

To the extent any such reform measures or any future initiatives reduce reimbursement or coverage eligibility or amount(s) for our

Platform and/or any future products we may market in the U.S.

(if any), our business may be adversely affected.

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Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the E.U.

Medical Device Directive

and became effective on May 26, 2021.

Medical Device Directive and

became effective on May 26, 2021.

The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent,

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The new regulations, among other things:

the rules on placing devices on the market and reinforce surveillance once they are available;

explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed

on the market;

the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available

in the European Union;

rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before

they are placed on the market.

strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the European Union;

strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

These modifications may have

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Any change in the laws or

regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more

difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products.

delays in receiving clearance or approval or the failure to receive clearance or approval for our new products would have an adverse

effect on our ability to expand our business.

regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult

and costly to obtain clearance or approval for new products or to produce, market and distribute existing products.

Significant delays

in receiving clearance or approval or the failure to receive clearance or approval for our new products would have an adverse effect on

our ability to expand our business.

Our products may cause or contribute to

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file various reports with FDA, including reports required by the medical device reporting regulations which require us to report to FDA

when we receive or become aware of information that reasonably suggests that one of our products may have caused or contributed to a

death or serious injury or malfunctioned in a way that, if the malfunction were to recur to the device or a similar device that we market,

could cause or contribute to a death or serious injury.

If we fail to comply with our reporting obligations, FDA or other governmental

authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition

of civil monetary penalties, revocation of our device clearance, seizure of our products, or delay in clearance of future products.

and certain foreign regulatory bodies have the authority to require the recall of commercialized products under certain circumstances.

A government-mandated or

voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects,

labeling or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations.

not adequately address problems associated with our devices, we may face additional regulatory requirements or enforcement action, including

required new marketing authorizations, FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal

when we receive or become aware of information that reasonably suggests that one of our products may have caused or contributed to a death

or serious injury or malfunctioned in a way that, if the malfunction were to recur to the device or a similar device that we market, could

cause or contribute to a death or serious injury.

If we fail to comply with our reporting obligations, FDA or other governmental authorities

could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary

penalties, revocation of our device clearance, seizure of our products, or delay in clearance of future products.

FDA and certain foreign

regulatory bodies have the authority to require the recall of commercialized products under certain circumstances.

A government-mandated or voluntary

recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling

or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations.

If we do not adequately

address problems associated with our devices, we may face additional regulatory requirements or enforcement action, including required

new marketing authorizations, FDA warning letters, product seizure, injunctions, administrative penalties, or civil or criminal proceedings.

We may initiate voluntary

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A future recall announcement

or other corrective action could harm our financial results and reputation, potentially lead to product liability claims against us,

require the dedication of our time and capital, and negatively affect our sales.

In addition, FDA’s

and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent,

limit, or delay regulatory approval of our product candidates.

For example, in November 2018, FDA announced that it plans to develop

proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.

It is unclear the extent to which any

proposals, if adopted, could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances,

increase the costs of compliance, or restrict our ability to maintain our current clearances.

or other corrective action could harm our financial results and reputation, potentially lead to product liability claims against us, require

the dedication of our time and capital, and negatively affect our sales.

In addition, FDA’s and

other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit,

or delay regulatory approval of our product candidates.

For example, in November 2018, FDA announced that it plans to develop proposals

to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.

It is unclear the extent to which any proposals,

if adopted, could impose additional regulatory requirements on us that could delay our ability to obtain new 510(k) clearances, increase

the costs of compliance, or restrict our ability to maintain our current clearances.

We also cannot predict the

likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action,

either in the U.S.

For example, the Trump Administration previously enacted several executive actions that could impose significant

burdens on, or otherwise materially delay, FDA’s ability to engage in routine regulatory and oversight activities.

It is difficult

to predict how these executive actions and executive actions that may be taken under the Biden Administration may affect FDA’s

ability to exercise its regulatory authority.

If these executive actions impose constraints on FDA’s ability to engage in oversight

and implementation activities in the normal course, our business may be negatively impacted.

Changes in internet regulations could adversely

affect our business.

likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either

If executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities

in the normal course, our business may be negatively impacted.

Changes in internet regulations could adversely affect our business.

Laws, rules, and regulations

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or future regulation or taxation could increase our operating expenses and expose us to significant liabilities.

Disruptions at the FDA, other agencies

or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership

and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved, or commercialized in a

timely manner, or at all, which could negatively impact our business.

Disruptions at the FDA, other agencies or

notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership

and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved, or commercialized in a timely

manner, or at all, which could negatively impact our business.

The ability of the FDA, other

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For example, over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees

and stop critical activities.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and

stop critical activities.

Separately, in response to

the global COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.

Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to

monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates

as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional

though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor

and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts

to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.

Regulatory authorities outside the United States may adopt similar policy measures in response to the COVID-19 pandemic.

prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting

their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory

If a prolonged

government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their

regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory

authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

In the E.U., notified

bodies must be officially designated to certify products and services in accordance with the MDR.

While several notified bodies have

been designated the COVID-19 pandemic has significantly slowed down their designation process and the current designated notified

bodies are facing a large amount of requests with the new regulation as a consequence of which review times have lengthened although

a new regulation amending the E.U.

MDR was recently adopted in March 2023, extending existing transitional provisions.

situation could significantly impact the ability of notified bodies to timely review and process our regulatory submissions, which

could have a material adverse effect on our business in the E.U.

In the E.U., notified bodies

must be officially designated to certify products and services in accordance with the MDR.

While several notified bodies have been designated

the COVID-19 pandemic has significantly slowed down their designation process and the current designated notified bodies are facing a

large amount of requests with the new regulation as a consequence of which review times have lengthened although a new regulation amending

MDR was adopted in March 2023, extending existing transitional provisions.

This situation could significantly impact the ability

of notified bodies to timely review and process our regulatory submissions, which could have a material adverse effect on our business

and the EEA (which consists of the 27 E.U.

member states plus

Norway, Liechtenstein and Iceland).

member states plus Norway, Liechtenstein and Iceland).

The misuse or off-label use of our Platform

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System is a Class II medical device was cleared by FDA for commercialization in the U.S.

pursuant to the 510(k) notification process

for movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

We are preparing to apply for 510(k)

clearance for the Platform.

If and when our Platform receives 510(k) clearance, it will be cleared for marketing by the FDA only for

movement and alignment of teeth during orthodontic treatment of malocclusion.

We, thus, will not be able to promote it for any other

indications for use or make any promotional claims that are inconsistent with, or outside the scope of, such FDA clearance (often referred

to as “off-label uses”).

However, the assessment of whether a given claim is or is not consistent with a given FDA clearance

or approval can often be subjective, and we cannot guarantee that FDA will always agree with our position regarding a particular claim

or that all of our employees, representatives, and agents will abide by our marketing policies.

If FDA determines that we have promoted

any product without the requisite clearance or approval and/or for an off-label or unapproved use, it could take any number of enforcement

actions against us, including (among others), issuing untitled or warning letters and/or pursuing an injunction, seizure, civil fine

and/or criminal penalties.

It is also possible that other federal, state or foreign enforcement authorities might take action under other

regulatory authority, such as laws prohibiting false claims for reimbursement, any of which would have a material adverse effect on our

business, financial condition, and/or business as a whole.

pursuant to the 510(k) notification process for

movement and alignment of teeth during orthodontic treatment of malocclusion in April 2020.

In February 2026, we received 510(k) clearance

for the Platform for marketing in the U.S.

by the FDA only for movement and alignment of teeth during orthodontic treatment of malocclusion.

We, thus, will not be able to promote it for any other indications for use or make any promotional claims that are inconsistent with,

or outside the scope of, such FDA clearance (often referred to as “off-label uses”).

However, the assessment of whether a

given claim is or is not consistent with a given FDA clearance or approval can often be subjective, and we cannot guarantee that FDA will

always agree with our position regarding a particular claim or that all of our employees, representatives, and agents will abide by our

marketing policies.

If FDA determines that we have promoted any product without the requisite clearance or approval and/or for an off-label

or unapproved use, it could take any number of enforcement actions against us, including (among others), issuing untitled or warning letters

and/or pursuing an injunction, seizure, civil fine and/or criminal penalties.

It is also possible that other federal, state or foreign

enforcement authorities might take action under other regulatory authority, such as laws prohibiting false claims for reimbursement, any

of which would have a material adverse effect on our business, financial condition, and/or business as a whole.

Additionally, we must have

competent and reliable scientific evidence or, where applicable, other adequate substantiation for each reasonable interpretation of

every promotional claim we make.

competent and reliable scientific evidence or, where applicable, other adequate substantiation for each reasonable interpretation of every

promotional claim we make.

In particular, comparative or superiority claims generally require adequate, well controlled, head-to-head

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Further, consumers can bring private false-advertising lawsuits, including class actions, against us for

any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional

materials or other advertising.

any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional materials

or other advertising.

Any of the foregoing could have a material adverse effect on our business.

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us to substantial penalties.

Additionally, any challenge to or investigation into our practices under these laws could cause adverse

publicity and be costly to respond to, and thus could harm our business.

Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity

and be costly to respond to, and thus could harm our business.

There are numerous U.S.

federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, and

physician transparency laws.

Efforts to ensure that our business arrangements with third parties will comply with applicable

healthcare laws and regulations involve substantial costs.

Our business practices and relationships with providers and patients are

subject to scrutiny under these laws.

We may also be subject to patient information privacy and security regulation by both the

federal government and the states and foreign jurisdictions in which we conduct our business.

The healthcare laws and regulations

that may affect our ability to operate include:

federal healthcare Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), which prohibits, among

other things, persons, and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly

or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arrange

for or recommend a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare

and Medicaid.

and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, and physician transparency

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations

involve substantial costs.

Our business practices and relationships with providers and patients are subject to scrutiny under these laws.

We may also be subject to patient information privacy and security regulation by both the federal government and the states and foreign

jurisdictions in which we conduct our business.

The healthcare laws and regulations that may affect our ability to operate include:

the federal healthcare Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), which prohibits, among other things, persons, and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arrange for or recommend a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid.

The term “remuneration” has been broadly interpreted to include anything of value.

The government can establish

a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent

Moreover, the government may assert that a claim including items or services resulting from a violation of the federal healthcare

Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Although there are

a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common

business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly.

that involve remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals

as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor.

practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability.

Moreover, there are

no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations;

federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to

be presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or

used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to

the federal government.

Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam

actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or

False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble

damages and serious mandatory penalties for each false or fraudulent claim or statement.

The government may assert that a claim including

items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal

civil False Claims Act.

Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements

under the federal civil False Claims Act in connection with alleged off-label promotion of their products and allegedly providing free

products to customers with the expectation that the customers would bill federal health care programs for the product.

In addition, manufacturers

can be held liable under the federal civil False Claims Act even when they do not submit claims directly to government payers if they

are deemed to “cause” the submission of false or fraudulent claims.

There are also criminal penalties, including imprisonment

and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government;

Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit,

among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including

private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a

criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or

making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document

knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or

payment for, healthcare benefits, items or services.

Similar to the federal healthcare Anti-Kickback Statute, a person or entity does

not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

federal Physician Payments Sunshine Act under the Affordable Care Act which requires certain manufacturers of drugs, devices, biologics

and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain

exceptions) to report annually to the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services,

information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists

and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and

investment interests held by physicians and their immediate family members.

Since January 2022, applicable manufacturers are also required

to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse

specialists, certified nurse anesthetists, and certified nurse-midwives;

as amended by Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing

regulations, which imposes privacy, security, and breach reporting obligations with respect to Protected Health Information (“PHI”),

upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, and their respective

business associates that perform services on their behalf that involve PHI.

HITECH also created new tiers of civil monetary penalties,

amended HIPAA to make HIPAA compliance as well as civil and criminal penalties directly applicable to business associates, and gave state

attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA laws and seek

attorneys’ fees and costs associated with pursuing federal civil actions;

state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items

or services reimbursed by any third-party payer, including commercial insurers or patients;

state laws that require device companies

to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal

government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state and local

laws that require the licensure of sales representatives;

state laws that require device manufacturers to report information related

to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information;

data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such

as the E.U., which adopted the GDPR, which became effective in May 2018);

state laws governing the privacy and security of health information

in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating

compliance efforts;

The government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate.

Moreover, the government may assert that a claim including items or services resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Although there are a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly.

Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor.

Our practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability.

Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations;

the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.

Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or settlement.

False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and serious mandatory penalties for each false or fraudulent claim or statement.

The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal civil False Claims Act.

Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements under the federal civil False Claims Act in connection with alleged off-label promotion of their products and allegedly providing free products to customers with the expectation that the customers would bill federal health care programs for the product.

In addition, manufacturers can be held liable under the federal civil False Claims Act even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims.

There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government;

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services.

Similar to the federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

the federal Physician Payments Sunshine Act under the Affordable Care Act which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians and their immediate family members.

Since January 2022, applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives;

HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, which imposes privacy, security, and breach reporting obligations with respect to Protected Health Information (“PHI”), upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, and their respective business associates that perform services on their behalf that involve PHI.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make HIPAA compliance as well as civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers or patients;

state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state and local laws that require the licensure of sales representatives;

state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information;

data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the E.U., which adopted the GDPR, which became effective in May 2018);

state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

and state laws related to insurance fraud in the case of claims involving private insurers.

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they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.

To enforce compliance

with healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between

healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and

settlements in the healthcare industry.

To enforce compliance with

healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies

and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

For example, U.S.

federal and state regulatory and enforcement agencies continue to actively

investigate violations of healthcare laws and regulations, including pursuing novel theories of liability under these laws.

government agencies recently have increased regulatory scrutiny and enforcement activity with respect to manufacturer reimbursement

support activities and patient support programs, including bringing criminal charges or civil enforcement actions under the federal

healthcare Anti-Kickback statute, federal civil False Claims Act, the health care fraud statute, and HIPAA privacy provisions.

Responding to investigations can be time and resource consuming and can divert management’s attention from the business.

such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

Even an unsuccessful

challenge or investigation into our practices could cause adverse publicity, and be costly to respond to.

federal and state regulatory and enforcement agencies continue to actively investigate violations of healthcare laws

and regulations, including pursuing novel theories of liability under these laws.

These government agencies recently have increased regulatory

scrutiny and enforcement activity with respect to manufacturer reimbursement support activities and patient support programs, including

bringing criminal charges or civil enforcement actions under the federal healthcare Anti-Kickback statute, federal civil False Claims

Act, the health care fraud statute, and HIPAA privacy provisions.

Responding to investigations can be time and resource consuming and

can divert management’s attention from the business.

Any such investigation or settlement could increase our costs or otherwise

have an adverse effect on our business.

Even an unsuccessful challenge or investigation into our practices could cause adverse publicity,

and be costly to respond to.

If our operations are found

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we may be subject to administrative, civil and criminal penalties, damages, fines, disgorgement, substantial monetary penalties, exclusion

from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations,

and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with

these laws, reputational harm, and the curtailment or restructuring of our operations.

from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations, and

oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these

laws, reputational harm, and the curtailment or restructuring of our operations.

Since our Platform will utilize cloud-based

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laws and regulations related to the privacy and security of personally identifiable information, including health information.

Among other data-privacy

and/or confidentiality laws to which we may be subject, HIPAA establishes privacy and security standards that limit the use and disclosure

of PHI and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure

the confidentiality, integrity, and availability of individually identifiable health information in electronic form, among other requirements.

Among other data-privacy and/or

confidentiality laws to which we may be subject, HIPAA establishes privacy and security standards that limit the use and disclosure of

PHI and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the

confidentiality, integrity, and availability of individually identifiable health information in electronic form, among other requirements.

Violations of HIPAA may result

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that protect the privacy and security of sensitive and personal information, including health information.

These laws may be similar

to or even more protective than HIPAA and other federal privacy laws.

These laws may be similar to

or even more protective than HIPAA and other federal privacy laws.

For example, the laws of the State of California are more restrictive

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effective on January 1, 2023, was enacted through a ballot initiative.

While information we maintain that is covered by HIPAA may be

exempt from the CCPA, other records and information we maintain on our patients may be subject to the CCPA.

In certain cases, it may

be necessary to modify our planned operations and procedures to comply with these more stringent state laws.

Not only may some of these

state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals

who believe their personal information has been misused.

While information we maintain that is covered by HIPAA may be exempt

from the CCPA, other records and information we maintain on our patients may be subject to the CCPA.

In certain cases, it may be necessary

to modify our planned operations and procedures to comply with these more stringent state laws.

Not only may some of these state laws

impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe

their personal information has been misused.

In addition, state and federal privacy laws subject to frequent change.

In addition to HIPAA and

state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit

unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on

certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain

safeguards and to take certain actions in response to a data breach.

Foreign data protection,

privacy, and other laws and regulations are often more restrictive than those in the U.S.

The E.U., for example, traditionally has imposed

stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S.

2018, the GDPR governing data practices and privacy in the E.U., became effective and replaced the data protection laws of the individual

member states.

In addition to HIPAA and state

health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy

and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of

activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain

actions in response to a data breach.

Foreign data protection, privacy,

and other laws and regulations are often more restrictive than those in the U.S.

The E.U., for example, traditionally has imposed stricter

obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S.

In May 2018, the

GDPR governing data practices and privacy in the E.U., became effective and replaced the data protection laws of the individual member

GDPR requires companies to meet stringent requirements regarding the handling of personal data of individuals in the E.U.

These more stringent requirements include expanded disclosures to inform members about how we may use their personal data, increased

controls on profiling members, and increased rights for members to access, control and delete their personal data.

In addition, there

are mandatory data breach notification requirements.

The law also includes significant penalties for non-compliance, which may result

in monetary penalties of up to 20 million Euros or 4% of a company’s worldwide turnover, whichever is higher.

GDPR and other similar

regulations require companies to give specific types of notice and informed consent is required for the placement of a cookie or similar

technologies on a user’s device for online tracking for behavioral advertising and other purposes and for direct electronic marketing,

and the GDPR also imposes additional conditions in order to satisfy such consent, such as a prohibition on pre-checked consents.

unclear how the U.K.

more stringent requirements include expanded disclosures to inform members about how we may use their personal data, increased controls

on profiling members, and increased rights for members to access, control and delete their personal data.

In addition, there are mandatory

data breach notification requirements.

The law also includes significant penalties for non-compliance, which may result in monetary penalties

of up to 20 million Euros or 4% of a company’s worldwide turnover, whichever is higher.

GDPR and other similar regulations require

companies to give specific types of notice and informed consent is required for the placement of a cookie or similar technologies on a

user’s device for online tracking for behavioral advertising and other purposes and for direct electronic marketing, and the GDPR

also imposes additional conditions in order to satisfy such consent, such as a prohibition on pre-checked consents.

It remains unclear

data protection laws or regulations will develop in the medium to longer term and how data transfer to the U.K.

from the E.U.

will be regulated.

Outside of the E.U., there are many other countries with data protection laws, and new countries are

adopting data protection legislation with increasing frequency.

Many of these laws may require consent from individuals for the use of

data for various purposes, including marketing, which may reduce our ability to market our products.

Outside of the E.U., there are many other countries with data protection laws, and new countries are adopting

data protection legislation with increasing frequency.

Many of these laws may require consent from individuals for the use of data for

various purposes, including marketing, which may reduce our ability to market our products.

There is no harmonized approach

to these laws and regulations globally.

Consequently, we increase our risk of non-compliance with applicable foreign data protection

laws and regulations when we expand internationally.

We may need to change and limit the way we use personal information in operating

our business and may have difficulty maintaining a single operating model that is compliant.

Compliance with such laws and regulations

will result in additional costs and may necessitate changes to our business practices and divergent operating models, limit the effectiveness

of our marketing activities, adversely affect our business, results of operations, and financial condition, and subject us to additional

Consequently, we increase our risk of non-compliance with applicable foreign data protection laws

and regulations when we expand internationally.

We may need to change and limit the way we use personal information in operating our business

and may have difficulty maintaining a single operating model that is compliant.

Compliance with such laws and regulations will result

in additional costs and may necessitate changes to our business practices and divergent operating models, limit the effectiveness of our

marketing activities, adversely affect our business, results of operations, and financial condition, and subject us to additional liabilities.

Our business could be adversely affected

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services in certain states.

Since the success of our

business will be dependent on the widespread adaptation of our Platform as a valid method for smile correction, many patients across

multiple geographies will be needed to use our Platform and provide positive feedback and results.

This will expose us to legal risk

of patients or dental practitioners who may have a negative experience with our Platform to file lawsuits claiming damages or other claims.

Although the we will seek insurance coverage for such legal actions, there is no assurance that the amount of coverage will be sufficient

to cover these claims.

In addition, such legal actions from consumers and dental professionals may result in material and adverse effects

on our ability to continue to conduct business due to negative press.

Since the success of our business

will be dependent on the widespread adaptation of our Platform as a valid method for smile correction, many patients across multiple geographies

will be needed to use our Platform and provide positive feedback and results.

This will expose us to legal risk of patients or dental

practitioners who may have a negative experience with our Platform to file lawsuits claiming damages or other claims.

Although the we

will seek insurance coverage for such legal actions, there is no assurance that the amount of coverage will be sufficient to cover these

In addition, such legal actions from consumers and dental professionals may result in material and adverse effects on our ability

to continue to conduct business due to negative press.

A number of dental and orthodontic

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customer personal and financial, patient health information and our own proprietary information and data essential to our business operations.

We will rely upon the effective operation of our IT systems, and those of our service providers, vendors, and other third parties to

safeguard the information and data.

Additionally, our success may be dependent on the success of healthcare providers, many of whom are

comprised of individual or small operations with limited IT experience and inadequate or untested security protocols, in managing data

privacy and data security requirements.

It is critical that the facilities, infrastructure and IT systems on which we depend to run our

business and the products we develop remain secure and be perceived by the marketplace and our potential customers to be secure.

the implementation of security features in our products and security measures in our IT systems, we and our service providers, vendors,

and other third parties may become subject to physical break-ins, computer viruses or other malicious code, unauthorized or fraudulent

access, programming errors or other technical malfunctions, hacking or phishing attacks, malware, ransomware, employee error or malfeasance,

cyber attacks, and other breaches of IT systems or similar disruptive actions, including by organized groups and nation-state actors.

For example, we may experience cybersecurity incidents and unauthorized internal employee exfiltration of company information.

We will rely upon the effective operation of our IT systems, and those of our service providers, vendors, and other third parties to safeguard

the information and data.

Additionally, our success may be dependent on the success of healthcare providers, many of whom are comprised

of individual or small operations with limited IT experience and inadequate or untested security protocols, in managing data privacy and

data security requirements.

It is critical that the facilities, infrastructure and IT systems on which we depend to run our business and

the products we develop remain secure and be perceived by the marketplace and our potential customers to be secure.

Despite the implementation

of security features in our products and security measures in our IT systems, we and our service providers, vendors, and other third parties

may become subject to physical break-ins, computer viruses or other malicious code, unauthorized or fraudulent access, programming errors

or other technical malfunctions, hacking or phishing attacks, malware, ransomware, employee error or malfeasance, cyber attacks, and other

breaches of IT systems or similar disruptive actions, including by organized groups and nation-state actors.

For example, we may experience

cybersecurity incidents and unauthorized internal employee exfiltration of company information.

Further, the frequency of

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We have internal monitoring and detection

systems as well as cybersecurity and other forms of insurance coverage related to a breach event covering expenses for notification,

credit monitoring, investigation, crisis management, public relations and legal advice.

However, damages and claims arising from such

incidents may not be covered or may exceed the amount of any coverage and do not cover the time and effort we may incur investigating

and responding to any incidents, which may be material.

The costs to eliminate, mitigate or recover from security problems and cyber

attacks and incidents could be material and depending on the nature and extent of the problem and the networks or products impacted,

may result in network or systems interruptions, decreased product sales, or data loss that may have a material impact on our operations,

net revenues and operating results.

systems as well as cybersecurity and other forms of insurance coverage related to a breach event covering expenses for notification, credit

monitoring, investigation, crisis management, public relations and legal advice.

However, damages and claims arising from such incidents

may not be covered or may exceed the amount of any coverage and do not cover the time and effort we may incur investigating and responding

to any incidents, which may be material.

The costs to eliminate, mitigate or recover from security problems and cyber attacks and

incidents could be material and depending on the nature and extent of the problem and the networks or products impacted, may result in

network or systems interruptions, decreased product sales, or data loss that may have a material impact on our operations, net revenues

and operating results.

Our business will expose us to potential

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to claims or litigation.

Our products and

services involve an inherent risk of claims concerning their design, manufacture, safety and performance, how they are marketed and

advertised in a complex framework of highly regulated domestic and international laws and regulations, how we package, bundle or

sell them to potential customers, who may be private individuals or companies or public entities such as hospitals and clinics, and

how we train and support doctors, their staffs and patients who administer or use our products.

Moreover, consumer products and

services are routinely subject to claims of false, deceptive or misleading advertising, consumer fraud and unfair business

Additionally, we may be held liable if any product we develop or manufacture or services we offer or perform causes

injury or is otherwise found unhealthy.

If our products are safe but they are promoted for off-label usage, we may be investigated,

fined or have our products or services enjoined or approvals rescinded or we may be required to defend ourselves in litigation.

Although we maintain insurance for product liability, business practices and other types of activities we make or offer, coverage

may not be available on acceptable terms, if at all, and may be insufficient for actual liabilities.

Any claim for product

liability, sales, advertising and business practices, regardless of its merit or eventual outcome, could result in material legal

defense costs and damage our reputation, increase our expenses and divert management’s attention.

Our products and services

involve an inherent risk of claims concerning their design, manufacture, safety and performance, how they are marketed and advertised

in a complex framework of highly regulated domestic and international laws and regulations, how we package, bundle or sell them to potential

customers, who may be private individuals or companies or public entities such as hospitals and clinics, and how we train and support

doctors, their staffs and patients who administer or use our products.

Moreover, consumer products and services are routinely subject

to claims of false, deceptive or misleading advertising, consumer fraud and unfair business practices.

Additionally, we may be held liable

if any product we develop or manufacture or services we offer or perform causes injury or is otherwise found unhealthy.

If our products

are safe but they are promoted for off-label usage, we may be investigated, fined or have our products or services enjoined or approvals

rescinded or we may be required to defend ourselves in litigation.

Although we maintain insurance for product liability, business practices

and other types of activities we make or offer, coverage may not be available on acceptable terms, if at all, and may be insufficient

for actual liabilities.

Any claim for product liability, sales, advertising and business practices, regardless of its merit or eventual

outcome, could result in material legal defense costs and damage our reputation, increase our expenses and divert management’s attention.

Increased focus on current and anticipated

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more complex and more costly laws and regulations that focus on ESG matters.

Our compliance obligations will likely span all aspects

of our business and operations, including product design and development, materials sourcing and other procurement activities, product

packaging, product safety, energy and natural resources usage, facilities design and utilization, recycling and collection, transportation,

disposal activities and workers’ rights.

Our compliance obligations will likely span all aspects of

our business and operations, including product design and development, materials sourcing and other procurement activities, product packaging,

product safety, energy and natural resources usage, facilities design and utilization, recycling and collection, transportation, disposal

activities and workers’ rights.

Environmental regulations

related to greenhouse gases are expected to have an increasingly larger impact on our or our suppliers’ energy sources.

and foreign regulators have enacted or are considering enacting new or additional disclosure requirements or limits on the emissions

of greenhouse gases, including, but not limited to, carbon dioxide and methane, from power generation units using fossil fuels.

and foreign regulators have enacted or are considering enacting new or additional disclosure requirements or limits on the emissions of

greenhouse gases, including, but not limited to, carbon dioxide and methane, from power generation units using fossil fuels.

of greenhouse gas emission limits on power generation are subject to significant uncertainties, including the timing of any new requirements,

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These limits may have the effect of increasing our costs

and those of our suppliers and could result in manufacturing, transportation and supply chain disruptions and delays if clean energy

alternatives are not readily available in adequate amounts when required.

Moreover, alternative energy sources, coupled with reduced

investments in traditional energy sources and infrastructure, may fail to provide the predictable, reliable, and consistent energy that

we, our suppliers and other businesses need for operations.

and those of our suppliers and could result in manufacturing, transportation and supply chain disruptions and delays if clean energy alternatives

are not readily available in adequate amounts when required.

Moreover, alternative energy sources, coupled with reduced investments in

traditional energy sources and infrastructure, may fail to provide the predictable, reliable, and consistent energy that we, our suppliers

and other businesses need for operations.

Meeting our obligations under

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compliance with these laws and regulations, and we cannot provide assurance that our efforts or operations will be compliant.

to comply with any requirements, we could be subject to significant penalties or liabilities and we may be required to implement new

and materially more costly processes and procedures to come into compliance.

to comply with any requirements, we could be subject to significant penalties or liabilities and we may be required to implement new and

materially more costly processes and procedures to come into compliance.

Further these laws are subject to unpredictable changes.

Even if we successfully comply with these laws and regulations, our suppliers may fail to comply.

if we successfully comply with these laws and regulations, our suppliers may fail to comply.

We may also suffer financial and reputational

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and results of operations.

Investor advocacy

groups, institutional investors, investment funds, proxy advisory services, stockholders, and consumers are also increasingly

focused on corporate ESG practices.

Additionally, public interest and legislative pressure related to public companies’ ESG

practices continues to grow.

If our ESG practices fail to meet investor or other industry stakeholders’ evolving expectations

and standards, including environmental stewardship, support for local communities, board of director and employee diversity, human

capital management, employee health and safety practices, product quality, supply chain management, corporate governance and

transparency and employing ESG strategies in our operations, our brand, reputation and employee retention may be negatively

impacted, potential customers and suppliers may be unwilling to do business with us and investors may be unwilling to invest in us.

In addition, as we work to align our ESG practices with industry standards, we have expanded and will likely continue to expand our

disclosures in these areas.

We also expect to incur additional costs and require additional resources to monitor, report, and comply

with our various ESG practices.

If we fail to adopt ESG standards or practices as quickly as stakeholders desire, report on our ESG

efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our reputation, business,

financial performance, growth, and stock price may be adversely impacted.

Investor advocacy groups,

institutional investors, investment funds, proxy advisory services, stockholders, and consumers are also increasingly focused on corporate

ESG practices.

Additionally, public interest and legislative pressure related to public companies’ ESG practices continues to grow.

If our ESG practices fail to meet investor or other industry stakeholders’ evolving expectations and standards, including environmental

stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety

practices, product quality, supply chain management, corporate governance and transparency and employing ESG strategies in our operations,

our brand, reputation and employee retention may be negatively impacted, potential customers and suppliers may be unwilling to do business

with us and investors may be unwilling to invest in us.

In addition, as we work to align our ESG practices with industry standards, we

have expanded and will likely continue to expand our disclosures in these areas.

We also expect to incur additional costs and require

additional resources to monitor, report, and comply with our various ESG practices.

If we fail to adopt ESG standards or practices as

quickly as stakeholders desire, report on our ESG efforts or practices accurately, or satisfy the disclosure and other expectations of

stakeholders, our reputation, business, financial performance, growth, and stock price may be adversely impacted.

We are subject to consumer protection laws

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Our actual or perceived failure to comply with

such obligations could harm our business, and changes in such regulations or laws could require us to modify our products, marketing

or advertising efforts.

such obligations could harm our business, and changes in such regulations or laws could require us to modify our products, marketing or

advertising efforts.

In connection with the marketing

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If we or our future processing

vendors fail to maintain adequate systems for the authorization and processing of credit and debit card transactions, it could cause

one or more of the major credit card companies to disallow our continued use of their payment products.

In addition, if these systems

fail to work properly and, as a result, we do not charge our patients’ credit or debit cards on a timely basis or at all, our business,

vendors fail to maintain adequate systems for the authorization and processing of credit and debit card transactions, it could cause one

or more of the major credit card companies to disallow our continued use of their payment products.

In addition, if these systems fail

to work properly and, as a result, we do not charge our patients’ credit or debit cards on a timely basis or at all, our business,

revenue, results of operations, and financial condition could be harmed.

The payment methods that

we will offer can also subject us to potential fraud and theft by criminals, who are becoming increasingly more sophisticated in exploiting

The payment methods that we

will offer can also subject us to potential fraud and theft by criminals, who are becoming increasingly more sophisticated in exploiting

weaknesses that may exist in the payment systems.

If we fail to comply with applicable rules or requirements for the payment methods

we will accept, or if payment-related data is compromised due to a breach, we may be liable for significant costs incurred by payment

card issuing banks and other third parties or subject to fines and higher transaction fees, or our ability to accept or facilitate certain

If we fail to comply with applicable rules or requirements for the payment methods we

will accept, or if payment-related data is compromised due to a breach, we may be liable for significant costs incurred by payment card

issuing banks and other third parties or subject to fines and higher transaction fees, or our ability to accept or facilitate certain

types of payments may be impaired.

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to other payment types or potential changes to our payment systems that may result in higher costs.

If we fail to adequately control

fraudulent credit card transactions, we may face civil liability, diminished public perception of our security measures, and significantly

higher card-related costs, each of which could harm our business, results of operations, and financial condition.

If we fail to adequately control fraudulent

credit card transactions, we may face civil liability, diminished public perception of our security measures, and significantly higher

card-related costs, each of which could harm our business, results of operations, and financial condition.

We will also be subject to

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We will be required to comply with payment card industry security standards.

Failing to comply with those standards may violate payment card association operating rules, federal and state laws and regulations,

and the terms of our contracts with payment processors.

Any failure to comply fully also may subject us to fines, penalties, damages,

and civil liability, and may result in the loss of our ability to accept credit and debit card payments.

Further, there is no guarantee

that such compliance will prevent illegal or improper use of our payment systems or the theft, loss, or misuse of data pertaining to

credit and debit cards, card holders, and transactions.

Failing to comply with those standards may violate payment card association operating rules, federal and state laws and regulations, and

the terms of our contracts with payment processors.

Any failure to comply fully also may subject us to fines, penalties, damages, and

civil liability, and may result in the loss of our ability to accept credit and debit card payments.

Further, there is no guarantee that

such compliance will prevent illegal or improper use of our payment systems or the theft, loss, or misuse of data pertaining to credit

and debit cards, card holders, and transactions.

If we are unable to maintain

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may differ from FDA requirements.

We may be unable to obtain regulatory approvals and may also incur significant costs in attempting

to obtain foreign regulatory approvals or maintain those we already have.

If we experience delays in receipt of approvals to market our

products in new jurisdictions, or if we fail to receive these approvals, we may be unable to market our products in international markets

in a timely manner, if at all, which could materially impact our international expansion and adversely affect our business as a whole.

In addition, we anticipate that regulations in certain foreign countries may challenge our teledentistry model.

Some international regulations

may also limit the availability of our Platform to patients in certain jurisdictions without our first obtaining a license or engaging

a third party to provide such financing, or limit the financing options we can offer our patients.

We may be unable to obtain regulatory approvals and may also incur significant costs in attempting to

obtain foreign regulatory approvals or maintain those we already have.

If we experience delays in receipt of approvals to market our products

in new jurisdictions, or if we fail to receive these approvals, we may be unable to market our products in international markets in a

timely manner, if at all, which could materially impact our international expansion and adversely affect our business as a whole.

we anticipate that regulations in certain foreign countries may challenge our teledentistry model.

Some international regulations may

also limit the availability of our Platform to patients in certain jurisdictions without our first obtaining a license or engaging a third

party to provide such financing, or limit the financing options we can offer our patients.

If any of these risks were to materialize,

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to do so could harm our competitive position.

We rely on our portfolio

of issued and pending patent applications in the U.S.

and other countries to protect a large part of our intellectual property and our

competitive position;

We rely on our portfolio of

issued and pending patent applications in the U.S.

and other countries to protect a large part of our intellectual property and our competitive

however, our currently pending or future patent filings may not result in the issuance of patents.

While we generally

apply for patents in those countries where we intend to make, have made, use, or sell patented products, we may not accurately predict

all of the countries where patent protection will ultimately be desirable.

If we fail to timely file for a patent, we may be precluded

from doing so at a later date.

Patent rights are

territorial, and patent protection extends only to those countries where we have issued patents.

Filing, prosecuting and defending

patents on our products and product candidates in all countries and jurisdictions throughout the world would be prohibitively

expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in

the United States.

Many countries do not protect intellectual property to the same extent as the U.S.

or Europe, and their

litigation processes differ.

Competitors may successfully challenge or avoid our patents, or manufacture products in countries where

we have not applied for patent protection.

Changes in the patent laws in the U.S.

or other countries may diminish the value of our

patent rights.

As a result of these and other factors, the scope, validity, enforceability, and commercial value of our patent

rights are uncertain and unpredictable.

While we generally apply

for patents in those countries where we intend to make, have made, use, or sell patented products, we may not accurately predict all of

the countries where patent protection will ultimately be desirable.

If we fail to timely file for a patent, we may be precluded from doing

so at a later date.

Patent rights are territorial,

and patent protection extends only to those countries where we have issued patents.

Filing, prosecuting and defending patents on our products

and product candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual

property rights in some countries outside the United States could be less extensive than those in the United States.

Many countries do

not protect intellectual property to the same extent as the U.S.

or Europe, and their litigation processes differ.

Competitors may successfully

challenge or avoid our patents, or manufacture products in countries where we have not applied for patent protection.

Changes in the patent

laws in the U.S.

or other countries may diminish the value of our patent rights.

As a result of these and other factors, the scope, validity,

enforceability, and commercial value of our patent rights are uncertain and unpredictable.

Furthermore, the issuance

of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide

us with adequate proprietary protection or competitive advantages against competitors with similar products.

Any patents issued to us

may be challenged, invalidated, held unenforceable, circumvented, or may not be sufficiently broad to prevent third parties from producing

of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us

with adequate proprietary protection or competitive advantages against competitors with similar products.

Any patents issued to us may

be challenged, invalidated, held unenforceable, circumvented, or may not be sufficiently broad to prevent third parties from producing

competing products similar in design to our products.

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we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.

We also may seek to rely

on protection of copyright, trade secrets, know how, and confidential and proprietary information.

We also may seek to rely on

protection of copyright, trade secrets, know how, and confidential and proprietary information.

We generally enter into confidentiality

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other confidential information, and adequate remedies may not exist if unauthorized use or disclosure were to occur.

The exposure of

our trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect

on our operating results, financial condition, and future growth prospects.

In particular, a failure to protect our proprietary rights

might allow competitors to copy our technology, which could adversely affect our pricing and market share.

We may not be able to prevent

the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors, former employees and current

The exposure of our

trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect on our

operating results, financial condition, and future growth prospects.

In particular, a failure to protect our proprietary rights might

allow competitors to copy our technology, which could adversely affect our pricing and market share.

We may not be able to prevent the

unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors, former employees and current employees.

Further, other parties may independently develop substantially equivalent know-how and technology.

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resources to enforce our trademarks.

interferences, oppositions, re-exams, inter partes reviews, post grant reviews, or other proceedings are, have been, and may in the

future be necessary in some instances to determine the validity and scope of certain of our proprietary rights, and in other

instances to determine the validity, scope, or non-infringement of certain proprietary rights claimed by third parties to be

pertinent to the manufacture, use, or sale of our products or provision of our services.

These types of proceedings are

unpredictable and may be protracted, expensive, and distracting to management.

The outcome of such proceedings could adversely

affect the validity and scope of our patent or other proprietary rights, hinder our ability to manufacture and market our products

and provide our services, require us to seek a license for the infringed product or technology, or result in the assessment of

significant monetary damages.

An unfavorable ruling could include monetary damages or, in cases where injunctive relief is sought,

an injunction prohibiting us from selling our products or providing our services.

Any of these results from litigation could

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

Litigation, interferences,

oppositions, re-exams, inter partes reviews, post grant reviews, or other proceedings are, have been, and may in the future be necessary

in some instances to determine the validity and scope of certain of our proprietary rights, and in other instances to determine the validity,

scope, or non-infringement of certain proprietary rights claimed by third parties to be pertinent to the manufacture, use, or sale of

our products or provision of our services.

These types of proceedings are unpredictable and may be protracted, expensive, and distracting

to management.

The outcome of such proceedings could adversely affect the validity and scope of our patent or other proprietary rights,

hinder our ability to manufacture and market our products and provide our services, require us to seek a license for the infringed product

or technology, or result in the assessment of significant monetary damages.

An unfavorable ruling could include monetary damages or, in

cases where injunctive relief is sought, an injunction prohibiting us from selling our products or providing our services.

results from litigation could adversely affect our business, financial condition, and results of operations.

If we infringe or violate the patents or

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Our commercial success also

depends upon our ability, and the ability of any third party with which we may partner, to develop, manufacture, market and sell our

products, if approved, and use our patent-protected technologies without infringing the patents of third parties.

Extensive litigation

over patents and other intellectual property rights is common in the dental and orthodontic industry.

depends upon our ability, and the ability of any third party with which we may partner, to develop, manufacture, market and sell our products,

if approved, and use our patent-protected technologies without infringing the patents of third parties.

Extensive litigation over patents

and other intellectual property rights is common in the dental and orthodontic industry.

We may not have identified

all patents, published applications or published literature that affect our business either by blocking our ability to commercialize

our products, by preventing the patentability of one or more aspects of our products, or by covering the same or similar technologies

that may affect our ability to market our products.

all patents, published applications or published literature that affect our business either by blocking our ability to commercialize our

products, by preventing the patentability of one or more aspects of our products, or by covering the same or similar technologies that

may affect our ability to market our products.

For example, we may not have conducted a patent clearance search sufficient to identify

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In some cases, however, patent applications remain confidential in the U.S.

Patent and Trademark

Office, or the USPTO, for the entire time prior to issuance as a U.S.

Patent applications filed in countries outside of the United

States are not typically published until at least 18 months from their first filing date.

Similarly, publication of discoveries in the

scientific or patent literature often lags behind actual discoveries.

We cannot be certain that we were the first to invent, or the first

to file, patent applications covering our products.

We also may not know if our competitors filed patent applications for technology

covered by our pending applications or if we were the first to invent the technology that is the subject of our patent applications.

Competitors may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block

or compete with our patents.

Patent and Trademark Office,

or the USPTO, for the entire time prior to issuance as a U.S.

Patent applications filed in countries outside of the United States

are not typically published until at least 18 months from their first filing date.

Similarly, publication of discoveries in the scientific

or patent literature often lags behind actual discoveries.

We cannot be certain that we were the first to invent, or the first to file,

patent applications covering our products.

We also may not know if our competitors filed patent applications for technology covered by

our pending applications or if we were the first to invent the technology that is the subject of our patent applications.

may have filed patent applications or received patents and may obtain additional patents and proprietary rights that block or compete

with our patents.

We may therefore in the future

be the subject of patent or other litigation.

From time to time, we may in the future receive letters from third parties drawing our

attention to their patent rights.

While we do not believe that we infringe upon any valid and enforceable rights that have been brought

to our attention, and we take necessary steps to ensure that we do not infringe on the rights of others, there may be other more pertinent

rights of which we are presently unaware.

The defense and prosecution of intellectual property suits, interference proceedings, and related

legal and administrative proceedings could result in substantial expense to us and significant diversion of effort by our technical and

management personnel.

An adverse determination of any litigation or interference proceeding to which we may become a party could subject

us to significant liabilities.

An adverse determination of this nature could also put our patents at risk of being invalidated or interpreted

narrowly or require us to seek licenses from third parties.

Licenses may not be available on commercially reasonable terms or at all,

in which event, our business would be materially adversely affected.

Intellectual property litigation or claims could force us to cease

developing, selling or otherwise commercializing one or more of our products;

to pay substantial damages for past use of the asserted

intellectual property;

and redesign, or rename in the case of trademark claims, our product(s) to avoid such third party rights, which

may not be possible or which could be costly and time-consuming.

Any of these risks coming to fruition could have a material adverse

effect on our business, results of operations, financial condition and prospects.

From time to time, we may in the future receive letters from third parties drawing our attention

to their patent rights.

While we do not believe that we infringe upon any valid and enforceable rights that have been brought to our attention,

and we take necessary steps to ensure that we do not infringe on the rights of others, there may be other more pertinent rights of which

we are presently unaware.

The defense and prosecution of intellectual property suits, interference proceedings, and related legal and

administrative proceedings could result in substantial expense to us and significant diversion of effort by our technical and management

An adverse determination of any litigation or interference proceeding to which we may become a party could subject us to significant

An adverse determination of this nature could also put our patents at risk of being invalidated or interpreted narrowly or

require us to seek licenses from third parties.

Licenses may not be available on commercially reasonable terms or at all, in which event,

our business would be materially adversely affected.

Intellectual property litigation or claims could force us to cease developing, selling

or otherwise commercializing one or more of our products;

to pay substantial damages for past use of the asserted intellectual property;

and redesign, or rename in the case of trademark claims, our product(s) to avoid such third party rights, which may not be possible or

which could be costly and time-consuming.

Any of these risks coming to fruition could have a material adverse effect on our business,

results of operations, financial condition and prospects.

Our failure to secure trademark registrations

could adversely affect our ability to market our products and operate our business.

Any future trademark

applications in the United States and any other jurisdictions where we may file may not be allowed registration, and we may not be

able to maintain or enforce our registered trademarks.

Any future trademark applications

in the United States and any other jurisdictions where we may file may not be allowed registration, and we may not be able to maintain

or enforce our registered trademarks.

During trademark registration proceedings, we may receive rejections.

Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections.

In addition, in

the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark applications and

to seek to cancel registered trademarks.

Opposition or cancellation proceedings may be filed against our applications and/or

registrations, and our applications and/or registrations may not survive such proceedings.

Failure to secure such trademark

registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our products and our

Although we are given an opportunity

to respond to those rejections, we may be unable to overcome such rejections.

In addition, in the USPTO and in corresponding foreign agencies,

third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.

or cancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may

not survive such proceedings.

Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely

affect our ability to market our products and our business.

We may be subject to claims that our employees

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experience of our management team may put us at a competitive disadvantage.

Our management team

Our management team lacks

public company experience and is generally unfamiliar with the requirements of the U.S.

securities laws and U.S.

Generally Accepted Accounting Principles (“GAAP”), which could impair our ability to comply with legal and regulatory

requirements such as those imposed by Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

The individuals who now

constitute our senior management team have never had responsibility for managing a publicly traded company.

Such responsibilities

include complying with federal securities laws and making required disclosures on a timely basis.

Our senior management may not be

able to implement programs and policies in an effective and timely manner that adequately responds to such increased legal,

regulatory compliance and reporting requirements.

Our failure to comply with all applicable requirements could lead to the

imposition of fines and penalties and distract our management from attending to the growth of our business.

Generally Accepted

Accounting Principles (“GAAP”), which could impair our ability to comply with legal and regulatory requirements such as those

imposed by Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

The individuals who now constitute our senior management

team have never had responsibility for managing a publicly traded company.

Such responsibilities include complying with federal securities

laws and making required disclosures on a timely basis.

Our senior management may not be able to implement programs and policies in an

effective and timely manner that adequately responds to such increased legal, regulatory compliance and reporting requirements.

to comply with all applicable requirements could lead to the imposition of fines and penalties and distract our management from attending

to the growth of our business.

Our Common Stock is not listed on any stock

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on any stock exchange.

Although our common stock is quoted on the OTC Pink Market operated by the OTC Markets Group Inc., there is a

limited public market for shares of our common stock, and limited trades of our common stock have taken place on the OTC Pink Market.

Even if the shares of our common stock may in the future trade greater volume on the OTC Pink Market, the liquidity and price of our

common stock is expected to be more limited than if such securities were quoted or listed on a national exchange.

No assurances can be

given that an active public trading market for our common stock will develop or be sustained.

Trading volume may be limited by the fact

that many major institutional investment funds, including mutual funds, as well as individual investors follow a policy of not investing

in over the counter stocks and certain major brokerage firms restrict their brokers from recommending over the counter stocks because

they are considered speculative, volatile and thinly traded.

Lack of liquidity will limit the price at which stockholders may be able

to sell our common stock.

Even if our common stock

will in the future trade more actively on the OTC Pink Market, the price of such common stock could be subject to wide fluctuations,

Although our Common Stock is quoted on the OTC Pink Limited Market operated by the OTC Markets Group Inc., there

is a limited public market for shares of our Common Stock, and limited trades of our Common Stock have taken place on the OTC Pink Limited

Even if the shares of our Common Stock may in the future trade greater volume on the OTC Pink Limited Market, the liquidity and

price of our Common Stock is expected to be more limited than if such securities were quoted or listed on a national exchange.

No assurances

can be given that an active public trading market for our Common Stock will develop or be sustained.

Trading volume may be limited by

the fact that many major institutional investment funds, including mutual funds, as well as individual investors follow a policy of not

investing in over the counter stocks and certain major brokerage firms restrict their brokers from recommending over the counter stocks

because they are considered speculative, volatile and thinly traded.

Lack of liquidity will limit the price at which stockholders may

be able to sell our Common Stock.

Even if our Common Stock will

in the future trade more actively on the OTC Pink Limited Market, the price of such Common Stock could be subject to wide fluctuations,

in response to quarterly variations in our operating results, announcements by us or others, developments affecting us, and other events

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Such risks could have an adverse effect on the stock’s future liquidity.

We cannot assure you that our common stock

will become eligible for listing or quotation on any exchange and the failure to do so may adversely affect your ability to dispose of

our common stock in a timely fashion.

In order for our common stock

to become eligible for listing or quotation on any exchange, reverse merger companies must have had their securities traded on an over-the-counter

market for at least one year, maintained a certain minimum closing price for not less than 30 of the most recent 60 days prior to the

filing of an initial listing application and prior to listing, and timely filed with the SEC all required reports since consummation

of the reverse merger, including one annual report containing audited consolidated financial statements for a full fiscal year commencing

after the date of filing of the Current Report on Form 8-K which discloses the reverse merger.

We may not be able to meet all of the

filing requirements above and may not be able to satisfy the initial standards for listing or quotation on any exchange in the foreseeable

future or at all.

Even if we are able to become listed or quoted on an exchange, we may not be able to maintain a listing of the common

stock on such stock exchange.

As a result of the Share Exchange, we became

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other projects, thus impairing our ability to grow.

As a result of the Share

Exchange, we became a public reporting company and, accordingly, subject to the information and reporting requirements of Securities

Exchange Act of 1934, as amended (the “Exchange Act”), and other federal securities laws, including compliance with the Sarbanes-Oxley

As a result of the Share Exchange,

we became a public reporting company and, accordingly, subject to the information and reporting requirements of Securities Exchange Act

of 1934, as amended (the “Exchange Act”), and other federal securities laws, including compliance with the Sarbanes-Oxley

The costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC (including reporting

of the Share Exchange) and furnishing audited reports to stockholders will cause our expenses to be higher than they would have been

if we remained privately held and did not consummate the Share Exchange.

of the Share Exchange) and furnishing audited reports to stockholders will cause our expenses to be higher than they would have been if

we remained privately held and did not consummate the Share Exchange.

Public company compliance may make it more

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The Sarbanes-Oxley Act and

new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.

company, we expect these new rules and regulations to increase our compliance costs and to make certain activities more time consuming

As a public company, we also expect that these new rules and regulations may make it more difficult and expensive for us

to obtain director and officer liability insurance in the future and we may be required to accept reduced policy limits and coverage

or incur substantially higher costs to obtain the same or similar coverage.

As a result, it may be more difficult for us to attract and

retain qualified persons to serve on our board of directors or as executive officers.

Because we became public by means of a

reverse merger, we may not be able to attract the attention of major brokerage firms.

rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.

As a public company,

we expect these rules and regulations to increase our compliance costs and to make certain activities more time consuming and costly.

As a public company, we also expect that these rules and regulations may make it more difficult and expensive for us to obtain director

and officer liability insurance in the future and we may be required to accept reduced policy limits and coverage or incur substantially

higher costs to obtain the same or similar coverage.

As a result, it may be more difficult for us to attract and retain qualified persons

to serve on our board of directors or as executive officers.

Because we became public by means of a reverse

merger, we may not be able to attract the attention of major brokerage firms.

There may be risks associated

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beyond our control, including the following:

in our industry;

pricing pressures;

to obtain working capital financing;

or departures of key personnel;

“public float” in the hands of a small number of persons whose sales or lack of sales could result in positive or negative

pricing pressure on the price at which our common stock is quoted;

of our common stock;

to execute our business plan;

results that fall below expectations;

any strategic relationship;

developments;

and other external factors;

period-to-period

fluctuations in our financial results.

changes in our industry;

competitive pricing pressures;

our ability to obtain working capital financing;

additions or departures of key personnel;

limited “public float” in the hands of a small number of persons whose sales or lack of sales could result in positive or negative pricing pressure on the price at which our Common Stock is quoted;

sales of our Common Stock;

our ability to execute our business plan;

operating results that fall below expectations;

loss of any strategic relationship;

regulatory developments;

economic and other external factors;

period-to-period fluctuations in our financial results.

In addition, the securities

markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance

of particular companies.

markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of

particular companies.

These market fluctuations may also materially and adversely affect the price at which our Common Stock is quoted.

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with limited transferability.

Our securities should be

considered a long-term, illiquid investment.

Our common stock has not been registered under the Securities Act of 1933, as amended (the

“Securities Act”), and cannot be sold without registration under the Securities Act or any exemption from registration.

addition, our common stock is not registered under any state securities laws that would permit its transfer.

Because of these restrictions,

a stockholder will likely find it difficult to liquidate an investment in our common stock.

Our securities should be considered

a long-term, illiquid investment.

Our Common Stock has not been registered under the Securities Act of 1933, as amended (the “Securities

Act”), and cannot be sold without registration under the Securities Act or any exemption from registration.

In addition, our Common

Stock is not registered under any state securities laws that would permit its transfer.

Because of these restrictions, a stockholder will

likely find it difficult to liquidate an investment in our Common Stock.

We are subject to penny stock rules which

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In addition to the “penny

stock” rules described above, the Financial Industry Regulatory Authority (“FINRA”) has adopted rules that require

that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable

stock” rules described above, the Financial Industry Regulatory Authority (“FINRA”) has adopted rules that require that

in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable

for that customer.

Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must

make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other

Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities

will not be suitable for at least some customers.

The FINRA requirements make it more difficult for broker-dealers to recommend that

their customers buy our common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market

for our shares.

Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make

reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information.

Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities will not

be suitable for at least some customers.

The FINRA requirements make it more difficult for broker-dealers to recommend that their customers

buy our Common Stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for our shares.

We do not anticipate paying any cash dividends.

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Stock in the future.

Our shares of common

stock are thinly traded.

Due to the illiquidity, the price at which our common stock is quoted may not accurately reflect our

relative value.

There can be no assurance that there will be an active market for our shares of common stock either now or in the

Investors may not be able to liquidate their investment or liquidate it at a price that reflects the value of the business.

If a more active market should develop, the price may be highly volatile.

Because there may be a low price for our shares of common

stock, many brokerage firms may not be willing to effect transactions in the securities.

Even if an investor finds a broker willing

to effect a transaction in the shares of our common stock, the combination of brokerage commissions, transfer fees, taxes, if any,

and any other selling costs may exceed the selling price.

Further, many lending institutions will not permit the use of such shares

of common stock as collateral for a loans.

We may apply the proceeds of the Private

Placement to uses that ultimately do not improve our operating results or increase the price of our common stock.

We intend to use the net

proceeds from the Private Placement.

However, our management has broad discretion in how we actually use these proceeds.

These proceeds

could be applied in ways that do not ultimately improve our operating results or otherwise increase the value of our common stock.

We may need additional financing which

may not be available on acceptable terms, which may in turn dilute your investment in us.

Our shares of Common Stock

are thinly traded.

Due to the illiquidity, the price at which our Common Stock is quoted may not accurately reflect our relative value.

There can be no assurance that there will be an active market for our shares of Common Stock either now or in the future.

Investors may

not be able to liquidate their investment or liquidate it at a price that reflects the value of the business.

If a more active market

should develop, the price may be highly volatile.

Because there may be a low price for our shares of Common Stock, many brokerage firms

may not be willing to effect transactions in the securities.

Even if an investor finds a broker willing to effect a transaction in the

shares of our Common Stock, the combination of brokerage commissions, transfer fees, taxes, if any, and any other selling costs may exceed

the selling price.

Further, many lending institutions will not permit the use of such shares of common stock as collateral for a loans.

We may need additional financing which may

not be available on acceptable terms, which may in turn dilute your investment in us.

Our future capital requirements

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competitive pressure on the price of our

the extent to which we invest in new locations, develop new relationships with producers of polymers and chemicals as well

as consumers of polymers and chemicals;

the extent to which we invest in new locations, develop new relationships with producers of polymers and chemicals as well as

consumers of polymers and chemicals;

and the response of competitors to our products.

We believe that the existing cash balances,

including the net proceeds from the Private Placement, and funds generated from operations will provide us with sufficient funds to finance

our operations for the foreseeable future.

To the extent that our current funds, together with existing resources, are insufficient to

fund our activities over the long-term, we may need to raise additional funds through equity or debt financing or from other sources.

We believe that the existing cash balances, including

the net proceeds from the Private Placement, and funds generated from operations will provide us with sufficient funds to finance our

operations for the foreseeable future.

To the extent that our current funds, together with existing resources, are insufficient to fund

our activities over the long-term, we may need to raise additional funds through equity or debt financing or from other sources.

Subject to the lock-up provisions

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Our board of directors can authorize the

issuance of preferred stock, which could diminish the rights of holders of our common stock, and make a change of control of us more

difficult even if it might benefit our stockholders.

issuance of preferred stock, which could diminish the rights of holders of our Common Stock, and make a change of control of us more difficult

even if it might benefit our stockholders.

Our board of directors is

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voting stock during the past three (3) years, subject to certain exceptions as described in Section 203 of the DGCL.

Future sales of significant amounts of

our common stock may depress our stock price.

Future sales of significant amounts of our Common Stock may

depress our stock price.

Future issuances of our Common

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sell their securities when the lock-ups expire, could adversely affect the price at which our Common Stock is quoted.

The Securities Purchase Agreement

entered into in connection with the Private Placement contains provisions that prevent us, subject to certain exceptions, from offering

additional shares of capital stock for up to eighteen (18) months after the closing of the Private Placement, subject to the approval

of the Lead Investor.

Further, in connection with the Share Exchange, Private Dror shareholders are subject to the lock-up provisions

contained in the Share Exchange Agreement.

These lock-up provisions may be waived pursuant to the terms of Securities Purchase Agreement

and the Share Exchange Agreement, as applicable.

If these restrictions on future offerings and lock-up restrictions are waived, additional

shares of our common stock may become available for sale or resale, subject to applicable law, including without notice, which could

reduce the price at which our common stock is quoted.

In connection with the Share

Exchange, Private Dror shareholders are subject to the lock-up provisions contained in the Share Exchange Agreement.

These lock-up provisions

may be waived pursuant to the terms of Securities Purchase Agreement and the Share Exchange Agreement, as applicable.

If these restrictions

on future offerings and lock-up restrictions are waived, additional shares of our Common Stock may become available for sale or resale,

subject to applicable law, including without notice, which could reduce the price at which our Common Stock is quoted.

Further, a significant percentage

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Financial, Tax and Accounting Risks

If our goodwill or long-lived assets become

impaired, we may be required to record a material charge to earnings.

Under GAAP, we review

our goodwill and long-lived asset group for impairment when events or changes in circumstances indicate the carrying value may not

be recoverable.

Additionally, goodwill must be tested for impairment at least annually.

The qualitative and quantitative analysis

used to test goodwill are dependent upon various assumptions and reflect management’s best estimates.

Changes in certain

assumptions, including revenue growth rates, discount rates, earnings multiples and future cash flows may cause a change in

circumstances indicating that the carrying value of goodwill or the asset group may be impaired and assessing these assumptions and

predicting and forecasting future events can be difficult.

Goodwill and purchased assets require periodic fair value assessments to

determine if they have become impaired.

Consequently, we may be required to record a material charge to earnings in the financial

statements during the period in which any impairment of goodwill or long-lived asset group is determined.

Changes in, or interpretations of, accounting

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financial statements in conformity with GAAP.

These principles are subject to interpretation by the SEC and various bodies formed to

interpret and create appropriate accounting policies.

A change in these policies or in the way these policies are interpreted by us or

regulators could have a material effect on our reported results and may even retroactively affect previously reported financial statements.

We are required to annually assess our

internal control over financial reporting and any adverse results from such assessment may result in a loss of investor confidence in

our financial reports and adversely affect our stock price.

We are required to furnish

in our Form 10-K a report by our management regarding the effectiveness of our internal control over financial reporting that includes,

among other things, an assessment of the effectiveness of our internal control over financial reporting as of the end of our fiscal year,

including a statement as to whether our internal control over financial reporting is effective.

Our internal controls may become inadequate

because of changes in personnel, updates and upgrades to existing software, failure to maintain accurate books and records, changes in

accounting standards or interpretations of existing standards, and, as a result, the degree of compliance of our internal control over

financial reporting with the existing policies or procedures may become ineffective.

Establishing, testing and maintaining an effective

system of internal control over financial reporting requires significant resources and time commitments on the part of our management

and our finance staff, may require additional staffing and infrastructure investments and increases our costs of doing business.

are unable to assert that our internal control over financial reporting is effective in any future period (or if our auditors are unable

to express an opinion on the effectiveness of our internal controls or conclude that our internal controls are ineffective), the timely

filing of our financial reports could be delayed or we could be required to restate past reports, and cause us to lose investor confidence

in the accuracy and completeness of our financial reports in the future, which could have an adverse effect on our stock price.

These principles are subject to interpretation by the SEC and various bodies formed to interpret

and create appropriate accounting policies.

A change in these policies or in the way these policies are interpreted by us or regulators

could have a material effect on our reported results and may even retroactively affect previously reported financial statements.

We have identified a material weakness in

our internal control over financial reporting, and if we are unable to remediate the material weakness, or if we experience additional

material weaknesses in the future, our business may be harmed.

Our management is responsible

for establishing and maintaining adequate internal control over financial reporting and for evaluating and reporting on the effectiveness

of our system of internal control.

Our internal control over financial reporting is a process designed to provide reasonable assurance

regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance

with Generally Accepted Accounting Principles in the United States (“GAAP”).

As a public company, we are required to comply

with the Sarbanes-Oxley Act and other rules that govern public companies.

In particular, we are required to certify our compliance with

Section 404 of the Sarbanes-Oxley Act, which requires us to furnish annually a report by management on the effectiveness of our internal

control over financial reporting.

Our management performed an

assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025, and concluded our internal control

over financial reporting was not effective as of December 31, 2025, due to the size of the Company and available resources, there are

limited personnel to assist with the accounting and financial reporting function, which results in a lack of segregation of duties and

due to the fact that the Company does not have Chief Financial Officer that can oversee day to day operations and the financial reporting

Remediation efforts place

a significant burden on management and add increased pressure to our financial resources and processes.

If we are unable to successfully

remediate our existing material weakness or any additional material weaknesses in our internal control over financial reporting that may

be identified in the future in a timely manner, the accuracy and timing of our financial reporting may be adversely affected;

our liquidity,

our access to capital markets, the perceptions of our creditworthiness may be adversely affected;

we may be unable to maintain or regain

compliance with applicable securities laws, the listing requirements of the NASDAQ;

we may be subject to regulatory investigations and

investors may lose confidence in our financial reporting;

our reputation may be harmed;

and our stock price may decline.

Our effective tax rate may vary significantly

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Various internal and external factors may affect our future effective tax rate.

factors include changes in the global economic environment, changes in our legal entity structure or activities performed within our

entities, changes in our business operations, changes in tax laws, regulations and/or rates, new or changes to accounting pronouncements,

changing interpretations of existing tax laws or regulations, changes in relative proportions of revenues and income before taxes in

the various jurisdictions in which we operate that have differing statutory tax rates, changes in overall levels of pretax earnings,

the future levels of tax benefits of stock-based compensation, settlement of income tax audits and non-deductible goodwill impairments.

factors include changes in the global economic environment, changes in our legal entity structure or activities performed within our entities,

changes in our business operations, changes in tax laws, regulations and/or rates, new or changes to accounting pronouncements, changing

interpretations of existing tax laws or regulations, changes in relative proportions of revenues and income before taxes in the various

jurisdictions in which we operate that have differing statutory tax rates, changes in overall levels of pretax earnings, the future levels

of tax benefits of stock-based compensation, settlement of income tax audits and non-deductible goodwill impairments.

Our effective tax rate is

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Furthermore, we may continue to experience significant

variation in our effective tax rate related to excess tax benefits on stock-based compensation, particularly in the first quarter of

each year when the majority of our equity awards vest.

New tax laws and practices, changes to

existing tax laws and practices, or disputes regarding the positions we take regarding tax laws, could negatively affect our provision

for income taxes as well as our ongoing operations.

We are subject to tax

laws both within and outside of the U.S.

variation in our effective tax rate related to excess tax benefits on stock-based compensation, particularly in the first quarter of each

year when the majority of our equity awards vest.

New tax laws and practices, changes to existing

tax laws and practices, or disputes regarding the positions we take regarding tax laws, could negatively affect our provision for income

taxes as well as our ongoing operations.

We are subject to tax laws

both within and outside of the U.S.

requiring significant judgment in determining our worldwide provision for income taxes.

Changes in tax laws or changes to how those laws are applied to our business in practice, could affect the amount of tax to which we

are subject and the manner in which we operate.

Additionally, the Organization for Economic Cooperation and Development’s

(“OECD”) Base Erosion and Profit Shifting (“BEPS”) project has resulted in considerable new reporting

obligations worldwide as OECD member countries have implemented its guidance.

The OECD continues to publish guidance pursuant to the

BEPS and other projects which, if adopted by member countries, may affect our tax positions in many of the countries in which we do

tax laws or changes to how those laws are applied to our business in practice, could affect the amount of tax to which we are subject

and the manner in which we operate.

Additionally, the Organization for Economic Cooperation and Development’s (“OECD”)

Base Erosion and Profit Shifting (“BEPS”) project has resulted in considerable new reporting obligations worldwide as OECD

member countries have implemented its guidance.

The OECD continues to publish guidance pursuant to the BEPS and other projects which,

if adopted by member countries, may affect our tax positions in many of the countries in which we do business.

Moreover, the application

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states, local and foreign taxing jurisdictions have differing

rules and regulations governing differing types of taxes, and these rules and regulations are subject to varying interpretations and

exemptions that may change over time.

We collect and remit SUT, VAT, GST and other taxes in many jurisdictions and we are routinely subject

We are also routinely subject to audits regarding our tax reporting and remissions by local and national government, and we

may also be subject to audits in U.S.

rules and regulations governing differing types of taxes, and these rules and regulations are subject to varying interpretations and exemptions

that may change over time.

We collect and remit SUT, VAT, GST and other taxes in many jurisdictions and we are routinely subject to audits.

We are also routinely subject to audits regarding our tax reporting and remissions by local and national government, and we may also be

subject to audits in U.S.

states, local and foreign jurisdictions for which we have not accrued tax liabilities.

The positions

we take regarding taxes as well as the amounts we collect or remit may be challenged and we may be liable for failing to collect or remit

all or any portion of taxes deemed owed or the taxes could exceed our estimates.

The positions we take

regarding taxes as well as the amounts we collect or remit may be challenged and we may be liable for failing to collect or remit all

or any portion of taxes deemed owed or the taxes could exceed our estimates.

One or more U.S.

states or countries may seek to impose

incremental or new sales, use, or other tax collection obligations on us or may determine that such taxes should have but have not been

If we dispute rulings or positions taken by tax authorities, we may incur expenses and expend significant time and effort

to defend our positions, which may be costly.

states or countries may seek to impose incremental

or new sales, use, or other tax collection obligations on us or may determine that such taxes should have but have not been paid by us.

If we dispute rulings or positions taken by tax authorities, we may incur expenses and expend significant time and effort to defend our

positions, which may be costly.

On August 16, 2022, the Inflation

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Furthermore, there have

been and will continue to be substantial ongoing costs associated with complying with the various tax requirements and defending our

positions in the numerous markets in which we conduct or will conduct business.

been and will continue to be substantial ongoing costs associated with complying with the various tax requirements and defending our positions

in the numerous markets in which we conduct or will conduct business.

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