What changed in this filing

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Item 1A. Risk Factors

2021-03-09 compared with 2020-03-17 · 348 added, 266 removed, 978 unchanged (39% of the section changed)

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of our common stock and warrants may decline, and you could lose all or part of your investment.

Summary of Risk Factors

Our business is subject to a number of

risks, including risks that may adversely affect our business, financial condition and results of operations.

These risks are discussed

more fully below and include, but are not limited to, risks related to:

Risks Related to Our Financial Position

and Capital Requirements

We were formed in August 2011 and are thus subject to

the risks associated with new businesses.

● Risks associated with our relatively new business;

● our future capital needs and their potential impact on our existing stockholders;

● our history of losses and stockholder’s inability to rely upon our historical operating performance;

Risks Related to Our Business

● the acceptance of our products in the market and our exposure to market trends;

● the impact of COVID-19 on our operations;

● our risks of basing our business on the sale of our principal technology;

● our reliance on manufacturers and distributors;

● the impact of a failure of our digital marketing efforts;

● our reliance on the Apple App Store and Google’s Android platform;

● the risks associated with conducting business internationally;

● potential errors in our business processes and product offerings;

● our reliance on the performance of key members of our management team and our need to attract highly

skilled personnel;

● the integration of Upright’s business;

Risks Related to Product Development and Regulatory Approval

● the expense and time required to obtain regulatory clearance of our products;

● our limited clinical studies and the susceptibility to varying interpretations of such studies;

● our ability to complete clinical trials;

● the failure to comply with the FDA’s Quality System Regulation or any applicable state equivalent;

● our reliance on third parties to conduct clinical trial work;

● the impact of legislation and federal, state and foreign laws on our business, including protecting

the confidentiality of patient health information;

● the potential impact of product liability suits;

Risks Related to Our Intellectual Property

● the risks relating to obtaining or maintaining our intellectual property;

● potential litigation relating to the protection of our intellectual property;

● our limited foreign intellectual property rights;

● Our reliance on confidentiality agreements and the difficulty in enforcing such agreements;

Risks Related to Our Industry

● the intense competition we face in the markets we operate;

● our need to respond quickly to technological developments;

● the risks relating to obtaining or maintaining our intellectual property;

● the risks relating to third-party payors not providing for adequate coverage and reimbursement

for our products;

Risks Related to Our Operations in Israel

● the risks relating to the political, economic and military instability that may exist in Israel;

● the potential for operations to be disrupted as a result of obligations of Israeli citizens to

perform military service;

● the difficulty in enforcing judgements against us or certain of our executive officers and directors;

Risks Related to the Ownership of Our Common Stock and Warrants

● the ability for our officers, directors and founding stockholders to exert influence over our affairs;

● the potential lack of liquidity, or volatility, of our common stock and warrants;

● the impact of analysts not publishing research or reports about us;

● the expense relating to our requirements as a U.S.

public company;

● the potential failure to maintain effective internal controls over financial reporting;

● the existence of anti-takeover provisions in our charter documents and Delaware law;

● that we do not intend to pay dividends on our common stock.

Risks Related to Our Financial Position

and Capital Requirements

We were formed in August 2011 and are thus subject

to the risks associated with new businesses.

We were formed in August 2011

as a new business and, commencing from 2015, we entered the commercialization stage of our technology.

As such, this limited

operating history may not be adequate to enable you to fully assess our ability to develop and commercialize the Dario Smart Diabetes

Management Solution, achieve market acceptance of the Dario Smart Diabetes Management Solution, develop other products and respond

to competition.

We commenced a commercial launch of the free Dario Smart Diabetes Management application in the United Kingdom

in late 2013 and commenced an initial soft launch of the full Dario Smart Diabetes Management Solution (including the app and the

Dario Blood Glucose Monitoring System) in selected jurisdictions in March 2014 with the goal of collecting customer feedback to

refine our longer-term roll-out strategy and continued to scale up launch during 2014 in the United Kingdom, the Netherlands and

New Zealand, in 2015 in Australia, Israel and Canada and in 2016 in the United States.

These efforts have not generated sufficient

revenues, and we will need to generate additional revenues over the next years.

Therefore, we are, and expect for the foreseeable

future to be, subject to all the risks and uncertainties, inherent in a new business and the development and sale of new medical

devices and related software applications.

As a result, we may be unable to fully develop, obtain regulatory approval for, commercialize,

manufacture, market, sell and derive material revenues in the timeframes we project, if at all, and our inability to do so would

materially and adversely impact our viability as a company.

In addition, we still must establish many functions necessary to operate

a business, including finalizing our managerial and administrative structure, continuing product and technology development, assessing

and commencing our marketing activities, implementing financial systems and controls and personnel recruitment.

As such, this limited operating

history may not be adequate to enable you to fully assess our ability to develop and commercialize the Dario Smart Diabetes Management

Solution, achieve market acceptance of the Dario Smart Diabetes Management Solution, develop other products and respond to competition.

We commenced a commercial launch of the free Dario Smart Diabetes Management application in the United Kingdom in late 2013 and

commenced an initial soft launch of the full Dario Smart Diabetes Management Solution (including the app and the Dario Blood Glucose

Monitoring System) in selected jurisdictions in March 2014 with the goal of collecting customer feedback to refine our longer-term

roll-out strategy and continued to scale up launch during 2014 in the United Kingdom, the Netherlands and New Zealand, in 2015

in Australia, Israel and Canada and in 2016 in the United States.

These efforts have not generated sufficient revenues, and

we will need to generate additional revenues over the next years.

Therefore, we are, and expect for the foreseeable future to be,

subject to all the risks and uncertainties, inherent in a new business and the development and sale of new medical devices and

related software applications.

As a result, we may be unable to fully develop, obtain regulatory approval for, commercialize, manufacture,

market, sell and derive material revenues in the timeframes we project, if at all, and our inability to do so would materially

and adversely impact our viability as a company.

In addition, we still must establish many functions necessary to operate a business,

including finalizing our managerial and administrative structure, continuing product and technology development, assessing and

commencing our marketing activities, implementing financial systems and controls and personnel recruitment.

Accordingly, you should

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investors should consider that there is a significant risk that we will not be able to:

implement or execute our current business plan, or that

our business plan is sound;

maintain our management team and Board of Directors;

raise sufficient funds in the capital markets or otherwise

to effectuate our business plan;

determine that our technologies that we have developed are

commercially viable;

attract, enter into or maintain contracts with, and retain

implement or execute our current business plan, or that our business plan is sound;

maintain our management team and the Company’s board of directors (the “Board of Directors”);

raise sufficient funds in the capital markets or otherwise to effectuate our business plan;

determine that our technologies that we have developed are commercially viable;

attract, enter into or maintain contracts with, and retain customers.

In the event that we

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According to our management’s

estimates, based on our current cash on hand and further based on our budget and the assumption that initial commercial sales will

commence during our anticipated timeframes, we believe that we will have sufficient resources to continue our activities only into

estimates, based on our current cash on hand and further based on our budget and the assumption that initial commercial sales

will commence during our anticipated timeframes, we believe that we will have sufficient resources to continue our activities

through 2023.

Since we might be unable

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Funding from any source

may be unavailable to us on acceptable terms, or at all, If we do not have sufficient capital to fund our operations and expenses,

may be unavailable to us on acceptable terms, or at all.

If we do not have sufficient capital to fund our operations and expenses,

we may not be able to achieve or maintain competitiveness, which could lead to the failure of our business and the loss of your

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since inception including net losses of $29 ,445 ,000 and $17,736,000 in 2020 and 2019, respectively.

Our accumulated deficit at

December 31, 2019 was approximately $110,145,000.

Our accumulated deficit at December 31, 2020 was approximately $143,248,000.

We do not know whether or when we will become profitable.

Our ability to generate

revenue and achieve profitability depends upon our ability, alone or with others, to launch Dario in additional European countries,

and elsewhere and manufacture, market and sell Dario where approved.

We may be unable to achieve any or all of these goals.

independent registered public accounting firm has expressed in its report to our 2019 audited consolidated financial statements

a substantial doubt about our ability to continue as a going concern .

2015 we entered the commercialization stage, and the development and commercialization of Dario is uncertain and expected

to require substantial expenditures.

We have not yet generated sufficient revenues from our operations to fund our activities and

are therefore dependent upon external sources for financing our operations.

There is a risk that we will be unable to obtain the

necessary financing to continue our operations on terms acceptable to us or at all.

As a result, our independent registered public

accounting firm has expressed in its auditors’

report on the consolidated financial statements for December 31, 2019, a substantial

doubt regarding our ability to continue as a going concern.

Our consolidated financial statements do not include any adjustments

that might result from the outcome of the uncertainty regarding our ability to continue as a going concern.

This going concern

opinion could materially limit our ability to raise additional funds through the issuance of equity or debt securities or otherwise.

Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going

If we cannot continue as a going concern, our stockholders may lose their entire investment in the common stock.

Our ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to launch Dario in additional

European countries, and elsewhere and manufacture, market and sell Dario where approved.

We may be unable to achieve any or all

of these goals.

We may be subject to claims for rescission

or damages in connection with certain sales of shares of our securities.

In March 2016, the

Securities and Exchange Commission declared effective a registration statement that we filed to cover the sale of 66,667 shares

of common stock, 76,667 warrants to purchase common stock, 76,667 shares of common stock underlying such warrants, and underwriters’

warrants to purchase up to 7,172 shares of common stock.

Sales of approximately 2,778 shares of common stock, approximately 12,778

shares of common stock underlying warrants and approximately 1,278 shares of common stock underlying underwriters’

may not have been made in accordance with Section 5 of the Securities Act of 1933, as amended.

In March 2016,

the Securities and Exchange Commission declared effective a registration statement that we filed to cover 66,667 shares 76,667

warrants to purchase common stock, 76,667 shares of common stock underlying such warrants, and underwriters’

purchase up to 7,172 shares of common stock.

Sales of approximately 2,778 shares of common stock, approximately 12,778 shares of

common stock underlying warrants and approximately 1,278 shares of common stock underlying underwriters’

warrants may not

have been made in accordance with Section 5 of the Securities Act of 1933, as amended.

Accordingly, the purchasers of those

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Canada, Israel and South Africa, and most recently in December 2015, we received FDA clearance.

As a result, we have a limited

history of commercializing Dario and commenced selling Dario in the United States in 2016.

We have limited experience engaging

in commercial activities and limited established relationships with physicians and hospitals as well as third-party suppliers on

whom we depend for the manufacture of our product.

As a result, we have

a limited history of commercializing Dario and commenced selling Dario in the United States in 2016.

We have limited experience

engaging in commercial activities and limited established relationships with physicians and hospitals as well as third-party suppliers

on whom we depend for the manufacture of our product.

We are faced with the risk that the marketplace will not be receptive

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the increased use of improved diabetes drugs that could encourage certain diabetics to test less often, resulting in less usage of a self-monitoring test device for certain types of diabetics;

the challenges of developing (or acquiring externally-developed) technology solutions that are adequate and competitive in meeting the requirements of next-generation design challenges;

the challenges of developing (or acquiring externally-developed) technology solutions that are adequate and competitive in meeting the requirements of next-generation design challenges, including interoperability with various electronic health records;

the significant number of current competitors in the BGMS market who have significantly greater brand recognition and more recognizable trademarks and who have established relationships with healthcare providers and payors;

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acceptance, our business and operating results would be materially and adversely affected.

There is no assurance that our recently

launched DarioEngage software platform will succeed or be adopted by healthcare providers.

We have recently launched

a new product offering of our DarioEngage software platform, where we digitally engage with Dario users, assist them in monitoring

their chronic illnesses and provide them with coaching, support, digital communications, and real-time alerts, trends and pattern

We expect that the DarioEngage software platform may be leveraged by our potential partners, such as clinics, health

care service providers, employers, and payers for scalable monitoring of people with diabetes in a cost-effective manner, which

we expect will open for us additional revenue streams.

However, the success of our DarioEngage software platform will depend entirely

on our potential partners’

adoption of the platform and we cannot assure you that our potential partners will do so, or,

if adopted, that they will continue to use the platform continually and for an extended period of time.

If we cannot encourage

potential partners to utilize our DarioEngage software platform we may not succeed in marketing the product to our potential partners,

the failure of which may materially and adversely affect our business and operating results.

There is no assurance that our DarioEngage

software platform will succeed or be adopted by healthcare providers.

Our product offering

consists of our DarioEngage software platform, where we digitally engage with Dario users, assist them in monitoring their chronic

illnesses and provide them with coaching, support, digital communications, and real-time alerts, trends and pattern analysis.

expect that the DarioEngage software platform may be leveraged by our potential partners, such as clinics, health care service

providers, employers, and payers for scalable monitoring of people with diabetes in a cost-effective manner, which we expect will

open for us additional revenue streams.

However, the success of our DarioEngage software platform will depend entirely on our potential

partners’

adoption of the platform and we cannot assure you that our potential partners will do so, or, if adopted, that

they will continue to use the platform continually and for an extended period of time.

If we cannot encourage potential partners

to utilize our DarioEngage software platform we may not succeed in marketing the product to our potential partners, the failure

of which may materially and adversely affect our business and operating results.

A pandemic, epidemic or outbreak

of an infectious disease in the United States, Israel or elsewhere may adversely affect our business.

If a pandemic, epidemic

or outbreak of an infectious disease occurs in the United States, Israel or elsewhere, our business may be adversely

In December 2019, a novel strain of coronavirus, COVID-19, was identified in Wuhan, China.

This virus continues

to spread globally and, as of March 2020, has spread to over 100 countries, including the United States and Israel.

spread of COVID-19 from China to other countries has resulted in the World Health Organization declaring the outbreak of COVID-19

as a “pandemic,”

or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed

quarantines and restrictions on travel and mass gatherings to slow the spread of the virus.

On March 10, 2020, the Government of

Israel announced that effective Thursday, March 12, 2020, at 20:00 (Israel time) foreign travelers arriving from any country will

be required to remain in home quarantine until 14 days have passed since the date of entry into Israel;

non-Israeli residents will

be required to prove they have the means to self-quarantine before being allowed entry into Israel and, in addition, non-Israeli

residents or citizens traveling from certain countries may be denied entry into Israel.

In addition, the Ministry of Health in

the State of Israel issued guidelines on March 11, 2020 recommending people avoid gatherings in one space and providing that no

gathering of more than 100 people should be held under any circumstances.

Employers (including us) are also required to prepare

and increase as much as possible the capacity and arrangement for employees to work remotely.

In addition, on March 11, 2020, the

President of the United States issued a proclamation to restrict travel to the United States from foreign nationals who have recently

been in certain European countries.

We are still assessing the effect on our business, from the spread of COVID-19 and the actions

implemented by the governments of the State of Israel, the United States and elsewhere across the globe.

The spread of an infectious disease, including COVID-19, may

also result in the inability of our manufacturers to deliver components or finished products on a timely basis.

In addition, health

professionals may reduce staffing and reduce or postpone meetings with clients in response to the spread of an infectious disease.

Such events may result in a period of business and manufacturing disruption, and in reduced operations, any of which could materially

affect our business, financial condition and results of operations.

The extent to which COVID-19 impacts our business will depend

on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning

the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others.

A regional or global

health pandemic, including COVID-19, could severely affect our business, results of operations and financial condition.

or global health pandemic, depending upon its duration and severity, could have a material adverse effect on our business.

example, the COVID-19 pandemic has had numerous effects on the global economy and governmental authorities around the world have

implemented measures to reduce the spread of COVID-19.

These measures, including shutdowns and “shelter-in-place”

suggested or mandated by governmental authorities or otherwise elected by companies as a preventive measure, have adversely affected

workforces, customers, consumer sentiment, economies and financial markets, and, along with decreased consumer spending, have led

to an economic downturn in many of our markets.

As a result of the

COVID-19 pandemic, as near-term measures, we have transitioned many of our employees to remote working arrangements.

The transition

has had little impact on our employee productivity and has not caused any interruption to our business.

Due to the uncertainty

of COVID-19, we will continue to assess the situation, including abiding by any government-imposed restrictions, market by market.

As a result of the

COVID-19 pandemic, many of our personnel are working remotely, and it is possible that this could have a negative impact on the

execution of our business plans and operations.

If a natural disaster, power outage, connectivity issue, or other event occurred

that impacted our employees’

ability to work remotely, it may be difficult or, in certain cases, impossible, for us to continue

our business for a substantial period of time.

The increase in remote working may also result in consumer privacy, IT security

and fraud concerns as well as increase our exposure to potential wage and hour issues.

We are unable to accurately

predict the impact that COVID-19 will have on our operations going forward due to uncertainties that will be dictated by the length

of time that the pandemic and related disruptions continue, the impact of governmental regulations that might be imposed in response

to the pandemic and overall changes in consumer behavior.

Numerous state and local jurisdictions have imposed, and others in the

future may impose, “shelter-in-place”

orders, quarantines, executive orders and similar government orders and restrictions

for their residents to control the spread of COVID-19.

For example, Israel, federal and state governments in the United States,

and various governments in Europe, continue to impose limitations on gatherings, social distancing measures and restrictions on

movement, only allowing essential businesses to remain open.

Such orders or restrictions have and are continuing to result in temporary

store closures, work stoppages, slowdowns and delays, travel restrictions and cancellation of events, among other effects, any

of which may negatively impact workforces, customers, consumer sentiment and the economies in many of our markets, and as a result,

may adversely affect our operations.

At this point in time, there is significant

uncertainty relating to the potential effect of COVID-19 on our business.

As infections may continue to become more widespread,

we could experience a severe negative impact on our business, financial condition and results of operations.

To the extent the

COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the

other risks described in this “Risk factors”

We may not be successful in launching

Dario Intelligence and even if we are successful in doing so, there is no assurance that we will be successful in marketing and/or

selling our product in the marketplace.

Dario Loop and even if we are successful in doing so, there is no assurance that we will be successful in marketing and/or selling

our product in the marketplace.

We intend to launch

our Dario Intelligence program, which will utilize a large amount of data collected on our servers to develop predictive models

and artificial intelligence algorithms to meet the potential demand of intelligence-driven analytics that healthcare providers

may be looking for to improve their services.

However, the launch of Dario Intelligence will require significant financial and

technical resources.

There is no assurance that we will successfully develop or launch Dario Intelligence.

Even if we are successful

in doing so, there is no assurance that the marketplace will accept or adopt the usage of Dario Intelligence.

If we cannot successfully

develop Dario Intelligence, or encourage the use and adoption of Dario Intelligence by market participants, our business and operating

results may be materially and adversely affected.

our Dario Loop program, which will utilize a large amount of data collected on our servers to develop predictive models and artificial

intelligence algorithms to meet the potential demand of intelligence-driven analytics that healthcare providers may be looking

for to improve their services.

However, the launch of Dario Loop will require significant financial and technical resources.

is no assurance that we will successfully develop or launch Dario Loop.

Even if we are successful in doing so, there is no assurance

that the marketplace will accept or adopt the usage of Dario Loop.

If we cannot successfully develop Dario Loop, or encourage the

use and adoption of Dario Loop by market participants, our business and operating results may be materially and adversely affected.

We cannot accurately predict the

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Our Dario Blood Glucose

Monitoring System is currently designed to be plugged into the audio jack or the charging jack of a mobile device.

we have recently completed the development of a version of the Dario Blood Glucose Monitoring System that connects to an iPhone

7 and later models through the Lightning jack instead of the missing audio jack.

As a result, our products are subject to future

technological changes to mobile devices that may occur in the future.

If we are unable to modify our products to keep pace with

such technological changes, it would have a material adverse effect the ability of our customers to use our products, which would

materially harm our business.

Monitoring System is currently designed to be plugged into the Lighting jack for Apple devices or the USB-C jack for other mobile

As a result, our products are subject to future technological changes to mobile devices that may occur in the future.

If we are unable to modify our products to keep pace with such technological changes, it would have a material adverse effect the

ability of our customers to use our products, which would materially harm our business.

As we conduct business internationally,

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in currency exchange rates, which could adversely affect our results of operations.

Because we expect to

conduct a material portion of our business outside of the United States but report our financial results in U.S.

Dollars, we face

exposure to adverse movements in currency exchange rates.

Our foreign operations will be exposed to foreign exchange rate fluctuations

as the financial results are translated from the local currency into U.S.

Because we expect

to conduct a material portion of our business outside of the United States but report our financial results in U.S.

face exposure to adverse movements in currency exchange rates.

Our foreign operations will be exposed to foreign exchange rate

fluctuations as the financial results are translated from the local currency into U.S.

Dollars upon consolidation.

Specifically, the U.S.

cost of our operations in Israel is influenced by any movements in the currency exchange rate of the New Israeli Shekel (NIS).

Specifically,

Dollar cost of our operations in Israel is influenced by any movements in the currency exchange rate of the New Israeli

Shekel (NIS).

Such movements in the currency exchange rate may have a negative effect on our financial results.

Dollar weakens against

foreign currencies, the translation of these foreign currencies denominated transactions will result in increased revenue, operating

expenses and net income.

weakens against foreign currencies, the translation of these foreign currencies denominated transactions will result in increased

revenue, operating expenses and net income.

Similarly, if the U.S.

Dollar strengthens against foreign currencies, the translation of these foreign

currencies denominated transactions will result in decreased revenue, operating expenses and net income.

As exchange rates vary,

sales and other operating results, when translated, may differ materially from our or the capital market’s expectations.

Dollar strengthens against foreign currencies, the translation

of these foreign currencies denominated transactions will result in decreased revenue, operating expenses and net income.

rates vary, sales and other operating results, when translated, may differ materially from our or the capital market’s expectations.

governments often impose

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our Chief Executive Officer and a member of our Board of Directors and Zvi Ben David, our Chief Financial Officer, Treasurer and

In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse

effect on our business, operations, and prospects.

If we are not

able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business

model successfully.

Secretary, Dror Bacher, our Chief Operating Officer, and Richard Anderson, our President and General Manager for North America.

In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse effect

on our business, operations, and prospects.

If we are not able to attract and

retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully.

We believe that our

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Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively.

We may not generate the expected

benefits of our recent acquisition of Upright, and the integration of Upright could disrupt our ongoing business, distract our

management and increase our expenses.

our recent acquisitions of Upright, we expanded our product offering to include solutions for MSK conditions.

that the successful integration of Upright’s business into our operations is important for our future financial performance.

This will require that we integrate more closely the companies’

product offerings and research and development capabilities,

retain key employees, assimilate diverse corporate cultures, further integrate management information systems and consolidate the

acquired operations, each of which could pose significant challenges.

The difficulty of combining Upright with our company may

be increased by the need to integrate personnel, and changes effected in the combination may cause key employees to leave.

It is possible that

the integration process could take longer than anticipated and could result in the loss of valuable employees, additional and unforeseen

expenses, the disruption of our ongoing business, processes and systems, or inconsistencies in standards, controls, procedures,

practices, policies and compensation arrangements, any of which could adversely affect our ability to achieve the anticipated benefits

of the acquisitions.

The diversion of the attention of management created by the integration process, any disruptions or other

difficulties encountered in the integration process, and unforeseen liabilities or unanticipated problems with the acquired businesses

could have a material adverse effect on our business, operating results and financial condition.

There can be no assurance that

these acquisitions will provide the benefits we expect or that we will be able to integrate and develop the operations of Upright

successfully.

Any failure to do so could have a material adverse effect on our business, operating results and financial condition.

Risks Related to Product Development

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to market Dario until we receive regulatory clearance.

To date, we have received regulatory clearance in Australia, Canada, Israel,

Italy, the Netherlands, New Zealand, the United Kingdom, and the United States.

To date, we have received regulatory clearance in Australia, Canada, Israel, Italy,

the Netherlands, New Zealand, the United Kingdom, and the United States.

The research, design,

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In addition, on September 23,

23, 2013, the FDA issued final guidance (which we refer to herein as the Guidance) for developers of mobile medical applications,

or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical

2013, the FDA issued final guidance (which we refer to herein as the Guidance) for developers of mobile medical applications, or

apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical

The Guidance outlines the FDA’s tailored approach to mobile apps.

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sites participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial;

delays that we may experience in enrollment, or completion of certain trials, as a result of COVID-19;

patients may not enroll in, remain in or complete, the clinical trial at the rates we expect;

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For example, in March 2010, U.S.

President Barack Obama signed the

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred

President Barack Obama signed

the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred

to as the Affordable Care Act.

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the statute of limitations period for the government to recover overpayments to providers from three to five years.

In December 2014,

Congress passed an omnibus funding bill (the Consolidated and Further Continuing Appropriations Act, 2015) and a tax extenders

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pricing pressure.

For example, U.S.

President Donald Trump has recently publicly indicated an intent to lower healthcare costs

through various potential initiatives.

In addition, President Trump and other U.S.

For example, former U.S.

President Donald Trump publicly indicated an intent to lower healthcare costs through

various potential initiatives.

In addition, former President Trump and other U.S.

lawmakers have made statements about potentially

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These privacy

rules protect medical records and other personal health information by limiting their use and disclosure, giving individuals the

right to access, amend and seek accounting of their own health information and limiting most use and disclosures of health information

to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties in holding such information

in compliance with applicable law.

If we are found to be in violation of the privacy rules under HIPAA, we could be subject to

civil or criminal penalties, which could increase our liabilities, harm our reputation and have a material adverse effect on our

business, financial condition and results of operations.

rules protect medical records and other personal health information by limiting their use and disclosure, giving individuals

the right to access, amend and seek accounting of their own health information and limiting most use and disclosures of health

information to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties in holding

such information in compliance with applicable law.

If we are found to be in violation of the privacy rules under HIPAA, we

could be subject to civil or criminal penalties, which could increase our liabilities, harm our reputation and have a material

adverse effect on our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

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in May 2011 which incorporates two U.S.

provisional applications submitted in the preceding

The PCT covers the specific processes related to blood glucose level measurement as well as more general methods of rapid

tests of body fluids and has subsequently been converted into several national phase patent applications.

We have also filed patent

applications for other aspects of the Dario Blood Glucose Monitoring Solution.

We have also obtained numerous Web domains.

provisional applications submitted in

the preceding year.

The PCT covers the specific processes related to blood glucose level measurement as well as more general methods

of rapid tests of body fluids and has subsequently been converted into several national phase patent applications.

filed patent applications for other aspects of the Dario Blood Glucose Monitoring Solution.

We have also obtained numerous Web

However, to date, we

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The Israeli Supreme Court ruled that the fact

that a contract revokes an employee’s right for royalties and compensation, does not rule out the right of the employee to

claim their right for royalties.

As a result, it is unclear whether and, if so, to what extent our employees may be able to claim

compensation with respect to our future revenue.

We may receive less revenue from future products if any of our employees successfully

claim for compensation for their work in developing our intellectual property, which in turn could impact our future profitability.

that a contract revokes an employee’s right for royalties and compensation, does not rule out the right of the employee

to claim their right for royalties.

As a result, it is unclear whether and, if so, to what extent our employees may be able to

claim compensation with respect to our future revenue.

We may receive less revenue from future products if any of our employees

successfully claim for compensation for their work in developing our intellectual property, which in turn could impact our future

profitability.

Risks Related to Our Industry

We face intense competition in the

self-monitoring of blood glucose market, and as a result we may be unable to effectively compete in our industry.

With our first product,

Dario, we compete directly and primarily with large pharmaceutical and medical device companies such as Abbott Laboratories, Asensia

(formerly Bayer Diabetes Care), Johnson & Johnson LifeScan, Roche Diagnostics and Sanofi.

The first four of these companies

has a combined majority market share of the BGMS business and strong research and development capacity for next-generation products.

digital support solution and the self-monitoring of blood glucose market, and as a result we may be unable to effectively compete

in our industry.

In recent years, a

number of digitally supported solutions have emerged to manage diabetes and other chronic conditions.

Competitors are developing

new technologies rapidly and, in some cases, are also expanding to manage other chronic conditions.

With our first product, Dario,

we compete directly and primarily with large pharmaceutical and medical device companies such as Abbott Laboratories, Asensia (formerly

Bayer Diabetes Care), Johnson & Johnson LifeScan, Roche Diagnostics and Sanofi.

The first four of these companies has

a combined majority market share of the BGMS business and strong research and development capacity for next-generation products.

Their dominant market position since the late 1990s, and significant control over the market could significantly limit our ability

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third-tier competitors.

In addition, we only

recently transformed our business to primarily focus on the sale of our digital support solution, which joins a crowded field of

competitors such as Amazon, Apple and Google.

Our competitors vary by intervention (devices, applications, coaching and analytics),

by channel (health plan, pharma, provider, employer) and by condition (including, for example, diabetes, MSK, blood hypertension,

Certain of our competitors offer this integrated approach in varying degrees, including, among others, , Hinge Health, Inc.,

Livongo Health Inc.

(acquired by Teladoc Health Inc.), Omada Health, Inc., Vida Health, Inc., Virta Health Corp., Informed

Data Systems Inc.

(OneDrop), Glooko, Inc., and OnDuo LLC .

We only recently commenced

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Competition in the

BGMS markets is extremely intense, which can lead to, among other things, price reductions, longer selling cycles, lower product

margins, loss of market share and additional working capital requirements.

To succeed, we must, among other critical matters, gain

consumer acceptance for Dario and potential future devices incorporating our principal technology and offer better strategic concepts,

technical solutions, prices and response time, or a combination of these factors, than those of other competitors.

If our competitors

offer significant discounts on certain products, we may need to lower our prices or offer other favorable terms in order to compete

successfully.

Moreover, any broad-based changes to our prices and pricing policies could make it difficult to generate revenues

or cause our revenues, if established, to decline.

Some of our competitors may bundle certain software products offering competing

applications for diabetes management at low prices for promotional purposes or as a long-term pricing strategy.

These practices

could significantly reduce demand for Dario or potential future products or constrain prices we can charge.

Moreover, if our competitors

develop and commercialize products that are more effective or desirable than Dario or the other products that we may develop, we

may not convince our customers to use our products.

Any such changes would likely reduce our commercial opportunity and revenue

potential and could materially adversely impact our operating results.

digitally supported solutions market and BGMS market is extremely intense, which can lead to, among other things, price reductions,

longer selling cycles, lower product margins, loss of market share and additional working capital requirements.

To succeed, we

must, among other critical matters, gain consumer acceptance for Dario and potential future devices incorporating our principal

technology and offer better strategic concepts, technical solutions, prices and response time, or a combination of these factors,

than those of other competitors.

If our competitors offer significant discounts on certain products, we may need to lower our prices

or offer other favorable terms in order to compete successfully.

Moreover, any broad-based changes to our prices and pricing policies

could make it difficult to generate revenues or cause our revenues, if established, to decline.

Some of our competitors may bundle

certain software products offering competing applications for diabetes management at low prices for promotional purposes or as

a long-term pricing strategy.

These practices could significantly reduce demand for Dario or potential future products or constrain

prices we can charge.

Moreover, if our competitors develop and commercialize products that are more effective or desirable than

Dario or the other products that we may develop, we may not convince our customers to use our products.

Any such changes would

likely reduce our commercial opportunity and revenue potential and could materially adversely impact our operating results.

If we fail to respond quickly to

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We cannot guarantee that we will be successful in any manner in these

third-party payors do not provide adequate coverage and reimbursement for the use of Dario, our revenue will be negatively impacted.

the United States and other jurisdictions such as Germany and England, we expect that Dario’s test strips should generally

third-party payors do not provide adequate coverage and reimbursement for the use of our products and

services , our revenue will be negatively impacted.

the United States and other jurisdictions such as Germany and England, we expect that our products and services should generally

be available for full or partial patient reimbursement by third-party payers.

Our success in marketing Dario depends and

will depend in large part on whether U.S.

Our success in marketing our services depend

and will depend in large part on whether U.S.

and international government health administrative authorities, private health insurers

and other organizations adequately cover and reimburse customers for the cost of our products.

the United States, we expect to derive nearly all our sales from sales of Dario from direct to consumer cash sales as well as retail

pharmacy and DME distributors who typically bill various third-party payors, including Medicare, Medicaid, private commercial insurance

companies, health maintenance organizations and other healthcare-related organizations, to cover all or a portion of the costs

and fees associated with Dario and bill patients for any applicable deductibles or co-payments.

Access to adequate coverage and

reimbursement for Center for Medicare and Medicaid Services (CMS) procedures using Dario (and our other products in development)

by third-party payors is essential to the acceptance of our products by our customers.

and other organizations adequately cover and reimburse customers for the cost of our products and services.

the United States, we expect to derive nearly all our sales from sales directly to consumers as well as retail pharmacy and DME

distributors who typically bill various third-party payors, including Medicare, Medicaid, private commercial insurance companies,

health maintenance organizations, health plans and other healthcare-related organizations, to cover all or a portion of the costs

and fees associated with our products and services and bill patients for any applicable deductibles or co-payments.

Access to adequate

coverage and reimbursement for Center for Medicare and Medicaid Services (CMS) procedures using our products and services (and

our other products and services in development) by third-party payors is essential to the acceptance of our products by our customers.

payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling

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of Israel, including areas in which our employees and some of our consultants are located, and negatively affected business conditions

Our offices, located in Caesarea, Israel, are within the range of the missiles and rockets that have been fired at Israeli

cities and towns from Gaza sporadically since 2006, with escalations in violence (such as the recent escalation in July 2014) during

which there were a substantially larger number of rocket and missile attacks aimed at Israel.

Our offices, located in Caesarea, Israel, are within the range of the missiles and rockets that have been fired

at Israeli cities and towns from Gaza sporadically since 2006, with escalations in violence (such as the recent escalation in July 2014)

during which there were a substantially larger number of rocket and missile attacks aimed at Israel.

In addition, since February 2011,

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and may have the potential for causing additional conflicts in the region.

In addition, Iran has threatened to attack Israel and

is widely believed to be developing nuclear weapons.

Iran is also believed to have a strong influence among extremist groups in

the region, such as Hamas in Gaza, Hezbollah in Lebanon, and various rebel militia groups in Syria.

Additionally, a violent jihadist

group named Islamic State of Iraq and Levant (ISIL) is involved in hostilities in Iraq and Syria and have been growing in influence.

Although ISIL’s activities have not directly affected the political and economic conditions in Israel, ISIL’s stated

purpose is to take control of the Middle East, including Israel.

These situations may potentially escalate in the future to more

violent events which may affect Israel and us.

Any armed conflicts, terrorist activities or political instability in the region

could adversely affect business conditions and could harm our results of operations and could make it more difficult for us to

raise capital.

In addition, Iran has threatened to attack Israel

and is widely believed to be developing nuclear weapons.

Iran is also believed to have a strong influence among extremist groups

in the region, such as Hamas in Gaza, Hezbollah in Lebanon, and various rebel militia groups in Syria.

Additionally, a violent

jihadist group named Islamic State of Iraq and Levant (ISIL) is involved in hostilities in Iraq and Syria and have been growing

in influence.

Although ISIL’s activities have not directly affected the political and economic conditions in Israel, ISIL’s

stated purpose is to take control of the Middle East, including Israel.

These situations may potentially escalate in the future

to more violent events which may affect Israel and us.

Any armed conflicts, terrorist activities or political instability in the

region could adversely affect business conditions and could harm our results of operations and could make it more difficult for

us to raise capital.

Parties with whom we do business may decline to travel to Israel during periods of heightened unrest or tension,

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and the outcome of corporate actions requiring stockholder approval, such as:

(i) a merger or a sale of our company, (ii) a sale

of all or substantially all of our assets, and (iii) amendments to our certificate of incorporation and bylaws.

This concentration

of voting power and control could have a significant effect in delaying, deferring or preventing an action that might otherwise

be beneficial to our other stockholders and be disadvantageous to our stockholders with interests different from those individuals.

Certain of these individuals also have significant control over our business, policies and affairs as officers or directors of

(i) a merger or a sale of our company, (ii) a

sale of all or substantially all of our assets, and (iii) amendments to our certificate of incorporation and bylaws.

concentration of voting power and control could have a significant effect in delaying, deferring or preventing an action that might

otherwise be beneficial to our other stockholders and be disadvantageous to our stockholders with interests different from those

Certain of these individuals also have significant control over our business, policies and affairs as officers or

directors of our company.

Therefore, you should not invest in reliance on your ability to have any control over our company.

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common stock or warrants or trading volume to decline.

The market price of our common stock and warrants may

be significantly volatile.

The market price of our common stock

and warrants may be significantly volatile.

The market price for

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attention and resources, which could significantly harm our business operations and reputation.

Shares eligible for future sale may adversely affect the

market for our common stock and warrants.

Shares eligible for future sale may

adversely affect the market for our common stock and warrants.

From time to time,

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transactions in the open market pursuant to Rule 144, promulgated under the Securities Act, subject to certain limitations.

general, pursuant to Rule 144, after satisfying a six month holding period:

(i) affiliated stockholder (or stockholders whose shares

are aggregated) may, under certain circumstances, sell within any three month period a number of securities which does not exceed

the greater of 1% of the then outstanding shares of common stock or the average weekly trading volume of the class during the four

calendar weeks prior to such sale and (ii) non-affiliated stockholders may sell without such limitations, provided we are current

in our public reporting obligations.

Rule 144 also permits the sale of securities by non-affiliates that have satisfied a one year

holding period without any limitation or restriction.

Any substantial sale of our common stock pursuant to Rule 144 or pursuant

to any resale report may have a material adverse effect on the market price of our securities.

In general, pursuant to Rule 144, after satisfying a six month holding period:

(i) affiliated stockholder (or stockholders

whose shares are aggregated) may, under certain circumstances, sell within any three month period a number of securities which

does not exceed the greater of 1% of the then outstanding shares of common stock or the average weekly trading volume of the class

during the four calendar weeks prior to such sale and (ii) non-affiliated stockholders may sell without such limitations,

provided we are current in our public reporting obligations.

Rule 144 also permits the sale of securities by non-affiliates

that have satisfied a one year holding period without any limitation or restriction.

Any substantial sale of our common stock pursuant

to Rule 144 or pursuant to any resale report may have a material adverse effect on the market price of our securities.

Our compliance with complicated U.S.

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officers have little experience in operating a U.S.

public company, which makes our ability to comply with applicable laws, rules

and regulations uncertain.

public company, which makes our ability to comply with applicable laws, rules and

regulations uncertain.

Our failure to company with all laws, rules and regulations applicable to U.S.

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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