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Item 1A. Risk Factors

2022-03-31 compared with 2021-04-13 · 237 added, 286 removed, 539 unchanged (49% of the section changed)

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in the near future.

Our initial product, GlucoTrack®

1.0, has not been approved for marketing in the United States and may

not be sold or marketed without FDA clearance or approval in the United States.

Our next generation product, GlucoTrack®

currently under development.

While our GlucoTrack®

1.0 received CE Mark approval in 2013, there is no assurance that we

will be able to generate any material revenues from sales of such model in the EU or any other jurisdictions.

We continue to incur research

and development and selling, marketing and general and administrative expenses related to our operations, development and commercialization

of our first product.

Our operating losses for the years ended December 31, 2020 and 2019 were approximately $3.1 million and

$3.5 million, respectively, and we had an accumulated deficit of approximately $93.4 million as of December 31, 2020.

Our initial product, GlucoTrack® 1.0, has not been approved for marketing in the United States and may not be

sold or marketed without FDA clearance or approval in the United States.

Our next generation product, GlucoTrack® 2.0 is currently

under development.

We continue to incur research and development and

selling, marketing and general and administrative expenses related to our operations, development and commercialization of our first

Our operating losses for the years ended December 31, 2021 and 2020 were approximately $4.0 million and $3.1 million,

respectively, and we had an accumulated deficit of approximately $97.5 million as of December 31, 2021.

We expect to continue

to incur losses for the foreseeable future, and these losses will likely increase as we develop and prepare to commercialize GlucoTrack®

If we are not successful in developing, manufacturing and distributing GlucoTrack®

2.0, or if GlucoTrack®

2.0 does not achieve market acceptance, we may never become profitable.

Even if we achieve profitability in the future, we may

not be able to sustain profitability in subsequent periods.

to incur losses for the foreseeable future, and these losses will likely increase as we develop and prepare to commercialize GlucoTrack®

If we are not successful in developing, manufacturing and distributing GlucoTrack® 2.0, or if GlucoTrack® 2.0 does not achieve

market acceptance, we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability

in subsequent periods.

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

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stock and other securities convertible into or exercisable for shares of our common stock.

Economic turmoil and instability in the world’s

equity and credit markets and in the unstable world may materially adversely affect our ability to sell additional securities and/or

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failure to do so may materially adversely affect our ability to continue operations.

GlucoTrack®

may not be approved for sale in the United States or other (non-CE Mark) jurisdictions.

will likely be required to undertake significant clinical trials to demonstrate to the FDA that GlucoTrack®

safe and effective for its intended use or is substantially equivalent in terms of safety and effectiveness to an existing, lawfully

marketed non-Section 515 premarket approval (PMA) device (refer to “

Management Discussion and Analysis - Government Regulatory ”).

We may also be required to undertake clinical trials by non-U.S.

will likely be required to undertake significant clinical trials to demonstrate to the FDA that GlucoTrack® is either safe and effective

for its intended use or is substantially equivalent in terms of safety and effectiveness to an existing, lawfully marketed non-Section

515 premarket approval (PMA) device (refer to “ Management Discussion and Analysis - Government Regulatory ”).

also be required to undertake clinical trials by non-U.S.

regulatory agencies in non-CE Mark jurisdictions.

Clinical trials are

expensive and uncertain processes that may take years to complete.

Failure can occur at any point in the process and early positive results

do not ensure that the entire clinical trial will be successful.

Clinical trials are expensive

and uncertain processes that may take years to complete.

Failure can occur at any point in the process and early positive results do

not ensure that the entire clinical trial will be successful.

Product candidates in clinical trials may fail to show desired efficacy

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be indicative of future results.

We will likely be required to demonstrate through well-controlled clinical trials that GlucoTrack®

or future product candidates, if any, are safe and effective for their intended uses.

In the event that the FDA deems GlucoTrack®

to be a Class II device, which we do not believe is likely at this point, then we would be required to demonstrate that it

is substantially equivalent in terms of safety and effectiveness to a device lawfully marketed either through a premarket notification

or prior to May 28, 1976.

In the event that the FDA deems GlucoTrack®

to be a Class II device, which we do not believe is likely at this point, then we would be required to demonstrate that it is substantially

equivalent in terms of safety and effectiveness to a device lawfully marketed either through a premarket notification or prior to May

Additionally,

although we have received our CE Mark approval for GlucoTrack®

1.0, EU member countries may request or require additional

performance and/or safety data from time to time, on a case-by-case basis.

GlucoTrack®

2.0 is currently under development.

Further, GlucoTrack®

or our future product candidates, if any, may not be cleared or approved, as the case may be, even if

the clinical data are satisfactory and support, in our view, its or their clearance or approval.

although we have received our CE Mark approval for GlucoTrack® 1.0, EU member countries may request or require additional performance

and/or safety data from time to time, on a case-by-case basis.

GlucoTrack® 2.0 is currently under development.

GlucoTrack® or our future product candidates, if any, may not be cleared or approved, as the case may be, even if the clinical data

are satisfactory and support, in our view, its or their clearance or approval.

The FDA or other non-U.S.

authorities may disagree with our trial design or interpretation of the clinical data.

In addition, any of these regulatory authorities

may change requirements for the clearance or approval of a product candidate even after reviewing and providing comment on a protocol

for a pivotal clinical trial that has the potential to result in FDA approval.

In addition, any of these regulatory authorities may also

clear or approve a product candidate for fewer or more limited uses than we request or may grant clearance or approval contingent on

the performance of costly post-marketing clinical trials.

In addition, the FDA or other non-regulatory authorities may not approve the

labeling claims necessary or desirable for the successful commercialization of GlucoTrack®

or our future product candidates,

are highly dependent on the success of our next generation product candidate, GlucoTrack®

2.0, and cannot give any

assurance that it will receive regulatory approval or clearance or be successfully commercialized.

are highly dependent on the success of our next generation product candidate, GlucoTrack®

give any assurance that the FDA will permit us to clinically test the device, nor can we give any assurance that the clinical trials

will be successful or that GlucoTrack®

2.0 will receive regulatory clearance or approval or be successfully

commercialized, for a number of reasons, including, without limitation, the potential introduction by our competitors of more

clinically-effective or cost-effective alternatives, failure in our sales and marketing efforts, or the failure to obtain positive

coverage determinations or reimbursement.

Any failure to obtain approval to conduct clinical trials, favorable clinical data,

clearance or approval of or to successfully commercialize GlucoTrack®

2.0 would have a material adverse effect on our

our competitors develop and market products that are more effective, safer or less expensive than GlucoTrack®

or our future

product candidates, if any, our commercial opportunities will be adversely affected.

regulatory authorities may disagree

with our trial design or interpretation of the clinical data.

In addition, any of these regulatory authorities may change requirements

for the clearance or approval of a product candidate even after reviewing and providing comment on a protocol for a pivotal clinical

trial that has the potential to result in FDA approval.

In addition, any of these regulatory authorities may also clear or approve a

product candidate for fewer or more limited uses than we request or may grant clearance or approval contingent on the performance of

costly post-marketing clinical trials.

In addition, the FDA or other non-regulatory authorities may not approve the labeling claims necessary

or desirable for the successful commercialization of GlucoTrack® or our future product candidates, if any.

are highly dependent on the success of our next generation product candidate, GlucoTrack® 2.0, and cannot give any assurance that

it will receive regulatory approval or clearance or be successfully commercialized.

are highly dependent on the success of our next generation product candidate, GlucoTrack® model 2.0.

We cannot give any assurance

that the FDA will permit us to clinically test the device, nor can we give any assurance that the clinical trials will be successful

or that GlucoTrack® 2.0 will receive regulatory clearance or approval or be successfully commercialized, for a number of reasons,

including, without limitation, the potential introduction by our competitors of more clinically-effective or cost-effective alternatives,

failure in our sales and marketing efforts, or the failure to obtain positive coverage determinations or reimbursement.

Any failure to

obtain approval to conduct clinical trials, favorable clinical data, clearance or approval of or to successfully commercialize GlucoTrack®

2.0 would have a material adverse effect on our business.

our competitors develop and market products that are more effective, safer or less expensive than GlucoTrack® or our future product

candidates, if any, our commercial opportunities will be adversely affected.

life sciences industry is highly competitive and we face significant competition from many medical device companies that are researching

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and Medtronic, Inc.

In addition, many other universities and private

and public research institutions are or may become active in research involving blood glucose measurement devices.

In addition, many other universities and private and public

research institutions are or may become active in research involving blood glucose measurement devices.

believe that our ability to successfully compete will depend on, among other things:

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ability to protect intellectual property rights related to our products.

our competitors market products that are more effective, safer, easier to use or less expensive than GlucoTrack®

future product candidates, if any, or that reach the market sooner than GlucoTrack®

or our future product candidates,

if any, we may not achieve commercial success.

our competitors market products that are more effective, safer, easier to use or less expensive than GlucoTrack® or our future product

candidates, if any, or that reach the market sooner than GlucoTrack® or our future product candidates, if any, we may not achieve

commercial success.

In addition, the medical device industry is characterized by rapid technological change.

It may be difficult for us to stay abreast of the rapid changes in each technology.

If we fail to stay at the forefront of technological

change, we may be unable to compete effectively.

Technological advances or products developed by our competitors may render our technologies

or product candidates obsolete or less competitive.

It may be difficult for

us to stay abreast of the rapid changes in each technology.

If we fail to stay at the forefront of technological change, we may be unable

to compete effectively.

Technological advances or products developed by our competitors may render our technologies or product candidates

obsolete or less competitive.

product development activities could be delayed or stopped.

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failure to obtain sufficient funding to pay for all necessary clinical trials;

number of, and competition for, suitable patients that meet the protocol’s inclusion criteria and do not meet any of the exclusion

number of, and competition for, suitable sites to conduct the clinical trials, and delay or failure to obtain FDA approval, if necessary,

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clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, the IRB for any given site, or us.

Any failure or significant delay in completing clinical trials for GlucoTrack®

or future product candidates, if any, could materially

Any failure or significant delay in completing clinical trials for GlucoTrack® or future product candidates, if any, could materially

harm our financial results and the commercial prospects for our product candidates.

regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization

of GlucoTrack®

or our future product candidates, if any.

of GlucoTrack® or our future product candidates, if any.

research, testing, manufacturing, labeling, approval, selling, marketing and distribution of medical devices are subject to extensive

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inspectional observations (Form 483), warning letters or non-warning letters incorporating inspectional observations, i.e., so-called

“untitled letter”;

and criminal penalties;

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officials may not find the data from the clinical trials sufficient;

FDA might not approve our third-party manufacturer’s processes or facilities;

FDA may change its clearance or approval policies or adopt new regulations.

while we have received CE Mark approval for GlucoTrack®

1.0, the MDD requires only minimum harmonization.

In practice, uniform

regulation throughout the EU is not ensured.

Rather, member countries may apply and enforce the MDD’s terms differently, and certain

EU member countries may request or require performance and/or safety data additional to the MDD’s requirements from time to time,

on a case-by-case basis.

Therefore, we cannot predict whether we will be able to successfully commercialize GlucoTrack®

or our future product candidates, if any, in the EU.

while we have received CE Mark approval for GlucoTrack® 1.0, the MDD requires only minimum harmonization.

In practice, uniform regulation

throughout the EU is not ensured.

Rather, member countries may apply and enforce the MDD’s terms differently, and certain EU member

countries may request or require performance and/or safety data additional to the MDD’s requirements from time to time, on a case-by-case

Therefore, we cannot predict whether we will be able to successfully commercialize GlucoTrack® or our future product candidates,

if any, in the EU.

to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed.

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regulatory authorities

clear or approve GlucoTrack®

or our future product candidates, if any, the labeling, packaging, adverse event reporting,

storage, advertising and promotion for the product will be subject to extensive regulatory requirements.

We, and the manufacturers of

our products, if other than us, also will be required to comply with the FDA’s Quality System Regulation, which includes requirements

relating to quality control and quality assurance, as well as the corresponding maintenance of records and documentation.

Moreover, device

manufacturers are required to report adverse events by filing Medical Device Reports with the FDA, which are publicly available.

regulatory agencies must approve our manufacturing facilities before they can be used to manufacture products, and these facilities are

subject to ongoing regulatory inspection.

clear or approve GlucoTrack® or our future product candidates, if any, the labeling, packaging, adverse event reporting, storage,

advertising and promotion for the product will be subject to extensive regulatory requirements.

We, and the manufacturers of our products,

if other than us, also will be required to comply with the FDA’s Quality System Regulation, which includes requirements relating

to quality control and quality assurance, as well as the corresponding maintenance of records and documentation.

Moreover, device manufacturers

are required to report adverse events by filing Medical Device Reports with the FDA, which are publicly available.

Further, regulatory

agencies must approve our manufacturing facilities before they can be used to manufacture products, and these facilities are subject

to ongoing regulatory inspection.

If we fail to comply with the regulatory requirements of the FDA and other non-U.S.

authorities, or if previously unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be

subject to administrative or judicially imposed sanctions, including:

regulatory authorities,

or if previously unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be subject to

administrative or judicially imposed sanctions, including:

on the products, manufacturers or manufacturing process;

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to market future product candidates and may not achieve or sustain profitability.

if we receive regulatory clearance or approval to market GlucoTrack®

or our future product candidates, if any, the

market may not be receptive to our products.

if GlucoTrack®

or our future product candidates, if any, obtain regulatory clearance or approval, resulting products may

not gain market acceptance among physicians, patients, health care payors or the medical community.

We believe that the degree of market

acceptance will depend on a number of factors, including:

if we receive regulatory clearance or approval to market GlucoTrack® or our future product candidates, if any, the market may not

be receptive to our products.

if GlucoTrack® or our future product candidates, if any, obtain regulatory clearance or approval, resulting products may not gain

market acceptance among physicians, patients, health care payors or the medical community.

We believe that the degree of market acceptance

will depend on a number of factors, including:

of market introduction of competitive products;

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of coverage and reimbursement from government and other third-party payors.

the GlucoTrack®

or our future product candidates, if any, fail to achieve market acceptance, we may not be able to generate

significant revenue or achieve or sustain profitability.

the GlucoTrack® or our future product candidates, if any, fail to achieve market acceptance, we may not be able to generate significant

revenue or achieve or sustain profitability.

coverage and reimbursement status of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage

and adequate reimbursement could limit our ability to market GlucoTrack®

or future product candidates, if any, and may

inhibit our ability to generate revenue from GlucoTrack®

or our future product candidates, if any, that may be cleared

and adequate reimbursement could limit our ability to market GlucoTrack® or future product candidates, if any, and may inhibit our

ability to generate revenue from GlucoTrack® or our future product candidates, if any, that may be cleared or approved.

is significant uncertainty related to the third-party coverage and reimbursement of newly cleared or approved medical devices.

The commercial

success of GlucoTrack®

or our future product candidates, if any, in both domestic and international markets will depend

in part on the availability of coverage and adequate reimbursement from third-party payors, including government payors, such as the

Medicare and Medicaid programs, managed care organizations and other third-party payors.

Government and other third-party payors are

increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new products and, as

a result, they may not cover or provide adequate payment for GlucoTrack®

or our future product candidates, if any.

payors may conclude that our products are not as safe or effective as existing devices or that the overall cost of using one of our devices

exceeds the overall cost of the competing device, and third-party payors may not approve GlucoTrack®

or our future product

candidates, if any, for coverage and adequate reimbursement.

Furthermore, deficit reduction and austerity measures in the United States

and abroad may put further pressure on governments to limit coverage of, and reimbursement for, our products.

The failure to obtain coverage

and adequate reimbursement for GlucoTrack®

or our future product candidates, if any, or health care cost containment initiatives

that limit or restrict reimbursement for such products may reduce any future product revenue.

success of GlucoTrack® or our future product candidates, if any, in both domestic and international markets will depend in part on

the availability of coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and

Medicaid programs, managed care organizations and other third-party payors.

Government and other third-party payors are increasingly

attempting to contain health care costs by limiting both coverage and the level of reimbursement for new products and, as a result, they

may not cover or provide adequate payment for GlucoTrack® or our future product candidates, if any.

These payors may conclude that

our products are not as safe or effective as existing devices or that the overall cost of using one of our devices exceeds the overall

cost of the competing device, and third-party payors may not approve GlucoTrack® or our future product candidates, if any, for coverage

and adequate reimbursement.

Furthermore, deficit reduction and austerity measures in the United States and abroad may put further pressure

on governments to limit coverage of, and reimbursement for, our products.

The failure to obtain coverage and adequate reimbursement for

GlucoTrack® or our future product candidates, if any, or health care cost containment initiatives that limit or restrict reimbursement

for such products may reduce any future product revenue.

may not obtain insurance coverage to adequately cover all significant risk exposures.

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to defend the related litigation;

diversion of management’s time and our resources;

monetary awards to trial participants or patients;

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or be able to obtain, sufficient capital to pay such amounts.

we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize GlucoTrack®

or our future product candidates, if any.

will need to expand and effectively manage our managerial, operational, financial, development and other resources in order to successfully

pursue our research, development and commercialization efforts for GlucoTrack®

or our future product candidates, if any.

pursue our research, development and commercialization efforts for GlucoTrack® or our future product candidates, if any.

depends on our continued ability to attract, retain and motivate highly qualified management and pre-clinical and clinical personnel.

The loss of the services of any of our senior management could delay or prevent the development or commercialization of GlucoTrack®

or our future product candidates, if any.

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difficulties in managing our growth and expanding our operations successfully.

We anticipate that, as our operations

expand, we will need to expand our manufacturing, marketing and sales capabilities by contracting with third parties.

Maintaining these relationships and managing our future growth will impose significant added responsibilities

on members of our management.

anticipate that, as our operations expand, we will need to expand our manufacturing, marketing and sales capabilities by contracting

with third parties.

Maintaining these relationships and managing our future growth will impose significant added responsibilities on

members of our management.

We must be able to manage our development efforts effectively;

manage our clinical trials effectively;

hire, train and integrate additional management, development, administrative and sales and marketing personnel;

train and integrate additional management, development, administrative and sales and marketing personnel;

improve managerial, development,

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rely on third parties to manufacture and supply our product.

do not own or operate manufacturing facilities for clinical or commercial production of GlucoTrack®, other than a prototype lab.

We have no experience in medical device manufacturing and lack the resources and the capability to manufacture the GlucoTrack®

do not own or operate manufacturing facilities for clinical or commercial production of GlucoTrack®, other than a prototype lab.

We have no experience in medical device manufacturing and lack the resources and the capability to manufacture the GlucoTrack® on

a commercial scale.

To date we have manufactured GlucoTrack®

with a third-party manufacturer in Israel.

To date we have manufactured GlucoTrack® with a third-party manufacturer in Israel.

our manufacturing partners are unable to produce our products in the amounts, timing or pricing that we require, we may not be able to

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We expect to depend on third-party contract manufacturers for the foreseeable future.

GlucoTrack®

and our future product candidates, if any, likely will require precise, high quality manufacturing.

does, and our future product candidates, if any, likely will require precise, high quality manufacturing.

Any of our contract manufacturers

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For this and other reasons, we may be unable to secure desired patent rights, thereby losing desired exclusivity.

Although we do not believe that we need any licenses for GlucoTrack®, we may need to obtain licenses in the future

for other products or in certain circumstances, such as if one of our patents were declared invalid in the future.

If such licenses are

not available to us on acceptable terms, we will not be able to market the affected products or conduct the desired activities, unless

we successfully challenge the validity, enforceability or infringement of the third-party patent or otherwise circumvent the third-party

Although we do not believe that we need any licenses for GlucoTrack®, we may need to obtain licenses in the future for other products

or in certain circumstances, such as if one of our patents were declared invalid in the future.

If such licenses are not available to

us on acceptable terms, we will not be able to market the affected products or conduct the desired activities, unless we successfully

challenge the validity, enforceability or infringement of the third-party patent or otherwise circumvent the third-party patent.

strategy depends on our ability to rapidly identify and seek patent protection for our discoveries.

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future, may be challenged, invalidated, unenforceable or circumvented.

Moreover, the United States Patent and Trademark Office (the “USPTO”)

may commence interference proceedings involving our patents or patent applications.

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These agreements generally require that all confidential information developed by the individual or made known to the individual

by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties.

Our agreements

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The cost to us of any litigation or other proceeding relating to intellectual

property rights, even if resolved in our favor, could be substantial, and the litigation would divert management’s efforts.

of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially

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any parties successfully claim that our creation or use of proprietary technologies infringes upon their intellectual property rights,

we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’

patent rights.

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In December 2012, we submitted our technical file to the Notified Body in

connection with our application to obtain CE Mark approval for GlucoTrack®

On June 4, 2013, we received CE Mark approval

for the GlucoTrack®

1.0 from the Notified Body.

Receipt of the CE Mark allows us to market and sell the GlucoTrack®

in EU member countries that have adopted the MDD without being subject to additional national regulations with regard to demonstration

of performance and safety.

connection with our application to obtain CE Mark approval for GlucoTrack® 1.0.

On June 4, 2013, we received CE Mark approval for

the GlucoTrack® 1.0 from the Notified Body.

Receipt of the CE Mark allows us to market and sell the GlucoTrack® 1.0 in EU member

countries that have adopted the MDD without being subject to additional national regulations with regard to demonstration of performance

The CE Mark also permits the sale in countries that have an MDD Mutual Recognition Agreement with the EU.

However, member countries may apply and enforce the MDD’s terms differently, and certain EU member countries may request or require

that we provide performance and/or safety data additional to the MDD’s requirements from time to time, on a case-by-case basis,

in order to be cleared to market and sale GlucoTrack®

in such countries.

Receipt of FDA approval does not ensure approval

by regulatory authorities in countries, and approval by one or more non-U.S.

regulatory authorities (including receipt of the CE Mark)

does not ensure approval by regulatory authorities in other countries or by the FDA.

regulatory approval process may include

all of the risks associated with obtaining FDA approval or clearance.

However, member

countries may apply and enforce the MDD’s terms differently, and certain EU member countries may request or require that we provide

performance and/or safety data additional to the MDD’s requirements from time to time, on a case-by-case basis, in order to be

cleared to market and sale GlucoTrack® in such countries.

Receipt of FDA approval does not ensure approval by regulatory authorities

in countries, and approval by one or more non-U.S.

regulatory authorities (including receipt of the CE Mark) does not ensure approval

by regulatory authorities in other countries or by the FDA.

regulatory approval process may include all of the risks associated

with obtaining FDA approval or clearance.

We may not obtain additional non-U.S.

regulatory approvals on a

timely basis, if at all.

We may not be able to file for additional non-U.S.

regulatory approvals and may not receive necessary approvals

to commercialize our product candidates in any market.

regulatory approvals on a timely basis, if at all.

may not be able to file for additional non-U.S.

regulatory approvals and may not receive necessary approvals to commercialize our product

candidates in any market.

governments often impose strict price controls, which may adversely affect our future profitability.

intend to seek approval to market GlucoTrack®

and our future product candidates, if any, in both the U.S.

intend to seek approval to market GlucoTrack® and our future product candidates, if any, in both the U.S.

and in non-U.S.

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If we obtain approval in one or more non-U.S.

jurisdictions, we will be subject to rules and regulations in those jurisdictions

relating to our products.

In some countries, particularly countries of the EU, each of which has developed its own rules and regulations,

pricing may be subject to governmental control under certain circumstances.

In these countries, pricing negotiations with governmental

authorities can take considerable time after the receipt of marketing approval for a medical device candidate.

Each of the EU member

states has its own unique legal system and thus it is difficult to predict the particular requirements to which we may be subject.

obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness

of our product to other available products.

If reimbursement of our product candidates is unavailable or limited in scope or amount,

or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

jurisdictions, we will be subject to rules and regulations in those jurisdictions relating

to our products.

In some countries, particularly countries of the EU, each of which has developed its own rules and regulations, pricing

may be subject to governmental control under certain circumstances.

In these countries, pricing negotiations with governmental authorities

can take considerable time after the receipt of marketing approval for a medical device candidate.

Each of the EU member states has its

own unique legal system and thus it is difficult to predict the particular requirements to which we may be subject.

To obtain reimbursement

or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product

to other available products.

If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is

set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

business may become subject to economic, political, regulatory and other risks associated with international operations, which could

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currency exchange rates and currency controls;

in a specific country’s or region’s political or economic environment;

protection measures, import or export licensing requirements or other restrictive actions by U.S.

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of former employees and tend, if at all, to enforce those provisions for only relatively brief periods of time or in restricted geographical

In addition, Israeli courts typically require the presence of additional circumstances, such as a demonstration of an employer’s

legitimate interest which was damaged;

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a payment of a special consideration

for employee’s non-compete obligation;

material concern for disclosing employer’s trade secrets;

for employee’s non-compete obligation;

material concern for disclosing employer’s trade secrets;

or a demonstration that

an employee has unique value to the employer specific to that employer’s business, before enforcing a non-competition undertaking

against such employee.

funding that we received through the Office of the Chief Scientist (the “OCS”) for research and development activities restricts

our ability to manufacture products or to transfer technology outside of Israel.

March 4, 2004, the OCS agreed to provide us with a grant of 420 thousand New Israeli Shekels (“NIS”), or approximately

$93 thousand at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive

blood glucose monitor (the “development plan”).

This grant constituted 60% of our research and development budget for the

development plan at that time.

Due to our acceptance of this grant, we are subject to the provisions of the Israeli Law for the Encouragement

of Industrial Research and Development, 1984 (the “R&D Law”).

funding that we received through the Israeli Innovation Authority (IIA) for research and development activities restricts our

ability to manufacture products or to transfer technology outside of Israel.

March 4, 2004, the OCS agreed to provide us with a grant of 420 thousand New Israeli Shekels (“NIS”), or approximately $93

thousand at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood

glucose monitor (the “development plan”).

This grant constituted 60% of our research and development budget for the development

plan at that time.

Due to our acceptance of this grant, we are subject to the provisions of the Israeli Law for the Encouragement of

Industrial Research and Development, 1984 (the “R&D Law”).

Among other things, the R&D Law restricts our ability

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Law) of us to non-Israeli entities.

The Industrial Research and Development Committee at the OCS (the “research committee”)

may, under special circumstances, approve the transfer outside of Israel of rights in technology or know-how developed with OCS funding

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to provide for this liability.

Company’s and its Israeli subsidiary’s agreements with all of their Israeli employees are in accordance with Section 14 of

the Israeli Severance Pay Law -1963 (“Section 14”).

Company’s and its Israeli subsidiary’s agreements with all of their Israeli employees are in accordance with Section 14 of

the Israeli Severance Pay Law -1963 (“Section 14”).

Payments in accordance with Section 14 release the Company from any other

future severance payments in respect of those employees.

Deposits under Section 14 are not recorded as an asset in the Company’s

balance sheet.

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and the pace of recovery when the COVID-19 pandemic subsides.

is a limited trading market for our common stock, which may make it difficult for our stockholders to sell their shares.

our stock is quoted on the OTCQB, few trades in our stock have taken place, to-date, and an active trading market in our securities may

not develop, or if developed, may not be sustained.

If no active market is ever developed for our Common Stock, it will be difficult

for you to sell any shares you purchase in our Company at the time you wish to sell them or at a price that you consider reasonable or

In such a case, you may find that you are unable to achieve any benefit from your investment or liquidate your shares without

considerable delay, if at all.

In the absence of an active public trading market, an investor may be unable to liquidate an investment

in our Common Stock.

As a result, investors:

(i) may be precluded from transferring their shares of Common Stock;

(ii) may have to hold

their shares of Common Stock for an indefinite period of time;

and (iii) must be able to bear the complete economic risk of losing their

investment in us.

In the event a market should develop for the Common Stock, there can be no assurance that the market price will equal

or exceed the price paid for such share by any of our stockholders.

may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may

materially harm our company.

systems of internal controls over financial accounting and disclosure are critical to the operation of a public company.

If we are unable

to effectively establish such systems, this would leave us without the ability to reliably assimilate and compile financial information

about our company and significantly impair our ability to prevent error and detect fraud, all of which would have a negative impact on

our company from many perspectives.

we do not expect that disclosure controls or internal control over financial reporting will prevent all error and all fraud.

system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s

objectives will be met.

Further, the design of a control system must reflect the fact that there are resource constraints and the benefits

of controls must be considered relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of

controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Failure of our control

systems to prevent error or fraud could materially adversely impact us.

We had identified a material weakness in

our internal control over financial reporting, and we may not be able to successfully implement remedial measures.

identified material weaknesses related to our internal control over financial reporting as of December 31, 2021 and concluded that internal

control over financial reporting as at December 31, 2021 were not effective.

The ineffectiveness of the Company’s internal control

over financial reporting was due to identification of material weaknesses related to lack of sufficient internal accounting personnel,

se gregation of duties, and lack of sufficient internal controls

(including IT general controls) that encompass the Company as a whole with respect to entity and transactions level controls in order

to ensure complete documentation of complex and non-routine transactions and adequate financial reporting.

expect to complete our remediation plan within the next 12 months.

However, we have not tested the effectiveness of our internal control

over financial reporting and cannot assure you that we will be able to successfully remediate this material weakness and, even if we

do, we cannot assure you that we will not suffer from other material weaknesses in the future.

Except for additional personnel costs,

the cost of systems and the costs of our third-party service providers, we do not expect to incur any material costs related to our remediation

there can be no assurance that we will not suffer from other material weaknesses or significant deficiencies in the future.

to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future,

such failure could result in a material misstatement of our annual or quarterly financial statements that would not be prevented or detected

on a timely basis and which could cause investors and other users to lose confidence in our financial statements, limit our ability to

raise capital and have a negative effect on the trading price of our common stock.

Additionally, failure to remediate the material weakness

or otherwise maintain effective internal controls over financial reporting may also negatively impact our operating results and financial

condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory

actions and cause us to incur substantial additional costs in future periods relating to the implementation of remedial measures.

market price of our common stock may fluctuate significantly.

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concerning intellectual property rights and regulatory approvals;

in our and our competitors’

results of operations;

in our and our competitors’ results of operations;

in earnings estimates or recommendations by securities analysts, if the common stock is covered by analysts;

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which could cause a decline in the value of the common stock.

Price volatility of our common stock might be significant if the trading

volume of the common stock is low, which often occurs with respect to newly traded securities on the OTCQB.

our common stock is a “penny stock,”

it may be more difficult for investors to sell shares of the common stock, and the market

our common stock is a “penny stock,” it may be more difficult for investors to sell shares of the common stock, and the market

price of the common stock may be adversely affected.

common stock may be a penny stock if, among other things, the stock price is below $5.00 per share, it is not listed on a national securities

exchange or approved for quotation on the Nasdaq Stock Market or any other national securities exchange or it has not met certain net

tangible asset or average revenue requirements.

Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized

risk- disclosure document prepared by the SEC.

This document provides information about penny stocks and the nature and level of risks

involved in investing in the penny-stock market.

A broker must also give a purchaser, orally or in writing, bid and offer quotations

and information regarding broker and salesperson compensation, make a written determination that the penny stock is a suitable investment

for the purchaser and obtain the purchaser’s written agreement to the purchase.

Broker-dealers must also provide customers that

hold penny stock in their accounts with such broker-dealer a monthly statement containing price and market information relating to the

If a penny stock is sold to an investor in violation of the penny stock rules, the investor may be able to cancel its purchase

and get its money back.

common stock may be a penny stock if, among other things, the stock price is below $5.00 per share.

Broker-dealers who sell penny

stocks must provide purchasers of these stocks with a standardized risk- disclosure document prepared by the SEC.

This document provides

information about penny stocks and the nature and level of risks involved in investing in the penny-stock market.

A broker must also

give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation, make

a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written agreement

to the purchase.

Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer a monthly

statement containing price and market information relating to the penny stock.

If a penny stock is sold to an investor in violation of

the penny stock rules, the investor may be able to cancel its purchase and get its money back.

applicable, the penny stock rules may make it difficult for investors to sell their shares of common stock.

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

adoption of the “Conflict Minerals”

regulations may adversely affect the manufacturing of our current and future products.

Regulatory requirements

regarding the use of “conflict minerals”

could affect the sourcing and availability of the raw materials used by our third-party

manufacturers.

We may be subject to costs associated with the new regulations, including for the diligence pertaining to the presence

of any conflict minerals used in our products and the cost of remediation and other changes to products, processes, or sources of supply

as a consequence of such verification activities.

The impact of the regulations may result in a limited pool of suppliers who provide

conflict free minerals, and we cannot assure that we will be able to obtain products in sufficient quantities or at competitive prices.

We may face reputational challenges with our customers and other stakeholders if we are unable to sufficiently verify the origins for

the metals used in the products we sell.

adoption of the “Conflict Minerals” regulations may adversely affect the manufacturing of our current and future products.

requirements regarding the use of “conflict minerals” could affect the sourcing and availability of the raw materials used

by our third-party manufacturers.

We may be subject to costs associated with the new regulations, including for the diligence pertaining

to the presence of any conflict minerals used in our products and the cost of remediation and other changes to products, processes, or

sources of supply as a consequence of such verification activities.

The impact of the regulations may result in a limited pool of suppliers

who provide conflict free minerals, and we cannot assure that we will be able to obtain products in sufficient quantities or at competitive

We may face reputational challenges with our customers and other stakeholders if we are unable to sufficiently verify the origins

for the metals used in the products we sell.

As a result, we may not be able to obtain the materials necessary to manufacture our products,

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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