What changed in this filing

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Item 1. Business

2021-04-13 compared with 2020-04-14 · 745 added, 940 removed, 321 unchanged (84% of the section changed)

15 unchanged sentences

We have developed a non-invasive glucose monitor, the GlucoTrack®

model DF-F glucose monitoring device, which is designed

to help people with diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty

of conventional (invasive) spot finger stick devices.

The GlucoTrack®

model DF-F utilizes a patented combination of ultrasound,

electromagnetic and thermal technologies to obtain glucose measurements in less than one minute via a small sensor that is clipped

onto one’s earlobe and connected to a small, handheld control and display unit, all without drawing blood or interstitial

We are currently

developing our own companion applications and a cloud-based solution, as well as conducting ongoing discussions with potential

partners, to offer an effective platform to provide real time, data driven personalized tools to effectively help a user manage

their diabetes.

In addition to being a critical and effective management tool for the end user, we believe that third parties

such as insurers, pharmaceutical companies and advertisers would be willing to pay for the de-identified data that we will obtain

through our platform, and that this is an opportunity for us to develop an additional revenue source.

June 2013, we received the initial Conformité

Européene (CE) Mark (indicating the conformity of the Company’s

product with health, safety, and environmental protection standards for products sold within the European Economic Area) approval

for the GlucoTrack®

model DF-F non-invasive glucose monitoring device from DEKRA Certification B.V., our European notified

body (the “Notified Body”), which is an entity that has been accredited by a member state of the European Union (“EU”)

to assess whether a product to be placed on the market meets certain preordained standards.

original approval required that the device be re-calibrated every 30 days, with each such re- calibration taking between 2.5 and

3 hours to complete.

In 2014, we received CE Mark approval for six months’

calibration validity of the same device.

approval eliminated the need for monthly re-calibrations and enabled the calibration process to be conducted only

when the sensor is replaced, once every 6 months.

In 2015, we received a further approval from the Notified Body for improvements

to the GlucoTrack®

model DF-F to simplify and shorten the initial calibration process for the device (from approximately 2.5

hours to approximately half an hour).

All these improvements enhance the competitiveness of the device and its commercial viability.

In addition, we received approval from the Notified Body on the updated intended use for the device, which expands the intended

user population to include not only Type 2 diabetics, but also people suffering from pre-diabetes conditions, which we believe

represents a material expansion of the potential market for the device.

Also in 2015, we received approval from

the Notified Body for further improvements to the GlucoTrack®

model DF-F that increase the accuracy and efficacy of the device.

January 21, 2020, the Company announced that it has received CE Mark approval for a major enhancement to GlucoTrack, allowing

for a user to perform the calibration process by themselves, without the need for a certified calibrator.

The initial CE Mark

approval received for GlucoTrack required a calibration process that took three hours to complete, required eight invasive finger

stick reference measurements, needed to be repeated every thirty days and required a certified calibrator to perform the calibration.

After a series of successful enhancements and approvals, the calibration process now takes just thirty minutes, requires just

three invasive reference measurements, and needs to be repeated only once every six months.

With self-calibration, a user can

now perform this simplified process in the privacy and convenience of their own home.

As a result of these incremental, but important,

enhancements to the performance of the device, we believe that the product is ready for commercial launch in specific market

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

model DF-F glucose monitoring device in EU member countries that

have adopted the European Medical Device Directive (the “MDD”) without being subject to additional national regulations

glucose monitoring device, which is designed to help

people with diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional

(invasive) spot finger stick devices.

The first generation GlucoTrack®

(“GlucoTrack 1.0”) utilizes

a patented combination of ultrasound, electromagnetic and thermal technologies to obtain glucose measurements in less than one

minute via a small sensor that is clipped onto one’s earlobe and connected to a small, handheld control and display unit,

all without drawing blood or interstitial fluid.

are currently developing our own companion applications and a cloud-based solution, as well as conducting ongoing discussions

with potential partners, to offer an effective platform to provide real time, data driven personalized tools to effectively help

a user manage their diabetes.

In addition to being a critical and effective management tool for the end user, we believe that

third parties such as insurers, pharmaceutical companies and advertisers would be willing to pay for the de-identified data that

we will obtain through our platform, and that this is an opportunity for us to develop an additional revenue source.

a short calibration process of approximately thirty minutes and consisting of three invasive reference measurements, GlucoTrack

1.0 can be used to non-invasively measure glucose levels for six months before a user is required to repeat the calibration process.

The entire calibration process can be performed by the user themselves without the need for a trained calibrator.

We believe the

simple-to-perform calibration, as well as the infrequency of the required re-calibration are significant advantages over our competition.

1.0 has received the initial Conformité

Européene

(CE) Mark (indicating the conformity of the Company’s product with health, safety, and environmental protection standards

for products sold within the European Economic Area) approval for the GlucoTrack®

1.0 from DEKRA Certification B.V.,

our European notified body (the “Notified Body”), which is an entity that has been accredited by a member state of

the European Union (“EU”) to assess whether a product to be placed on the market meets certain preordained standards.

The intended use for GlucoTrack 1.0 received by the Notified Body is for both those with Type 2 diabetes as well as those suffering

from pre-diabetes.

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

1.0 glucose monitoring device in EU member countries that have

adopted the European Medical Device Directive (the “MDD”) without being subject to additional national regulations

with regard to demonstration of performance and safety.

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Recognition Agreement with the EU.

This would include some countries in South East Asia as well as in Latin America,

opening new potential markets for Integrity on a global basis.

This would include some countries in South East Asia as well as in Latin America, opening new

potential markets for Integrity on a global basis.

and quality are non-negotiables in the medical devices industry.

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process of future GlucoTrack®

model DF-F enhancements or revisions, including software updates and other improvements of the

device that do not affect the intended use and/or safety performance.

The ISO 13485:2003 and Annex II certifications enable us

to potentially reduce the time to market for product sales on new, enhanced or modified GlucoTrack®

model DF-F devices.

GlucoTrack®

model DF-F has not yet been approved for commercial sale in the United States.

On August 10, 2015, we submitted

pre- submission documents to the U.S.

Food and Drug Administration (the “FDA”) in connection with our proposed future

application for FDA approval of our U.S.

clinical trial protocol.

The pre-submission documentation was submitted to the FDA in

order to obtain the FDA’s guidance regarding the U.S.

regulatory pathway for the GlucoTrack®

model DF-F, the proper

approach to refining the trial protocol and preparing the pre-marketing application.

On October 19, 2015, we met with the FDA

to discuss the pre-submission documents, including the approach to and details of the clinical trial protocol for the GlucoTrack®

On May 10, 2016, we submitted a pre-submission supplement (including clinical trial protocol) to the FDA which reflects

the feedback received from the FDA at our October 2015 meeting.

On July 18, 2016, we completed a teleconference with the FDA to

further discuss our pre-submission supplement.

At the end of this discussion, we received verbal confirmation from the FDA that

clinical trials of the GlucoTrack®

model DF-F constitute non-significant risk device studies, which allows the trials to proceed

without an Investigational Device Exemption (IDE) application.

Such trials are assessed by the FDA and not considered to present

a potential for serious risk to the health, safety or the welfare of subjects.

We expect that the regulatory pathway would be

that of a de novo 510k, requiring a clinical trial design based on feedback from the agency.

initiation of clinical trials in the USA requires adequate financing to fund the clinical program through completion.

closing of our recent financing, we have restarted out internal planning for commencing such clinical trials.

enhancements or revisions, including software updates and other improvements of the device that

do not affect the intended use and/or safety performance.

The ISO 13485:2003 and Annex II certifications enable us to potentially

reduce the time to market for product sales on new, enhanced or modified GlucoTrack®

trials conducted in Germany by Pfutzner Science & Health Institute, GmbH, headed by Prof.

Andreas Pfutzner, on subjects

with Type 2 diabetes and pre-diabetics, as well as at Soroka University Medical Center, Beer-Sheva, Israel, demonstrated favorable

results, which were presented on November 10, 2016 by the Company at the 16th annual Diabetes Technology Meeting (DTM), Bethesda,

MD in an invited presentation.

Most notably, the presentation included data validating that GlucoTrack’s accuracy has increased

significantly.

Results from the trials show 99.7% of the study data points within the clinically accepted A and B zones of the

Consensus Error Grid (which is a new tool for evaluating the accuracy of a blood glucose meter) (Type 2), 99.3% of the study data

points were within the clinically accepted A and B zones of the Clarke Error Grid (which is a tool used to quantify the clinical

accuracy of blood glucose estimates generated by meters as compared to a reference value), 17.0% Mean Absolute Relative Difference,

and 12.9% Median Absolute Relative Difference.

In addition, the German trial concluded that the data confirms the performance

of the GlucoTrack®

with Type 2 diabetes and pre-diabetes, as well as at Soroka University Medical Center, Beer-Sheva, Israel, demonstrated

favorable results.

Results from the trials show 99.7% of the study data points within the clinically accepted A and B zones

of the Consensus Error Grid (which is a new tool for evaluating the accuracy of a blood glucose meter) (Type 2), 99.3% of the

study data points were within the clinically accepted A and B zones of the Clarke Error Grid (which is a tool used to quantify

the clinical accuracy of blood glucose estimates generated by meters as compared to a reference value), 17.0% Mean Absolute Relative

Difference, and 12.9% Median Absolute Relative Difference.

In addition, the German trial concluded that the data confirms the

performance of the GlucoTrack®

among its intended users, including pre-diabetic patients.

September 2016, we had a booth at the 52nd annual conference of the European Association for Study of Diabetes (EASD) in Munich.

December 2016, we had a poster at the 9th Annual World Congress on Prevention of Diabetes and its Complications (WCPD, in Atlanta,

This Congress provided the Company with an opportunity to showcase GlucoTrack®

model DF-F as a tool to fight diabetes

and its complications, as well as using GlucoTrack®

model DF-F as a tool to assist pre-diabetics.

February 2017, the Company presented at the 10th International Conference on Advanced Technologies & Treatments for Diabetes

(ATTD 2017) in Paris, France.

The Company presented key findings including (1) the latest generation GlucoTrack®

which compensates for the tissue-lagging effect relative to blood glucose changes post-meal intake, significantly improves GlucoTrack®

accuracy at different post-prandial (post- meal) states, and equalizes accuracy for pre- and post-meal glucose readings;

addition, the Company has demonstrated (1) the GlucoTrack®

algorithm, which compensates for the tissue-lagging effect

relative to blood glucose changes post-meal intake, significantly improves GlucoTrack®

accuracy at different post-prandial

(post- meal) states, and equalizes accuracy for pre- and post-meal glucose readings;

(2) GlucoTrack®

clinical accuracy as measured by Consensus Error Grid (CEG) showed 100% of the pre-prandial readings in the A+B zones, and 98.2%

of the post-prandial readings in the A+B zones;

clinical accuracy as

measured by Consensus Error Grid (CEG) showed 100% of the pre-prandial readings in the A+B zones, and 98.2% of the post-prandial

readings in the A+B zones;

(3) GlucoTrack®

Model DF-F demonstrates consistent glucose measurement repeatability

between different GlucoTrack®

1.0 demonstrates consistent glucose measurement repeatability between different

GlucoTrack®

devices and on each earlobe of the same subject;

(4) the repeatability of different GlucoTrack®

devices is similar at all tested glucose ranges and post-prandial time periods;

similar at all tested glucose ranges and post-prandial time periods;

and (5) the GlucoTrack®

mean precision absolute

relative difference (PARD) of 8.2% is equivalent or better than the independently reported PARD values of commercially available

continuous glucose monitoring systems.

the second half of 2017 we conducted a strategic review of our previous commercial activities.

We established a cross-functional

task force with the goal of reviewing the current commercial performance in all countries and identifying the critical success

factors (CSF’s) necessary for successful commercialization.

The CSF’s that were determined to be most important to

our future commercial success include:

1) selecting the right distribution partner within countries that have knowledge and experience

in diabetes, the appropriate capabilities and proven performance in the sales, marketing, and customer service in support of medical

devices, and a commitment to investing the appropriate resources required for a successful launch and building of the business;

2) segmenting and targeting the right customers including key opinion leaders, treating physicians, and diabetes nurses within

the healthcare provider communities as well as those patient groups that will benefit most from the use of a non-invasive device;

3) revising the cost structure for GlucoTrack®

so that it will be more affordable on a monthly basis for patients;

working with government authorities and health insurance companies to achieve full or partial reimbursement for GlucoTrack®

within covered medical plans.

We have started

the implementation of this new commercial program by selecting the Netherlands, where we will pilot this approach as our proof-of-concept.

This country was chosen based on the relatively smaller size of the marketplace that will allow us to be able to rapidly

assess our performance and make adjustments as necessary.

On December 22, 2017 we signed an exclusive distribution agreement

with a new partner in the Netherlands (MediReva B.V.) and are underway.

We have been working closely with our new distributor

and have accomplished:

product and disease area training across the organization;

segmentation of the local target audiences including

key opinion leaders, treating physicians, and diabetes nurses.

The most important aspect of our launch preparations are the

discussions being held with many health insurance companies.

Approval of full or partial reimbursement by the health insurance

companies will be a key factor in enabling us to achieve significant sales volume.

We are currently working with several of these

companies on initial pilot programs with GlucoTrack®

as an important step towards reimbursement approval.

June 12, 2017, we announced new data demonstrating the clinical performance of GlucoTrack®, further supporting its suitability

for people with type 2 diabetes across various medication regimes.

The data was presented at the American Diabetes Association’s

(ADA) 77 th Scientific Sessions in San Diego, CA.

September 2017, we presented key findings at the European Association for the Study of Diabetes Congress (EASD) in Lisbon, Portugal.

The study evaluated GlucoTracker accuracy in 172 adults with type 2 diabetes who were prescribed one or more medications for major

medical conditions associated with diabetes.

The experiment stratified participants into five medication groups, focusing on anti-cholesterolemia,

anti-hypertension, anti-thrombotic, and anti-diabetic (prolonged duration and short and mixed duration) medications.

demonstrated that the use of these common concomitant medications in diabetes had no effect on the performance of GlucoTrack®.

We also had a display booth at this conference that was well attended by hundreds of treating physicians and diabetes nurses.

February 2018, the Company presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes

(ATTD 2018) in Vienna, Austria.

mean precision absolute relative

difference (PARD) of 8.2% is equivalent or better than the independently reported PARD values of commercially available continuous

glucose monitoring systems.

Company conducted a study that evaluated GlucoTracker accuracy in 172 adults with type 2 diabetes who were prescribed one or more

medications for major medical conditions associated with diabetes, and presented key findings of this study at the European Association

for the Study of Diabetes Congress (EASD) in Lisbon, Portugal.

The experiment stratified participants into five medication groups,

focusing on anti-cholesterolemia, anti-hypertension, anti-thrombotic, and anti-diabetic (prolonged duration and short and mixed

duration) medications.

The study demonstrated that the use of these common concomitant medications in diabetes had no effect on

the performance of GlucoTrack®.

2018, the Company presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD

2018) in Vienna, Austria.

The Company presented data on the performance of a non-invasive glucose monitoring device (GlucoTrack®)

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9.0%, Freestyle Navigator:

July 3, 2018 we signed a new exclusive distribution agreement for GlucoTrack®

with CuraTec Nordic for the Scandinavian countries

(Denmark, Sweden, Norway, and Finland).

We anticipate that they will be a strong partner due to their previous experience in diabetes,

strong sales presence in all four countries, and established relationships with key opinion leaders.

Launch preparations are underway

to enter the markets in 2020.

Company had begun the implementation of a proof

of concept pilot program for GlucoTrack 1.0 in the Netherlands, a country chosen based on the relatively smaller

size of the marketplace to allow us to be able to rapidly assess our performance and make adjustments as necessary.

We have been working closely with our exclusive distributor in the Netherlands, Medireva B.V., and have accomplished

product and disease area training across the organization and segmentation of the local target audiences including key

opinion leaders, treating physicians, and diabetes nurses.

The most important aspect of our pilot program in the Netherlands

are the discussions held with many health insurance companies.

Approval of full or partial reimbursement by the health insurance

companies will be a key factor in enabling us to achieve significant sales volume.

The Company has made progress with several

of these companies on initial programs with GlucoTrack 1.0 as an important step towards reimbursement approval.

development, recruiting and organizational health have been a critical focus of the Company over the last 12 months.

of high-quality individuals have joined the Company, each of whom bring extensive experience in their respective fields.

bolstered our Senior Management with the recruitment of Erez Ben-Zvi, a highly experienced MedTech development professional who

joined us last year as Vice President of Product, and recently took on the additional role of General Manager, and Shalom Shushan,

a seasoned executive who joined us as Chief Technology Officer.

Goode PhD, who has a decorated career developing innovative

medical technologies, including at DexCom and MiniMed, joined our board of directors.

Several highly talented and accomplished

executives joined the Company as senior advisors to the Board.

These include Yair Briman, the former CEO of Philips Healthcare

Informatics, Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert currently at Samsung Health

and formerly of Dexcom, and Dr.

Alexander Raykhman PhD, a measurement and artificial intelligence expert.

We intend to continue

to invest in our talent and to expand and strengthen all areas within the company.

the Company performed a top-down analysis of the GlucoTrack 1.0 model to identify areas of potential enhancement, as it relates

to the platform, integrations, sensor technologies, accuracy as well as costs to manufacture.

The result of this comprehensive

review is an accelerated development plan for GlucoTrack 2.0.

GlucoTrack 2.0 will be a completely wireless and rechargeable earclip

to be paired with a smartphone, with more capabilities and features, increased accuracy, significantly greater margins for the

Company and lower cost to the end-user as compared to GlucoTrack 1.0.

previously reported, the Company has made significant progress towards receiving insurance reimbursement in the Netherlands.

the new accelerated development plan for GlucoTrack 2.0, with all of the expected advantages over GlucoTrack 1.0, it made clear

to the Company that introducing GlucoTrack 2.0 rather than the GlucoTrack 1.0 would serve the diabetes market and the Company

more effectively.

We are currently working with our European partners on the roadmap for distribution of GlucoTrack 2.0 when completed

and ready to market.

addition to the European markets, the Company is now focused on the U.S.

market as well, including building out its U.S.

strategy and planning the required FDA clinical trials and field testing to support its entrance into the market.

is currently in the process of identifying clinical sites in the U.S., interviewing Contract Research Organizations (CRO’s),

and forming its Scientific and Medical Advisory Boards.

We intend to build out a team to support the U.S.

activities, while continuing

our technology development in our R&D facility located in Israel.

February 14, 2020, the Company entered into a Securities Purchase Agreement and Registration Rights Agreement (collectively, the

“Agreements”) with an accredited investor, pursuant to which the accredited investor purchased 37,500,000 shares of

the Company’s common stock, par value $0.001 per share, for an aggregate gross purchase price of $15,000,000, less expenses

of approximately $1.6 million.

The Agreements contain industry standard representations and warranties and contain covenants that

the Company must file a resale registration statement within 90 days of closing which must be effective within 120 days from the

date of filing.

March 24, 2020, Integrity Applications, Inc., a Delaware corporation (the “Corporation”), held an annual meeting of

shareholders (the “Meeting”).

the Meeting, the Company’s stockholders approved the following proposals:

review and tabulation, the ballots and proxies case for and against granting authority to the Board of Directors to effect a reverse

Votes Against

review and tabulation, the ballots and proxies cast for and against the increase in authorized shares:

Votes Against

review and tabulation, the ballots and proxies cast for and against the reelection of each of the following current directors

of the Company, who were candidates for reelection:

Votes Against

Robert Fischell

Andrew Sycoff

review and tabulation, the ballots and proxies case for and against the ratification of the appointment of Fahn Kanne as the Corporation’s

independent registered public accountants for fiscal 2019:

Votes Against

review and tabulation, the ballots and proxies case for and against amendment of the Corporation’s 2010 Equity Incentive

Votes Against

review and tabulation, the ballots and proxies cast for and against the amendment of the Corporation’s certificate of incorporation

to change its name:

Votes Against

the Company’s common stock, par value $0.001 per share, for an aggregate gross purchase price of $15 million, less

cash expenses of approximately $2 million.

June, 2020, Erez Ben-Zvi has joined the Company as its Vice President of Product and as a member of the Company’s

executive leadership team.

On February 8, 2021 the Company promoted Mr.

Ben-Zvi to General Manager in addition to his role as

Vice President of Product

February 2, 2021 David Malka resigned from his role as

President, effective April 6, 2021.

do not own commercial manufacturing facilities and do not intend to build commercial manufacturing facilities of our own in the

foreseeable future.

We currently utilize a third-party manufacturer in Israel to manufacture the GlucoTrack®

intend to utilize the services of both the Israeli third-party manufacturer as well as others that we have identified to produce

the GlucoTrack®

have not yet generated any material revenues from our operations and, as of December 31, 2020, have incurred an accumulated deficit

of $90,843,518, stockholders’

deficit of $1,708,358 and negative operating cash flows.

We currently have no material sources

of recurring revenue and therefore are dependent upon external sources for financing our operations.

However, on February 14,

2020, we closed on a private placement of our common stock with gross proceeds of $15,000,000, so the Company has operating capital

to last at least one year from the date of this Annual Report without generating any revenue.

of $93,399 thousand and negative operating cash flows.

We currently have no material sources of recurring revenue and therefore

are dependent upon external sources for financing our operations.

However, on February 14, 2020, we closed on a private placement

of our common stock with gross proceeds of $15,000,000, so the Company has operating capital to last at least one year from the

date of this Annual Report without generating any revenue.

is a chronic, life-threatening disease for which there is no known cure.

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and nutrition management, exercise, oral medications or insulin injections to regulate blood glucose levels.

According to the Diabetes

Atlas (Ninth Edition) published by the International Diabetes Federation in 2019, approximately 463 million adults worldwide,

between the ages of 20 and 79, or over 9% of the world’s adult population, were estimated to suffer from diabetes in 2019

(not including those persons who suffer from impaired glucose tolerance or gestational diabetes, diabetic conditions first arising

during pregnancy).

The International Diabetes Federation estimates that this number will grow to approximately 700 million adults

worldwide by 2045.

to the Diabetes Atlas (Ninth Edition) published by the International Diabetes Federation in 2019, approximately 463 million adults

worldwide, between the ages of 20 and 79, or over 9% of the world’s adult population, were estimated to suffer from diabetes

in 2019 (not including those persons who suffer from impaired glucose tolerance or gestational diabetes, diabetic conditions first

arising during pregnancy).

The International Diabetes Federation estimates that this number will grow to approximately 700 million

adults worldwide by 2045.

glucose levels can be affected by many factors, including the carbohydrate and fat content of meals, exercise, stress, illness

55 unchanged sentences

in place for up to fourteen days and then must be replaced.

A transmitter sends information about glucose levels via radio

waves from the sensor to a pager-like wireless monitor.

According to the National Institute of Diabetes and Digestive and Kidney

Diseases at the National Institutes of Health, CGMS device users must check blood samples with a conventional glucose meter to

calibrate the CGMS devices, and because currently approved CGMS devices are not as accurate as standard blood glucose meters,

users should confirm glucose levels with a conventional glucose meter when making treatment decisions.

our knowledge, with the exception of one other device, the GlucoTrack®

model DF-F is still the only approved device

for use in the EU for spot non-invasive blood glucose measurement.

The FDA has previously approved a single non-invasive product

for glucose trend analysis, the GlucoWatch®, so long as the device was used with conventional finger stick glucose monitoring

A transmitter sends information about glucose levels via radio waves

from the sensor to a pager-like wireless monitor.

According to the National Institute of Diabetes and Digestive and Kidney Diseases

at the National Institutes of Health, CGMS device users must check blood samples with a conventional glucose meter to calibrate

the CGMS devices, and because currently approved CGMS devices are not as accurate as standard blood glucose meters, users should

confirm glucose levels with a conventional glucose meter when making treatment decisions.

our knowledge, with the exception of one other device, the GlucoTrack 1.0 is still the only approved device for use in

the EU for spot non-invasive blood glucose measurement.

The FDA has previously approved a single non-invasive product for glucose

trend analysis, the GlucoWatch®, so long as the device was used with conventional finger stick glucose monitoring devices.

However, the device is no longer available commercially.

We are not aware of any other devices that have been approved

for use in either the United Stated or the EU for spot or continuous non-invasive blood glucose measurement.

We are not aware of any other devices that have been approved for use

in either the United Stated or the EU for spot or continuous non-invasive blood glucose measurement.

believe that a significant market opportunity exists for a reliable, inexpensive, non-invasive blood glucose measurement device

1 unchanged sentence

better manage their disease, providing significant benefits to both patients and payors.

non-invasive blood glucose monitor, the GlucoTrack®

model DF-F, utilizes a patented combination of ultrasound, electromagnetic

and thermal technologies to obtain blood glucose measurements in less than one minute via a small sensor that is clipped onto

one’s earlobe and connected to a handheld control and display unit.

See Figure A, below.

believe that the GlucoTrack®

model DF-F addresses the unmet need for more frequent monitoring of blood glucose among people

with diabetes by overcoming two of the most significant challenges facing the market:

as the GlucoTrack®

model DF-F is a truly non-invasive device;

as, despite the relatively high upfront cost of purchasing a GlucoTrack®

model DF-F, we anticipate that the total cost

of purchasing a device and purchasing replacement ear clips every six months (anticipated to be the only recurring cost) over the useful life of the device will be significantly lower than

the cost of purchasing single use glucose sticks over that same period.

first generation non-invasive blood glucose monitor, the GlucoTrack 1.0, utilizes a patented combination of ultrasound,

electromagnetic and thermal technologies to obtain blood glucose measurements in less than one minute via a small sensor that

is clipped onto one’s earlobe and connected to a handheld control and display unit.

GlucoTrack 2.0, currently under development,

utilizes substantially identical underlying sensor technology, and is expected to be a completely wireless sensor to be clipped

on the earlobe.

GlucoTrack eliminates the handheld unit and will transmit results directly to a user’s smartphone.

believe that GlucoTrack addresses the unmet need for more frequent monitoring of blood glucose among people with diabetes by overcoming

two of the most significant challenges facing the market:

as GlucoTrack is a truly non-invasive device;

as we anticipate that the total cost of purchasing a device

and purchasing replacement ear clips every six months (anticipated to be the only recurring cost) over the useful life of

the device will be significantly lower than the cost of purchasing single use glucose sticks over that same period.

believe that the overall costs associated with owning and using a GlucoTrack®

model DF-F device are expected to be substantially

lower than the cost of purchasing and using single use invasive devices over an extended period of time.

device are expected to be substantially lower

than the cost of purchasing and using single use invasive devices over an extended period of time.

We intend to seek reimbursement

approval for the GlucoTrack®

model DF-F from third-party payors, including government payors (such as the Medicare and Medicaid

programs in the United States, in the event the GlucoTrack®

model DF-F is approved for commercial sale in the United States),

managed care organizations and other third-party payors.

There can be no assurance that such third party-payors will provide reimbursement

coverage for the GlucoTrack®

model DF-F or, if so, whether such reimbursement coverage will be adequate.

See “Risk Factors

- If the GlucoTrack®

model DF-F or our future product candidates, if any, fail to achieve market acceptance or reimbursement

coverage from managed care organizations or third-party payors, we may not be able to generate significant revenue or achieve

or sustain profitability”.

of directly measuring the glucose level of a user’s blood, as conventional spot finger stick devices do, the GlucoTrack®

model DF-F uses a small, non-invasive sensor that is clipped onto a user’s earlobe to obtain certain body measurements using

three technologies, which are then analyzed using a proprietary algorithm on a small, handheld control and display unit.

one minute, the GlucoTrack®

model DF-F will produce a blood glucose measurement that can be simultaneously audibly announced

and displayed on the control unit, as well as recorded on internal flash memory.

The two units of the device (main unit and personal

ear-clip) are connected through a multi-wire flexible cable.

approval for GlucoTrack®

from third-party payors, including government payors (such as the Medicare and Medicaid programs

in the United States, in the event GlucoTrack®

is approved for commercial sale in the United States), managed care organizations

and other third-party payors.

There can be no assurance that such third party-payors will provide reimbursement coverage for GlucoTrack®

or, if so, whether such reimbursement coverage will be adequate.

See “Risk Factors - If GlucoTrack®

or our future product

candidates, if any, fail to achieve market acceptance or reimbursement coverage from managed care organizations or third-party

payors, we may not be able to generate significant revenue or achieve or sustain profitability”.

of directly measuring the glucose level of a user’s blood, as conventional spot finger stick devices do, GlucoTrack®

uses a small, non-invasive sensor that is clipped onto a user’s earlobe to obtain certain body measurements using three

technologies.

Within one minute, GlucoTrack®

will produce a blood glucose measurement.

the GlucoTrack®

model DF-F non-invasive measurement does not directly measure glucose levels in the blood, but rather measures

non-invasive measurement does not directly measure glucose levels in the blood, but rather measures

a series of physiological characteristics that correlate with glucose levels, each patient must be calibrated by using a reference

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Calibration consists of comparing an individual patient’s physiological

measurements obtained using the GlucoTrack®

model DF-F to measurements obtained from an invasive device under different circumstances

over a defined 30-minute period (three measurements that require approximately 10 minutes each).

three different technologies used by GlucoTrack®

model DF-F, ultrasound, electromagnetic and thermal, simultaneously measure

three independent criteria.

These three measurements (criteria) are combined together by a unique (online) algorithm to produce

an acceptable measurement of a user’s blood glucose level.

measurements obtained using GlucoTrack®

to measurements obtained from an invasive device under different circumstances over

a defined 30-minute period (three measurements that require approximately 10 minutes each).

three different technologies used by GlucoTrack®, ultrasound, electromagnetic and thermal, simultaneously measure three independent

These three measurements (criteria) are combined together by a unique (online) algorithm to produce an acceptable measurement

of a user’s blood glucose level.

technologies operate as follows:

The GlucoTrack®

model DF-F uses ultrasound technology to measure the change of speed of sound through the earlobe, which

is impacted by the glucose concentration in the capillary blood vessels.

GlucoTrack®

uses ultrasound technology to measure the change of speed of sound through the earlobe, which is impacted

by the glucose concentration in the capillary blood vessels.

Electromagnetic :

The GlucoTrack®

model DF-F’s electromagnetic technology uses a measurement of conductivity to measure the change

in tissue impedance, which is a function of glucose concentration.

The GlucoTrack®

model DF-F’s electromagnetic

technology analyzes criteria similar to those analyzed by conventional invasive devices, such as spot finger stick devices,

but does so in a non-invasive manner.

The GlucoTrack®

model DF-F’s thermal technology uses a measurement of heat capacity characteristics of the tissue,

which are influenced by glucose concentration.

GlucoTrack’s electromagnetic technology uses a measurement of conductivity to measure the change in tissue impedance,

which is a function of glucose concentration.

GlucoTrack’s electromagnetic technology analyzes criteria similar

to those analyzed by conventional invasive devices, such as spot finger stick devices, but does so in a non-invasive manner.

GlucoTrack’s thermal technology uses a measurement of heat capacity characteristics of the tissue, which are

influenced by glucose concentration.

devices generally require frequent recalibration.

The main reasons for calibration are

that tissue parameters generally fluctuate in the area of the measurement and are sensitive to the location of the sensor and

the impact of potential disturbances.

Disturbances are less frequent in the earlobes, where the GlucoTrack®

model DF-F takes

its measurements.

Utilizing three channels simultaneously reduces the noise contribution in the measurement.

In addition, the

personal ear-clip contains sensors to help users attach the device to the proper part of the ear lobe.

The Notified Body for our

CE Mark approval has determined that the initial calibration of the GlucoTrack®

model DF-F device is valid for a period of

six months which we believe is a significant competitive advantage, while to our knowledge, competing products require recalibration

significantly much more frequently.

Therefore, we expect the GlucoTrack®

model DF-F will require only an initial calibration

upon use of a new personal ear-clip (to be replaced every six months) and will not require further recalibration.

The main reasons for calibration are that tissue parameters generally fluctuate

in the area of the measurement and are sensitive to the location of the sensor and the impact of potential disturbances.

are less frequent in the earlobes, where GlucoTrack®

takes its measurements.

Utilizing three channels simultaneously reduces

the noise contribution in the measurement.

In addition, the personal ear-clip contains sensors to help users attach the device

to the proper part of the ear lobe.

The Notified Body for our CE Mark approval has determined that the initial calibration of

the GlucoTrack 1.0 device is valid for a period of six months which we believe is a significant competitive advantage,

while to our knowledge, competing products require recalibration significantly much more frequently.

Therefore, we expect GlucoTrack®

will require only an initial calibration upon use of a new personal ear-clip (to be replaced every six months) and will not require

further recalibration.

GlucoTrack®

model DF-F does not use any optical method (either Infra-Red (IR) or Near Infra-Red (NIR) technology), which we

understand are being used by other developers of non-invasive blood glucose measurement devices.

We believe that optical technologies

are less reliable than the GlucoTrack®

model DF-F’s combination of ultrasound, electromagnetic and thermal technologies

due to inherent physiological limitations with optical technology.

More specifically, optical technology is based on dispersion

of a beam that is analyzed by spectrometric methods.

As such devices are non-invasive, the beam passes through other components

in the fingertip, such as skin, bone, muscle and fat tissue, which interfere with the measurements.

Generally, most of these interferences

have been overcome, but not the epidermis, primarily due to roughness, pigmentation and perspiration, which act like lenses in

optical wavelengths.

conventional spot finger stick devices, which require single-use glucose test strips, the GlucoTrack®

model DF-F requires

no short- term disposables.

We believe that the personal ear-clip that accompanies each GlucoTrack®

model DF-F will need to

be replaced only once every six months, although regulatory authorities may require that replacement occur more frequently.

there is no additional cost or pain involved with each blood glucose measurement using the GlucoTrack®

model DF-F, we believe

that users of our device would be encouraged to take multiple blood glucose measurements per day, significantly increasing compliance

with blood glucose measurement recommendations and helping diabetics better manage their disease.

More frequent testing of blood

glucose levels may provide a patient with information that can be used to determine optimal timing and dosage for corrective treatments

such as insulin, and can also direct a patient to seek a clinical analysis or detailed testing and diagnosis.

does not use any optical method (either Infra-Red (IR) or Near Infra-Red (NIR) technology), which we understand are being used

by other developers of non-invasive blood glucose measurement devices.

We believe that optical technologies are less reliable

than the GlucoTrack’s combination of ultrasound, electromagnetic and thermal technologies due to inherent physiological

limitations with optical technology.

More specifically, optical technology is based on dispersion of a beam that is analyzed by

spectrometric methods.

As such devices are non-invasive, the beam passes through other components in the fingertip, such as skin,

bone, muscle and fat tissue, which interfere with the measurements.

Generally, most of these interferences have been overcome,

but not the epidermis, primarily due to roughness, pigmentation and perspiration, which act like lenses in optical wavelengths.

conventional spot finger stick devices, which require single-use glucose test strips, GlucoTrack®

requires no short- term

We believe that the GlucoTrack’s personal ear-clip will need to be replaced only once every six months,

although regulatory authorities may require that replacement occur more frequently.

Since there is no additional cost or pain

involved with each blood glucose measurement using GlucoTrack®, we believe that users of our device would be encouraged to

take multiple blood glucose measurements per day, significantly increasing compliance with blood glucose measurement recommendations

and helping diabetics better manage their disease.

More frequent testing of blood glucose levels may provide a patient with information

that can be used to determine optimal timing and dosage for corrective treatments such as insulin, and can also direct a patient

to seek a clinical analysis or detailed testing and diagnosis.

GlucoTrack 1.0 has received CE Mark approval, which allows us to market and sell 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

While the MDD is applicable throughout the EU, it requires only a minimum level of harmonization among member countries.

Accordingly, 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.

Moreover, the MDD notwithstanding, because the regulatory regimes of the EU member countries are significantly diverse, it is

difficult to predict future regulatory developments and risks.

GlucoTrack®

model DF-F has received CE Mark approval, which allows us to market and sell the GlucoTrack®

model DF-F glucose

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

regard to demonstration of performance and safety.

While the MDD is applicable throughout the EU, it requires only a minimum level

of harmonization among member countries.

Accordingly, 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.

Moreover, the MDD notwithstanding, because the regulatory regimes of the EU member

countries are significantly diverse, it is difficult to predict future regulatory developments and risks.

The GlucoTrack®

model DF-F has not yet been cleared or approved for commercial sale in the United States.

Government Regulatory

- Regulation of the Design, Manufacture and Distribution of Medical Devices ”

below for a discussion of the approval

process for commercial sale in the United States.

There can be no assurance that approval for commercial sale in any additional

jurisdiction will be obtained on a timely basis or at all.

1.0 has not yet been cleared or approved

for commercial sale in the United States.

Government Regulatory - Regulation of the Design, Manufacture and Distribution

of Medical Devices ”

below for a discussion of the approval process for commercial sale in the United States.

be no assurance that approval for commercial sale in any additional jurisdiction will be obtained on a timely basis or at all.

January 21, 2020, we announced receipt of a CE Mark for a significant improvement to our product, an enhancement which allows

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foreseeable future.

We currently utilize a third-party manufacturer in Israel to manufacture the GlucoTrack®

suppliers and their manufacturing facilities must comply with applicable regulations in the jurisdictions in which the GlucoTrack®

model DF-F is being marketed (including ISO 13485 in the EU), current quality system regulations, which include current good manufacturing

practices, and to the extent laboratory analysis is involved, current good laboratory practices.

There can be no assurance that

we will be able to enter into agreements with qualified manufacturers on terms acceptable to us, or at all, or that, once contracted,

such manufacturers will perform as expected.

the manufacturing of the GlucoTrack®

model DF-F may be impacted by the Recast Directive on the Restriction of Hazardous Substances

in Electrical and Electronic Equipment, 2011/65/EU (“RoHS 2”).

RoHS 2 is a new EU directive that came into force on

July 22, 2014.

Like the MDD, RoHS 2, a recast of Directive 2002/95/EC that will cover electrical and electronic medical devices,

is relevant in order to obtain CE Marking for certain products.

Our suppliers and their manufacturing facilities must comply with applicable regulations in the jurisdictions

in which GlucoTrack®

is to be marketed (including ISO 13485 in the EU), current quality system regulations, which include

current good manufacturing practices, and to the extent laboratory analysis is involved, current good laboratory practices.

can be no assurance that we will be able to enter into agreements with qualified manufacturers on terms acceptable to us, or at

all, or that, once contracted, such manufacturers will perform as expected.

the manufacturing of GlucoTrack®

may be impacted by the Recast Directive on the Restriction of Hazardous Substances in Electrical

and Electronic Equipment, 2011/65/EU (“RoHS 2”).

RoHS 2 is a new EU directive that came into force on July 22, 2014.

Like the MDD, RoHS 2, a recast of Directive 2002/95/EC that will cover electrical and electronic medical devices, is relevant

in order to obtain CE Marking for certain products.

RoHS 2 compliance requires medical device manufacturers to:

up required technical documentation;

conduct an internal control procedure in accordance with Module A of Annex II to Decision

draw up required

technical documentation;

conduct an internal control procedure in accordance with Module A of Annex II to Decision No.

prepare a Declaration of Conformity;

and affix CE Marking to a finished product.

Although these requirements

are similar to those of the MDD, RoHS 2 does not require a Notified Body assessment of compliance.

However, if they are not compliant

with RoHS 2, medical device manufacturers face the risk of being barred from selling medical devices in the EU after July 22,

Although these requirements are similar to those

of the MDD, RoHS 2 does not require a Notified Body assessment of compliance.

However, if they are not compliant with RoHS 2,

medical device manufacturers face the risk of being barred from selling medical devices in the EU after July 22, 2014.

have a limited number of dedicated sales and marketing personnel, as we intend to collaborate with third parties with established

sales and marketing operations in the medical device industry (such as the distributors described below) to market and sell the

GlucoTrack®

model DF-F to point of sale end users and/or local distributors.

sales and marketing operations in the medical device industry (such as the distributors described below) to market and sell GlucoTrack®

to point of sale end users and/or local distributors.

However, there can be no assurance that we will be able to enter

into additional distribution agreements on terms acceptable to us or at all or that, once contracted, our distributors will perform

GlucoTrack®

model DF-F has been cleared and approved for commercial sale in the following jurisdictions:

EU (subject to registration

by the local distributors with the respective countries), Israel, Turkey, South Korea, Hong Kong, New Zealand and numerous

Arab countries.

We cannot provide any assurance that we will receive the required local regulatory approvals in any of the

countries in which such approvals are required, and therefore we may never be permitted to commence commercial sales of our products

in such territories.

1.0 has been cleared and approved for commercial sale in the following jurisdictions:

EU (subject to registration by the

local distributors with the respective countries), Israel, Turkey, South Korea, Hong Kong, New Zealand and numerous Arab countries.

We cannot provide any assurance that we will receive the required local regulatory approvals in any of the countries in which

such approvals are required, and therefore we may never be permitted to commence commercial sales of our products in such territories.

Further discussions with other potential distributors are in different stages.

However, there can be no assurance

that we will be able to enter into additional distribution agreements on terms acceptable to us or at all or that, once contracted,

our distributors will perform as expected.

distribution agreements entered into to date generally appoint the counterparty as the exclusive distributor of the GlucoTrack®

model DF- F in a stated territory.

Where local regulatory approval of the device is required, such appointment is generally conditioned

upon receipt of such approval.

are currently in the process of developing our wireless 2.0 model and upon readiness, we intend to conduct clinical trials in

for eventual domestic commercialization.

& Development

focus significant time and resources on research and development in connection with our efforts to continue to develop, improve

and commercialize the GlucoTrack®

model DF-F, as well as in connection with our development of other GlucoTrack®

Our continuing research and development activities are primarily focused on software and algorithm improvements intended to improve

the accuracy of the device, clinical trials to test the performance of the GlucoTrack®

device when used by children and teenagers

between the ages of six and 18, preparation for future FDA trials, testing new characteristics of the device, development of a

new device in the GlucoTrack®

and commercialize GlucoTrack®, as well as in connection with our development of other GlucoTrack®

Our continuing

research and development activities are primarily focused on software and algorithm improvements intended to improve the accuracy

of the device, clinical trials to test the performance of the GlucoTrack®

device when used by children and teenagers between

the ages of six and 18, preparation for future FDA trials, testing new characteristics of the device, development of a new device

in the GlucoTrack®

family and seeking to streamline and continue to simplify the calibration process.

See “Item

See “Item 7 –

Management’s Discussion and Analysis of Financial Condition and Results of Operation –

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We are focusing our research and development activities around 2

main strategic pillars:

have developed a wireless module (“GlucoTrack Link”) with embedded Bluetooth Low-Energy (BLE), which enables the transmission

of measurement data captured by the GlucoTrack®

model DF-F to a cloud-based server or a smart device.

This module and the

related applications facilitate the viewing of glucose related data and correlate it closely with lifestyle choices made by the

users, be that dietary choices or activity-based choices, among other things.

The wireless module will facilitate sharing, viewing

and analysis of GlucoTrack®

measurements and glucose profiles by clinicians and other caregivers.

main strategic areas:

GlucoTrack®

objective of this project is to transform the existing device into a simple, easy to use wireless ear-clip which would measure

glucose and communicate the results seamlessly to any other platform through a wireless connection or a Bluetooth connection to

a smart device such as a smartphone, tablet or computer, eliminating the current handheld display.

The result would be a user-friendly,

inconspicuous measuring device for the management of diabetes and pre-diabetes.

We expect this new device to have much greater

patient desire to purchase and user acceptance.

We also expect this new device will have a significantly lower cost to manufacture

than our current device.

Health Applications

are currently developing smart device applications (“Apps”) to facilitate the interaction of users with Glucotrack®

DF-F and the glucose data collected.

and the glucose data collected.

The Apps will be compatible with both IOS and Android operating systems.

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improved management of the condition and better disease outcomes.

Self-Personalization

original version of Glucotrack®

DF-F required each patient to be calibrated in a face-to-face session with a

certified trained calibrator.

The calibration requires patients to participate in a one-hour session when first using their new

device and again every six months when the personal ear clip is replaced.

We have developed a self-calibration module for Glucotrack®

DF-F which will allow patients to set up the device on their own without the need for a trained calibrator, for which we received

CE Mark approval in January 2020.

This enhancement allows patients to set up Glucotrack®

DF-F themselves easier and faster

without support from a calibrator.

For our distributors, this will lower patient initiation and support costs allowing them to

re-deploy these funds into their marketing and sales efforts.

It will also provide them with a substantial opportunity to open

up additional distribution channels including pharmacies, clinics and online.

Generation GlucoTrack

objective of this project is to transform the existing device into a simple, easy to use wireless ear-clip which would measure

glucose and communicate the results seamlessly to any other platform through a wireless connection or a Bluetooth connection to

a smart device such as a smartphone, tablet or computer, eliminating the current handheld display.

The result would be a user-friendly,

inconspicuous measuring device for the management of diabetes and pre-diabetes.

We expect this new device to have much greater

patient desire to purchase and user acceptance.

We also expect this new device will have a significantly lower cost to manufacture

than our current device.

Considerations

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and other measures.

Future significant changes in the healthcare systems in any jurisdiction in which the GlucoTrack®

model DF-F or our future products, if any, may be cleared for sale could also have a negative impact on the demand for the GlucoTrack®

model DF-F or our future products, if any.

Future significant changes in the healthcare systems in any jurisdiction in which GlucoTrack®

or our future products, if any, may be cleared for sale could also have a negative impact on the demand for the GlucoTrack®

or our future products, if any.

These include changes that may reduce reimbursement or payment rates for such products.

17 unchanged sentences

program and their internal laws regulating all healthcare activities.

If and when we receive FDA approval to market the GlucoTrack®

DF-F in the United States, we will be subject to regulation by some or all of the foregoing agencies.

If and when we receive FDA approval to market GlucoTrack®

in the United States, we will be subject to regulation by some or all of the foregoing agencies.

applicable regulatory schemes in the EU are significantly more diverse than those in the United States and do not lend themselves

11 unchanged sentences

controls in others.

As a result, the processes and time periods required to obtain foreign marketing approval may be longer or

shorter than those necessary to obtain FDA approval (as described below).

These differences may affect the efficiency and timeliness

of international market introduction of GlucoTrack®

For countries in the EU, medical devices must display a CE

Mark before they may be imported or sold and must comply with the requirements of the MDD or the Active Implantable Medical Device

On June 4, 2013, we received our CE Mark approval for the GlucoTrack®

model DF-F non-invasive glucose monitoring

device from the Notified Body.

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

model DF-F glucose monitoring

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

demonstration of performance and safety.

However, although the MDD is applicable throughout the EU, in practice it does not ensure

uniform regulation throughout the EU.

Rather, the MDD requires only a minimum level of harmonization in the EU.

Accordingly, 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 in addition to the MDD’s requirements from time to time, on a case-by-case basis.

The CE Mark also permits

the sale in countries that have an MDD Mutual Recognition Agreement with the EU.

On August 31, 2015, we received approval from

the Notified Body for improvements to the GlucoTrack®

model DF-F which simplify and shorten (from approximately 2.5 hours

to approximately half an hour) the initial calibration process for the device.

These improvements are intended to reduce the backlog

created as purchasers of the device await calibration.

In addition, we received approval from the Notified Body on the updated

intended use for the device, which expands the intended user population to include not only Type 2 diabetics, but persons suffering

from pre-diabetes conditions as well, which we believe represents a material expansion of the potential market for the device.

In December 2015, we received approval from the Notified Body for further improvements to the GlucoTrack®

model DF-F that

increase the accuracy and efficacy of the device.

On February 19, 2016, we received an extension of our ISO 13485:2003 certificate

and Annex II certification from the EU.

The ISO 13485:2003 certification signifies that we have met the standards required for

company-wide implementation of device quality management system(s).

The scope of the certification is design, development, manufacture

and service of non-invasive glucose monitoring systems for home use.

Annex II also addresses quality control systems.

The certification

allows us to self-certify certain modifications and changes and simplifies some of the reporting to and review by the relevant

Notified Body.

As a result, the processes and time periods required to obtain foreign marketing approval may be longer or shorter

than those necessary to obtain FDA approval (as described below).

These differences may affect the efficiency and timeliness of international

market introduction of GlucoTrack®.

For countries in the EU, medical devices must display a CE Mark before they may be imported or

sold and must comply with the requirements of the MDD or the Active Implantable Medical Device Directive.

On June 4, 2013, we received

our CE Mark approval for the first generation GlucoTrack®

non-invasive glucose monitoring device from the Notified Body.

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

1.0 model glucose monitoring device in EU member countries that

have adopted the MDD without being subject to additional national regulations with regard to demonstration of performance and safety.

However, although the MDD is applicable throughout the EU, in practice it does not ensure uniform regulation throughout the EU.

the MDD requires only a minimum level of harmonization in the EU.

Accordingly, 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 in addition to the MDD’s

requirements from time to time, on a case-by-case basis.

The CE Mark also permits the sale in countries that have an MDD Mutual Recognition

Agreement with the EU.

On August 31, 2015, we received approval from the Notified Body for improvements to the GlucoTrack®

model which simplify and shorten (from approximately 2.5 hours to approximately half an hour) the initial calibration process for

These improvements are intended to reduce the backlog created as purchasers of the device await calibration.

we received approval from the Notified Body on the updated intended use for the device, which expands the intended user population to

include not only Type 2 diabetics, but persons suffering from pre-diabetes conditions as well, which we believe represents a material

expansion of the potential market for the device.

In December 2015, we received approval from the Notified Body for further improvements

to the GlucoTrack®

model 1.0 that increase the accuracy and efficacy of the device.

On February 19, 2016, we received an extension

of our ISO 13485:2003 certificate and Annex II certification from the EU.

The ISO 13485:2003 certification signifies that we have met

the standards required for company-wide implementation of device quality management system(s).

The scope of the certification is design,

development, manufacture and service of non-invasive glucose monitoring systems for home use.

Annex II also addresses quality control

The certification allows us to self-certify certain modifications and changes and simplifies some of the reporting to and review

by the relevant Notified Body.

This can shorten CE-mark review process of future GlucoTrack®

model DF-F enhancements or revisions.

an Annex II certification, each new device enhancement or modified version would be subject to the full EU CE-mark review process.

enhancements or revisions.

Without an Annex II certification, each new device enhancement or modified version would be subject to the full EU CE-mark review process.

The ISO 13485:2003 and Annex II certifications enable us to potentially improve the time to market for product sales on new, enhanced

or modified GlucoTrack®

model DF-F devices.

On January 21, 2020, the Company announced that it has received CE Mark approval

for a major enhancement to GlucoTrack, allowing for a user to perform the calibration process by themselves, without the need

for a certified calibrator.

The initial CE Mark approval received for GlucoTrack required a calibration process that took three

hours to complete, required eight invasive finger stick reference measurements, needed to be repeated every thirty days and required

a certified calibrator to perform the calibration.

After a series of successful enhancements and approvals, the calibration process

now takes just thirty minutes, requires just three invasive reference measurements, and needs to be repeated only once every six

With self-calibration, a user can now perform this simplified process in the privacy and convenience of their own home.

As a result of these incremental, but important, enhancements to the performance of the device we believe that the product is

ready for commercial launch in specific market segments.

the United States, under Section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is an article which, among other

things, is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention

of disease in man or other animals.

On January 21, 2020, the Company announced that it has received CE Mark approval for

a major enhancement to GlucoTrack, allowing for a user to perform the calibration process by themselves, without the need for a certified

The initial CE Mark approval received for GlucoTrack required a calibration process that took three hours to complete, required

eight invasive finger stick reference measurements, needed to be repeated every thirty days and required a certified calibrator to perform

the calibration.

After a series of successful enhancements and approvals, the calibration process now takes just thirty minutes, requires

just three invasive reference measurements, and needs to be repeated only once every six months.

With self-calibration, a user can now

perform this simplified process in the privacy and convenience of their own home.

As a result of these incremental, but important, enhancements

to the performance of the device we believe that the product is ready for commercial launch in specific market segments.

the United States, under Section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is an article which, among other things,

is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in

man or other animals.

We believe that GlucoTrack®

devices will be classified as medical devices and subject

to regulation by numerous agencies and legislative bodies, including the FDA and its foreign counterparts.

Devices are subject

to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation be conducted before

a device receives approval for commercial distribution.

devices will be classified as medical devices and subject to regulation by numerous

agencies and legislative bodies, including the FDA and its foreign counterparts.

Devices are subject to varying levels of regulatory

control, the most comprehensive of which requires that a clinical evaluation be conducted before a device receives approval for commercial

distribution.

The FDA classifies medical devices into one of three classes.

devices are relatively simple and can be manufactured and distributed with general controls.

Class II devices are somewhat more

complex and require greater scrutiny.

Class III devices are new and frequently help sustain life.

Class I devices are relatively simple and can be manufactured

and distributed with general controls.

Class II devices are somewhat more complex and require greater scrutiny.

Class III devices are

new and frequently help sustain life.

the United States, a company generally can obtain permission to distribute a new device in two ways –

through a so-called

“510(k)”

through a so-called “510(k)”

premarket notification application or through a Section 515 premarket approval (“PMA”) application.

The 510(k) submission applies to any device that is substantially equivalent to a device first marketed prior to May 28, 1976

or to another device marketed after that date, but which was substantially equivalent to a pre-May 28, 1976 device.

These devices

are either Class I or Class II devices.

Under the 510(k) submission process, the FDA will issue an order finding substantial equivalence

to a predicate device (pre-May 28, 1976 or post-May 28, 1976 device that was substantially equivalent to a pre- May 28, 1976 device)

and permitting commercial distribution of that device for its intended use.

A 510(k) submission must provide information supporting

its claim of substantial equivalence to the predicate device.

The FDA permits certain low risk medical devices to be marketed

without requiring the manufacturer to submit a premarket notification.

In other instances, the FDA may require that a premarket

notification not only be submitted, but also be accompanied by clinical data.

If clinical data from human experiments are required

to support the 510(k) submissions, these data must be gathered in compliance with investigational device exemption regulations

for investigations performed in the United States.

The FDA review process for premarket notifications submitted pursuant to section

510(k) should take about 90 days, but it can take substantially longer if the FDA has concerns, and there is no guarantee that

the FDA will clear the device for marketing, in which case the device cannot be lawfully distributed in the United States.

the FDA finds that the device subject to the premarket notification is substantially equivalent to a proper predicate device,

then the FDA may “clear”

The 510(k) submission

applies to any device that is substantially equivalent to a device first marketed prior to May 28, 1976 or to another device marketed

after that date, but which was substantially equivalent to a pre-May 28, 1976 device.

These devices are either Class I or Class II devices.

Under the 510(k) submission process, the FDA will issue an order finding substantial equivalence to a predicate device (pre-May 28, 1976

or post-May 28, 1976 device that was substantially equivalent to a pre- May 28, 1976 device) and permitting commercial distribution of

that device for its intended use.

A 510(k) submission must provide information supporting its claim of substantial equivalence to the

predicate device.

The FDA permits certain low risk medical devices to be marketed without requiring the manufacturer to submit a premarket

notification.

In other instances, the FDA may require that a premarket notification not only be submitted, but also be accompanied by

clinical data.

If clinical data from human experiments are required to support the 510(k) submissions, these data must be gathered in

compliance with investigational device exemption regulations for investigations performed in the United States.

The FDA review process

for premarket notifications submitted pursuant to section 510(k) should take about 90 days, but it can take substantially longer if the

FDA has concerns, and there is no guarantee that the FDA will clear the device for marketing, in which case the device cannot be lawfully

distributed in the United States.

If the FDA finds that the device subject to the premarket notification is substantially equivalent

to a proper predicate device, then the FDA may “clear”

that device for marketing.

These devices are not “approved”

is no guarantee, however, that the FDA will deem the device subject to the 510(k) process, as opposed to the more time-consuming,

There is no guarantee, however, that the FDA will deem the device subject to the 510(k) process, as opposed to the more time-consuming,

resource intensive and problematic PMA application process described below.

more comprehensive PMA process applies to a new device that either is not substantially equivalent to a pre-May 28, 1976 product

or is to be used in supporting or sustaining life or preventing impairment.

These devices are normally Class III devices and can

only be marketed following approval of a PMA application.

For example, most implantable devices are subject to the PMA approval

Two steps of FDA approval generally are required before a company can market a product in the U.S.

that is subject to

Section 515 PMA approval, as compared to a Section 510(k) clearance.

First, a company must comply with investigational device

exemption regulations in connection with any human clinical investigation of the device;

however, those regulations permit a company

to undertake a clinical study of a “non-significant risk”

more comprehensive PMA process applies to a new device that either is not substantially equivalent to a pre-May 28, 1976 product or is

to be used in supporting or sustaining life or preventing impairment.

These devices are normally Class III devices and can only be marketed

following approval of a PMA application.

For example, most implantable devices are subject to the PMA approval process.

FDA approval generally are required before a company can market a product in the U.S.

that is subject to Section 515 PMA approval, as

compared to a Section 510(k) clearance.

First, a company must comply with investigational device exemption regulations in connection

with any human clinical investigation of the device;

however, those regulations permit a company to undertake a clinical study of a “non-significant

device without formal FDA approval.

Prior express FDA approval

is required if the device is a significant risk device.

If there is any doubt as to whether a device is a “non-significant

device, companies normally seek prior approval from the FDA.

Normally, clinical studies of new diagnostic products

are conducted in tandem with a cleared or approved device and treatment decisions are based on the results from the existing diagnostic

In such a setting, the FDA may consider the clinical trial as one not posing a significant risk.

However, FDA action is

always uncertain and dependent on the contours of the design of the clinical trial and the device and there is no assurance that

the FDA would consider any proposed clinical trial as one posing a non-significant risk.

Moreover, before undertaking any clinical

trial, the company sponsoring the trial and the investigator conducting the trial are required by federal law to seek and obtain

the approval of institutional review boards (“IRB”).

An IRB weighs the risks and benefits of a proposed trial to ensure

that the human subjects are not exposed to unnecessary risk and reviews the informed consent form to ensure that it meets federal

requirements and accurately describes the risks and benefits, if any, of the clinical trial.

IRB review occurs annually, and annual

re-approval is required.

Prior express FDA approval is required if the device is a significant risk device.

there is any doubt as to whether a device is a “non-significant risk”

device, companies normally seek prior approval from

Normally, clinical studies of new diagnostic products are conducted in tandem with a cleared or approved device and treatment

decisions are based on the results from the existing diagnostic device.

In such a setting, the FDA may consider the clinical trial as

one not posing a significant risk.

However, FDA action is always uncertain and dependent on the contours of the design of the clinical

trial and the device and there is no assurance that the FDA would consider any proposed clinical trial as one posing a non-significant

Moreover, before undertaking any clinical trial, the company sponsoring the trial and the investigator conducting the trial are

required by federal law to seek and obtain the approval of institutional review boards (“IRB”).

An IRB weighs the risks and

benefits of a proposed trial to ensure that the human subjects are not exposed to unnecessary risk and reviews the informed consent form

to ensure that it meets federal requirements and accurately describes the risks and benefits, if any, of the clinical trial.

occurs annually, and annual re-approval is required.

University medical centers as well as other entities maintain and operate IRB.

Second, the FDA must review

a company’s PMA, which contains, among other things, clinical information acquired under the investigational device exemption.

The FDA will approve the PMA if it finds there is reasonable assurance that the device is safe and effective for its intended

the FDA must review a company’s PMA, which contains, among other things, clinical information acquired under the investigational

device exemption.

The FDA will approve the PMA if it finds there is reasonable assurance that the device is safe and effective for its

intended use.

The premarket approval process takes substantially longer than the 510(k) process.

GlucoTrack®

model DF-F has not yet been approved for commercial sale in the United States.

1.0 has not yet been approved for commercial sale in the United States.

The GlucoTrack®

2.0 is still under

development and has not yet been approved for commercial sale in or outside the United States.

In discussions with the FDA regarding

the regulatory pathway, the FDA is not yet entirely sure whether a de novo pathway is acceptable and recommended that the Company

should plan to support this approach through risk analysis and an explanation of why the new measurement paradigm it is proposing

does not introduce greater risks.

the regulatory pathway, the FDA is not yet entirely sure whether a de novo pathway is acceptable and recommended that the Company should

plan to support this approach through risk analysis and an explanation of why the new measurement paradigm it is proposing does not introduce

greater risks.

FDA noted that no decision has been made that a PMA will be required.

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clinical trial protocol.

The pre-submission documentation was submitted to the FDA in order to obtain the FDA’s

guidance regarding the U.S.

The pre-submission documentation was submitted to the FDA in order to obtain the FDA’s guidance

regarding the U.S.

regulatory pathway for the GlucoTrack®

model DF-F, the proper approach to refining the trial protocol,

and preparing the pre-marketing application.

On October 19, 2015, we met with the FDA to discuss the pre-submission documents,

including the approach to and details of the clinical trial protocol for the GlucoTrack®

On May 10, 2016, we submitted

a pre-submission supplement (including clinical trial protocol) to the FDA which modifies the pre-submission documentation to

reflect the feedback received from the FDA at the meeting.

On July 18, 2016, we completed a teleconference with the FDA to further

discuss our pre-submission supplement.

At the end of this discussion, we received verbal confirmation from the FDA that clinical

trials of the GlucoTrack®

model DF-F constitute non-significant risk device studies, which allows the trials to proceed without

an Investigational Device Exemption (IDE) application.

Such trials are assessed by the FDA and not considered to present a potential

for serious risk to the health, safety or the welfare of subjects.

The initiation of clinical trials in the USA requires adequate

financing to fund the clinical program through completion.

With the closing of our recent financing, we have restarted out internal

planning for commencing such clinical trials.

1.0, the proper approach to refining the trial protocol, and preparing

the pre-marketing application.

On October 19, 2015, we met with the FDA to discuss the pre-submission documents, including the approach

to and details of the clinical trial protocol for the GlucoTrack®

On May 10, 2016, we submitted a pre-submission supplement

(including clinical trial protocol) to the FDA which modifies the pre-submission documentation to reflect the feedback received from

the FDA at the meeting.

On July 18, 2016, we completed a teleconference with the FDA to further discuss our pre-submission supplement.

At the end of this discussion, we received verbal confirmation from the FDA that clinical trials of the GlucoTrack®

1.0 constitute

non-significant risk device studies, which allows the trials to proceed without an Investigational Device Exemption (IDE) application.

Such trials are assessed by the FDA and not considered to present a potential for serious risk to the health, safety or the welfare of

The initiation of clinical trials in the USA requires adequate financing to fund the clinical program through completion.

the closing of our recent financing, we have restarted out internal planning for commencing such clinical trials.

when a clinical study has been approved or cleared by the FDA or a notified body or deemed approved, the study is subject to factors

beyond a manufacturer’s control, including, but not limited to the fact that the IRB at a given clinical site might not

approve the study, might decline to renew approval which is required annually, or might suspend or terminate the study before

the study has been completed.

Also, the interim results of a study may not be satisfactory, in which case the sponsor may terminate

or suspend the study on its own initiative or the FDA or a notified body may terminate or suspend the study.

There is no assurance

that a clinical study at any given site will progress as anticipated;

there may be an insufficient number of patients who qualify

for the study or who agree to participate in the study, or the investigator at the site may have priorities other than the study.

Also, there can be no assurance that the clinical study will provide sufficient evidence to assure the FDA or a notified body

that the product is safe and effective, a prerequisite for FDA approval of a PMA, or substantially equivalent in terms of safety

and effectiveness to a predicate device, a prerequisite for clearance under 510(k).

Even if the FDA or a notified body approves

or clears a device, it may limit its intended uses in such a way that manufacturing and distributing the device may not be commercially

clearance or approval to market is given, the FDA and foreign regulatory agencies, upon the occurrence of certain events, are

authorized under various circumstances to withdraw the clearance or approval or require changes to a device, its manufacturing

process or its labeling or additional proof that regulatory requirements have been met.

manufacturer of a device approved through the PMA process is not permitted to make changes to the device which affects its safety

or effectiveness without first submitting a supplement application to its PMA and obtaining FDA approval for that supplement.

In some instances, the FDA may require clinical trials to support a supplement application.

A manufacturer of a device cleared

through a 510(k) submission must submit another premarket notification if it intends to make a change or modification in the device

that could significantly affect the safety or effectiveness of the device, such as a significant change or modification in design,

material, chemical composition, energy source or manufacturing process.

Any change in the intended uses of a PMA device or a 510(k)

device requires an approval supplement or cleared premarket notification.

Exported devices are subject to the regulatory requirements

of each country to which the device is exported, as well as certain FDA export requirements.

Patient Protection and Affordable Care Act was signed into law on March 23, 2010, and on March 30, 2010, a reconciliation bill

that modifies certain provisions of the same was signed into law.

These two laws are jointly referred to as the “Affordable

Care Act”

or “ACA.”

beyond a manufacturer’s control, including, but not limited to the fact that the IRB at a given clinical site might not approve

the study, might decline to renew approval which is required annually, or might suspend or terminate the study before the study has been

Also, the interim results of a study may not be satisfactory, in which case the sponsor may terminate or suspend the study

on its own initiative or the FDA or a notified body may terminate or suspend the study.

There is no assurance that a clinical study at

any given site will progress as anticipated;

there may be an insufficient number of patients who qualify for the study or who agree to

participate in the study, or the investigator at the site may have priorities other than the study.

Also, there can be no assurance that

the clinical study will provide sufficient evidence to assure the FDA or a notified body that the product is safe and effective, a prerequisite

for FDA approval of a PMA, or substantially equivalent in terms of safety and effectiveness to a predicate device, a prerequisite for

clearance under 510(k).

Even if the FDA or a notified body approves or clears a device, it may limit its intended uses in such a way

that manufacturing and distributing the device may not be commercially feasible.

clearance or approval to market is given, the FDA and foreign regulatory agencies, upon the occurrence of certain events, are authorized

under various circumstances to withdraw the clearance or approval or require changes to a device, its manufacturing process or its labeling

or additional proof that regulatory requirements have been met.

manufacturer of a device approved through the PMA process is not permitted to make changes to the device which affects its safety or

effectiveness without first submitting a supplement application to its PMA and obtaining FDA approval for that supplement.

In some instances,

the FDA may require clinical trials to support a supplement application.

A manufacturer of a device cleared through a 510(k) submission

must submit another premarket notification if it intends to make a change or modification in the device that could significantly affect

the safety or effectiveness of the device, such as a significant change or modification in design, material, chemical composition, energy

source or manufacturing process.

Any change in the intended uses of a PMA device or a 510(k) device requires an approval supplement or

cleared premarket notification.

Exported devices are subject to the regulatory requirements of each country to which the device is exported,

as well as certain FDA export requirements.

Patient Protection and Affordable Care Act was signed into law on March 23, 2010, and on March 30, 2010, a reconciliation bill that modifies

certain provisions of the same was signed into law.

These two laws are jointly referred to as the “Affordable Care Act”

“ACA.”

principal aim of the ACA was to expand health insurance coverage to approximately 32 million Americans who were uninsured.

law’s most far-reaching changes did not take effect until 2014, including a requirement that most Americans carry health

The consequences of these significant coverage expansions on the sales of our products is still unknown and speculative

at this point, although the ACA and certain state initiatives may compel private insurers to reduce coverage or reimbursement

for various items and services, including medical devices of the type that we contemplate distributing.

The law’s

most far-reaching changes did not take effect until 2014, including a requirement that most Americans carry health insurance.

The consequences

of these significant coverage expansions on the sales of our products is still unknown and speculative at this point, although the ACA

and certain state initiatives may compel private insurers to reduce coverage or reimbursement for various items and services, including

medical devices of the type that we contemplate distributing.

legislation contains many provisions designed to generate the revenues necessary to fund the coverage expansions.

The most relevant

of these provisions are those that impose fees or taxes on certain health-related industries, including medical device manufacturers.

Beginning in 2013, each medical device manufacturer is required to pay an excise tax (or sales tax) in an amount equal to 2.3%

of the price for which such manufacturer sells its medical devices.

The tax applies to all medical devices, including our products

and product candidates.

The most relevant of

these provisions are those that impose fees or taxes on certain health-related industries, including medical device manufacturers.

in 2013, each medical device manufacturer is required to pay an excise tax (or sales tax) in an amount equal to 2.3% of the price for

which such manufacturer sells its medical devices.

The tax applies to all medical devices, including our products and product candidates.

The ACA also provides for increased enforcement of the fraud and abuse regulations previously mentioned.

January 2017, Congress voted in favor of a budget resolution that will produce legislation that would repeal certain aspects of

enacted into law.

Congress is also considering subsequent legislation to replace or repeal elements or all of the ACA .

In addition, there have been recent public announcements by members of Congress and the new presidential administration regarding

their plans to repeal and replace the ACA .

Further, President Trump signed an Executive

Order directing federal agencies with authorities and responsibilities under the ACA to

waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that

would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of

pharmaceuticals or medical devices.

At this time, it is not clear whether the ACA will

be repealed in whole or in part, and, if it is repealed, whether it will be replaced in whole or in part by another plan, and

what impact those changes will have on coverage and reimbursement for healthcare items and services covered by plans that were

authorized by the ACA .

We expect that additional state and federal healthcare reform

measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare

products and services, and also indirectly affect the amounts that private payers are willing to pay.

In addition, any healthcare

reforms enacted in the future may be phased in over a number of years but, if enacted, could impact our revenue, increase our

costs, or require us to revise the ways in which we conduct business or put us at risk for loss of business.

In addition, our

future results of operations, financial position and cash flows could be materially adversely affected by changes under the ACA

and changes under any federal or state legislation adopted in the future.

are ongoing discussions in the EU regarding amending the relevant regulatory framework.

It is difficult to predict what effect

any amendments to the existing EU legislation may have.

Furthermore, each individual EU member country has the authority to amend

its regulations and requirements additional to the minimum harmonization required by the MDD.

Because the EU member countries

have diverse legal systems, it is difficult to predict what, if any, amendments may be implemented in each of the EU member countries

and whether they may adversely affect us.

anticipate that sales volumes and prices of the GlucoTrack®

model DF-F and any other products we commercialize will depend

in large part on the availability of reimbursement from third-party payors.

Third-party payors include governmental programs such

as Medicare and Medicaid, private insurance plans and workers’

It is difficult to predict what effect any amendments

to the existing EU legislation may have.

Furthermore, each individual EU member country has the authority to amend its regulations and

requirements additional to the minimum harmonization required by the MDD.

Because the EU member countries have diverse legal systems,

it is difficult to predict what, if any, amendments may be implemented in each of the EU member countries and whether they may adversely

anticipate that sales volumes and prices of GlucoTrack®

and any other products we commercialize will depend in large

part on the availability of reimbursement from third-party payors.

Third-party payors include governmental programs such as Medicare

and Medicaid, private insurance plans and workers’

compensation plans.

These third-party payors may deny reimbursement

for a product or therapy if they determine that the product was not medically appropriate or necessary.

Also, third-party payors

are increasingly challenging the prices charged for medical products and services.

Some third-party payors must also approve coverage

for new or innovative devices before they will reimburse health care providers who use the products.

Even though a new product

may have been cleared for commercial distribution, it may find limited demand for the device until reimbursement approval has

been obtained from governmental and private third-party payors.

as a percentage of the projected patient population that could potentially benefit from the GlucoTrack®

model DF-F is elderly,

Medicare would likely be a potential source of reimbursement in the United States.

Medicare is a federal program that provides

certain hospital and medical insurance benefits to persons age 65 and over, certain disabled persons, persons with end-stage renal

disease and those suffering from Lou Gehrig’s disease.

In contrast, Medicaid is a medical assistance program jointly funded

by United States federal and state governments and administered by each state pursuant to which benefits are available to certain

indigent patients.

The Medicare and Medicaid statutory framework is subject to administrative rulings, interpretations and discretion

that affect the amount and timing of reimbursement made under Medicare and Medicaid.

These third-party payors may deny reimbursement for a product

or therapy if they determine that the product was not medically appropriate or necessary.

Also, third-party payors are increasingly challenging

the prices charged for medical products and services.

Some third-party payors must also approve coverage for new or innovative devices

before they will reimburse health care providers who use the products.

Even though a new product may have been cleared for commercial

distribution, it may find limited demand for the device until reimbursement approval has been obtained from governmental and private

third-party payors.

as a percentage of the projected patient population that could potentially benefit from GlucoTrack®

is elderly, Medicare

would likely be a potential source of reimbursement in the United States.

Medicare is a federal program that provides certain hospital

and medical insurance benefits to persons age 65 and over, certain disabled persons, persons with end-stage renal disease and those suffering

from Lou Gehrig’s disease.

In contrast, Medicaid is a medical assistance program jointly funded by United States federal and state

governments and administered by each state pursuant to which benefits are available to certain indigent patients.

The Medicare and Medicaid

statutory framework is subject to administrative rulings, interpretations and discretion that affect the amount and timing of reimbursement

made under Medicare and Medicaid.

reimburses for medical devices in a variety of ways depending on where and how the device is used.

However, Medicare only provides

reimbursement if CMS determines that the device should be covered and that the use of the device is consistent with the coverage

A coverage determination can be made at the local level by the Medicare administrative contractor (formerly called carriers

and fiscal intermediaries) or a private contractor that processes and pays claims on behalf of CMS for the geographic area where

the services were rendered, or at the national level by CMS.

There are new statutory provisions intended to facilitate coverage

determinations for new technologies under the Medicare Prescription Drug Improvement and Modernization Act of 2003 §731 and

§942, but it is unclear how these new provisions will be implemented.

Coverage presupposes that the device has been cleared

or approved by the FDA and, further, that the coverage will be no broader than the approved intended uses of the device (i.e.,

the device’s label) as cleared or approved by the FDA, but coverage can be narrower.

In that regard, a narrow Medicare coverage

determination may undermine the commercial viability of a device.

a coverage determination, whether local or national, is a time-consuming, expensive and highly uncertain proposition, especially

for a new technology, and inconsistent local determinations are possible.

On average, according to an industry report, Medicare

coverage determinations for medical devices lag 15 months to five years or more behind FDA approval for respective devices.

Medicaid programs and private insurers are frequently influenced by Medicare coverage determinations.

A key component in the reimbursement

decision by most private insurers will be whether the GlucoTrack®

model DF-F is reimbursed by virtue of a national coverage

determination by CMS.

We may negotiate contracted rates for the GlucoTrack®

model DF-F with private insurance providers for

the purchase of the GlucoTrack®

model DF-F by their members pending a coverage determination by CMS.

Our inability to obtain

a favorable coverage determination for the GlucoTrack®

model DF-F may adversely affect our ability to market the GlucoTrack®

model DF-F and thus, the commercial viability of the product.

In international markets, reimbursement and healthcare payment systems

vary significantly by country and many countries have instituted price ceilings on specific product lines.

Distributors expressly

support the reimbursement process and, depending on the distribution agreement and geographic area, may assume responsibility

for the process.

believe that the overall escalating cost of medical products and services has led to, and will continue to lead to, increased

pressures on the healthcare industry to reduce the costs of products and services.

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.

There can be no assurance that third-party reimbursement and coverage will be available or adequate, or that future

legislation, regulation, or reimbursement policies of third-party payors will not adversely affect the demand for our products

or our ability to sell these products on a profitable basis.

The unavailability or inadequacy of third-party payor coverage or

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

Until reimbursement

or insurance coverage is established, patients will have to bear the financial cost of GlucoTrack®.

Third-party coverage may

be particularly difficult to obtain while the GlucoTrack®

model DF-F is not approved by the FDA as a replacement for existing

single-point finger stick devices.

However, Medicare only provides reimbursement

if CMS determines that the device should be covered and that the use of the device is consistent with the coverage criteria.

determination can be made at the local level by the Medicare administrative contractor (formerly called carriers and fiscal intermediaries)

or a private contractor that processes and pays claims on behalf of CMS for the geographic area where the services were rendered, or

at the national level by CMS.

There are new statutory provisions intended to facilitate coverage determinations for new technologies

under the Medicare Prescription Drug Improvement and Modernization Act of 2003 §731 and §942, but it is unclear how these new

provisions will be implemented.

Coverage presupposes that the device has been cleared or approved by the FDA and, further, that the coverage

will be no broader than the approved intended uses of the device (i.e., the device’s label) as cleared or approved by the FDA,

but coverage can be narrower.

In that regard, a narrow Medicare coverage determination may undermine the commercial viability of a device.

a coverage determination, whether local or national, is a time-consuming, expensive and highly uncertain proposition, especially for

a new technology, and inconsistent local determinations are possible.

On average, according to an industry report, Medicare coverage

determinations for medical devices lag 15 months to five years or more behind FDA approval for respective devices.

Moreover, Medicaid

programs and private insurers are frequently influenced by Medicare coverage determinations.

A key component in the reimbursement decision

by most private insurers will be whether GlucoTrack®

is reimbursed by virtue of a national coverage determination

We may negotiate contracted rates for GlucoTrack®

with private insurance providers for the purchase of GlucoTrack®

by their members pending a coverage determination by CMS.

Our inability to obtain a favorable coverage determination

for GlucoTrack®

may adversely affect our ability to market GlucoTrack®

and thus, the commercial

viability of the product.

In international markets, reimbursement and healthcare payment systems vary significantly by country and many

countries have instituted price ceilings on specific product lines.

Distributors expressly support the reimbursement process and, depending

on the distribution agreement and geographic area, may assume responsibility for the process.

believe that the overall escalating cost of medical products and services has led to, and will continue to lead to, increased pressures

on the healthcare industry to reduce the costs of products and services.

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.

be no assurance that third-party reimbursement and coverage will be available or adequate, or that future legislation, regulation, or

reimbursement policies of third-party payors will not adversely affect the demand for our products or our ability to sell these products

on a profitable basis.

The unavailability or inadequacy of third-party payor coverage or reimbursement could have a material adverse

effect on our business, operating results and financial condition.

Until reimbursement or insurance coverage is established, patients

will have to bear the financial cost of GlucoTrack®.

Third-party coverage may be particularly difficult to obtain while GlucoTrack®

is not approved by the FDA as a replacement for existing single-point finger stick devices.

the United States, availability of reimbursement from third parties varies widely from country to country.

Within the EU, member

countries’

Within the EU, member countries’

medical reimbursement and healthcare coverage regulations and systems differ significantly.

It is, therefore,

difficult to analyze and predict the prospect of consistent availability of adequate reimbursement in the various EU member countries.

a reimbursement code is achieved, in order to reduce out of pocket expenses for users and increase the number of devices sold,

we are suggesting to distributors of the GlucoTrack®

model DF-F in the United States (and would anticipate suggesting to our

distributors in the United States in the future if and when we receive FDA approval to market the GlucoTrack®

model DF-F in

the United States) that they consider offering end users financing and/or leasing options to lessen the initial financial burden

associated with purchasing a GlucoTrack®

There can be no assurance that any such alternatives will be made available

to end users.

It is, therefore, difficult to analyze and

predict the prospect of consistent availability of adequate reimbursement in the various EU member countries.

and Abuse Rule

are extensive United States federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that

can result in significant criminal and civil penalties that can materially affect us, if and when we receive FDA approval to market

the GlucoTrack®

model DF-F in the United States.

are extensive United States federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that can result

in significant criminal and civil penalties that can materially affect us, if and when we receive FDA approval to market GlucoTrack®

in the United States.

These federal laws include, by way of example, the following:

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that might affect the provision and cost of healthcare services reimbursable under Medicare, Medicaid and other federal healthcare

programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare

or other governmental programs;

physician self-referral prohibition (Ethics in Patient Referral Act of 1989, as amended, commonly referred to as the Stark

Law, Section 1877 of the Social Security Act), which prohibits referrals by physicians of Medicare or Medicaid patients to

providers of a broad range of designated healthcare services in which the physicians (or their immediate family members) have

ownership interests or with which they have certain other financial arrangements;

anti-inducement provisions of the Civil Monetary Penalties Law (Section 1128A(a)(5) of the Social Security Act), which prohibit

providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services

covered by either program;

programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare or other

governmental programs;

physician self-referral prohibition (Ethics in Patient Referral Act of 1989, as amended, commonly referred to as the Stark Law, Section

1877 of the Social Security Act), which prohibits referrals by physicians of Medicare or Medicaid patients to providers of a broad

range of designated healthcare services in which the physicians (or their immediate family members) have ownership interests or with

which they have certain other financial arrangements;

anti-inducement provisions of the Civil Monetary Penalties Law (Section 1128A(a)(5) of the Social Security Act), which prohibit providers

from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either

False Claims Act (31 U.S.C.

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false or fraudulent claims for payment to the federal government (including the Medicare and Medicaid programs);

Civil Monetary Penalties Law (Section 1128A of the Social Security Act), which authorizes the United States Department of

Health and Human Services to impose civil penalties administratively for fraudulent or abusive acts.

for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments,

monetary penalties, imprisonment and/or denial of Medicare and Medicaid payments or exclusion from the Medicare and Medicaid programs,

These laws also impose an affirmative duty on those receiving Medicare or Medicaid funding to ensure that they do not

employ or contract with persons excluded from the Medicare and other government programs.

states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend

beyond the Medicare and Medicaid programs, to prohibit the payment or receipt of remuneration for the referral of patients and

physician self-referrals regardless of whether the service was reimbursed by Medicare or Medicaid.

Many states have also adopted

or are considering legislative proposals to increase patient protections, such as limiting the use and disclosure of patient specific

health information.

These state laws also impose criminal and civil penalties similar to the federal laws.

Civil Monetary Penalties Law (Section 1128A of the Social Security Act), which authorizes the United States Department of Health

and Human Services to impose civil penalties administratively for fraudulent or abusive acts.

for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, monetary

penalties, imprisonment and/or denial of Medicare and Medicaid payments or exclusion from the Medicare and Medicaid programs, or both.

These laws also impose an affirmative duty on those receiving Medicare or Medicaid funding to ensure that they do not employ or contract

with persons excluded from the Medicare and other government programs.

states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend beyond

the Medicare and Medicaid programs, to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals

regardless of whether the service was reimbursed by Medicare or Medicaid.

Many states have also adopted or are considering legislative

proposals to increase patient protections, such as limiting the use and disclosure of patient specific health information.

laws also impose criminal and civil penalties similar to the federal laws.

the EU and EU member countries may have similar fraud and abuse laws which would regulate our business in those jurisdictions.

However, given the diversity of legal systems within the EU, it is difficult to predict with specificity what anti-fraud legislation

and regulations may be implemented and the penalties that they impose.

the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries,

investigations and audits by federal and state agencies that oversee these laws and regulations.

Recent federal and state legislation

has greatly increased funding for investigations and enforcement actions, which have increased dramatically over the past several

This trend is expected to continue.

Private enforcement of healthcare fraud also has increased due in large part to amendments

to the civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government.

whistleblower suits by private persons, known as qui tam relators, may be filed by almost anyone, including present and former

patients or nurses and other employees, as well as competitors.

HIPAA, in addition to its privacy provisions, created a series

of new healthcare-related crimes.

federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation

and enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs.

A violation of any

of these federal and state fraud and abuse laws and regulations could have a material adverse effect on a supplier’s liquidity

and financial condition.

An investigation into the use of a device by physicians may dissuade physicians from recommending that

their patients use the device.

This could have a material adverse effect on our ability to commercialize the GlucoTrack®

given the diversity of legal systems within the EU, it is difficult to predict with specificity what anti-fraud legislation and regulations

may be implemented and the penalties that they impose.

the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations

and audits by federal and state agencies that oversee these laws and regulations.

Recent federal and state legislation has greatly increased

funding for investigations and enforcement actions, which have increased dramatically over the past several years.

This trend is expected

Private enforcement of healthcare fraud also has increased due in large part to amendments to the civil False Claims Act

in 1986 that were designed to encourage private persons to sue on behalf of the government.

These whistleblower suits by private persons,

known as qui tam relators, may be filed by almost anyone, including present and former patients or nurses and other employees, as well

as competitors.

HIPAA, in addition to its privacy provisions, created a series of new healthcare-related crimes.

federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and

enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs.

A violation of any of these

federal and state fraud and abuse laws and regulations could have a material adverse effect on a supplier’s liquidity and financial

An investigation into the use of a device by physicians may dissuade physicians from recommending that their patients use

This could have a material adverse effect on our ability to commercialize GlucoTrack®.

Privacy Provisions of HIPAA

the United States, HIPAA, among other things, protects the privacy and security of individually identifiable health information

by limiting its use and disclosure.

the United States, HIPAA, among other things, protects the privacy and security of individually identifiable health information by limiting

its use and disclosure.

HIPAA directly regulates “covered entities,”

such as healthcare providers, insurers

and clearinghouses, and regulates “business associates,”

such as healthcare providers, insurers and clearinghouses,

and regulates “business associates,”

with respect to the privacy of patients’

medical information.

All entities that receive and process protected health information are required to adopt certain procedures to safeguard the security

of that information.

It is uncertain whether we would be deemed to be a covered entity under HIPAA and, owing to changes in the

law, it is uncertain, based on our current business model, whether we would be a business associate.

Nevertheless, we will likely

be contractually required to physically safeguard the integrity and security of any patient information that we receive, store,

create or transmit in the United States.

If we fail to adhere to our contractual commitments, then our physician, hospital or

insurance customers may be subject to civil monetary penalties, which could adversely affect our ability to market our devices.

Changes in the law wrought by the provisions of Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted

as part of the American Recovery and Reinvestment Act of 2009, increase the duties of business associates and covered entities

with respect to protected health information that thereby subject them to direct government regulation, increasing its compliance

costs and exposure to civil monetary penalties and other government sanctions.

While HITECH does not alter the definition of a

business associate, it makes it more likely that covered entities with whom we are likely to do business in the United States,

if and when we receive FDA approval to market the GlucoTrack®

model DF-F in the United States, will require us to enter into

business associate agreements.

maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United

States and other commercially significant markets.

We currently hold 59 issued patents in various regions including patents issued

by the United States, Australian, Brazilian, Canadian, Chinese, European, Hong Kong, Indian, Israeli, Japanese, Korean, Mexican,

Philippine, Russian, South African, and Taiwanese patent offices that cover various parts of our technology, which include A

Method Of Monitoring Glucose Levels, Device For Non-Invasively Measuring Glucose, Individual Measuring Channels For Non-Invasively

Measuring Glucose, Ear Clip For Medical Monitoring Device.

All entities that

receive and process protected health information are required to adopt certain procedures to safeguard the security of that information.

It is uncertain whether we would be deemed to be a covered entity under HIPAA and, owing to changes in the law, it is uncertain, based

on our current business model, whether we would be a business associate.

Nevertheless, we will likely be contractually required to physically

safeguard the integrity and security of any patient information that we receive, store, create or transmit in the United States.

fail to adhere to our contractual commitments, then our physician, hospital or insurance customers may be subject to civil monetary penalties,

which could adversely affect our ability to market our devices.

Changes in the law wrought by the provisions of Health Information Technology

for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, increase the duties

of business associates and covered entities with respect to protected health information that thereby subject them to direct government

regulation, increasing its compliance costs and exposure to civil monetary penalties and other government sanctions.

While HITECH does

not alter the definition of a business associate, it makes it more likely that covered entities with whom we are likely to do business

in the United States, if and when we receive FDA approval to market GlucoTrack®

in the United States, will require

us to enter into business associate agreements.

maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United States

and other commercially significant markets.

We currently hold 59 issued patents in various regions including patents issued by the United

States, Australian, Brazilian, Canadian, Chinese, European, Hong Kong, Indian, Israeli, Japanese, Korean, Mexican, Philippine, Russian,

South African, and Taiwanese patent offices that cover various parts of our technology, which include A Method Of Monitoring Glucose

Levels, Device For Non-Invasively Measuring Glucose, Individual Measuring Channels For Non-Invasively Measuring Glucose, Ear Clip For

Medical Monitoring Device.

understand the importance of obtaining patent and trade secret protection for new technologies, products and processes.

will depend in large part on our ability to file for and obtain patent protection of our principal products and procedures, to

defend existing or future patents, to maintain trade secrets and to operate without infringing upon the proprietary rights of

Our success will

depend in large part on our ability to file for and obtain patent protection of our principal products and procedures, to defend existing

or future patents, to maintain trade secrets and to operate without infringing upon the proprietary rights of others.

have obtained trademark registrations for GlucoTrack®

in 24 countries, including the US, Europe, China and Israel, and also

own an allowed trademark applications for GlucoTrack®

Trademark registrations were issued in ten countries for

“JUST CLIP IT,”

including France and China, and additional applications are pending in three countries, including

the United States.

In addition, trademark registrations were issued in seven countries for “YOUR TRACK TO HEALTH,”

in 24 countries, including the US, Europe, China and Israel, and also own an

allowed trademark applications for GlucoTrack®

Trademark registrations were issued in ten countries for “JUST CLIP

including France and China, and additional applications are pending in three countries, including the United States.

registrations have been issued in Israel to register “Integrity,”

trademark registrations were issued in seven countries for “YOUR TRACK TO HEALTH,”

including France and China, and additional

applications are pending in three countries, including the United States.

Trademark registrations have been issued in Israel to register

“Integrity,”

the Company’s logo and the GlucoTrack logo.

Registration have issued in Hong Kong and Taiwan and are pending in China and Singapore to register GlucoTrack in Chinese characters.

Our application in South Korea to register GlucoTrack in Korean characters has been allowed.

believe that our patents and products do not and will not infringe patents or violate proprietary rights of others, although it

is possible that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary

rights may occur.

Litigation may be necessary to defend or enforce our patent rights or to determine the scope and validity of

the proprietary rights of others.

Defense and enforcement of patent claims can be expensive and time consuming, even in those

instances in which the outcome is favorable, and could result in the diversion of substantial resources and management time and

attention from our other activities.

An adverse outcome could subject us to significant liability to third parties, require us

to obtain licenses from third parties, require us to alter our products or processes, or require that we cease altogether any

related research and development activities or product sales.

Registration have issued in Hong Kong and Taiwan and are pending

in China and Singapore to register GlucoTrack in Chinese characters.

Our application in South Korea to register GlucoTrack in Korean

characters has been allowed.

believe that our patents and products do not and will not infringe patents or violate proprietary rights of others, although it is possible

that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary rights may occur.

Litigation may be necessary to defend or enforce our patent rights or to determine the scope and validity of the proprietary rights of

Defense and enforcement of patent claims can be expensive and time consuming, even in those instances in which the outcome is

favorable, and could result in the diversion of substantial resources and management time and attention from our other activities.

adverse outcome could subject us to significant liability to third parties, require us to obtain licenses from third parties, require

us to alter our products or processes, or require that we cease altogether any related research and development activities or product

protection is highly uncertain and involves complex legal and factual questions and issues.

The patent application and issuance

process can be expected to take several years and entails considerable expense.

There can be no assurance that patents will be

issued as a result of any applications or that any patents resulting from such applications or our existing patents will be sufficiently

broad to afford protection against competitors with similar or competing technology.

Patents that we obtain may be challenged,

invalidated or circumvented, or the rights granted under such patents may not provide us with any competitive advantages.

market for blood glucose monitoring devices is intensely competitive, subject to rapid change and significantly affected by new

product introductions.

The patent application and issuance process

can be expected to take several years and entails considerable expense.

There can be no assurance that patents will be issued as a result

of any applications or that any patents resulting from such applications or our existing patents will be sufficiently broad to afford

protection against competitors with similar or competing technology.

Patents that we obtain may be challenged, invalidated or circumvented,

or the rights granted under such patents may not provide us with any competitive advantages.

market for blood glucose monitoring devices is intensely competitive, subject to rapid change and significantly affected by new product

introductions.

Four companies, Roche;

1 unchanged sentence

Abbott Laboratories;

and Ascensia,

a spin off from the Bayer Corporation, currently account for substantially all of the worldwide sales of self-monitored glucose

testing systems.

and Ascensia, a spin

off from the Bayer Corporation, currently account for substantially all of the worldwide sales of self-monitored glucose testing systems.

These competitors’

products use a meter and disposable test strips to test blood obtained by pricking the

finger or, in some cases, the palm or forearm.

the last few years, Continuous Glucose Monitoring (CGM) devices have been introduced into the market and will compete with the

GlucoTrack®

model DF-F and our future devices.

Currently, three different brands have obtained FDA clearance to market and

are selling CGM devices in the U.S.

products use a meter and disposable test strips to test blood obtained by pricking the finger or, in some cases,

the palm or forearm.

the last few years, Continuous Glucose Monitoring (CGM) devices have been introduced into the market and will compete with GlucoTrack®

and our future devices.

Currently, to our knowledge, three different brands have obtained FDA clearance to market and are selling

CGM devices in the U.S.

and EU markets.

1 unchanged sentence

Abbott Laboratories and Dexcom, Inc.

CGM devices are invasive devices, in which a needle is inserted under the skin (either in the abdomen or the upper arm) and measures

interstitial fluid.

Although we cannot predict what standards will be employed by applicable regulatory authorities as we seek

FDA clearance, the results achieved by the GlucoTrack®

model DF-F in our safety and performance clinical trial conducted in

2012 and 2013 were similar to the results obtained from the CGM devices that have been introduced to the market, as of the time

of their introduction.

CGM devices are

invasive devices, in which a needle is inserted under the skin (either in the abdomen or the upper arm) and measures interstitial fluid.

Although we cannot predict what standards will be employed by applicable regulatory authorities as we seek FDA clearance, the results

achieved by GlucoTrack®

1.0 in our safety and performance clinical trial conducted were similar to the results

obtained from the CGM devices that have been introduced to the market, as of the time of their introduction.

addition, other companies are developing non-invasive glucose testing devices and technologies that could compete with our devices.

There are also a number of academic and other institutions involved in various phases of technology development regarding blood

glucose monitoring devices.

We believe that the majority of non-invasive glucose monitors in development require frequent calibrations

(from a few hours to a few days, compared to the GlucoTrack®

model DF-F, which has a demonstrated efficacy period of six months

from the initial calibration).

Other companies developing continuous measurement devices, based on minimally invasive methods,

such as implants or subdermal needles include Medtronic, Inc., Abbot Laboratories and Dexcom, Inc.

of our competitors are either publicly traded or are divisions of publicly-traded companies, and they enjoy several competitive

advantages, including:

are also a number of academic and other institutions involved in various phases of technology development regarding blood glucose monitoring

We believe that the majority of non-invasive glucose monitors in development require frequent calibrations (from a few hours

to a few days, compared to the GlucoTrack®

1.0, which has a demonstrated efficacy period of six months from the initial calibration).

Other companies developing continuous measurement devices, based on minimally invasive methods, such as implants or subdermal needles

include Medtronic, Inc., Abbot Laboratories and Dexcom, Inc.

of our competitors are either publicly traded or are divisions of publicly-traded companies, and they enjoy several competitive advantages,

significantly

3 unchanged sentences

lines of products, and the ability to offer rebates or bundle products to offer higher discounts or incentives to gain a competitive

experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products

and marketing approved products;

experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products and

marketing approved products;

financial and human resources for product development, sales and marketing, and patent litigation.

of our other non-publicly traded competitors also enjoy these competitive advantages.

As a result, we cannot assure that we will

be able to compete effectively against these companies or their products.

our knowledge, a summary of potential competitors with non-invasive products in development is set forth below in Figure B.

As a result, we cannot assure that we will be able

to compete effectively against these companies or their products.

our knowledge, a summary of potential competitors with non-invasive products in development is set forth below in Figure A.

blood glucose in capillaries using high- frequency radio waves.

Includes a wearable sensor and displays the data on smartphone.

a range of measurements including exercise, diet, body mass index, medication and illness and includes cloud-based data

management system to store historical Glucowise data.

a range of measurements including exercise, diet, body mass index, medication and illness and includes cloud-based data management

system to store historical Glucowise data.

LED signals are beamed through the finger;

2 unchanged sentences

mid-infrared pulses from an infrared laser to excite glucose molecules in the interstitial layer of skin.

Absorption of these

pulses depends on the concentration of glucose and results in a heat wave migrating to the skin surface, where it is picked

up by photo-thermal detection.

Absorption of these pulses

depends on the concentration of glucose and results in a heat wave migrating to the skin surface, where it is picked up by photo-thermal

heat confirmation (MHC)

of 9 independent measurements that are performed simultaneously and based on method of metabolic heat conformation (MHC) by

radiation, convection and evaporation with electromagnetic technologies.

of 9 independent measurements that are performed simultaneously and based on method of metabolic heat conformation (MHC) by radiation,

convection and evaporation with electromagnetic technologies.

The device integrates 3 types of sensors:

humidity and infrared.

temperature, humidity and

GlucoTrack®

model DF-F does not directly measure the glucose level concentration in the blood.

Rather, it measures several

physiological phenomena that are correlated with the glucose level.

In order to correlate between the measured signal and the

glucose level, a translation is needed.

This translation is accomplished through the individual calibration of the device by reference

to a measurement obtained from an invasive device.

does not directly measure the glucose level concentration in the blood.

Rather, it measures several physiological

phenomena that are correlated with the glucose level.

In order to correlate between the measured signal and the glucose level, a translation

This translation is accomplished through the individual calibration of the device by reference to a measurement obtained from

an invasive device.

devices under different stages of development generally require frequent recalibration.

For example, GlucoWatch, a single non-invasive

product for glucose trend analysis that was previously approved for sale by the FDA, but which is no longer available commercially,

required recalibrations approximately every 13 hours.

The main reasons for calibration are that tissue parameters generally fluctuate

in the area of the measurement and are sensitive to the location of the sensor and the impact of potential disturbances.

are less frequent in the earlobes, where the GlucoTrack®

model DF-F takes its measurements.

Utilizing three channels simultaneously

reduces the noise contribution in the measurement.

In addition, the personal ear clip contains sensors to help users attach the

device to the proper part of the ear lobe.

product for glucose trend analysis that was previously approved for sale by the FDA, but which is no longer available commercially, required

recalibrations approximately every 13 hours.

The main reasons for calibration are that tissue parameters generally fluctuate in the area

of the measurement and are sensitive to the location of the sensor and the impact of potential disturbances.

Disturbances are less frequent

in the earlobes, where GlucoTrack®

takes its measurements.

Utilizing three channels simultaneously reduces the noise

contribution in the measurement.

In addition, the personal ear clip contains sensors to help users attach the device to the proper part

of the ear lobe.

GlucoTrack®

model DF-F has received CE Mark approval, which allows us to market and sell the GlucoTrack®

model DF-F glucose

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

regard to demonstration of performance and safety.

While the MDD is applicable throughout the EU, it requires only a minimum level

of harmonization among member countries.

Accordingly, 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.

Moreover, the MDD notwithstanding, because the regulatory regimes of the EU member

countries are significantly diverse, it is difficult to predict future regulatory developments and risks.

The GlucoTrack®

model DF-F has not yet been cleared or approved for commercial sale in any other jurisdiction, including the United States.

Government Regulation - Regulation of the Design, Manufacture and Distribution of Medical Devices ”

a discussion of the approval process for commercial sale in the United States.

There can be no assurance that approval for commercial

sale in any additional jurisdiction will be obtained on a timely basis or at all.

1.0 has received CE Mark approval, which allows us to market and sell GlucoTrack®

1.0 glucose monitoring device in

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

performance and safety.

While the MDD is applicable throughout the EU, it requires only a minimum level of harmonization among member

Accordingly, 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.

Moreover, the MDD notwithstanding, because the regulatory regimes of the EU member countries are significantly diverse, it is difficult

to predict future regulatory developments and risks.

GlucoTrack®

1.0 has not yet been cleared or approved for commercial sale

in any other jurisdiction, including the United States.

Government Regulation - Regulation of the Design, Manufacture and

Distribution of Medical Devices ”

below for a discussion of the approval process for commercial sale in the United States.

can be no assurance that approval for commercial sale in any additional jurisdiction will be obtained on a timely basis or at all.

2.0 is currently under development.

principal offices are located at 19 Ha’Yahalomim St., Ashdod, Israel 7760049 and our telephone number is 972-8-675-7878.

Our website address is http://www.integrity-app.com;

the reference to such website address does not constitute incorporation by

reference of the information contained on the website and such information should not be considered part of this report.

is no relationship between us and Integrity Applications, Incorporated, the engineering and software services company based in

Chantilly, Virginia.

address is http://www.integrity-app.com;

the reference to such website address does not constitute incorporation by reference of the

information contained on the website and such information should not be considered part of this report.

There is no relationship between

us and Integrity Applications, Incorporated, the engineering and software services company based in Chantilly, Virginia.

and Committees

have four members on our Board, three of whom are independent.

The Board has an Audit Committee and a Compensation Committee and

Nominating and Corporate Governance Committee, the Audit consisting solely of independent directors.

We are continuing

to consider expansion of the Board and the establishment of additional appropriate Board committees to support the Company.

have five members on our Board, four of whom are independent.

The Board has an Audit Committee and a Compensation Committee and Nominating

and Corporate Governance Committee, the Audit consisting solely of independent directors.

We are continuing to consider expansion of

the Board and the establishment of additional appropriate Board committees to support the Company.

of December 31, 2020, we had 11 full-time employees.

None of our employees are represented by a collective bargaining agreement.

In addition, as of December 31, 2019, we had 3 consultants.

as of December 31, 2020, we had 3 consultants.

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 1. Business