What changed in this filing

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Item 1. Business

2022-03-31 compared with 2021-04-13 · 626 added, 682 removed, 384 unchanged (77% of the section changed)

in Delaware in May 2010, we are a medical device company focused on the design, development and commercialization of non-invasive

glucose monitoring devices for use by people with diabetes and pre-diabetics.

On July 15, 2010, we completed a reverse triangular

merger with Integrity Israel and Integrity Acquisition Corp.

Ltd., an Israeli corporation and a wholly owned subsidiary of ours,

pursuant to which Integrity Acquisition Corp.

merged with and into Integrity Israel and all of the stockholders and option

holders of Integrity Israel became entitled to receive shares and options in us in exchange for their shares and options in Integrity

Israel (the “Reorganization”).

Following the Reorganization, the former equity holders of Integrity Israel were entitled

to the same proportional ownership in us as they had in Integrity Israel prior to the Reorganization.

As a result of the Reorganization,

Integrity Israel became a wholly owned subsidiary of ours.

in Delaware in May 2010, we are a medical device company focused on the design, development and commercialization of non-invasive glucose

monitoring devices for use by people with diabetes and pre-diabetics.

On July 15, 2010, we completed a reverse triangular merger with

Integrity Israel and Integrity Acquisition Corp.

Ltd., an Israeli corporation and a wholly owned subsidiary of ours, pursuant to which

Integrity Acquisition Corp.

merged with and into Integrity Israel and all of the stockholders and option holders of Integrity Israel

became entitled to receive shares and options in us in exchange for their shares and options in Integrity Israel (the “Reorganization”).

Following the Reorganization, the former equity holders of Integrity Israel were entitled to the same proportional ownership in us as

they had in Integrity Israel prior to the Reorganization.

As a result of the Reorganization, Integrity Israel became a wholly owned subsidiary

We operate primarily through Integrity Israel.

Israel was founded in 2001 with a mission to develop, produce and market non-invasive glucose monitors for home use by diabetics.

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

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

have developed a non-invasive glucose monitor, the GlucoTrack® 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 first generation GlucoTrack (“GlucoTrack 1.0”) utilizes a 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

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 home-based short calibration process of approximately thirty minutes consisting of three typical blood glucose 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

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.

However, although the MDD is applicable throughout the EU, in practice

it does not ensure uniform regulation throughout 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.

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.

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

1.0 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

The intended use for GlucoTrack 1.0 received by the Notified Body is for both those subjects 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.

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

throughout 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

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

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

Regulatory requirements are increasingly stringent throughout

every step of a product’s life cycle, including service and delivery.

More and more, organizations in the industry are expected

to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, is an internationally

agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

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

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.

This can shorten the CE-mark review

process of future GlucoTrack®

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®

Regulatory requirements are increasingly stringent throughout every

step of a product’s life cycle, including service and delivery.

More and more, organizations in the industry are expected to demonstrate

their quality management processes and ensure best practice in everything they do.

ISO 13485 is an internationally agreed standard that

sets out the requirements for a quality management system specific to the medical devices industry.

On March 1, 2019, we received an

extension of our ISO 13485:2016 certificate and Annex II certification from the EU.

The ISO 13485:2016 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.

This can shorten the CE-mark review process of future GlucoTrack enhancements or revisions,

including software updates and other improvements of the device that do not affect the intended use and/or safety performance.

13485:2016 and Annex II certifications enable us to potentially reduce the time to market for product sales on new, enhanced or modified

GlucoTrack devices.

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

Andreas Pfutzner, on subjects

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®

Andreas Pfutzner, on subjects 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 99.3% 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),

and 17.0% Mean 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.

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;

(3) 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®

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.

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

addition, the Company has demonstrated (1) GlucoTrack 1.0 demonstrates consistent glucose measurement repeatability between different

GlucoTrack devices and on each earlobe of the same subject;

(2) the repeatability of different GlucoTrack 1.0 devices is similar at all

tested glucose ranges and post-prandial time periods;

and (3) the GlucoTrack 1.0 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 an additional study that evaluated GlucoTrack 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®)

with regard to accuracy and precision.

Device accuracy data was presented for 37 people with type 2 diabetes using the consensus

error grid analysis for type 2 diabetes and measuring the median absolute relative difference (ARD).

The results showed that 99.6%

of 257 measurements were in zones A and B of the Consensus error grid, with 90.3% of the measurements in zone A, the mean and

median ARD were 17.2% and 12.9%, respectively, and at various glucose levels, mean PARD ranged from 7.7%-8.7%.

Data was also presented

on sensor to sensor precision in 20 people with type 2 diabetes where ~19 simultaneous measurements using two GlucoTrack®

devices, one on each earlobe.

The results show that GlucoTrack®

is highly accurate with sensor-to-sensor precision is comparable

to that of CGMs (GlucoTrack:

8.1%, Dexcom G6:

9.0%, Freestyle Navigator:

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.

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

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 rapidly assess our performance and make adjustments as necessary.

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

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.

A number of high-quality individuals have

joined the Company, each of whom bring extensive experience in their respective fields.

We have 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 later on took on the additional role of General Manager.

Goode PhD, who has a decorated career developing innovative medical

technologies, including at DexCom and MiniMed and was a member of the Board of Directors of the Company, was appointed as President and

Chief Operating Officer.

In addition, James P.

Thrower PhD, a seasoned executive formerly of Sterling Medical Devices, Mindray DS

USA and DexCom, Inc.

joined as Vice President of Engineering.

Malavé, formerly of Insulet Corp, Medtronic and MiniMed

has joined as an independent board member.

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 formerly at Samsung Health and Dexcom, Inc., Dr.

Alexander Raykhman PhD,

a measurement and artificial intelligence expert and Dr.

Klonoff, world renowned endocrinologist and diabetes technology thought

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 manufacturing costs.

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 made significant progress towards receiving insurance reimbursement in the Netherlands.

new accelerated development plan for GlucoTrack 2.0, and all of the expected advantages over GlucoTrack 1.0, it became 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.

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.

1 unchanged sentence

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.

The Company 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 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.

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

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.

activities while continuing our technology

development in our R&D facility located in Israel.

June 22, 2021, Luis J.

Malavé has been appointed to the Company’s Board of Directors.

Malavé brings more than

30 years of leadership experience in the MedTech industry, primarily in diabetes management, spanning all company stages, from private

startups to large-cap publicly listed companies.

He has extensive expertise in product development, operations, marketing, strategic

partnerships, and US FDA regulatory strategy.

October 2017, Mr.

Malavé has served as President of EOFLOW CO.

Ltd., a company listed on the Korea Stock Exchange that has developed

a wearable disposable insulin pump.

From October 2014 to June 2016, he was COO of Mikroscan Technologies.

Prior to that, Mr.

was the President and CEO of Palyon Medical, maker of an implantable drug-delivery system that spun out from German medical-technology

giant Fresenius SE.

Prior to Palyon, he spent nearly a decade at insulin pump maker Insulet Corp., including as its Senior Vice President

of Research, Development and Engineering, and as Chief Operating Officer.

He also held various senior positions at Medtronic and MiniMed,

overseeing product development of various diabetes management devices.

Malavé earned his Bachelor’s degree in Mathematics

and Computer Science from the University of Minnesota, a Master’s degree in Software Engineering from the University of St.

and an MBA from the University of Maryland.

October 19, 2021, Paul V.

Goode was appointed as President and Chief Operating Officer of the Company, effective November 1, 2021 (“Effective

He has served as a member of Integrity’s Board of Directors since December 17, 2020.

Concurrent with his new appointment,

Goode will be stepping down from the Board.

In this role, Goode will lead the company’s operations, overseeing strategy, design,

manufacturing, business and product development and begin to build the U.S.

infrastructure in preparation for the U.S.

clinical trials

of GlucoTrack.

He will devote such time as necessary to perform his duties but shall be able to pursue other professional opportunities

at the same time.

His base salary shall be $175,000 per year, and he shall be entitled to a cash bonus of up to 20% of his annual base

salary as determined by the Company’s Compensation Committee and shall be granted options to purchase up to One and half Percent

(1.5%) of the fully diluted common stock, par value $0.001 per share, of the Company (“Common Stock”) as of the Effective

Date, with a per share exercise price equal to the greater of (A) $5.20 per share or (B) the closing price of a share of Common Stock

on the Effective Date, as reported by Bloomberg L.P., which shall vest in equal monthly installments over a three year period following

the Effective Date.

The bonus and equity incentives shall be subject to clawback rights if there is a misstatement of financials which

changes any metrics upon which a bonus or incentives are based and the clawback will be pro rata based upon the changes in the financials

with respect to the effect on any underlying metrics.

connection with our application to list our shares of common stock

on Nasdaq Capital Market (“NASDAQ”), on August 13, 2021, we effected a reverse split of our common stock in a ratio of

1 for 13 (the “Reverse Share Split”).

September 27, 2021, our shelf registration statement on Form S-3 (file no.

333-259664) was declared effective by the SEC.

The shelf registration

statement permits us to register up to $100,000,000 of certain equity and debt securities of the Company via prospectus supplement.

December 8, 2021, we announced that our shares of common stock were approved for listing on the NASDAQ.

Trading on NASDAQ commenced

on December 10, 2021 under its existing trading symbol, IGAP.

March 14, 2022, we changed our name to GlucoTrack, Inc.

with Nasdaq and our trading symbol to GCTK.

March 22, 2022, Shalom Shushan, Chief Technology Officer, provided notice of his resignation from the Company, effective May 22, 2022,

for personal reasons.

In connection with the Company’s previously announced plans to migrate certain aspects of product development

to the United States, James P.

Thrower PhD, Vice President of Engineering, will be assuming Mr.

Shushan’s responsibilities.

may be at risk as a result of the current COVID-19 pandemic.

Risks that could affect our business include the duration and scope of the

COVID-19 pandemic and the impact on the demand for our products;

actions by governments, businesses and individuals taken in response

to the pandemic;

the length of time of the COVID-19 pandemic and the possibility of its reoccurrence;

the timing required to develop

effective treatments and a vaccine in the event of future outbreaks;

the eventual impact of the pandemic and actions taken in response

to the pandemic on global and regional economies;

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

its inception date, the Company did not conduct any material operations other than those carried out by Integrity Israel.

The development

and commercialization of the Product is expected to require substantial expenditures.

The Group has not yet generated significant revenues

from operations, and therefore they are dependent upon external sources for financing their operations.

As of December 31, 2021, the

Group has incurred accumulated deficit of $97,466 thousand.

During the year ended December 31, 2021 the Company incurred losses from

ongoing operation and has negative cash flow from operating activity.

February 14, 2020, the Company closed on a $15 million private placement of its common stock, for which it received net cash in

excess of $13,009 thousand.

In addition, on September 27, 2021, the Company’s shelf registration statement on Form S-3

was declared effective by the Securities and Exchange Commission (SEC) which permits the Company to register up to $100,000 thousand

of certain equity and debt securities of the Company via prospectus supplement.

To date, funds have not been raised through this

shelf registration statement

believes the cash balance amounted to $6,062 thousand as of December 31, 2021, is sufficient to meet its capital needs of the Group for

at least 12 months from the issuance date of these consolidated financial statements.

Thus, it is expected that the Company will be able

to operate as a going concern for at least 12 months from the date hereof.

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

Diabetes is caused by the body’s inability to produce

or effectively utilize the hormone insulin.

This inability prevents the body from adequately regulating blood glucose levels.

Glucose, the primary source of energy for cells, must be maintained at certain concentrations in the blood in order to permit

optimal cell function and health.

Normally, the pancreas provides control of blood glucose levels by secreting the hormone insulin

to decrease blood glucose levels when concentrations are too high.

In people with diabetes, blood glucose levels fluctuate between

very high levels, a condition known as hyperglycemia, and very low levels, a condition known as hypoglycemia.

Hyperglycemia can

lead to serious long-term complications, such as blindness, kidney disease, nervous system disease, amputations, stroke and cardiovascular

Hypoglycemia can lead to confusion, loss of consciousness or death.

the primary source of energy for cells, must be maintained at certain concentrations in the blood in order to permit optimal cell function

Normally, the pancreas provides control of blood glucose levels by secreting the hormone insulin to decrease blood glucose

levels when concentrations are too high.

In people with diabetes, blood glucose levels fluctuate between very high levels, a condition

known as hyperglycemia, and very low levels, a condition known as hypoglycemia.

Hyperglycemia can lead to serious long-term complications,

such as blindness, kidney disease, nervous system disease, amputations, stroke and cardiovascular disease.

Hypoglycemia can lead to confusion,

loss of consciousness or death.

is typically classified into two major groups:

Type 1 and Type 2.

Type 1 diabetes is characterized by the body’s inability

to produce insulin, resulting from destruction of the insulin producing cells of the pancreas.

Individuals with Type 1 diabetes

must rely on frequent insulin injections in order to regulate and maintain blood glucose levels.

Type 1 diabetes is frequently

diagnosed during childhood or adolescence, although disease onset can occur at any age.

Type 2 diabetes, the more common form

of diabetes, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin.

2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose

metabolism, physical inactivity and race or ethnicity.

Depending on the severity of Type 2 diabetes, individuals may require diet

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

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

or impending illness, hormonal releases, variability in insulin absorption and changes in the effects of insulin in the body.

Given the many factors that affect blood glucose levels, maintaining glucose within a normal range can be difficult.

generally manage their blood glucose levels by administering insulin or ingesting carbohydrates throughout the day to maintain

blood glucose within normal ranges.

Type 1 diabetes is characterized by the body’s inability to produce

insulin, resulting from destruction of the insulin producing cells of the pancreas.

Individuals with Type 1 diabetes must rely on frequent

insulin injections in order to regulate and maintain blood glucose levels.

Type 1 diabetes is frequently diagnosed during childhood or

adolescence, although disease onset can occur at any age.

Type 2 diabetes, the more common form of diabetes, is characterized by the

body’s inability to either properly utilize insulin or produce enough insulin.

Type 2 diabetes is associated with older age, obesity,

family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race or ethnicity.

Depending on the severity of Type 2 diabetes, individuals may require diet and nutrition management, exercise, oral medications or insulin

injections to regulate blood glucose levels.

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

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

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

illness, hormonal releases, variability in insulin absorption and changes in the effects of insulin in the body.

Given the many factors

that affect blood glucose levels, maintaining glucose within a normal range can be difficult.

Diabetics generally manage their blood

glucose levels by administering insulin or ingesting carbohydrates throughout the day to maintain blood glucose within normal ranges.

Normal ranges in diabetics vary from person to person.

In order to maintain blood glucose

levels within normal ranges, diabetics must first measure their blood glucose levels so that they can make the proper therapeutic

As adjustments are made, additional blood glucose measurements may be necessary to gauge the individual’s response

to the adjustments.

More frequent testing of blood glucose levels provides patients with information that can be used to better

understand and manage their diabetes.

Testing of blood glucose levels is usually done before meals, after meals and before going

Diabetics who take insulin usually need to test more often than those who do not take insulin.

data supports the recommendation that frequent monitoring of blood glucose levels is an important component of effective diabetes

The Diabetes Control and Complications Trial 1 , consisting of patients with Type 2 diabetes, and the 1993

UK Prospective Diabetes Study 2 , consisting of patients with Type 2 diabetes, demonstrated that patients who intensely

managed blood glucose levels delayed the onset and slowed the progression of diabetes-related complications.

In the Diabetes Control

and Complications Trial, a major component of intensive management was monitoring blood glucose levels at least four times per

day using conventional spot finger stick blood glucose meters.

The Diabetes Control and Complications Trial demonstrated that

intensive management reduced the risk of complications by 76% for eye disease, 60% for nerve disease and 50% for kidney disease.

Furthermore, a recent meta-analysis of over 25 prospective studies concluded that chronic hyperglycemia in type 2 diabetes is

associated with increased risks of all-cause mortality and cardiovascular outcomes independently from other conventional risk

3 However, despite the evidence that intensive glucose management reduces the long-term complications associated

with diabetes, Karter et al.

reported in the 2000 issue of Diabetes Care that 67% of people with type 2 diabetes fail to routinely

monitor their glucose levels.

In order to maintain blood glucose levels within normal ranges, diabetics must

first measure their blood glucose levels so that they can make the proper therapeutic adjustments.

As adjustments are made, additional

blood glucose measurements may be necessary to gauge the individual’s response to the adjustments.

More frequent testing of blood

glucose levels provides patients with information that can be used to better understand and manage their diabetes.

Testing of blood glucose

levels is usually done before meals, after meals and before going to sleep.

Diabetics who take insulin usually need to test more often

than those who do not take insulin.

data supports the recommendation that frequent monitoring of blood glucose levels is an important component of effective diabetes management.

The Diabetes Control and Complications Trial 1 , consisting of patients with Type 2 diabetes, and the 1993 UK Prospective Diabetes

Study 2 , consisting of patients with Type 2 diabetes, demonstrated that patients who intensely managed blood glucose levels

delayed the onset and slowed the progression of diabetes-related complications.

In the Diabetes Control and Complications Trial, a major

component of intensive management was monitoring blood glucose levels at least four times per day using conventional spot finger stick

blood glucose meters.

The Diabetes Control and Complications Trial demonstrated that intensive management reduced the risk of complications

by 76% for eye disease, 60% for nerve disease and 50% for kidney disease.

Furthermore, a recent meta-analysis of over 25 prospective

studies concluded that chronic hyperglycemia in type 2 diabetes is associated with increased risks of all-cause mortality and cardiovascular

outcomes independently from other conventional risk factors.

3 However, despite the evidence that intensive glucose management

reduces the long-term complications associated with diabetes, Karter et al.

reported in the 2000 issue of Diabetes Care that 67% of people

with type 2 diabetes fail to routinely monitor their glucose levels.

finger stick devices are the most prevalent devices for blood glucose monitoring.

These devices require users to insert a strip

into a glucose meter, take a blood sample with a finger stick and place a drop of blood on a test strip that yields a single point

in time blood glucose measurement.

Despite continued developments in the field of blood glucose monitors, the routine measurement

of glucose levels remains invasive, painful, inconvenient, difficult and costly.

This has resulted in a sub-optimal and irregular

measurement regimen for many diabetics.

others Intensive blood-glucose control with sulphonylureas or insulin compared with conventional

treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).

The Lancet 1998 , 352 , 837–853.

These devices require users to insert a strip into

a glucose meter, take a blood sample with a finger stick and place a drop of blood on a test strip that yields a single point in time

blood glucose measurement.

Despite continued developments in the field of blood glucose monitors, the routine measurement of glucose

levels remains invasive, painful, inconvenient, difficult and costly.

This has resulted in a sub-optimal and irregular measurement regimen

for many diabetics.

others Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment

and risk of complications in patients with type 2 diabetes (UKPDS 33).

The Lancet 1998 , 352 , 837–853.

Diabetes Control and Complications Research Group;

others The effect of intensive treatment of diabetes on the development

and progression of long-term complications in insulin-dependent diabetes mellitus.

others The effect of intensive treatment of diabetes on the development and

progression of long-term complications in insulin-dependent diabetes mellitus.

N Engl J Med 1993 , 329 , 977–986.

977–986.

Glycosylated Hemoglobin in Relationship to Cardiovascular Outcomes and Death in Patients

with Type 2 Diabetes:

Glycosylated Hemoglobin in Relationship to Cardiovascular Outcomes and Death in Patients with

Type 2 Diabetes:

A Systematic Review and Meta-Analysis.

2 unchanged sentences

Self-monitoring of blood glucose:

financial barriers in a managed care population with diabetes.

Diabetes Care 2000 , 23 , 477–483.

FDA has approved continuous glucose monitoring system (“CGMS”) devices for blood glucose monitoring, when prescribed

language and financial

barriers in a managed care population with diabetes.

Diabetes Care 2000 , 23 , 477–483.

FDA has approved continuous glucose monitoring system (“CGMS”) devices for blood glucose monitoring, when prescribed by a

CGMS devices use sensors inserted under the skin to check glucose levels in interstitial fluid.

The sensor stays

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 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.

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

and that such a device could greatly increase compliance with blood glucose measurement recommendations and help many diabetics

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

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.

The sensor stays 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.

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.

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

such a device could greatly increase compliance with blood glucose measurement recommendations and help many diabetics better manage

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

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

1 unchanged sentence

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®

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 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®

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

to a measurement obtained from an invasive device.

Calibration consists of comparing an individual patient’s physiological

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

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® 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 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

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® 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 to a measurement obtained from

an invasive device.

Calibration consists of comparing an individual patient’s physiological 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:

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.

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 :

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.

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.

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®

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®

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

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

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

foreseeable future.

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”).

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.

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.

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 disposables.

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.

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

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.

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 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.

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:

draw up required

technical documentation;

draw up required technical documentation;

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

1 unchanged sentence

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, 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 GlucoTrack®

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 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®

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.

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

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.

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

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 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 7 –

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

Results of Operation”

below for a discussion of the research and development expenses for the fiscal years ended 2020 and 2019.

strategic priorities include the research and development of product enhancements that will improve the ease and usability of

GlucoTrack for patients with a future generation of products.

We are focusing our research and development activities around 2

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.

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

GlucoTrack®, as well as in connection with our development of other GlucoTrack® models.

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 7 – Management’s Discussion and Analysis

of Financial Condition and Results of Operation – Results of Operation” below for a discussion of the research and development

expenses for the fiscal years ended 2021 and 2020.

strategic priorities include the research and development of product enhancements that will improve the ease and usability of GlucoTrack

for patients with a future generation of products.

We are focusing our research and development activities around 2 main strategic areas:

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®

and the glucose data collected.

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

the glucose data collected.

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

We intend to develop

Apps that support the management of Type 2 diabetes and pre-diabetic patients by providing immediate feedback and insights that

can be derived from glucose measurements.

Enhanced capabilities within the Apps may include goal setting, alarms and reminders,

and diabetes management tips and tools.

We intend to develop Apps that support

the management of Type 2 diabetes and pre-diabetic patients by providing immediate feedback and insights that can be derived from glucose

measurements.

Enhanced capabilities within the Apps may include goal setting, alarms and reminders, and diabetes management tips and

It will also be designed to provide analyses of trends over multiple time periods.

goal is to provide relevant information to guide patients in their journey to change behaviors and improve the management of their

The Apps are expected to have a user-directed capability to connect with third party healthcare providers (physicians,

dieticians, and nurse practitioners) in order to receive professional guidance based on the accumulated information leading to

improved management of the condition and better disease outcomes.

The goal is to provide relevant information

to guide patients in their journey to change behaviors and improve the management of their condition.

The Apps are expected to have a

user-directed capability to connect with third party healthcare providers (physicians, dieticians, and nurse practitioners) in order

to receive professional guidance based on the accumulated information leading to improved management of the condition and better disease

Considerations

is heavily regulated by federal, state and local governments in the United States, and by similar authorities in other countries.

Any product that we develop must receive all relevant regulatory approvals or clearances, as the case may be, before it may be

marketed in a particular country.

The laws and regulations affecting healthcare change regularly, thereby increasing the uncertainty

and risk associated with any healthcare- related venture.

The United States government has in the past considered, is currently

considering and may in the future consider healthcare policies and proposals intended to curb rising healthcare costs, including

those that could significantly and adversely affect reimbursement for healthcare products such as GlucoTrack®

policies have included, and may in the future include:

basing reimbursement policies and rates on clinical outcomes, the comparative

effectiveness and costs of different treatment technologies and modalities;

imposing price controls and taxes on medical device

product that we develop must receive all relevant regulatory approvals or clearances, as the case may be, before it may be marketed in

a particular country.

The laws and regulations affecting healthcare change regularly, thereby increasing the uncertainty and risk associated

with any healthcare- related venture.

The United States government has in the past considered, is currently considering and may in the

future consider healthcare policies and proposals intended to curb rising healthcare costs, including those that could significantly

and adversely affect reimbursement for healthcare products such as GlucoTrack® devices.

These policies have included, and may in

the future include:

basing reimbursement policies and rates on clinical outcomes, the comparative effectiveness and costs of different

treatment technologies and modalities;

imposing price controls and taxes on medical device providers;

and other measures.

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.

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.

the United States, the federal government regulates healthcare through various agencies, including but not limited to the following:

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(ii) the Centers for Medicare &

& Medicaid Services (“CMS”), which administers the Medicare and Medicaid programs;

(iii) the Office of Inspector

General, which enforces various laws aimed at curtailing fraudulent or abusive practices including, by way of example, the Anti-Kickback

Law, the Anti-Physician Referral Law, commonly referred to as the Stark Law, the Anti-Inducement Law, the Civil Money Penalty

Law, and the laws that authorize the Office of Inspector General to exclude health care providers and others from participating

in federal healthcare programs;

and (iv) the Office of Civil Rights which administers the privacy and security aspects of the

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

All of the aforementioned are agencies within

the Department of Health and Human Services.

Healthcare is also provided or regulated, as the case may be, by the Department of

Defense through its TriCare program, the Department of Veterans Affairs under, among other laws, the Veterans Health Care Act

of 1992, the Public Health Service within the Department of Health and Human Services under the Public Health Service Act, the

Department of Justice through the Federal False Claims Act and various criminal statutes, and state governments under the Medicaid

program and their internal laws regulating all healthcare activities.

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

to similar summary.

Although the CE Mark system and the MDD require a minimum level of harmonization in the EU, each EU member

country may impose additional regulatory requirements.

Because there are numerous EU member countries with distinct legal systems,

the scope of potential regulatory requirements in each of the EU countries (additional to the harmonized EU requirements) is difficult

to summarize or predict.

Medicaid Services (“CMS”), which administers the Medicare and Medicaid programs;

(iii) the Office of Inspector General, which

enforces various laws aimed at curtailing fraudulent or abusive practices including, by way of example, the Anti-Kickback Law, the Anti-Physician

Referral Law, commonly referred to as the Stark Law, the Anti-Inducement Law, the Civil Money Penalty Law, and the laws that authorize

the Office of Inspector General to exclude health care providers and others from participating in federal healthcare programs;

the Office of Civil Rights which administers the privacy and security aspects of the Health Insurance Portability and Accountability

Act of 1996 (“HIPAA”).

All of the aforementioned are agencies within the Department of Health and Human Services.

is also provided or regulated, as the case may be, by the Department of Defense through its TriCare program, the Department of Veterans

Affairs under, among other laws, the Veterans Health Care Act of 1992, the Public Health Service within the Department of Health and

Human Services under the Public Health Service Act, the Department of Justice through the Federal False Claims Act and various criminal

statutes, and state governments under the Medicaid program and their internal laws regulating all healthcare activities.

we receive FDA approval to market GlucoTrack® in the United States, we will be subject to regulation by some or all of the foregoing

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

similar summary.

Although the CE Mark system and the MDD require a minimum level of harmonization in the EU, each EU member country may

impose additional regulatory requirements.

Because there are numerous EU member countries with distinct legal systems, the scope of potential

regulatory requirements in each of the EU countries (additional to the harmonized EU requirements) is difficult to summarize or predict.

of the Design, Manufacture and Distribution of Medical Devices

product that we develop must receive all relevant regulatory clearances or approvals, as the case may be, before it may be marketed

in a particular country.

product that we develop must receive all relevant regulatory clearances or approvals, as the case may be, before it may be marketed in

a particular country.

of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country.

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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

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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®

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®

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.

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.

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

On August 31, 2015, we received approval from the Notified Body for improvements to the GlucoTrack® 1.0 model 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 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 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.

can shorten CE-mark review process of future GlucoTrack® 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® devices.

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.

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

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man or other animals.

We believe that GlucoTrack®

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

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.

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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)”

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

the United States, a company generally can obtain permission to distribute a new device in two ways – through a so-called “510(k)”

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

The 510(k) submission

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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”

to a proper predicate device, then the FDA may “clear” that device for marketing.

These devices are not “approved”

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,

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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.

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

risk” device without formal FDA approval.

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

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

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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

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

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

device exemption.

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

GlucoTrack®

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.

GlucoTrack® 1.0 has not 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

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.

regulatory pathway for the GlucoTrack®

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

regulatory pathway for the GlucoTrack® 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®

to and details of the clinical trial protocol for the GlucoTrack® 1.0.

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

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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

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.

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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

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certain provisions of the same was signed into law.

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

“ACA.”

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

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

The law’s

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

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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.

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

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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.

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.

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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.

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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.

by most private insurers will be whether GlucoTrack® is reimbursed by virtue of a national coverage determination by CMS.

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

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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®

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’

medical reimbursement and healthcare coverage regulations and systems differ significantly.

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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.

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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

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its use and disclosure.

HIPAA directly regulates “covered entities,”

such as healthcare providers, insurers and clearinghouses,

and regulates “business associates,”

with respect to the privacy of patients’

medical information.

HIPAA directly regulates “covered entities,” such as healthcare providers, insurers and clearinghouses,

and regulates “business associates,” with respect to the privacy of patients’ medical information.

All entities that

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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.

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

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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

including France and China, and additional applications are pending in three countries, including the United States.

trademark registrations were issued in seven countries for “YOUR TRACK TO HEALTH,”

including France and China, and additional

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® in Canada.

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.

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.

“Integrity,” the Company’s logo and the GlucoTrack logo.

Registration have issued in Hong Kong and Taiwan and are pending

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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,

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 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.

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.

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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 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.

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.

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.

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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).

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

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temperature, humidity and

GlucoTrack®

Gluco Station

Using spectrophotometry to measure the scattering of

light by glucose molecules to determine glucose concentration.

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.

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

devices under different stages of development generally require frequent recalibration.

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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®

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.

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.

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

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 countries.

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

GlucoTrack® 1.0 has not yet been cleared or approved for commercial sale in any other jurisdiction, including the United

See “ 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.

There can be no assurance that approval for commercial

sale in any additional jurisdiction will be obtained on a timely basis or at all.

GlucoTrack 2.0 is currently under development.

principal offices are located at 8 Ariel Sharon Street, P.O.

Box 6037607, Or Yehuda, 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.

There is no relationship

between us and Integrity Applications, Incorporated, the engineering and software services company based in Chantilly, Virginia.

and Committees

6 unchanged sentences

None of our employees are represented by a collective bargaining agreement.

as of December 31, 2020, we had 3 consultants.

In addition, as of December 31, 2021, we had 5 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