What changed in this filing

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Item 1. Business

2023-03-31 compared with 2022-03-31 · 366 added, 600 removed, 410 unchanged (70% 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

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.

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 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 medical device company focused on the design, development and commercialization of novel technologies for use by people with diabetes

and prediabetes.

We are currently developing two products;

a non-invasive glucose monitor for use by those with Type 2 diabetes and prediabetes,

and an implantable continuous glucose monitor for those with Type 1 diabetes and insulin-dependent Type 2 diabetes.

incorporated in Delaware in May 2010 as Integrity Applications, Inc.

In July 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 (the “Reorganization”).

As a result of the Reorganization, Integrity

Israel became a wholly owned subsidiary of ours.

Until recently, we operated primarily through Integrity Israel and moved our operations

primarily to the US in 2022.

In connection with our application

to list our shares 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”).

For accounting purposes, all Shares, options and warrants to

purchase Common Stock and loss per share amounts have been adjusted to give retroactive effect to this Reverse Share Split for all periods

presented in these interim consolidated financial statements.

Any fractional shares resulting from the Reverse Share Split were rounded

up to the nearest whole share.

December 8, 2021 our shares of Common Stock were approved for listing on the Nasdaq Capital Market (“NASDAQ”) and trading

on NASDAQ commenced on December 10, 2021 under the trading symbol, IGAP.

March 14, 2022, we completed our corporate name change to GlucoTrack, Inc., and ticker symbol change to GCTK.

was founded with a mission to develop GlucoTrack®, a noninvasive glucose monitoring device 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”), which successfully received CE Mark approval and ISO certifications,

utilized a combination of ultrasound, electromagnetic and thermal technologies to obtain glucose measurements in approximately 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.

After a limited release beta test in Europe and the Middle East, the Company determined that it would focus

on developing its next generation non-invasive monitor (“GlucoTrack 2.0”), and we have since withdrawn our CE Mark and ISO

certifications for GlucoTrack 1.0.

We are currently developing

GlucoTrack 2.0.

The current clinical prototype utilizes ultrasound-only sensor technology, reduces the overall cost and complexity of

the device, and reduces the measurement time from approximately sixty seconds to less than two seconds.

Initial testing has produced promising

results, suggesting measurement accuracies could be relatively comparable with those of conventional, already in-the-market CGM technologies.

We expect to begin our first-in-human (FIH) study in the second quarter of 2023.

Collecting data for sensor characterization and algorithm

development will be the primary goals of the FIH study.

The results of this study will also drive the development of the commercial version

of the device, which is expected to commence late in the third quarter of 2023.

Once the development of the commercial device version

is complete, we intend to conduct a scaled down version of the FDA pivotal trial to resolve any lingering device performance or human

factors issues prior to executing the larger pivotal trial for FDA submission.

the acquisition of certain IP in the fourth quarter of 2022, we are also developing an implantable continuous glucose monitor

for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients.

Implant longevity is key to the success of such a device,

and we are currently in the feasibility phase to demonstrate the potential of a multi-year implant life.

We intend to complete the feasibility

study in the second quarter of 2023.

We believe our technology, if successful, has the potential to be more accurate, more convenient

and have a longer duration than other implantable glucose monitors that are either in the market or currently under development.

currently developing our own companion applications and a cloud-based solutions to offer an effective platform to provide real time, data

driven personalized tools to effectively help a user manage their diabetes, which will be utilized during the clinical trials.

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,

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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.

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 99.3% 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) 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

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

Management team includes;

CEO and President, Paul V.

Goode PhD, who has a decorated career developing innovative medical technologies,

including at DexCom and MiniMed, James P.

Thrower PhD, Vice President of Engineering, a seasoned executive formerly of Sterling Medical

Devices, Mindray DS USA and DexCom, Inc., and Mark Tapsak PhD, Vice President of Sensor Technology, a medical research scientist who brings

over 25 years of experience in the diabetes industry, including previous senior roles at DexCom and Medtronic.

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.

Raykhman PhD, a measurement and artificial intelligence expert and Dr.

Klonoff, world renowned endocrinologist and diabetes technology

thought leader.

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.

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

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

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.

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”).

19, 2021, Paul V.

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

He previously served as a member of the Company’s Board of Directors since December 17, 2020.

Concurrent with his

new appointment, Dr.

Goode stepped down from the Board.

In December 2021, Mr.

Goode has been appointed Chief Executive Officer.

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.

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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.

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 the trading symbol IGAP.

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

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,

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to the United States, James P.

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

Thrower PhD, Vice President of Engineering, assumed 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.

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

as well as in preparation for U.S.

clinical trials, Erez Ben-Zvi, VP of Product in Israel, resigned from the Company, effective June 12,

October 10, 2022, the Company announced that it has acquired certain IP related to a long-term implantable continuous glucose monitor

and that it intends to develop the technology to address the growing Type 1 and insulin dependent Type 2 diabetes market.

October 14, 2022, the Company announced the hiring of Dr.

Mark Tapsak as Vice President of Sensor Technology.

November 22, 2022, Nasdaq provided notice that pursuant to Nasdaq Listing Rule 5550(b)(1), the Company did not meet the alternatives of

market value of listed securities or net income from continuing operations.

January 4, 2023, Nasdaq provided notice that since the Company had not held an annual meeting of shareholders within twelve months of

the end of the Company’s fiscal year end ended December 31, 2021, it no longer complied with Listing Rules for continued listing.

February 7, 2023, Nasdaq issued a letter to the Company granting an extension until May 22, 2023 to obtain compliance with the Listing

Rule 5550(b).

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

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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.

According to the Diabetes Atlas

(Ninth Edition) published by the International Diabetes Federation in 2021, approximately 537 million adults worldwide, between the ages

of 20 and 79, or approximately 10% of the world’s adult population, were estimated to suffer from diabetes in 2021 (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 784 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, medications, variability in insulin absorption and changes in the effects of insulin in the

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.

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 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.

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 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.

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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

two of the most significant challenges facing the market:

as GlucoTrack is a truly non-invasive device;

as we anticipate that the total cost of purchasing a device and purchasing replacement ear clips every six months (anticipated to

be the only recurring cost) over the useful life of the device will be significantly lower than the cost of purchasing single use

glucose sticks over that same period.

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

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.

devices generally require frequent recalibration.

The main reasons for calibration are that tissue parameters generally fluctuate in

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

Disturbances are

less frequent in the earlobes, where 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.

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;

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

prepare a Declaration of Conformity;

and affix CE Marking to a finished product.

Although these requirements are similar to those of the MDD, RoHS 2 does not require a Notified

Body assessment of compliance.

However, if they are not compliant with RoHS 2, medical device manufacturers face the risk of being barred

from selling medical devices in the EU after July 22, 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 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.

FDA has previously approved a single non-invasive product for glucose trend analysis, the GlucoWatch®, so long as the device was

used with conventional finger stick glucose monitoring devices.

However, the device is no longer available commercially.

We are not aware

of any other devices that have been approved for use in either the United Stated or the EU for spot or continuous non-invasive blood

glucose measurement.

We believe that a significant

market opportunity exists for our devices which could greatly increase compliance with blood glucose measurement recommendations and help

many suffering from diabetes better manage their disease, providing significant benefits to both patients and payors.

generation GlucoTrack (“GlucoTrack 1.0”), which successfully received CE Mark approval and ISO certifications, utilized a

combination of ultrasound, electromagnetic and thermal technologies to obtain glucose measurements in approximately 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.

After a limited release beta test in Europe and the Middle East, the Company determined that it would focus on

developing its next generation non-invasive monitor (“GlucoTrack 2.0”), and we have since withdrawn our CE Mark and ISO certifications

for GlucoTrack 1.0.

We are currently in the development

phase of GlucoTrack 2.0.

Our development team began our Glucotrack 2.0 redesign program as a project to miniaturize the Glucotrack 1.0

technology into a smaller wireless ear clip that would connect to a smartphone via Bluetooth.

As our miniaturization project progressed,

the glucose sensing landscape evolved as continuous glucose monitoring (CGM) devices in the market reached similar accuracy as the conventional

fingerstick blood glucose monitoring (BGM) devices.

This inevitably raised the regulatory bar for any glucose sensor performance, as regulatory

bodies such as the FDA could now point to the accuracy levels of BGM and CGM alternatives already available to the patient.

the Company recognized the advent and significant growth of digital health.

Particularly, CGM companies set a new bar for a mobile experience

with diabetes data and its associated cloud management, with BGM companies quickly following.

Also, from a user experience perspective,

while a 60 second measurement time may have been acceptable to the market in the past, we determined this is no longer the case, and that

we needed to significantly reduce the time it took to complete a measurement.

As a result of these changing

dynamics, we concluded that the GlucoTrack 2.0 project scope not only had to reduce the size of our device, but also had to improve the

user experience and to significantly improve sensor accuracy.

Accordingly, the Company had to return to a research mode to design, develop,

and test a new, more innovative device that would meet these criteria and to invest in software development to ensure that the GlucoTrack

2.0 product would be supported by both iOS and Android devices with a cloud-based infrastructure.

By the end of 2022 we had a clinical

prototype of a newly designed system.

This system utilizes ultrasound-only sensor technology, reduces the overall cost and complexity

of the device, and reduces the measurement time from 60 seconds to 2 seconds.

Initial testing produced promising results, suggesting measurement

accuracies could be relatively comparable to those of conventional, already in-the-market CGM technologies.

Continued testing however,

exposed certain human factors that complicated consistent sensor placement.

We have identified several mechanical techniques to address

this challenge and we expect to complete this process and begin our first-in-human (FIH) study in the second quarter of 2023.

data for sensor characterization and algorithm development will be the primary goals of the FIH study.

The results of this study will

also drive the development of the commercial version of the device, which is expected to commence late in the third quarter of 2023.

the development of the commercial device version is complete, we intend to conduct a scaled down version of the FDA pivotal trial to resolve

any lingering device performance or human factors issues prior to executing the larger pivotal trial for FDA submission.

In the fourth quarter of 2022

we acquired certain IP relating to an implantable continuous glucose monitor.

We designed and developed a laboratory CGM sensing system,

integrated into a cloud-based automated data collection system and a prototype model of this system was implemented and validated.

also designed, manufactured, and tested a prototype sensor lead.

In addition, we have identified and consummated key vendor relationships

with expertise in designing and manufacturing implantable leads and electronics, and we are developing a sensor life simulation system

that will take real bench data as inputs and predict total enzyme longevity.

Our focus now is to complete the

feasibility assessment of achieving a multi-year implant life.

In parallel, we have initiated an implantable electronics design effort.

A paper-based design has been completed, and a physical mock-up is expected in the second quarter of 2023, with a targeted prototype design

for an animal study to commence in the third quarter of 2023.

By the end of 2023 we intend to

have completed the feasibility assessment based on bench data and sensor life modeling/prediction, have bench data (in solution) demonstrating

at least six months of sensor life without significant degradation, have animal data demonstrating at least three months of sensor life

without significant degradation, and have initiated a human clinical device/system design and development program.

developed our own companion applications and a cloud-based solutions 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.

These applications will be utilized during the clinical trials.

We 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 our devices are 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.

& 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® 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.

We focus significant time and

resources on research and development in connection with our efforts to continue to develop and improve GlucoTrack, as well as in connection

with our development of our implantable continuous glucose monitor.

See “Item 7 – Management’s Discussion and Analysis

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expenses for the fiscal years ended 2022 and 2021.

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.

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

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

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.

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;

Healthcare 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.

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 our 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 our devices, may be cleared for sale could also have a negative impact on the demand for our devices.

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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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

we receive FDA approval to market our devices 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

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

impose additional regulatory requirements.

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

These laws and regulations range from simple product registration requirements in some countries to complex clearance and production

controls in others.

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

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

These differences may affect the efficiency and timeliness of international

market introduction of GlucoTrack®.

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

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

On June 4, 2013, we received

our CE Mark approval for the first generation GlucoTrack® non-invasive glucose monitoring device from the Notified Body.

of the CE Mark allows us to market and sell the GlucoTrack® 1.0 model glucose monitoring device in EU member countries that have

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

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,

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

man or other animals.

We believe that GlucoTrack® devices will be classified as medical devices and subject to regulation by numerous

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

Devices are subject to varying levels of regulatory

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

distribution.

The FDA classifies medical devices into one of three classes.

Class I devices are relatively simple and can be manufactured

and distributed with general controls.

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

Class III devices are

new and frequently help sustain life.

These laws and regulations range from simple product registration requirements in some countries to complex clearance and production controls

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

necessary to obtain FDA approval (as described below).

These differences may affect the efficiency and timeliness of international market

introduction of our devices.

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

comply with the requirements of the MDR.

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

regulation throughout the EU.

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

Accordingly, member countries

may apply and enforce the MDr’s terms differently, and certain EU member countries may request or require performance and/or safety

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

The CE Mark also permits the sale in countries

that have an MDR Mutual Recognition Agreement with the EU.

In the United States, under Section

201(h) of the Food, Drug, and Cosmetic Act, a medical device is an article which, among other things, is intended for use in the diagnosis

of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in man or other animals.

We believe that

our devices will be classified as medical devices and subject to regulation by numerous agencies and legislative bodies, including the

FDA and its foreign counterparts.

Devices are subject to varying levels of regulatory control, the most comprehensive of which requires

that a clinical evaluation be conducted before a device receives approval for commercial distribution.

The FDA classifies medical devices

into one of three classes.

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

II devices are somewhat more complex and require greater scrutiny.

Class III devices are new and frequently help sustain life.

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

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

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.

August 10, 2015, we submitted pre-submission documents to the FDA in connection with our proposed future application for FDA approval

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

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® 1.0.

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

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

the FDA at the meeting.

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

At the end of this discussion, we received verbal confirmation from the FDA that clinical trials of the GlucoTrack® 1.0 constitute

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

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

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

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

The 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 prior 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.

FDA noted that

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

The implantable CGM product will most likely fall under the PMA process.

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

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

requirements additional to the minimum harmonization required by the MDD.

requirements additional to the minimum harmonization required by the MDR.

Because the EU member countries have diverse legal systems,

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

anticipate that sales volumes and prices of GlucoTrack® and any other products we commercialize will depend in large part on the

availability of reimbursement from third-party payors.

Third-party payors include governmental programs such as Medicare and Medicaid,

private insurance plans and workers’ compensation plans.

These third-party payors may deny reimbursement for a product or therapy

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

Also, third-party payors are increasingly challenging

the prices charged for medical products and services.

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

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

Even though a new product may have been cleared for commercial

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

We anticipate that sales volumes

and prices of our products will depend in large part on the availability of reimbursement from third-party payors.

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.

include governmental programs such as Medicare and Medicaid, private insurance plans and workers’ compensation plans.

These third-party

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

Also, third-party payors are increasingly challenging the prices charged for medical products and services.

Some third-party payors must

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

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

has been obtained from governmental and private third-party payors.

Inasmuch as a percentage of the

projected patient population that could potentially benefit from our products 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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In that regard, a narrow Medicare coverage determination may undermine the commercial viability of a device.

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

a new technology, and inconsistent local determinations are possible.

On average, according to an industry report, Medicare coverage

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

Moreover, Medicaid

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

A key component in the reimbursement decision

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

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

Furthermore, deficit reduction and austerity measures in the

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

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

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

on a profitable basis.

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

effect on our business, operating results and financial condition.

Until reimbursement or insurance coverage is established, patients

will have to bear the financial cost of GlucoTrack®.

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

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

Obtaining a coverage determination,

whether local or national, is a time-consuming, expensive and highly uncertain proposition, especially for a new technology, and inconsistent

local determinations are possible.

On average, according to an industry report, Medicare coverage determinations for medical devices lag

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

Moreover, Medicaid programs and private insurers are frequently

influenced by Medicare coverage determinations.

A key component in the reimbursement decision by most private insurers will be whether

our products is reimbursed by virtue of a national coverage determination by CMS.

We may negotiate contracted rates our products with

private insurance providers for the purchase of our products by their members pending a coverage determination by CMS.

Our inability to

obtain a favorable coverage determination for our products may adversely affect our ability to market our products 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.

We believe that the overall escalating

cost of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare industry to reduce

the costs of products and services.

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

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

There can be no assurance that third-party reimbursement

and coverage will be available or adequate, or that future legislation, regulation, or reimbursement policies of third-party payors will

not adversely affect the demand for our products or our ability to sell these products on a profitable basis.

The unavailability or inadequacy

of third-party payor coverage or reimbursement could have a material adverse effect on our business, operating results and financial condition.

Until reimbursement or insurance coverage is established, patients will have to bear the financial cost of our products.

Third-party coverage

may be particularly difficult to obtain while our products 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.

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

in the United States.

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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®.

This could have a material adverse effect on our ability to commercialize our products.

Privacy Provisions of HIPAA

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Medical Monitoring Device.

However, since we have taken Glucotrack 1.0 form the market, we have not maintained these patents across

the geographies.

New IP is being generated for both Glucotrack 2.0 and the Invasive CGM that will add to our patent portfolio while providing

more longevity.

understand the importance of obtaining patent and trade secret protection for new technologies, products and processes.

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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

have obtained trademark registrations for GlucoTrack® in various countries, including the US, Europe, China and Israel, and also own an

allowed trademark applications for GlucoTrack® in Canada.

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the palm or forearm.

the last few years, Continuous Glucose Monitoring (CGM) devices have been introduced into the market and will compete with GlucoTrack®

and our future devices.

Currently, to our knowledge, three different brands have obtained FDA clearance to market and are selling CGM

devices in the U.S.

and EU markets.

These brands are sold by Medtronic plc.

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.

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.

are also a number of academic and other institutions involved in various phases of technology development regarding blood glucose monitoring

We believe that the majority of non-invasive glucose monitors in development require frequent calibrations (from a few hours

to a few days, compared to the GlucoTrack® 1.0, which has a demonstrated efficacy period of six months from the initial calibration).

Other companies developing continuous measurement devices, based on minimally invasive methods, such as implants or subdermal needles

include Medtronic, Inc., Abbot Laboratories and Dexcom, Inc.

Within the last few years, Continuous

Glucose Monitoring (CGM) devices have been introduced into the market and will compete with GlucoTrack® and our future devices.

to our knowledge, three different brands have obtained FDA clearance to market and are selling CGM devices in the U.S.

These brands are

sold by Medtronic plc., Abbott Laboratories, and Dexcom, Inc.

Several new and smaller players have obtained clearance to market in EU,

although their performances are significantly inferior to those of Medtronic, Abbott, and DexCom.

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®

2.0 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.

As mentioned above, we expect the performance requirements from the regulating agencies

will be more stringent as the CGM products have improved their performance since initial market introduction.

In addition, other companies are

developing non-invasive glucose testing devices and technologies that could compete with our devices.

There are also a number of academic

and other institutions involved in various phases of technology development regarding blood glucose monitoring devices.

We believe that

the majority of non-invasive glucose monitors in development require frequent calibrations (from a few hours to a few days, compared to

the GlucoTrack® 1.0, which has a demonstrated efficacy period of six months from the initial calibration).

Other than Know Labs and

Movano, companies known to be developing non-invasive measurement devices are all privately held such as Alertgy, Gwave, Diamontech, Boydsense,

Companies known to be developing an implantable CGM are Sensionics and privately-held Profusa and Indigo Diabetes NV.

of our competitors are either publicly traded or are divisions of publicly-traded companies, and they enjoy several competitive advantages,

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to compete effectively against these companies or their products.

our knowledge, a summary of potential competitors with non-invasive products in development is set forth below in Figure A.

blood glucose in capillaries using high- frequency radio waves.

Includes a wearable sensor and displays the data on smartphone.

a range of measurements including exercise, diet, body mass index, medication and illness and includes cloud-based data management

system to store historical Glucowise data.

LED signals are beamed through the finger;

color image sensor executes a special algorithm

absorption spectroscopy

mid-infrared pulses from an infrared laser to excite glucose molecules in the interstitial layer of skin.

Absorption of these pulses

depends on the concentration of glucose and results in a heat wave migrating to the skin surface, where it is picked up by photo-thermal

heat confirmation (MHC)

of 9 independent measurements that are performed simultaneously and based on method of metabolic heat conformation (MHC) by radiation,

convection and evaporation with electromagnetic technologies.

The device integrates 3 types of sensors:

temperature, humidity and

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.

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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.

Our principal

offices are located at 301 17 North, suite 800, Rutherford NJ 07070, and our telephone number is 201-842-7715.

Our website address is

http://www.glucotrack;

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

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the Board and the establishment of additional appropriate Board committees to support the Company.

of December 31, 2021, we had 5 full-time employees.

As of December 31, 2022, we had

three full-time employees.

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

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

In addition, as of December 31,

2022, we had five significant 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