What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-03-31 · 492 added, 572 removed, 204 unchanged (84% of the section changed)

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.

are a medical device company focused on the design, development and commercialization of novel technologies for people with diabetes.

Our mission is to become a leader in diabetes management by bringing to market innovative and cost-effective technologies that address

multiple verticals within the diabetes market.

Company 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, which successfully received CE Mark approval, obtained glucose measurements via

a small sensor clipped onto one’s earlobe.

A limited release beta test in Europe and the Middle East demonstrated the need for

an updated product with improved accuracy and human factors.

As the glucose monitoring landscape rapidly moved away from point-in-time

measurement to continuous measurement since then, the Company recently determined that it would focus its efforts on developing its Implantable

continuous glucose monitor (“CGM”).

As such, we have since withdrawn our CE Mark for GlucoTrack and are no longer pursuing commercialization of this product or development

of any further iterations.

Company is currently developing an Implantable CGM 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 have recently completed a feasibility study successfully demonstrating that

a minimum two-year implant life is highly probable with the current sensor design.

We have also initiated an animal study with an initial

prototype system that has thus far demonstrated a simple implant procedure and good functionality.

The Company will initiate a long-term

animal trial in late Q4 as well as initiate development of its commercial device, also in late Q4, in preparation of regulatory submission

in late 2024 for a first in human study.

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,

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.

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

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.

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”).

are currently developing our own mobile companion application and a cloud-based solution 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.

Senior Management team includes;

Chief Executive Officer and President, Paul V.

who has a decorated career developing innovative medical technologies, including at DexCom and MiniMed, CFO, James Cardwell, CPA who

has over 16 years of experience as a Chief Financial Officer and Chief Operating Officer with a concentration in both SEC financial reporting

and tax compliance, James P.

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

DS USA and DexCom, Inc.

(“DexCom”) , 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 plc (“Medtronic”);

and Drinda Benjamin, Vice President

of Marketing, an experienced commercial leader with experience at Medtronic and MiniMed, Abbott Diabetes Care, Senseonics and Intuitive

and Vincent Wong, Vice President of Quality, a proven quality systems leader with extensive high-volume implantable device

manufacturing experience from Cirtec Medical Corp.

(“Cirtec Medical”) and TOMZ Corporation.

Malavé, formerly of Insulet Corp, Medtronic and MiniMed is the Chairman of the Company’s Board of Directors (the “Board”

or “Board of Directors”).

We intend to continue to invest in our talent and to expand and strengthen all areas within the

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.

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,

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, assumed Mr.

Shushan’s responsibilities.

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).

333-259664) (the “Shelf Registration Statement”)

was declared effective by the Securities and Exchange Commission (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.

October 7, 2022, the Company announced that it has acquired certain intellectual property related to a long-term implantable CGM from Paul V.

Goode, the Chief Executive Officer and that it intends to develop the technology to

address the growing Type 1 and insulin-dependent Type 2 diabetes market.

April 13, 2023, the Company completed an underwritten public offering under which the Company received gross proceeds of approximately

$10 million for issuance of (i) 5,376,472 shares of common stock and (ii) 1,976,470 pre-funded warrants at a price to the public of $1.36

After completing this transaction, the Company regained compliance with NASDAQ regarding the notice it received on November

April 17, 2023, the Company announced the closing of a firm commitment underwritten public offering of shares of its common stock with

gross proceeds to the Company of approximately $10 million, before deducting underwriting discounts and other estimated expenses.

offering consisted of 5,376,472 shares of common stock and 1,976,470 pre-funded warrants to purchase shares of common stock at a price

to the public of $1.36 per share (less $0.001 in exercise price per pre-funded warrant).

The Company entered into an underwriting agreement

with Aegis Capital Corp.

on April 13, 2023.

The Company intends to use the net proceeds from this offering primarily for working capital

and general corporate purposes, which may include, without limitation, engaging in acquisitions or other business combinations or investments,

sales and marketing activities, general and administrative matters and capital expenditures.

July 25, 2023, the Company announced the completion and positive results of its feasibility study for its implantable continuous glucose

monitor technology for patients with Type 1 and Type 2 insulin-dependent diabetes.

The primary goal of the feasibility study was to demonstrate

that the CGM sensor design could reliably report glucose measurements for two years post-implant.

Laboratory bench testing confirmed

that a minimum two-year implant longevity is highly probable with the current sensor design.

The implant longevity was independently

verified by a third-party using sensor parameters to simulate sensor performance over time.

Given the positive results of the study,

the Company is now preparing for long-term animal studies, which are expected to begin later this year.

On October 12, 2023, the Company

issued a press release with respect to its initial Animal Study.

as of October 6, 2023, Jolie Kahn resigned as Chief Financial Officer of GlucoTrack, Inc.

(the “Company”) to pursue other

career interests.

Kahn’s resignation was not because of any disagreement with the Company on any matter relating to the Company’s

operations, policies or practices, including accounting principles and practices.

October 11, 2023, the Company appointed James S Cardwell, 63, as Chief Financial Officer of the Company, effective immediately.

Cardwell has over 16 years of experience as a Chief Financial Officer and Chief Operating Officer with a concentration in both SEC financial

reporting and tax compliance.

He also serves as the Chief Operating Officer of the CFO Squad LLC, an accounting firm, since July 2015

providing additional accounting and financial reporting services to the Company.

In connection with his role at the CFO Squad LLC, he

also served as interim Chief Financial Officer at several entities.

Cardwell has no family relationships with any of the Company’s directors or executive officers, and he is not a party to, and does

not have any direct or indirect material interest in, any transaction requiring disclosure under Item 404(a) of Regulation S-K.

October 11, 2023, in connection with Mr.

Cardwell’s appointment as the Company’s Chief Financial Officer, Mr.

Cardwell entered

into a consulting agreement (the “Cardwell Consulting Agreement”) with the Company.

Pursuant to the terms of the Cardwell

Consulting Agreement, Mr.

Cardwell will perform all duties typically required of a Chief Financial Officer.

As compensation for his services,

the Company shall pay Mr.

Cardwell One Thousand Five Hundred Dollars ($1,500) per month.

The Cardwell Consulting Agreement is for a term

Either party may terminate the agreement upon thirty (30) day written notice.

On November 13, 2023, the Company

announced its decision to shift its strategic focus from non-invasive point-in-time glucose monitoring (“GlucoTrack 2.0”)

to CGM technology.

This decision was driven by market trends indicating a growing preference for CGM and

supported by changes in clinical guidelines recommending CGM over point-in-time monitoring for certain patient populations.

This historical

shift reflects the Company’s proactive response to evolving industry dynamics, aiming to better align its offerings with the needs of

individuals managing diabetes.

November 24, 2023, we received a letter from the Staff of Nasdaq notifying us that we have been granted an additional 180 calendar

days, or until May 20, 2024, to regain compliance with the Bid Price Rule.

If at any time during the Extended Compliance Period, the

closing bid price of our Common Stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Staff of Nasdaq

will provide written confirmation that we have achieved compliance with the Bid Price Rule.

If we cannot demonstrate compliance

during the Extended Compliance Period, then the Staff of Nasdaq will provide notice that our Common Stock will be subject to

At that time, the Company may appeal the Staff’s determination to a hearings

The stock price on March 12, 2024, was $0.31.

The Company agreed to do a reverse stock split if the stock does not trade for

more than $1.00 for more than 10 consecutive days before May 20, 2024.

February 13, 2024, the Company entered into an exchange agreement with certain shareholders (the “Holders”), pursuant to

which the Company and the Holders agreed to exchange 4,381,953 of common stock purchase warrants owned by the Holders for 3,593,203 shares

of the Company’s common stock, par value $0.001 per share.

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

19 unchanged sentences

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.

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

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.

Type 2 diabetes, the more common form of diabetes, is a metabolic disorder

that 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 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

The Centers for Disease Control and Prevention in its National Diabetes Statistics Report, 2023 provided crude estimates for

2021 that there are approximately 38 million people with diabetes in the U.S., of which 29.7 million have diagnosed diabetes.

adults ages 18 years or older, there were 1.2 million new cases of diabetes diagnosed in 2021.

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 body.

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

People with diabetes generally

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

normal ranges.

Normal ranges vary from person to person.

In order to maintain blood glucose levels within normal ranges, people with

diabetes 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 these individuals 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.

People with diabetes who take insulin

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

Company is developing a CGM that will allow continuous monitoring of glucose level, which the Company believes is a significant improvement

in quality compared to spot finger stick devices.

Spot finger stick devices have been 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.

In contrast, CGM systems involve the insertion of sensors into the body to measure glucose levels in the interstitial

fluid throughout the day and night, providing real-time data that shows trends in glucose measurements.

Several published clinical studies

demonstrate that CGMs improve glycemic control in people with type 1 diabetes or people with insulin-requiring type 2 diabetes.

result, CGM use is rapidly increasing and has become the clinically recommended standard of care for these patients.

the benefits in glycemic control, many people with diabetes still have not adopted CGM.

We believe that a significant market opportunity

exists for an innovative CGM devices that addresses the remaining barriers to adoption.

According to a 2017 Diabetes Care study,

these barriers include the hassle of wearing devices all the time, dislike for having diabetes devices on the body, and dislike for how

diabetes devices look on the body.

Additionally, the study reported that reasons that people discontinued using a CGM included the device

being uncomfortable or painful and the belief that the device is not accurate.

4 We believe that improved CGM devices that

address these barriers could provide significant benefits to patients, healthcare providers and payors, thereby increasing overall CGM

adoption and ongoing satisfaction.

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

9 unchanged sentences

PLOS ONE 2012 , 7 , e42551, doi:10.1371/journal.pone.0042551.

Darbinian, J.

Self-monitoring of blood glucose:

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.

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

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

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 2022 and 2021.

Tanenbaum ML, Hanes SJ, Miller KM, Naranjo D, Bensen R, Hood KK.

Diabetes device use in adults with type 1 diabetes:

uptake and potential intervention targets.

Diabetes Care 2017 Feb 1;40(2):181-7.

As mentioned in the “History” section above, the Company

retired its non-invasive point-in-time glucose monitoring (“GlucoTrack 2.0”) and shifted its focus to CGM technology.

we are currently developing a long-term implantable Continuous Blood Glucose Monitor (CBGM) with no requirement for an additional wearable

component with maintained calibration status.

The CBGM utilizes an intravascular approach, in which the device is implanted subcutaneously

and connected to a lead that is placed directly into a blood vessel.

This facilitates continuous blood glucose measurements with zero

In comparison, all CGM systems measure glucose in the interstitial fluid, which lags behind blood glucose.

The approach is based

on design elements, implant techniques, and implant tools commonly used for active implantable devices in the cardiovascular space.

a result, it employs a recognized, established, and widely utilized implant procedure and device form factor.

the second quarter of 2023, we completed the laboratory-based feasibility study demonstrating that the CBGM sensor is capable of measuring

glucose for at least two years post-implant.

By the end of 2023 we completed our initial preclinical in vivo animal study.

preclinical study produced very strong results, demonstrating at least three months of well-sustained sensor life while also demonstrating

that the sensor is safe for animals.

The study also indicated the CBGM is capable of a high level of measurement accuracy as compared

with conventional CGM technologies on the market.

the fourth quarter of 2023, we also initiated a human clinical device/system design and development program and expect to begin our first-in-human

(“FIH”) study in the first quarter of 2025.

This will require a submission to, and eventual approval from, the eventual U.S.

Food and Drug Administration (“FDA”).

We are targeting up to 30 patients across up to 3 US clinical centers;

FDA may limit number of patients and/or clinical centers.

Collecting data for sensor characterization and algorithm development, along

with implant procedure characterization and refinement, will be the primary goals of the FIH study.

These results will drive any necessary

refinements to the system.

Upon incorporation of any required refinements, we intend to conduct a pilot study of the eventual FDA pivotal

trial to prepare for the larger pivotal trial for FDA clearance.

parallel, we are also currently developing the Glucotrack CBGM a companion mobile application and a cloud-based solution to provide real

time, data-driven personalized tools to effectively help a user manage their diabetes and assist healthcare providers with making treatment

In addition to being a critical and effective management tool for the end user, we believe such data may be effectively monetized

for use by third parties such as insurers, pharmaceutical companies and advertisers.

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

Our strategy has been to select leaders in the manufacturing of similar or complementary products.

We recently announced a development

and manufacturing agreement with Cirtec Medical (Brooklyn Park, MN), one of the leading medical device solutions providers of implantable

We require our critical suppliers and their manufacturing facilities to comply with applicable regulations in the jurisdictions

in which our devices are to be marketed (including ISO 13485 in the European Union (“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 our manufacturing partners will perform as expected.

and Development

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

blood continuous glucose monitor, CBGM.

2023 was focused on proving the feasibility of the acquired technology, specifically that the

CBGM technology may last at least two (2) years in a human body, could accurately measure during that time, and would be safe to implant

This was accomplished via three major studies:

in vitro (in liquid solution), in silico (computer modeling and simulation),

and in vivo (animal study).

These studies required development of laboratory and animal study prototypes necessary for these evaluations,

as well as partnering with experts in computational modeling of chemical materials and their interaction with the body.

and in silico efforts successfully completed by late Q2, both confirming that a two-year implant life was possible.

These results triggered

development of the animal prototype and initiation of those studies, which were successfully completed in late Q4 demonstrating very

good accuracy and safety profile.

2023, we began our migration from feasibility to product development.

More specifically, we have partnered with an experienced contract

manufacturing organization, Cirtec Medical, to manufacture the implantable products for the commercial version of the CBGM system that

will be used in forthcoming clinical trials.

Cirtec is one of the leading contract manufacturing organizations specializing in implantable

medical device production.

These efforts have already begun and are expected to provide clinical trial use units in late Q4 of 2024.

parallel, we are developing a dedicated mobile app and cloud system for collecting and managing CBGM System data.

The initial version

will be scaled appropriately for a FIH clinical trial.

This version will serve as a foundation for the eventual commercial version, incrementally

increasing features along with regulatory guidance through clinical trials prior to commercialization.

respect to clinical trials, we are targeting Q1 2025 for initiation of the FIH trial.

This trial is expected to use the commercial version

of the implantable system products (device and sensor), along with the scaled mobile app and cloud as described above.

Throughout 2024,

we will identify potential clinical sites, obtain regulatory approval, and prepare the sites for trial initiation.

We will also be working

with key physician partners to refine the implant, explant, and replacement procedures and associated tool set.

we will continue to increment the implantable sensor design for even better performance.

These efforts will focus on techniques that

can lead to increased longevity of the implanted sensor, increased accuracy of the sensor, and simpler and safer implant, explant, and

replacement tools and procedures.

Further to that, we continue to research materials and techniques that can reduce overall system cost.

“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 2023 and 2022.

Considerations

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.

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 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;

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 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.

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:

(i) the FDA, which administers the Food, Drug, and Cosmetic Act, as well as other relevant laws;

(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;

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

(i) the FDA, which administers the Food, Drug, and Cosmetic Act (the “FDCA”) as well as other relevant laws;

(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

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

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 (the

“FCA”) 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 our devices 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 MDR 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.

Although the CE Mark system and the Medical Device Regulation (“MDR”) 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

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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

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.

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 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.

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.

the United States, under Section 201(h) of the FDCA, 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

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

Class III devices are new and frequently help sustain

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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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,

It is very unlikely, however, that the FDA will deem our CBGM subject to the 510(k) process, as opposed to the more time-consuming,

resource intensive and problematic PMA application process described below.

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

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.

Glucotrack CBGM is still under development and has not yet been approved for commercial sale in or outside the United States.

implantable nature of the Glucotrack CBGM, it is most likely that the device will be assigned a Class III designation and need to follow

the PMA process for regulatory approval.

The Company is preparing for this approach.

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

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

clearance under 510(k).

for FDA approval of a PMA.

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

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

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

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

or additional proof that regulatory requirements have been met.

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

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

proof that regulatory requirements have been met.

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

2 unchanged sentences

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

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

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

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

source or manufacturing process.

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

cleared premarket notification.

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

as well as certain FDA export requirements.

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

certain provisions of the same was signed into law.

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

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

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

The consequences

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

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

medical devices of the type that we contemplate distributing.

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

The most relevant of

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

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

which such manufacturer sells its medical devices.

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

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

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

It is difficult to predict what effect any amendments

to the existing EU legislation may have.

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

requirements additional to the minimum harmonization required by the 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

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

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.

However, Medicare only provides reimbursement

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

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

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

at the national level by CMS.

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

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

provisions will be implemented.

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

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

but coverage can be narrower.

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

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

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

device requires an approval supplement.

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

is exported, as well as certain FDA export requirements.

Company plans to leverage the FDA approval for immediate ability to sell product in Switzerland (as well as the US).

The Swiss competent

authority, SwissMedic, allows entry into the Swiss market with FDA approval.

This will be an initial entry to the central European market

until CE Mark can be obtained.

Geographical proximities enable servicing self-paying customers from nearby countries such as Germany,

France, Austria, and Italy.

Company plans to leverage the PMA clinical trial data, if successful, along with the associated development and manufacturing information,

for CE Mark certification.

The company will choose a notified body and submit via the MDR regulations to obtain this necessary clearance

for marketing in EU member states.

Upon approval, if granted, the Company may consider alternative markets that can leverage both the

FDA and CE Mark approvals.

Reimbursement

Considerations

market, coverage and reimbursement from Medicare, Medicaid or other governmental healthcare programs or systems, and private

third-party healthcare payors is critical to the success of a medical device company.

CGM systems have been broadly accepted by Medicare

and commercial third-party payors.

Currently, Medicare covers CGM systems, which includes supplies necessary

for the use of the device under the Durable Medical Equipment, or DME, benefit category.

Previously, Medicare coverage for CGM was only

available to Medicare patients who take at least three doses of insulin a day.

The Local Coverage Determination, or LCD, that the Medicare

Administrative Contractors (MACs) released in April 2023 extends Medicare CGM coverage to all patients using insulin.

The LCD also allows

coverage for patients not taking insulin if the patient has a history of problematic hypoglycemia.

is currently one commercially available implantable CGM product and the current reimbursement landscape includes coverage for the product

itself, coverage for the implantation process and coverage for the removal and reinsertion process.

Additionally, an LCD was recently

released (NGS ICGM LCD - Effective 4/1/2024) allowing for expanded access of this product to include all people with diabetes using insulin,

removing the previous requirement for at least three doses of insulin a day.

Like non-implantable CGM, the LCD also allows coverage for

patients not taking insulin if the patient has a history of problematic hypoglycemia.

though CGM coverage is broad, we anticipate that sales volumes and prices of our implantable Continuous Blood Glucose Monitor (CBGM)

product will depend in large part on the availability of adequate reimbursement from Medicare and third-party payors.

Medicare reimburses

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

However, Medicare only provides reimbursement if

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

determination can be made at the national level by CMS or at the local level by the Medicare administrative contractor (formerly called

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

the services were rendered.

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.

Our inability to obtain a

favorable coverage determination for our CBGM product may adversely affect our ability to market the product 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

Additionally,

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.

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.

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

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

mitigate these risks, we are starting our reimbursement planning process early, well in advance of obtaining regulatory approval.

have engaged a leading reimbursement consultancy to complete an analysis of the current landscape for CGM technologies.

Additionally,

since our product is an implantable device and very similar in form factor and procedure to commercially available cardiovascular devices,

we are also assessing the current reimbursement landscape for those technologies.

This will enable us to craft a reimbursement strategy

that is best suited to our CBGM product and reflects the different healthcare providers that may be involved in utilizing the product.

reimbursement strategy also incorporates coverage for the product , the implantation procedure, and the removal and reinsertion procedures.

While we can proactively prepare our reimbursement strategy, some activities such as coding applications, if needed, are not able to

be executed until FDA approval is obtained.

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.

It is, therefore, difficult to analyze and

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

healthcare reimbursement, coverage regulations, and systems differ significantly.

An EU reimbursement analysis and strategy may begin

if and when we decide to enter the EU market.

and Abuse Rule

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

False Claims Act (31 U.S.C.

§ 3729 et seq.), which prohibits any person from knowingly presenting or causing to be presented

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

FCA (31 U.S.C.

§ 3729 et seq.), which prohibits any person from knowingly presenting or causing to be presented false or fraudulent

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

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

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This trend is expected

Private enforcement of healthcare fraud also has increased due in large part to amendments to the civil False Claims Act

in 1986 that were designed to encourage private persons to sue on behalf of the government.

These whistleblower suits by private persons,

known as qui tam relators, may be filed by almost anyone, including present and former patients or nurses and other employees, as well

as competitors.

HIPAA, in addition to its privacy provisions, created a series of new healthcare-related crimes.

Private enforcement of healthcare fraud also has increased due in large part to amendments to the civil FCA that were designed

to encourage private persons to sue on behalf of the government.

These whistleblower suits by private persons, known as qui tam relators,

may be filed by almost anyone, including present and former patients or nurses and other employees, as well as competitors.

addition to its privacy provisions, created a series of new healthcare-related crimes.

federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and

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Changes in the law wrought by the provisions of Health Information Technology

for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, increase the duties

of business associates and covered entities with respect to protected health information that thereby subject them to direct government

regulation, increasing its compliance costs and exposure to civil monetary penalties and other government sanctions.

While HITECH does

not alter the definition of a business associate, it makes it more likely that covered entities with whom we are likely to do business

in the United States, if and when we receive FDA approval to market GlucoTrack® in the United States, will require us to enter into

business associate agreements.

maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United States

and other commercially significant markets.

We currently hold 59 issued patents in various regions including patents issued by the United

States, Australian, Brazilian, Canadian, Chinese, European, Hong Kong, Indian, Israeli, Japanese, Korean, Mexican, Philippine, Russian,

South African, and Taiwanese patent offices that cover various parts of our technology, which include A Method Of Monitoring Glucose

Levels, Device For Non-Invasively Measuring Glucose, Individual Measuring Channels For Non-Invasively Measuring Glucose, Ear Clip For

Medical Monitoring Device.

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.

Our success will

depend in large part on our ability to file for and obtain patent protection of our principal products and procedures, to defend existing

or future patents, to maintain trade secrets and to operate without infringing upon the proprietary rights of others.

have obtained trademark registrations for GlucoTrack® in various 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.

Registration have issued in Hong Kong and Taiwan and are pending

in China and Singapore to register GlucoTrack in Chinese characters.

Our application in South Korea to register GlucoTrack in Korean

characters has been allowed.

believe that our patents and products do not and will not infringe patents or violate proprietary rights of others, although it is possible

that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary rights may occur.

Litigation may be necessary to defend or enforce our patent rights or to determine the scope and validity of the proprietary rights of

Defense and enforcement of patent claims can be expensive and time consuming, even in those instances in which the outcome is

favorable, and could result in the diversion of substantial resources and management time and attention from our other activities.

adverse outcome could subject us to significant liability to third parties, require us to obtain licenses from third parties, require

for Economic and Clinical Health (“HITECH”) Act, enacted as part of the American Recovery and Reinvestment Act of 2009 (“ARRA”),

increase the duties of business associates and covered entities with respect to protected health information that thereby subject them

to direct government regulation, increasing its compliance costs and exposure to civil monetary penalties and other government sanctions.

While HITECH does not alter the definition of a business associate, it makes it more likely that covered entities with whom we are likely

to do business in the United States, if and when we receive FDA approval to market GlucoTrack in the United States, will require us to

enter into business associate agreements.

are pursuing a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United

States and other commercially significant markets.

We understand the importance of obtaining patent and trade secret protection for new

technologies, products and processes.

Our success will depend in large part on our ability to file for and obtain patent protection of

our principal products and procedures, to defend existing or future patents, to maintain trade secrets and to operate without infringing

upon the proprietary rights of others.

currently have a published U.S.

patent application number 17/932,238 Methods and Systems for Continuously Monitoring the Glucose Level

of a Patient , awaiting review as well as its associated international application PCT/US22/76435.

Multiple new filings are planned

for 2024 that will broaden the intellectual property protection for our core product, the Glucotrack CBGM.

We have also obtained trademark

registrations for Glucotrack® in the U.S.

and various other jurisdictions.

believe that our intellectual property and products do not and will not infringe patents or violate proprietary rights of others, although

it is possible that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary rights

Litigation may be necessary to defend or enforce our patent rights or to determine the scope and validity of the proprietary

rights of others.

Defense and enforcement of patent claims can be expensive and time consuming, even in those instances in which the

outcome is favorable and could result in the diversion of substantial resources and management time and attention from our other activities.

An adverse outcome could subject us to significant liability to third parties, require us to obtain licenses from third parties, require

us to alter our products or processes, or require that we cease altogether any related research and development activities or product

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or the rights granted under such patents may not provide us with any competitive advantages.

market for blood glucose monitoring devices is intensely competitive, subject to rapid change and significantly affected by new product

introductions.

Four companies, Roche;

LifeScan, Inc., a division of Johnson & Johnson;

Abbott Laboratories;

and Ascensia, a spin

off from the Bayer Corporation, currently account for substantially all of the worldwide sales of self-monitored glucose testing systems.

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.

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,

market for CGM devices is intensely competitive, subject to rapid change and significantly affected by new product introductions.

companies, Abbott Laboratories (“Abbott”), DexCom and Medtronic currently account for substantially all of the worldwide

sales of CGM systems.

These products are all transcutaneous systems with sensor longevities of 7-15 days.

These systems have a sensor

that is worn on the back of the upper arm or the abdomen, depending on the system.

The sensor measures glucose in the interstitial fluid,

which lags glucose in the blood, so the CGM readings may lag about 15-20 minutes behind blood glucose readings.

Depending on the system,

the sensor provides glucose readings every one to five minutes and streams directly to the users’ compatible smartphone.

the insertion of a new Abbott FreeStyle Libre 3 or DexCom G7 sensor, there is a warm-up period of 30-60 minutes, depending on the system,

during which time no readings are available.

After that period, both systems are factory-calibrated, which means that no fingersticks

(blood glucose measurements using a glucometer) are required for calibration.

For the Medtronic Guardian 4 system, there is a 2-hour

warm-up period;

after that period, no fingersticks are required for calibration when using as a part of the MiniMed 780G insulin pump

is currently one implantable CGM that is commercially available in the US and Europe:

Senseonics Holdings, Inc.

The sensor is inserted

by a doctor under the skin of the upper arm and lasts up to 180 days.

The wearable smart transmitter provides on-body vibe alerts and

is worn over the sensor using a daily adhesive.

There is a 24-hour warm up period with this system and, after that period, fingersticks

are required for calibration twice a day for the 1st 21 days and then once daily.

Similar to the transcutaneous systems, this system

also measures glucose in the interstitial fluid.All four competitors are either publicly traded or are divisions of publicly traded companies,

and they enjoy several competitive advantages, including:

significantly

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financial and human resources for product development, sales and marketing, and patent litigation.

of our other non-publicly traded competitors also enjoy these competitive advantages.

As a result, we cannot assure that we will be able

to compete effectively against these companies or their products.

does not directly measure the glucose level concentration in the blood.

Rather, it measures several physiological phenomena that are

correlated with the glucose level.

In order to correlate between the measured signal and the glucose level, a translation is needed.

This translation is accomplished through the individual calibration of the device by reference to a measurement obtained from an invasive

devices under different stages of development generally require frequent recalibration.

For example, GlucoWatch, a single non-invasive

product for glucose trend analysis that was previously approved for sale by the FDA, but which is no longer available commercially, required

recalibrations approximately every 13 hours.

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

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

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

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.

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.

a result, we cannot ensure that we will be able to compete effectively against these companies or their products.

are several new and smaller players that have obtained clearance to market in EU or Asia.

Their systems are transcutaneous systems with

similar form factors and longevity as the Abbott, DexCom and Medtronic systems.

None of these companies has yet achieved a significant

Additionally,

Medtronic and other companies have developed or are developing, insulin pumps integrated with CGM systems that provide, among other things,

the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal or bolus insulin dosing.

Both Abbott and DexCom have received FDA clearance to integrate certain versions of their sensors into automated insulin delivery systems.

we face potential competition from many different sources, we believe that our technology, experience and scientific knowledge provide

us with competitive advantages of accuracy, longevity, discretion and usability, though our technology is not in any way integrated with

an automatic insulin delivery system.

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

address is http://www.glucotrack.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.

and Committees

have five members on our Board, four of whom are independent.

have six members on our Board, five of whom are independent.

The Board has an Audit Committee and a Compensation Committee and Nominating

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

As of December 31, 2022, we had

three full-time employees.

of December 31, 2023, we had six full-time employees.

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

In addition, as of December 31,

2022, we had five significant consultants.

addition, as of December 31, 2023, 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