GCTK US Equity☆

Item 1A. Risk Factors 15

Item 1B. Unresolved Staff Comments 29

Item 1C. Cybersecurity 29

Item 2. Properties 30

Item 3. Legal Proceedings 30

Item 4. Mine Safety Disclosures 30

PART II

Item 6. [Reserved] 35

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 45

Item 8. Financial Statements and Supplementary Data 45

Item 9A. Controls and Procedures 45

Item 9B. Other Information 46

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 46

PART III

Item 10. Directors, Executive Officers and Corporate Governance 47

Item 11 Executive Compensation 50

Item 14. Principal Accountant Fees and Services 61

PART IV

Item 15. Exhibits and Financial Statement Schedules 62

Signatures 64

Cautionary

Note Regarding Forward-Looking Statements

This

Annual Report on Form 10-K (the “Annual Report”) includes statements that express our opinions, expectations, beliefs, plans,

objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking

statements.” All statements other than statements of historical facts contained in this Annual Report may be forward-looking statements.

These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms “believes,”

“estimates,” “continues,” “anticipates,” “expects,” “seeks,” “projects,”

“intends,” “plans,” “may,” “will,” “would” or “should” or, in

each case, their negative or other variations or comparable terminology. They appear in a number of places throughout this Annual Report,

and include statements regarding our intentions, beliefs or current expectations concerning, among other things, our results of operations,

financial condition, liquidity, prospects, growth, strategies, future acquisitions and the industry in which we operate.

By

their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that

may or may not occur in the future. We believe that these risks and uncertainties include, but are not limited to, those described in

the “Risk Factors” section of this Annual Report, which include, but are not limited to, risks related

to the following:

● our ability to manufacture, market and sell our products;

● our ability to launch and penetrate markets;

● our ability to hire and retain key personnel;

● our ability to internally develop new inventions and intellectual property;

● our ability to remain a going concern;

● our ability to be profitable;

● interpretations of current laws and the passages of future laws;

● acceptance of our business model by investors;

● the risks inherent with international operations;

● the impact of governmental regulations on our business and industry;

These

factors should not be construed as exhaustive and should be read with the other cautionary statements in this Annual Report.

Readers

are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this report is filed with

the Securities and Exchange Commission (“SEC”). We cannot guarantee the accuracy of any such forward-looking statements contained

in this Annual Report, and we do not intend to publicly update or revise any forward-looking statements, whether as a result of new information,

future events, or otherwise. For further information regarding risks and uncertainties associated with our business, and important factors

that could cause our actual results to vary materially from those expressed or implied in such forward-looking statements, please refer

to the factors listed and described in this Annual Report and in our other SEC filings.

PART

I

Item

1. Business

Unless

the context otherwise requires, the terms “we”, “our”, “ours” “us”,

“Company” and “Glucotrack” refer to Glucotrack, Inc., a Delaware corporation.

Overview

The

Company was incorporated on May 18, 2010 under the laws of the State of Delaware. We are a medical device company focused on the

development of an implantable continuous blood glucose monitor (“CBGM”) for persons with Type 1 diabetes and insulin-dependent Type 2

diabetes (the “Glucotrack CBGM”).

The

Company was founded with a mission to develop Glucotrack®, a non-invasive 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 has since rapidly moved away from point-in-time

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

CBGM. 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.

On

October 7, 2022, the Company acquired certain intellectual property related to the Glucotrack CBGM from Paul V. Goode, the

Company’s Chief Executive Officer and intends to develop the technology to address the growing Type 1 and insulin-dependent

Type 2 diabetes market.

The

Company is currently developing the Glucotrack CBGM 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. We have continued to evolve our sensor chemistry following our successful

in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor design. Recently

we announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also completed multiple

animal studies with initial prototype systems which demonstrated a simple implant procedure with good safety and functionality. The results

of both were presented in poster form at the 2024 American Diabetes Association annual conference.

Further

to the above progress on the Glucotrack CBGM, we have also successfully demonstrated continuous glucose sensing in the epidural space. This

latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their condition.

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.

The

Company has recently completed a first in human study. This study was an acute study intended to demonstrate device performance and safety,

as well as safety of the implant and removal procedures. The study used the planned commercial version of the implantable sensor connected

to an externalized prototype electronics device. Patients were monitored in hospital for 4 days. Results of the study were positive,

meeting the endpoints of no serious safety events while demonstrating similar performance and accuracy as observed in longer-term animal

studies.

A

regulatory submission has recently been made for a first in human study of the planned commercial version of the Glucotrack CBGM

system: fully implantable sensor and electronics with no on-body wearable. This will be a long-term study intended to demonstrate

device performance and safety over a period of at least one year. Most of the preparatory clinical activities are complete and the

study is expected to initiate late in the second quarter of 2025, pending regulatory approval. In parallel, the Company is also

preparing for pre-submission discussions with the U.S. Food and Drug Administration (FDA) regarding our planned multi-center United

States (“U.S.”) clinical trial we hope to launch before the end of 2025.

As

part of this effort, the Company has recently obtained ISO13485 certification, an internationally agreed-upon standard of quality

system requirements for the design, production, distribution, and sale of medical devices. The Company has successfully completed

all necessary audits without any major nonconformities. Certification of compliance to the standard is recognized and accepted by

the FDA, the European Medicines Agency (EMA), and many other regulatory authorities worldwide.

Our

executive management team consists of our Chief Executive Officer and President, Paul V. Goode PhD, an experienced executive with a

25+ year career developing innovative medical technologies, including at Dexcom, Inc. (“Dexcom”) and MiniMed (now

Medtronic Diabetes) and Chief Financial Officer, Peter C. Wulff, who has over 35 years of experience as a chief financial officer

and chief operating officer in both public and private entities. Our senior management team consists of: Mark Tapsak PhD, Chief

Scientific Officer, a medical research scientist who brings over 25 years of experience in the diabetes industry, including previous

senior roles at Dexcom and Medtronic; James P. Thrower PhD, Vice President of Advanced Technologies, a seasoned engineering

executive with 20 years’ experience formerly of Sterling Medical Devices, Mindray DS USA and Dexcom.; Drinda Benjamin, Vice

President of Marketing, a medical device professional with over 20 years of experience in the medical device and diabetes industry

with senior roles at Intuity Medical, Senseonics, Incorporated, Abbott Diabetes, and Medtronic Diabetes; Vincent Wong, Vice

President of Operations, a medical device professional with 15 years of experience in quality system for implantable medical device

manufacturing with senior roles at Cirtec Medical and TOMZ Corporation (“TOMZ”); Sandie Martha, Vice President Clinical Operations, a medical device

professional with over 20 years of experience in the medical device and diabetes industry with senior roles at Dexcom and GlySens Incorporated (“GlySens”);

and Ted Williams, Vice President Regulatory, a medical device professional with over 20 years of experience in the biotech and

diabetes industry with a senior role at GlySens.

Our

Board of Directors (the “Board” or “Board of Directors”) includes the Chairman Luis J. Malavé, formerly

of Insulet Corp, Medtronic and MiniMed (now Medtronic Diabetes); Andy Balo, formerly of Dexcom and St Jude Medical (now Abbott), Erin

Carter, formerly of Medtronic and Boston Scientific; John Ballantyne, formerly of Aldeveron; Robert Fischell, formerly of Pacesetter

(now Abbott), NeuroPace, and IsoStent, Inc.; and Allen Danzig, formerly of L3-Harris Technologies and Celanese.

Market

Opportunity

Diabetes

Diabetes

is a chronic, life-threatening disease for which there is no known cure. Diabetes is caused by the body’s inability to produce

or effectively utilize the hormone insulin. This inability prevents the body from adequately regulating blood glucose levels. Glucose,

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

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

levels when concentrations are too high. In people with diabetes, blood glucose levels fluctuate between very high levels, a condition

known as hyperglycemia, and very low levels, a condition known as hypoglycemia. Hyperglycemia can lead to serious long-term complications,

such as blindness, kidney disease, nervous system disease, amputations, stroke and cardiovascular disease. Hypoglycemia can lead to confusion,

loss of consciousness or death.

Diabetes

is typically classified into two major groups: Type 1 and Type 2. Type 1 diabetes is characterized by the body’s inability to produce

insulin, resulting from destruction of the insulin producing cells of the pancreas. Individuals with Type 1 diabetes must rely on frequent

insulin injections in order to regulate and maintain blood glucose levels. Type 1 diabetes is frequently diagnosed during childhood or

adolescence, although disease onset can occur at any age. Type 2 diabetes, the more common form of diabetes, is 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.

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. The Centers for Disease Control and Prevention in its 2023 National Diabetes

Statistics Report 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. Among US adults ages 18 years or older, there were 1.2 million new cases of diabetes

diagnosed in 2021.

Glucose

Monitoring

Blood

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. Given the

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 should be performed (at a minimum) 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.

Until

recently, spot finger stick devices known as blood glucose monitors (“BGM”) 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 BGMs, the routine measurement of glucose levels remains invasive, painful, inconvenient, difficult and costly. Moreover, the American

Diabetes Association updated guidelines (released 2023) indicated there is no clinical evidence of benefit for non-insulin dependent

Type 2 diabetes patients; and recommended CGM as the standard of care for those patients.

Continuous glucose monitor (“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. Many published clinical studies demonstrate that CGMs improve glycemic

control in people with Type 1 diabetes or people with insulin-requiring Type 2 diabetes. As a result, CGM use is rapidly increasing and

has become the clinically recommended standard of care for these patients.

Despite

the benefits in glycemic control and significant insurance coverage, almost half of the people with diabetes still have not adopted CGM.

We believe that a significant market opportunity exists for an innovative CGM device that addresses the remaining barriers to adoption.

According to a 2017 Diabetes Care study, these barriers include the inconvenience of wearing devices all the time, discomfort

and inconvenience of bi-weekly device replacement, 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.1 The Company conducted its own market research study in 2024 to

validate these findings as still being relevant. The results on over 750 patients demonstrated that patients with diabetes still have

the same issues as expressed in 2017.2 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. The Company

is developing a long-term implantable blood-based CGM that will allow continuous monitoring of blood glucose levels, which the Company

believes is a significant improvement in quality compared to spot finger stick devices and CGM.

1 Tanenbaum

ML, Hanes SJ, Miller KM, Naranjo D, Bensen R, Hood KK. Diabetes device use in adults with type 1 diabetes: barriers to uptake and potential

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

2

“Evaluating Acceptance of a Continuous Blood Glucose Monitor for People with Insulin Requiring Diabetes”, Presented

at 2024 ADCES annual conference.

Our

Product

The

Company is currently developing a long-term implantable CBGM with no requirement for an additional

wearable component with maintained calibration status (the “Glucotrack CBGM”). The Glucotrack 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 lag time. In comparison, all other CGM systems of which we are

aware measure glucose in the interstitial fluid, which lags behind blood glucose. Our approach is based on design elements, implant techniques,

and implant tools commonly used for active implantable devices in the cardiovascular space. As a result, it employs a recognized, established,

and widely utilized implant procedure and device form factor.

In

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. This initial

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.

In

the fourth quarter of 2023, we initiated a human clinical device/system design and development program. The objective was to complete

this effort in time to initiate regulatory filings for a first-in-human acute (“FIH-A”) study in the second quarter of 2024.

In

the first quarter of 2024, we advanced the program of the commercial device/system design and development program with our contract manufacturing

partner, Cirtec Medical. The objective was to complete this effort in time to initiate regulatory filings for a first-in-human chronic

(“FIH-C”) study in the fourth quarter of 2024.

During

the second quarter of 2024, we announced that the Glucotrack CBGM successfully completed 30 days of a 60-day long-term preclinical

study on measuring glucose in the epidural space. The Glucotrack CBGM sensor, implanted in the epidural space of animals,

closely tracked both blood glucose and a commercially available subcutaneous CGM throughout the 30-day period. The implantation

procedure took approximately 20 minutes, and the animals recovered without complications. No abnormal clinical signs or findings in

the spinal cord or surrounding tissues were observed at the 30-day mark. We subsequently announced that the 60-day long-term study

was completed, demonstrating the feasibility of glucose monitoring in the epidural space. No abnormal clinical signs were observed

throughout the study period, and no abnormal findings were observed in the spinal cord or surrounding tissues during post-explant

analysis. The study also confirmed that the implanted sensor did not cause any delayed latent effects over the long-term period,

which is particularly important as a complete healing process in animal studies with implanted devices may take several weeks. With

the completion of this study, the durability of the epidural approach for continuous glucose monitoring has now been confirmed over

the 60-day period.

Also

in the second quarter of 2024, a regulatory submission was prepared and eventually submitted for the FIH-A study to be performed in Sao

Paulo, Brazil. This study was a small cohort of up to 10 patients evaluated in-hospital for 4 days. The goals of the study were to prove

the implant and removal procedures were safe and reasonable, the device was safe and functional, and the overall experience was well-tolerated.

The trial began in December 2024 and was completed in late January 2025. The study successfully met all objectives.

During

the third quarter of 2024, we presented data at the Diabetes Technology Society annual meeting that demonstrated a sensor longevity of

3 years. Using in silico modeling to iterate membrane parameter design changes and further validated by in vitro bench testing, we were

able to improve our projected sensor longevity from 2 years to 3 years.

During

the fourth quarter of 2024, a regulatory submission was prepared and eventually submitted for the FIH-C study to be performed in Melbourne,

Australia. This study is to be up to 30 patients across up to 3 centers evaluated in daily life for one year, with the option to extend

the study longer. The goals of the study are to collect data for sensor characterization and algorithm development, along with implant

procedure characterization and refinement. These results will drive any necessary refinements to the system. Upon incorporation of any

required refinements, we intend to conduct a U.S. Pilot Study. Initial regulatory feedback from the Australian regulatory body is expected

in first quarter 2025 with trial start expected in second quarter 2025.

With

respect to clinical trials, we are targeting the second quarter of 2025 for initiation of the FIH-C 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. Throughout

2025, 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 also

request our first pre-submission meeting with the FDA. The goal of this is to initiate

discussions culminating in an Investigational Device Exemption (“IDE”) submission in the third quarter of 2025. The IDE submission

will be for a U.S. Pilot Study targeting up to 40 patients across up to 3 U.S. clinical centers; however, the FDA may limit number of patients

and/or clinical centers. The primary goal of this study is to be a ‘dry run’ for the eventual FDA pivotal trial for FDA approval.

In

the first quarter of 2025, we received ISO 13485:2016 certification from the British Standards Institute (“BSI”). We successfully

completed Stage I and Stage II Assessments performed by the notified body, BSI, to verify the Company has established, and is maintaining,

a quality management system that meets all requirements of the ISO 13485:2016 standard for design and development of our products.

We

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

future. 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

therapies. 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.

Research

and Development

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 December 31, 2024 and

2023.

Regulatory

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. 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; 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.

In

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 (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

programs; and (iv) the Office of Civil Rights which administers the privacy and security aspects of the Health Insurance Portability

and Accountability Act of 1996 (“HIPAA”). All of the aforementioned are agencies within the Department of Health and Human

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

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

of Health and Human Services under the Public Health Service Act, the Department of Justice through the federal False Claims Act (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.

The

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 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.

Regulation

of the Design, Manufacture and Distribution of Medical Devices

Any

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

a particular country.

Sales

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

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

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

than those necessary to obtain FDA approval (as described below). These differences may affect the efficiency and timeliness of international

market introduction of 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 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

controls. Class II devices are somewhat more complex and require greater scrutiny. Class III devices are new and frequently help sustain

life.

In

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

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

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

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

either Class I or Class II devices. Under the 510(k) submission process, the FDA will issue an order finding substantial equivalence

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

and permitting commercial distribution of that device for its intended use. A 510(k) submission must provide information supporting

its claim of substantial equivalence to the predicate device. The FDA permits certain low risk medical devices to be marketed

without requiring the manufacturer to submit a premarket notification. In other instances, the FDA may require that a premarket

notification not only be submitted, but also be accompanied by clinical data. If clinical data from human experiments are required

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

investigations performed in the United States. The FDA review process for premarket notifications submitted pursuant to section

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

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

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

may “clear” that device for marketing. These devices are not “approved” by the FDA. It is very unlikely,

however, that the FDA will deem our Glucotrack CBGM subject to the 510(k) process, as opposed to the more time-consuming, resource

intensive and problematic PMA application process described below.

The

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

to be used in supporting or sustaining life or preventing impairment. These devices are normally Class III devices and can only be marketed

following approval of a PMA application. For example, most implantable devices are subject to the PMA approval process. Two steps of

FDA approval generally are required before a company can market a product in the U.S. that is subject to Section 515 PMA approval, as

compared to a Section 510(k) clearance. First, a company must comply with investigational device exemption regulations in connection

with any human clinical investigation of the device; however, those regulations permit a company to undertake a clinical study of a “non-significant

risk” device without formal FDA approval. Prior express FDA approval is required if the device is a significant risk device. If

there is any doubt as to whether a device is a “non-significant risk” device, companies normally seek prior approval from

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

decisions are based on the results from the existing diagnostic device. In such a setting, the FDA may consider the clinical trial as

one not posing a significant risk. However, FDA action is always uncertain and dependent on the contours of the design of the clinical

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

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

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

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

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

occurs annually, and annual re-approval is required. University medical centers as well as other entities maintain and operate IRB. Second,

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

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

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

The

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

the implantable nature of our 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. We are preparing for this approach.

Even

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

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

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

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

on its own initiative or the FDA or a notified body may terminate or suspend the study. There is no assurance that a clinical study at

any given site will progress as anticipated; there may be an insufficient number of patients who qualify for the study or who agree to

participate in the study, or the investigator at the site may have priorities other than the study. Also, there can be no assurance that

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

for FDA approval of a PMA. 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.

After

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.

A

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

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

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

The

Company plans to leverage the De Novo/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

In

the U.S. 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 (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 (LCD), that the Medicare Administrative Contractors

(MACs) released in April 2023 extended 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.

There

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.

Even

though CGM coverage is broad, we anticipate that sales volumes and prices of the Glucotrack CBGM 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. A coverage 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.

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

To

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

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 Glucotrack CBGM and reflects the different healthcare providers

that may be involved in utilizing the product.

Our

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

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

be executed until FDA approval is obtained.

Outside

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

Anti-Fraud

and Abuse Rule

There

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

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

in the United States. These federal laws include, by way of example, the following:

Sanctions

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

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

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

with persons excluded from the Medicare and other government programs.

Many

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

the Medicare and Medicaid programs, to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals

regardless of whether the service was reimbursed by Medicare or Medicaid. Many states have also adopted or are considering legislative

proposals to increase patient protections, such as limiting the use and disclosure of patient specific health information. These state

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

Similarly,

the EU and EU member countries may have similar fraud and abuse laws which would regulate our business in those jurisdictions. However,

given the diversity of legal systems within the EU, it is difficult to predict with specificity what anti-fraud legislation and regulations

may be implemented and the penalties that they impose.

In

the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations

and audits by federal and state agencies that oversee these laws and regulations. Recent federal and state legislation has greatly increased

funding for investigations and enforcement actions, which have increased dramatically over the past several years. This trend is expected

to continue. 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. HIPAA, in

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

As

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

enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs. A violation of any of these

federal and state fraud and abuse laws and regulations could have a material adverse effect on a supplier’s liquidity and financial

condition. An investigation into the use of a device by physicians may dissuade physicians from recommending that their patients use

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

The

Privacy Provisions of HIPAA

In

the United States, HIPAA, among other things, protects the privacy and security of individually identifiable health information by

limiting its use and disclosure. HIPAA directly regulates “covered entities,” such as healthcare providers, insurers and

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

All entities that receive and process protected health information are required to adopt certain procedures to safeguard the

security of that information. It is uncertain whether we would be deemed to be a covered entity under HIPAA and, owing to changes in

the law, it is uncertain, based on our current business model, whether we would be a business associate. Nevertheless, we will

likely be contractually required to physically safeguard the integrity and security of any patient information that we receive,

store, create or transmit in the United States. If we fail to adhere to our contractual commitments, then our physician, hospital or

insurance customers may be subject to civil monetary penalties, which could adversely affect our ability to market our devices.

Changes in the law wrought by the provisions of Health Information Technology for Economic and Clinical Health

(“HITECH”) Act, enacted as part of the American Recovery and Reinvestment Act of 2009 (“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 the Glucotrack CBGM in the United States,

will require us to enter into business associate agreements.

Intellectual

Property

We

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.

The

Company’s U.S. patent application, US20230079720A1, titled ‘Methods and Systems for Continuously Monitoring the Glucose Level

of a Patient,’ is currently under review. Two related international applications, EP4401635A1 and WO2023044347A1, have been published

and are also pending review. Additionally, the Company has filed during 2024 four new provisional patent applications: US63/563,880,

‘Systems and Methods for Integrated Spinal Cord Stimulation and Glucose Monitoring’; US63/633,647, ‘Methods and Systems

for Continuously Monitoring the Glucose Level of a Patient’; US63/661,648, ‘Methods and Systems for Continuously Monitoring

the Glucose Level of a Patient’ ; and US63/661,526, ‘Amperometric Electrochemical Enzyme Oxidase Sensor’. We have trademark

registrations for Glucotrack® in the U.S. and Europe and various other jurisdictions.

We

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

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

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

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

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

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

sales.

Patent

protection is highly uncertain and involves complex legal and factual questions and issues. The patent application and issuance process

can be expected to take several years and entails considerable expense. There can be no assurance that patents will be issued as a result

of any applications or that any patents resulting from such applications, or our existing patents will be sufficiently broad to afford

protection against competitors with similar or competing technology. Patents that we obtain may be challenged, invalidated or circumvented,

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

Competition

The

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

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. Following

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

system.

There

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 365 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 greater name recognition;

● established distribution networks;

As

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

There

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

user base.

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.

Although

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.

Corporate

Information

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.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 Annual Report.

Board

and Committees

We

have seven members on our Board, five of whom are independent. The Board has an audit committee (the “Audit Committee”),

a compensation committee and a nominating and corporate governance committee. Each of our committees consist solely of independent

directors.

Employees

As

of December 31, 2024, we had eleven full-time employees. None of our employees are represented by a collective bargaining agreement.

In addition, as of December 31, 2024, we had three significant consultants.

Item

1A. Risk Factors

An

investment in our Common Stock involves a high degree of risk. You should carefully consider the following risks and all of the other