What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-30 compared with 2025-03-31 · 273 added, 287 removed, 382 unchanged (59% of the section changed)

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

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

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

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

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”).

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

As such, we have since withdrawn our CE Mark for Glucotrack and are no longer pursuing commercialization of this product

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 Type 2 diabetes using insulin

or at risk for hypoglycemia (the “Glucotrack CBGM”).

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 determined in 2023 that it would focus its efforts on developing the

Glucotrack CBGM.

As such, the Company withdrew the CE Mark for Glucotrack and are no longer pursuing commercialization of this product

or development of any further iterations.

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

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

Type 2 diabetes market.

Company is currently developing the Glucotrack CBGM for use by Type 1 diabetes patients as well as insulin-dependent Type 2

Goode, the Company’s

Chief Executive Officer and intends to develop the technology to address the growing Type 1 and Type 2 diabetes market.

Company is currently developing the Glucotrack CBGM for use by Type 1 diabetes patients as well as Type 2 diabetes using insulin or at

risk for hypoglycemia..

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.

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.

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

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

Subsequently we announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results.

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.

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.

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

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.

Company has recently completed a first in human study.

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

The Company believes this approach may enable integrated chronic disease management with one system that provides dual benefits of pain

relief and glucose monitoring.

Company completed a first in human study in 2025.

This study was an acute study intended to demonstrate device performance and safety,

5 unchanged sentences

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

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

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.

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.

Initial results were presented in poster form at the 2025 Advanced Technologies & Treatments for Diabetes annual meeting

and final results were presented in poster form at the 2025 American Diabetes Association annual conference.

Company initiated a long-term, multicenter feasibility study in Australia to evaluate the CBGM product performance and safety.

first phase of the clinical study provided early product learnings about how the complexity of certain health conditions may impact

study eligibility as well as identified certain product improvements.

Following a reassessment of the study in light of planned

product updates and anticipated protocol modifications, the Company determined that continuation of the study in its current

form was no longer practical and elected to close the study.

Consequently, the Company is expediting discussions with the U.S.

Food and Drug Administration

(FDA) regarding our planned United States (“U.S.”) clinical trial program that we expect to launch in the second

half of 2026, subject to FDA approval of our Investigational Device Exemption (“IDE”) submission expected to be filed in the second quarter of 2026.

Company initially obtained ISO13485 certification in 2024 and successfully passed the 2025 annual audit, both efforts without any

major nonconformities.

ISO 13485 is an internationally agreed-upon standard of quality system requirements for the design, production,

distribution, and sale of medical devices.

Certification of compliance to the standard is recognized and accepted by the FDA, the European

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

executive management team consists of our Chief Executive Officer and President, Paul V.

1 unchanged sentence

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.

(“Dexcom”) and MiniMed (now Medtronic Diabetes)

and Chief Financial Officer, Peter C.

Wulff, who has 40 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;

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.

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;

Wong, Chief Operating Officer, a medical device professional with over 15 years of experience in operations and quality systems for implantable

medical device manufacturing with senior roles at Cirtec Medical and TOMZ Corporation (“TOMZ”);

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

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

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

3 unchanged sentences

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.

and Victoria Carr-Brendel, formerly of Dexcom, Boston Scientific, JenaValve Technology,

and Advanced Bionics.

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

26 unchanged sentences

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 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.

to the Diabetes Atlas (Eleventh Edition) published by the International Diabetes Federation in 2025, approximately 589 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 2025 (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 853 million adults worldwide

The Centers for Disease Control and Prevention in its 2025 National Diabetes Statistics Report provided crude estimates for

2021 that there are approximately 40.1 million people with diabetes in the U.S., of which 29.1 million have diagnosed diabetes.

US adults ages 18 years or older, there were 1.5 million new cases of diabetes diagnosed in 2023.

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

21 unchanged sentences

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;

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

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.

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

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.

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.

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.

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

at 2024 ADCES annual conference.

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

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.

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.

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.

The Company believes 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 conducted its own market research studies in 2024 and 2025 to validate its belief that these findings are still relevant.

The results on over 1,500 patients demonstrated that patients with diabetes still have the same issues as expressed in 2017 and that interest

in a long-term, fully implantable CBGM is high.

The Company is developing a long-term CBGM 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.

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

(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 effectively

zero lag time.

In comparison, commercially-available CGM systems 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

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

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 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.

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.

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

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.

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

the 60-day period.

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.

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

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.

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

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.

Initial regulatory feedback from the Australian regulatory body is expected

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

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.

2025, we will identify potential clinical sites, obtain regulatory approval, and prepare the sites for trial initiation.

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

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.

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.

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.

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.

Since 2023, we have completed three additional preclinical animal studies for our CBGM sensor, demonstrating

performance and accuracy up to six months.

the end of 2023, we initiated a human clinical device/system design and development program.

The program outsourced development and manufacturing

to respective contract design and contract manufacturing organizations.

Since then, we have developed a dual supply source for both implantable

system components (the electronics assembly and the sensor lead), both of which are ISO 13485 certified with dedicated experience in

manufacturing active implantable medical devices.

Both organizations have since manufactured products used in various Glucotrack pre-clinical

bench and animal studies, as well products used in both our human clinical trials.

in 2024, we worked with The Technology Partnership, or “TTP” (Cambridge, UK) to demonstrate 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.

Since then, we have worked with TTP to migrate sensor chemistry into

a production environment under ISO 13485 certification.

2024, we announced that the Glucotrack CBGM successfully completed a 60-day long-term preclinical study on measuring glucose in the epidural

The Glucotrack CBGM sensor, implanted in the epidural space of animals, closely tracked both blood glucose and a commercially

available subcutaneous CGM throughout the 60-day period.

The implantation procedure took approximately 20 minutes, and the animals recovered

without complications.

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.

The Company is currently working with a renowned neuromodulation physician

to evaluate a clinical development program to further advance the medical application of this technology.

late 2024, we initiated an acute (5 day) FIH study for a prototype version of our CBGM in Sao Paulo, Brazil.

The clinical trial

evaluated the CBGM sensor technology in a cohort of 8 in-hospital patients.

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.

study was completed in early 2025 and successfully met all objectives.

late 2025, the Company initiated a clinical study outside the United States to evaluate the CBGM product performance and safety.

first phase of the clinical study provided early learnings about how the complexity of certain health conditions may impact study eligibility

as well as identified certain product improvements.

Based on these findings, the Company plans to continue its clinical program with

protocol amendments.

These learnings have been incorporated into the Company’s ongoing discussions with the FDA regarding the U.S.

clinical study program.

In the first half of 2026, the Company intends to advance these discussions

and reprioritize its clinical activities to place greater emphasis on the U.S.

clinical study program.

second quarter 2025, the Company has been in discussions with the FDA through the presub process and preparing for an Investigational

Device Exemption (“IDE”) submission in the second quarter of 2026.

The presub discussions pertain to the protocol study design and

related requirements to secure IDE approval for the initial Feasibility Study and future long-term human clinical trials in the United

In anticipation of the IDE approval for the Feasibility Study, the Company has identified and is collaborating with a respected

physician investigator and medical institution well known for conducting CGM studies.

early 2025, we received ISO 13485:2016 certification from the British Standards Institute (“BSI”).

This verified 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.

The Company had the annual compliance audit in late 2025 and was found to be in compliance with no major

and Development

“ 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

“ 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, 2025 and

Considerations

72 unchanged sentences

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)” 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.

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 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”

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.

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

31 unchanged sentences

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

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.

the implantable nature of our CBGM, it is most likely that the device will be assigned a Class III designation which commonly

requires the PMA process for regulatory approval.

However, in discussions with the FDA, the Company believes it can file under a De

Novo 510k process provided it meets interoperable Continuous Glucose Monitor (“iCGM”) requirements.

The clinical trial rigor necessary to meet this is the same as that for a PMA,

but the benefits of a 510k classification are impactful post-clearance.

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

23 unchanged sentences

is exported, as well as certain FDA export requirements.

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

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

for CE Mark certification.

24 unchanged sentences

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 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.

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.

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,

8 unchanged sentences

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 Glucotrack CBGM and reflects the different healthcare providers

that may be involved in utilizing the product.

have engaged a leading reimbursement consultant to complete an initial 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.

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.

While we are proactively preparing our reimbursement strategy, some activities such as coding applications, if needed, may not be executed

until FDA approval is obtained.

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

53 unchanged sentences

Privacy Provisions of HIPAA

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

limiting its use and disclosure.

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.

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.

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.

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

5 unchanged sentences

upon the proprietary rights of others.

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.

of December 31, 2025, the Company has strengthened its patent portfolio with the issuance of three U.S.

12,453,494, Methods and Systems for Measuring Glucose Having Improved Decay Rates and Lag Times (issued October 28, 2025).

This patent covers methods and system architectures for implantable glucose sensing that address signal decay and response lag over time.

The claims relate to sensor configurations, control strategies, and data-processing approaches intended to improve temporal response

characteristics and signal stability during long-term glucose monitoring.

12,458,257, Implantable Glucose Sensors and Methods of Glucose Measurement Configured for Minimal Sensor Surface Obstruction

(issued November 4, 2025).

This patent covers implantable glucose sensor designs and related measurement methods that reduce functional

impairment caused by surface obstruction or fouling.

The claims focus on structural, material, and interface features intended to preserve

sensor performance in vivo by mitigating the effects of tissue interaction and biological accumulation at the sensor surface.

12,458,258, Low Power Implantable Glucose Sensors and Methods of Glucose Measurement (issued November 4, 2025).

covers implantable glucose sensing systems and operational methods designed to reduce power consumption while maintaining measurement

functionality.

The claims relate to low-power sensor architectures, measurement strategies, and system-level approaches intended to support

extended operational lifetimes in implantable glucose monitoring applications.

patents described above resulted from the prosecution of previously filed and previously disclosed patent applications that

were converted to issued patents in 2025.

In addition to these issued patents, the Company filed one U.S.

utility patent application,

continuation application and one U.S.

provisional application.

The Company may evaluate additional patent filings from time

to time as its technology development progresses.

2025, one related international patent application has been published:

2025/193719 A1, Systems and Methods for Integrated Spinal Cord Stimulation and Glucose Monitoring (published September 18, 2025).

have trademark registrations for Glucotrack® in the U.S.

and Europe and various other jurisdictions.

69 unchanged sentences

and Committees

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

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

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

of December 31, 2024, we had eleven full-time employees.

Each of our committees consists solely of independent directors.

of December 31, 2025, we had fifteen 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.

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