What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-03-28 · 309 added, 336 removed, 360 unchanged (64% of the section changed)

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

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

multiple verticals within the diabetes market.

Company was founded with a mission to develop GlucoTrack®, a noninvasive glucose monitoring device designed to help people with diabetes

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

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an updated product with improved accuracy and human factors.

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

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

continuous glucose monitor (“CGM”).

As such, we have since withdrawn our CE Mark for GlucoTrack and are no longer pursuing commercialization of this product or development

of any further iterations.

Company is currently developing an Implantable CGM for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients.

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As such, we have since withdrawn our CE Mark for Glucotrack and are no longer pursuing commercialization of this product

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

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

We have recently completed a feasibility study successfully demonstrating that

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

We have also initiated an animal study with an initial

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

The Company will initiate a long-term

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

in late 2024 for a first in human study.

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

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

are currently developing our own mobile companion application and a cloud-based solution platform to provide real time, data driven personalized

tools to effectively help a user manage their diabetes.

In addition to being a critical and effective management tool for the end user,

we believe that third parties such as insurers, pharmaceutical companies and advertisers would be willing to pay for the de-identified

data that we will obtain through our platform, and that this is an opportunity for us to develop an additional revenue source.

Senior Management team includes;

Chief Executive Officer and President, Paul V.

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

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

and tax compliance, James P.

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

DS USA and DexCom, Inc.

(“DexCom”) , Mark Tapsak PhD, Vice President of Sensor

Technology, a medical research scientist who brings over 25 years of experience in the diabetes industry, including previous senior roles

at DexCom and Medtronic plc (“Medtronic”);

and Drinda Benjamin, Vice President

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

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

manufacturing experience from Cirtec Medical Corp.

(“Cirtec Medical”) and TOMZ Corporation.

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

or “Board of Directors”).

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

September 27, 2021, our shelf Registration Statement on Form S-3 (File No.

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

was declared effective by the Securities and Exchange Commission (the “SEC”).

The shelf registration statement permits us

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

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

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

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

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

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

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

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

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

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

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

The Company entered into an underwriting agreement

with Aegis Capital Corp.

on April 13, 2023.

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

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

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

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

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

The primary goal of the feasibility study was to demonstrate

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

Laboratory bench testing confirmed

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

The implant longevity was independently

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

Given the positive results of the study,

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

On October 12, 2023, the Company

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

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

(the “Company”) to pursue other

career interests.

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

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

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

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

reporting and tax compliance.

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

providing additional accounting and financial reporting services to the Company.

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

also served as interim Chief Financial Officer at several entities.

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

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

October 11, 2023, in connection with Mr.

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

Cardwell entered

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

Pursuant to the terms of the Cardwell

Consulting Agreement, Mr.

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

As compensation for his services,

the Company shall pay Mr.

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

The Cardwell Consulting Agreement is for a term

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

On November 13, 2023, the Company

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

to CGM technology.

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

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

This historical

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

individuals managing diabetes.

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

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

If at any time during the Extended Compliance Period, the

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

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

If we cannot demonstrate compliance

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

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

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

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

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

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

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

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

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.

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 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

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.

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;

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.

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.

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

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

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

between the ages of 20 and 79, or approximately 10% of the world’s adult population, were estimated to suffer from diabetes in

2021 (not including those persons who suffer from impaired glucose tolerance or gestational diabetes, diabetic conditions first arising

during pregnancy).

The International Diabetes Federation estimates that this number will grow to approximately 784 million adults worldwide

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

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

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

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

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of blood glucose levels provides these individuals with information that can be used to better understand and manage their diabetes.

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

People with diabetes who take insulin

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

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

in quality compared to spot finger stick devices.

Spot finger stick devices have been the most prevalent devices for blood glucose monitoring.

These devices require users to insert a strip into a glucose meter, take a blood sample with a finger stick and place a drop of blood

on a test strip that yields a single point in time blood glucose measurement.

Despite continued developments in the field of blood glucose

monitors, the routine measurement of glucose levels remains invasive, painful, inconvenient, difficult and costly.

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

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

Several published clinical studies

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

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

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

We believe that a significant market opportunity

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

According to a 2017 Diabetes Care study,

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

diabetes devices look on the body.

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

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

4 We believe that improved CGM devices that

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

adoption and ongoing satisfaction.

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

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

The Lancet 1998 , 352 , 837–853.

Diabetes Control and Complications Research Group;

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

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

N Engl J Med 1993 , 329 , 977–986.

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

Type 2 Diabetes:

A Systematic Review and Meta-Analysis.

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

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

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.

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.

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:

uptake and potential intervention targets.

barriers to uptake and potential

intervention targets.

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

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

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

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

component with maintained calibration status.

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

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

This facilitates continuous blood glucose measurements with zero

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

The approach is based

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

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

“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

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with conventional CGM technologies on the market.

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

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

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

Food and Drug Administration (“FDA”).

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

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

Collecting data for sensor characterization and algorithm development, along

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

These results will drive any necessary

refinements to the system.

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

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

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

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

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

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

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

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and Development

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

blood continuous glucose monitor, CBGM.

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

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

This was accomplished via three major studies:

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

and in vivo (animal study).

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

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

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

These results triggered

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

good accuracy and safety profile.

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

More specifically, we have partnered with an experienced contract

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

will be used in forthcoming clinical trials.

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

medical device production.

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

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

The initial version

will be scaled appropriately for a FIH clinical trial.

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

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

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

This trial is expected to use the commercial version

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

Throughout 2024,

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

We will also be working

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

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

These efforts will focus on techniques that

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

replacement tools and procedures.

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

“Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operation – Results of Operation”

below for a discussion of the research and development expenses for the fiscal years ended 2023 and 2022.

“ 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

Considerations

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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.

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 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.

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.

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

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

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

the 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.

The Company is preparing for this approach.

We are preparing for this approach.

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

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is exported, as well as certain FDA export requirements.

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

The Swiss competent

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

This will be an initial entry to the central European market

until CE Mark can be obtained.

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

France, Austria, and Italy.

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

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.

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and commercial third-party payors.

Currently, Medicare covers CGM systems, which includes supplies necessary

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

Previously, Medicare coverage for CGM was only

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

The Local Coverage Determination, or LCD, that the Medicare

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

The LCD also allows

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

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.

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

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

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

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

Medicare reimburses

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

However, Medicare only provides reimbursement if

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

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

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

the services were rendered.

Obtaining a coverage determination, whether local or national, is a time-consuming, expensive and highly

uncertain proposition, especially for a new technology, and inconsistent local determinations are possible.

Our inability to obtain a

favorable coverage determination for our CBGM product may adversely affect our ability to market the product and thus, the commercial

viability of the product.

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.

Additionally,

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

Additionally,

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

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

This will enable us to craft a reimbursement strategy

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

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

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.

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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.

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 GlucoTrack 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.

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.

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

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upon the proprietary rights of others.

currently have a published U.S.

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

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

Multiple new filings are planned

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

We have also obtained trademark

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 various other jurisdictions.

and Europe and various other jurisdictions.

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

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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:

also measures glucose in the interstitial fluid.

All four competitors are either publicly traded or are divisions of publicly traded

companies, and they enjoy several competitive advantages, including:

significantly

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the reference to such website address does not constitute incorporation by reference of the information

contained on the website and such information should not be considered part of this report.

contained on the website and such information should not be considered part of this Annual Report.

and Committees

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

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

and Corporate Governance Committee, the Audit consisting solely of independent directors.

We are continuing to consider expansion of

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

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

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

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

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

addition, as of December 31, 2023, we had five significant consultants.

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