What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-30 compared with 2025-03-31 · 217 added, 370 removed, 125 unchanged (82% of the section changed)

23 unchanged sentences

has been adjusted to reflect the application of the one-for-five reverse stock split of our Common Stock that we effected on May 27,

2024 and the one-for-twenty reverse stock split of our Common Stock that we effected on February 3, 2025, as further described below,

on a retroactive basis.

2024, the one-for-twenty reverse stock split of our Common Stock that we effected on February 3, 2025, and the one-for-sixty reverse

stock split of our Common Stock that we effected on June 13, 2025, as further described below, on a retroactive basis.

Company was incorporated on May 18, 2010 under the laws of the State of Delaware.

We are currently developing an implantable CBGM,

the Glucotrack CBGM, for persons with Type 1 diabetes and insulin-dependent Type 2 diabetes.

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

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for an updated product with improved accuracy and human factors.

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

measurement to continuous measurement since then, the Company recently determined that it would focus its efforts on developing its 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As such, we have since withdrawn our CE Mark for Glucotrack and are no longer pursuing commercialization of this product or development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.

Company is currently developing the Glucotrack CBGM 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 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.

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.

Recently we announced

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

We have also completed four animal studies with evolving

prototype systems, all four of which consistently demonstrated a simple implant procedure, good functionality, and safety.

has also successfully demonstrated continuous glucose sensing in the epidural space via two additional animal trials, both of which demonstrated

a simple implant procedure, good functionality, and safety.

This latter approach is of importance for patients with painful diabetic

neuropathy contemplating spinal cord stimulation therapy for their condition.

The results of these animal trials were recently presented

in poster form at the American Diabetes Association, the Diabetes Technology Society, and the DiabetesMine annual conferences.

regulatory submission has been made for a first in human study outside of the United States.

This will be an acute study intended to

demonstrate device performance and safety.

All preparatory clinical activities and applicable regulatory approvals are complete.

the Company is also preparing for a long-term clinical trial outside the United States that is expected to begin in the second quarter of 2025.

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.

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 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, 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;

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;

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.

and Development

of Preclinical Study

May 16, 2024, we announced that our implantable continuous glucose monitor successfully completed 30 days of a 60-day long-term preclinical

study on measuring glucose in the epidural space.

The Glucotrack 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.

On June 13, 2024, we announced that the 60-day long-term study was completed, demonstrating

the feasibility of glucose monitoring in the epidural space.

No abnormal clinical signs were observed throughout the study period, and

no abnormal findings were observed in the spinal cord or surrounding tissues during post-explant analysis.

The study also confirmed that

the implanted sensor did not cause any delayed latent effects over the long-term period, which is particularly important as a complete

healing process in animal studies with implanted devices may take several weeks.

With the completion of this study, the durability of

the epidural approach for continuous glucose monitoring has now been confirmed over the 60-day period.

These developments mark another

potential use of the Glucotrack technology by combining the technology with a conventional spinal cord stimulator for treating patients

who have chronic lower back and lower limb pain, a significant proportion of which have diabetes.

February 4, 2025, we announced the successful completion of our first in-human clinical study, marking a significant milestone in continuous

glucose monitoring.

This study represents the first real-time CBGM placed in the subclavian vein,

offering the potential for direct blood glucose measurement without the limitations often seen with traditional continuous glucose monitors

that measure glucose levels in interstitial fluid.

prospective single arm study was a short-term in-hospital study over a period of four days, focusing on the safety and procedural

aspects of the Glucotrack CBGM sensor lead placement, use, and removal.

The sensor lead was placed intravascularly via a

percutaneous procedure and connected to a prototype sensor electronics component that was placed on the skin.

The six study

participants had been previously diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin

results established safety of the placement, usage and removal of the CBGM sensor lead.

While neither the study nor prototype system

was designed to evaluate sensor accuracy, the system performed as expected with similar accuracy results as previously seen in our animal

study met its primary endpoint with no procedure or device related serious adverse events reported from implant through seven days post-removal

of the CBGM sensor lead.

The study also confirmed the function of the CBGM sensor lead in the subclavian vein.

Placement and removal

procedures were successfully performed by interventional cardiologists.

13485:2016 Certification

January 21, 2025, we announced that we received ISO 13485:2016 certification from the British Standards Institute

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 its products.

ISO 13485 is an internationally recognized standard for quality management systems,

created by the International Organization for Standardization to ensure the safety and effectiveness of medical devices.

on the ISO 9001 standard with additional regulatory requirements specific to medical devices.

In 2024, the FDA issued the Quality Management System Regulation Final Rule, which harmonizes U.S.

requirements with global standards

through the adoption of ISO 13485 for medical devices.

ISO 13485 is also strongly recommended and widely used in the European

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.

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,

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

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.

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 2 nd

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.

and Regulatory

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Listing Rule 5550(b)(1) requires companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders’ equity for continued

On May 21, 2024, Nasdaq notified us that our Quarterly Report

on Form 10-Q for the period ended March 31, 2024, indicated that we no longer met the Minimum Stockholders’ Equity Requirement.

Failure to meet the Minimum Stockholders’ Equity Requirement was a basis for delisting our Common Stock.

we were not in compliance with the Bid Price Rule at the time we were notified about the non-compliance with the Minimum

Stockholders’ Equity Requirement, we were not eligible to submit a plan to regain compliance with the Staff.

However, we timely

requested a hearing before the Nasdaq Hearings Panel and paid the fee, which resulted in a stay of any suspension or delisting action

pending the hearing.

The hearing took place on July 9, 2024, and on August 5, 2024, we received the decision of the Panel, and they granted

us an extension until November 18, 2024 to regain compliance with the Minimum Stockholders’ Equity Requirement.

November 19, 2024, the Company received a Compliance Letter from Nasdaq, informing the Company that it had regained compliance with

the Minimum Stockholders’ Equity Requirement.

The Compliance Letter noted, that because the Company’s bid price has

closed below the minimum required by the Bid Price Rule following the 2024 November Offering (defined below), the Panel had

determined to impose on the Company a Discretionary Panel Monitor, pursuant to Listing Rule 5815(d)(4)(B), for a period of one year

from the date of the Compliance Letter, to ensure that the Company maintains long-term compliance with the Minimum

Stockholders’ Equity Requirement, the Bid Price Rule, and all of Nasdaq’s continued listing requirements.

December 31, 2024, we received a notification from Nasdaq that for at least the last 30 consecutive business days, the Company was not

in compliance with the Bid Price Rule and, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a compliance period of 180 calendar

days, or until June 30, 2025, to regain compliance with the Bid Price Rule.

If at any time before June 30, 2025, the bid price of our

Common Stock closes at $1.00 per share or more for a minimum of ten consecutive business days, Nasdaq will provide us with a written

confirmation of compliance with the Bid Price Rule and the matter will be deemed closed.

we do not regain compliance with the Bid Price Rule by June 30, 2025, we may be eligible for an additional 180-day compliance period.

To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial

listing standards for the Nasdaq Capital Market, with the exception of the Bid Price Rule, and would need to provide written notice of

our intention to cure the bid price deficiency during the second compliance period by effecting a reverse stock split, if necessary.

On May 21, 2024, Nasdaq notified us that our Quarterly Report on Form 10-Q for the period ended March 31, 2024, indicated that

we no longer met the Minimum Stockholders’ Equity Requirement.

Failure to meet the Minimum Stockholders’ Equity Requirement

was a basis for delisting our Common Stock.

we were not in compliance with the Bid Price Rule at the time we were notified about the non-compliance with the Minimum Stockholders’

Equity Requirement, we were not eligible to submit a plan to regain compliance with the Staff.

However, we timely requested a hearing

before the Nasdaq Hearings Panel and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing.

The hearing took place on July 9, 2024, and on August 5, 2024, we received the decision of the Panel, and they granted us an extension

until November 18, 2024 to regain compliance with the Minimum Stockholders’ Equity Requirement.

November 19, 2024, the Company received a Compliance Letter from Nasdaq, informing the Company that it had regained compliance with the

Minimum Stockholders’ Equity Requirement.

The Compliance Letter noted, that because the Company’s bid price has closed below

the minimum required by the Bid Price Rule following the 2024 November Offering (defined below), the Panel had determined to impose on

the Company a Discretionary Panel Monitor, pursuant to Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Compliance

Letter, to ensure that the Company maintains long-term compliance with the Minimum Stockholders’ Equity Requirement, the Bid Price

Rule, and all of Nasdaq’s continued listing requirements.

December 31, 2024, Nasdaq notified us that for at least the last 30 consecutive business days, the bid price for our Common Stock had

closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to the Bid Price Rule.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a compliance period of 180 calendar days, or until June 30, 2025, to regain

compliance with the Bid Price Rule.

On February 3, 2025, the Company implemented a reverse stock split at a ratio of 1-for-20 to regain

compliance with the Bid Price Rule.

On April 2, 2025, we received a letter from Nasdaq notifying us that as a result of non-compliance

with the Bid Price Rule, Nasdaq Staff had determined to delist our securities.

We timely submitted a hearing request to the hearings

panel on April 9, 2025, and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing.

took place on May 13, 2025, and on June 2, 2025, we received the decision of the panel granting us an extension until July 3, 2025, to

regain compliance with the Bid Price Rule.

On June 13, 2025, the Company implemented a reverse stock split at a ratio of 1-for-60 to

regain compliance with the Bid Price Rule.

July 18, 2025, we received notice from Nasdaq that we had regained compliance with the Bid Price Rule.

The Panel retained jurisdiction

over the Company through September 29, 2025.

On November 5, 2025, the Company was notified by Nasdaq Staff that the Company was in compliance

with all Nasdaq Listing Rules.

can be no assurance that we will be able to continue to maintain compliance with Nasdaq’s continued listing requirements, the Bid

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Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment (the “May Certificate of Amendment”), to our

Certificate of Incorporation, as amended (the “Certificate of Incorporation”), which became effective at 4:30 p.m.

May 17, 2024 (the “First Effective Time”) to implement a one-for-five (1:5) reverse stock split (the “2024 Reverse

Stock Split”) of the shares of our Common Stock.

The 2024 Reverse Stock Split was approved by our stockholders at the 2024

annual meeting of the stockholders on April 26, 2024.

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30

on May 17, 2024, to implement a reverse stock split at a ratio of 1-for-5 (the “2024 Reverse Stock Split”) of the shares

of our Common Stock.

The 2024 Reverse Stock Split was approved by our stockholders at the 2024 annual meeting of the stockholders on

April 26, 2024.

a result of the 2024 Reverse Stock Split, every five (5) shares of issued and outstanding Common Stock were automatically combined into

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shares to 100,000,000 shares.

Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation (the “2025

Certificate of Amendment”) which became effective at 4:30 p.m.

on February 3, 2025 (the “Second Effective Time”),

to implement a reverse stock split at a ratio of 1-for-20 (the “2025 Reverse Stock Split”) of the shares of our Common

The 2025 Reverse Stock Split was approved by our stockholders at the special meeting of our stockholders held on January 3,

2025 (the “Special Meeting”).

As a result of the 2025 Reverse Stock Split, every twenty (20) shares of issued and outstanding Common Stock were

automatically combined into one (1) issued and outstanding share of Common Stock, without any change in the par value per share.

No fractional

shares were issued as a result of the 20254 Reverse Stock Split, and instead, stockholders who otherwise would have been entitled to receive

fractional shares because they held a number of shares not evenly divisible by the Reverse Stock Split ratio were entitled to receive

an additional fraction of a share of Common Stock to round up to the next whole share.

addition, the stockholders approved at the Special Meeting an increase in our authorized shares of Common Stock from 100,000,000 to 250,000,000,

as well as the full issuance of shares of Common Stock issuable by us upon the exercise of Series A Warrants and Series B Warrants (further

described below).

in Authorized Common Stock

January 3, 2025, the Company filed an amendment to the Company’s Certificate of Incorporation, as to increase the Company’s

authorized shares of Common Stock from 100,000,000 to 250,000,000.

2024 Exchange

February 13, 2024, we entered into the February Exchange Agreement with the February Holders, pursuant to which the Company and the

February Holders agreed to exchange the February

Warrants owned by the February Holders for shares of Common Stock to be issued by the Company.

February 13, 2024, the Company closed the February Exchange and issued to the February Holders an aggregate of 35,932 shares of Common Stock in exchange for 43,820 February Warrants.

Private Placement

April 22, 2024, we entered into a private placement agreement under which the Company issued 3,968 shares of its Common Stock at a price

of $126.0 per share for aggregate gross proceeds of $500,000.

The Offering included participation of certain members of the Company’s executive management, Board

of Directors and existing shareholders.

27 Private Placement

June 27, 2024, we entered into note and warrant purchase agreements with the June 27 Investors, providing for the private placement of unsecured promissory notes in the

aggregate principal amount of $100,000 and to purchase

up to an aggregate of 15,000 shares of Common Stock.

The closing occurred on June 27, 2024.

18 Private Placement

July 18, 2024, we entered into a series of convertible promissory notes with the July 18 Investors, providing for the private placement of unsecured convertible promissory notes in the aggregate

principal amount of $360,000.

August 23, 2024, two of the June 27 Investors entered into conversion agreements with the Company, pursuant to which the Company agreed

to convert the principal amount, plus any accrued but unpaid interest, of each of the June 27 Notes, totaling $20,076 each, held by the

investors into Common Stock at a conversion price of $20.40 per share.

On September 5, 2024, another June 27 Investor entered into a separate

conversion agreement with the Company, under which the Company agreed to convert

the principal amount, plus any accrued but unpaid interest, of the June 27 Note held by the investor, totaling $259,310, into Common

Stock at the same conversion price of $20.40 per share.

in satisfaction of the debt and pursuant to the August Conversion Agreement, the Company issued to each of the two June 27 Investors

that converted their notes in August, three August 23 Warrants.

Each August 23 Warrant becomes

exercisable on August 16, 2025 and has term of 10 years.

The August 23 Warrants are exercisable for cash only and have no

price-based antidilution.

The first August 23 Warrant is for 535 shares of Common Stock and is exercisable at $37.50 per share.

second August 23 Warrant is for 382 shares of Common Stock, exercisable at $52.50 per share.

The third August 23 Warrant is for 297

shares of Common Stock, exercisable at $67.50 per share.

The June 27 Investor that converted his note in September was issued three September 5 Warrants on the same terms as the August 23 Warrants.

The first September 5 Warrant is

for 6,915 shares of Common Stock and is exercisable at $37.50 per share.

The second September 5 Warrant is for 4,940 shares of

Common Stock, exercisable at $52.50 per share.

The third September 5 Warrant is for 3,842 shares of Common Stock, exercisable at

$67.50 per share.

30 Private Placement

July 30, 2024, we entered into the July 30 Note and three July 30 Warrants with the July 30 Holder, providing for the private placement

of a secured convertible promissory note in the aggregate principal amount of $4,000,000.

Note bore simple interest at the rate of eight percent (8%) per annum and is due and payable in cash on the earlier of:

(a) the twelve

(12) month anniversary of July 30 Note, or (b) the date of closing of a Sale Transaction.

The July 30 Note was secured by a first-priority security interest on all Company assets.

Million Public Offering and Concurrent Private Placement

November 13, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain

purchasers identified on the signature pages therein, pursuant to which the Company sold in a “best efforts” public

offering (the “2024 November Offering”), pursuant to an effective registration statement on Form S-1 (File No.

282158) under the Securities Act, an aggregate of (i) 121,867 shares of its

Common Stock (the “Shares”), (ii) 237,845 pre-funded warrants to purchase up to an aggregate of 237,845 shares of Common

Stock in lieu of Shares (the “Pre-Funded Warrants”), (iii) 359,712 Series A Common Warrants, and (iv) 359,712 Series B

Common Warrants.

The public offering price for each Share and accompanying Common Warrants was $27.80, and the public offering price

for each Pre-Funded Warrant and accompanying Common Warrants was $27.78 (the “Offering Price”).

a private placement offering completed concurrently with the Offering (the “Concurrent Private Offering”), the July 30

Holder, converted approximately $4,093,112 of debt, which represented the then outstanding principal and accrued interest under a

convertible promissory note dated July 30, 2024 (the “July 30 Note Debt”).

The July 30 Note Debt was converted to Common

Stock and Series A Common Warrants and Series B Common Warrants on substantially the same terms as the November 2024 Offering,

resulting in the issuance of 132,036 shares of Common Stock, 132,036 accompanying Series A Common Warrants, and 132,036 accompanying

Series B Common Warrants, based on a conversion price of $31.00 per share, which is equal to the consolidated closing bid price of

the Common Stock on the Nasdaq Capital Market on November 12, 2024.

addition, concurrently with the November 2024 Offering, the Company completed the July 18 Note Conversion of the outstanding July 18

The July 18 Notes, which represented an aggregate outstanding principal and accrued interest in the amount of $304,494 were converted

at a conversion price of $31.20, which is equal to the Floor Price as defined in the July 18 Notes, for an aggregate of 9,760 shares

of Common Stock, 9,760 Series A Common Warrants, and 9,760 Series B Common Warrants.

Reverse Stock Splits and Increase in Authorized Common Stock

2025 1-for-20 Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30

on February 3, 2025, to implement a reverse stock split at a ratio of 1-for-20 (the “February 2025 Reverse Stock Split”)

of the shares of our Common Stock.

The February 2025 Reverse Stock Split was approved by our stockholders at the special meeting of stockholders

held on January 3, 2025 (the “Special Meeting”).

January 3, 2025, we filed an amendment to our Certificate of Incorporation to increase the Company’s authorized shares of Common

Stock from 100,000,000 to 250,000,000.

On February 3, 2025, the stockholders approved at the Special Meeting the increase in our authorized

shares of Common Stock from 100,000,000 to 250,000,000, as well as the full issuance of shares of Common Stock issuable by us upon the

exercise of Series A Warrants and Series B Warrants (defined herein).

2025 1-for-60 Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30

on June 13, 2025, to implement a reverse stock split at a ratio of 1-for-60 (the “June 2025 Reverse Stock Split”) of

the shares of its Common Stock.

The June 2025 Reverse Stock Split was approved by the Company’s stockholders at the 2025 annual

meeting of the stockholders held on May 22, 2025.

shares, options and warrants to purchase shares of Common Stock and loss per share amounts have been adjusted to give retroactive effect

to the February and June 2025 reverse share splits, (the “Reverse Stock Splits”) for all periods presented in these interim

consolidated financial statements.

Any fractional shares resulting from the Reverse Stock Splits were rounded up to the nearest whole

information below is stated in thousands of US dollars (except share data).

Sales Agreement

December 17, 2024, we entered into an ATM sales agreement (the “Sales Agreement”) with Dawson James Securities, Inc.

James”), pursuant to which we have agreed to issue and sell shares of Common Stock, having an aggregate offering price of up to

$8.23 million, from time to time, through an “at-the-market” equity offering program under which Dawson James will act as

sales agent (the “Agent”).

As of December 31, 2024, no sales of Common Stock had been made pursuant to the Sales Agreement.

On March 21, 2025, we sold

12,377,967 shares of Common Stock at an average offering price of $0.304 per share pursuant to the Sales Agreement (the “March

We received net proceeds of approximately $3,643,000, after deducting fees owed to the placement agent from such

2025 Registered Direct Offering

James”), pursuant to which we agreed to issue and sell shares of Common Stock, having an aggregate offering price of up to $8,230,

from time to time, through an “at-the-market” equity offering program (the “ATM Program”) under which Dawson

James will act as sales agent (the “Agent”).

March 21, 2025, we sold 206,300 shares of Common Stock at an average offering price of $18.24 per share pursuant to the Sales Agreement,

for net proceeds of $3,593, after deducting fees owed to the Agent from such sale.

the three months ended June 30, 2025, we sold 414,784 shares of Common Stock at an average offering price of $10.74 per share pursuant

to the Sales Agreement for net proceeds of $4,320, after deducting fees owed to the Agent from such sale.

As of September 30, 2025, there

was no remaining capacity available under the ATM Program.

shares of Common Stock sold in conformance to the Sales Agreement were offered by us pursuant to a prospectus supplement dated December

17, 2024, and accompanying prospectus dated October 3, 2024, which forms a part of our registration statement on Form S-3 (Registration

333-282297) (the “S-3 Registration Statement”), which was declared effective by the Securities and Exchange Commission,

on October 3, 2024.

Direct Offering

February 4, 2025, we entered into a securities purchase agreement with certain institutional investors, relating to the registered direct

offering and sale of an aggregate of 2,638,042 shares of Common Stock at an offering price of $1.15 per share.

The shares of Common Stock

were offered by the Company pursuant to a prospectus supplement dated February 4, 2025, and accompanying prospectus dated October 3,

2024, in connection with a takedown from the Company’s shelf registration statement on Form S-3 (Registration No.

which was declared effective by the SEC, on October 3, 2024 (the “February 2025 Offering” and, together with the March ATM Sale, the “2025 Offerings”).

Dawson James acted as

the placement agent for the offering pursuant to a placement agency agreement, dated February 4, 2025, by and between the Company and

Dawson James.

The net proceeds to the Company from the offering were approximately $2,706,000, after deducting fees owed to Dawson

James and other offering expenses.

offering and sale of an aggregate of 43,968 shares of Common Stock at an offering price of $69.00 per share (the “February 2025

The net proceeds to us from the February 2025 Offering were approximately $2,752, after deducting fees owed to placement

agent and other offering expenses.

The February 2025 Offering closed on February 5, 2025.

on January 6, 2025, through March 13, 2025, the Company received exchange notices from certain holders of the Series B Warrants, with

respect to an aggregate of 359,612 of the Series B Warrants, requiring the delivery of 9,721,782 shares of Common Stock.

The remaining

100 Series B Warrants are exchangeable for an aggregate of approximately 1,940 shares of Common Stock (subject to adjustment in the event

of any stock dividend and split, reverse stock split, recapitalization, reorganization or similar transaction).

Pro Forma Impact of Registered Direct Offerings,

Warrant Exchange, and Series A Warrant Revaluation

The following financial information

has been developed by application of pro forma adjustments to the historical financial statements of the Company appearing elsewhere in

this Annual Report.

The unaudited pro forma information gives effect to the 2025 Offerings, the exchange of Series B Warrants to common

stock, and the revaluation of Series A Warrants.

The unaudited pro forma

financial information is presented for informational purposes only and does not purport to represent what the results of operations or

financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do

they purport to project the financial condition of the Company for any future period or as of any future date.

The unaudited pro forma

financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this

Annual Report.

Pro Forma Balance Sheet

Year Ended December 31, 2024

Series B Warrant Exercise

2025 Offerings

Revaluation of Series A Warrants

Pro Forma as Adjusted

Current Assets

Cash and cash equivalents

Other current assets

Total current assets

Operating lease right-of-use asset, net

Property and equipment, net

Restricted cash

LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY

Current Liabilities

Accounts payable

Operating lease liability

Convertible promissory notes

Other current liabilities

Total current liabilities

Non-Current Liabilities

Derivative financial liabilities

Operating lease liability, non-current

Loans from stockholders

Total liabilities

Commitments and contingent liabilities

Stockholders’ (Deficit) Equity

Common Stock of $0.001 par value

100,000,000 shares authorized as of December 31, 2024 and 2023;

791,609 and 208,914 shares issued and outstanding as of December 31, 2024 and 2023, respectively

Additional paid-in capital

Receipts on account of shares

Accumulated other comprehensive income

Accumulated deficit

Total stockholders’ (deficit) equity

TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY

shares of Common Stock from the February 2025 Offering were offered by us pursuant to a prospectus supplement dated February 4, 2025,

and accompanying prospectus dated October 3, 2024, which forms a part of our S-3 Registration Statement.

Dawson James acted as the placement

agent for the offerings pursuant to a placement agency agreement, dated February 4, 2025, by and between us and Dawson James.

Placement December 2025

December 29, 2025, we entered into a Securities Purchase Agreement with Armistice Capital Master Fund Ltd.

for a private placement

of securities (the “Private Placement”).

The closing of the Private Placement occurred on December 31, 2025 (the

At the Closing, we issued (i) 1,033,591 pre-funded warrants to purchase 1,033,591 shares of Common Stock (the “Pre-Funded Warrants”),

and (ii) 2,067,182 warrants to purchase shares of Common Stock (the “Common Warrants”).

Each Pre-Funded Warrant was sold with two Common Warrants at

a combined purchase price of $3.869, which is equal to the Nasdaq Official Closing Price (as reflected on Nasdaq.com) of the Common

Stock on December 29, 2025, minus the exercise price of the Pre-Funded Warrant of $0.001 per share.

connection with the Private Placement, on December 29, 2025, we entered into a Placement Agency Agreement with Curvature Securities,

LLC (the “Placement Agent”).

As part of its compensation for acting as Placement Agent for the Private Placement, we paid

the Placement Agent a cash fee of 7.0% of the aggregate gross proceeds and issued to the Placement Agent warrants to purchase 124,030

shares of Common Stock at an exercise price of $4.257 per share, which are exercisable at any time on or after the date that is one hundred

eighty (180) days from the date of the commencement of sales in connection with the Private Placement, and expire on the five year anniversary

of the commencement date (the “Placement Agent Warrants”).

received aggregate net proceeds from the Private Placement of approximately $3,544, after deducting estimated placement agent commissions

and expenses in connection with the Private Placement, which were payable by us.

September 12, 2025, we entered into a Note Purchase Agreement, with an investor, pursuant to which we issued a Promissory Note to the

investor in the principal amount of $3,600 for a purchase price of $3,000.

on January 6, 2025, through March 15, 2025, we received exchange notices from certain holders of the Series B Warrants, with respect

to an aggregate of 54,021 of the Series B Warrants, requiring the delivery of 162,603 shares of Common Stock according to the alternative

cashless exercise provision of the Series B Warrants sold in the November 2024 registered direct offering.

The remaining 11 Series B

Warrants are exchangeable for 11 shares of Common Stock (subject to adjustment in the event of any stock dividend and split, reverse

stock split, recapitalization, reorganization or similar transaction).

the fiscal year ended December 31, 2025, we repurchased 51,529 of its Series A Warrants from existing warrant holders for $166.

value of the Series A Warrants on the date of exercise was $67, resulting in a loss on repurchase of $99.

and Development

and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation expenses,

materials, travel expenses, clinical trials and other expenses.

We expect research and development expenses to increase in 2025 and beyond,

primarily due to expanding clinical trial activities, hiring additional personnel, as well the development of Glucotrack CBGM;

we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our

commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models

and other product candidates.

and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation

expenses, materials, travel expenses, clinical trials and other expenses.

We expect research and development expenses to increase in

2026 and beyond, primarily due to expanding clinical trial activities, hiring additional personnel, as well the development of

Glucotrack CBGM;

however, we may adjust or allocate the level of our research and development expenses based on available financial

resources and based on our commercial needs, including the FDA registration process, specific requirements from customers,

development of new Glucotrack CBGM models and other product candidates.

and Administrative

3 unchanged sentences

include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal,

and accounting services.

accounting, media, and public and investor relation services.

(Income) Expense

2 unchanged sentences

of Operations – Comparison of the Years Ended December 31, 2025 and 2024

All information below is stated in thousands of US dollars.

information below is stated in thousands of US dollars.

following discussion of our operating results explains material changes in our results of operations for the years ended December 31,

7 unchanged sentences

and Administrative Expense

and administrative expenses were $4,655 for the year ended December 31, 2024, as compared to $2,278 for the prior-year period.

of $2,377 is primarily attributable to increased legal and professional fees, personnel costs and placement agent fees.

compensation expense included in research and development and general and administrative expense, for the fiscal years ended December

31, 2024 and 2023, was comprised as follows:

and administrative expenses were $6,277 for the year ended December 31, 2025, as compared to $5,048 for the prior-year

The increase of $1,229 is primarily attributable to increased professional fees, personnel costs and placement

compensation expense included in research and development and selling, general and administrative expense, for the fiscal years ended

December 31, 2025 and 2024, was comprised as follows:

Research and development

General and administrative

increase in share-based compensation expense is attributable to the current year vesting of equity awards granted to employees, directors

and consultants supporting our research and development and general and administrative functions.

decrease in share-based compensation expense is primarily attributable to a reduction in the fair value of shares issued for Board compensation

and shares issued under IP agreements.

(Income) Expense, net

expense was $3,298 for the year ended December 31, 2025, as compared to other income $8,050 for the prior-year period.

The increase in other

expense is primarily attributed to recognized losses on the settlement of debt and the issuance of warrants containing derivative features.

The decrease in

other expense is primarily attributed to reductions in recognized losses on the settlement of debt and reduced losses from the issuance

These reductions were offset by the current year fair value change in derivative liabilities.

loss was $19,388 for the year ended December 31, 2025, as compared to a net loss of $22,579 for the prior-year period.

The increase in

net loss is attributable primarily to the expense classifications discussed above.

and Capital Resources

of December 31, 2024, we had $5,617 in cash and cash equivalents compared with $4,492 in cash and cash equivalents as of December 31,

The net increase in cash and cash equivalents was attributable to the $13,743 received from financing activities offset by cash

used in operating and investing activities of $12,594.

have a history of recurring losses, and as of December 31, 2024, we have a stockholders’ deficiency of $13,000.

During the fiscal

year ended December 31, 2024, we recorded a net loss of $22,597.

Our primary requirements for liquidity have been to fund product and

clinical development activities and to satisfy our general corporate and working capital needs.

to December 31, 2024, we received approximately $6,349 through the February 2025 Offering and the March ATM Sale.

as noted above, the impact of the subsequent financings, the exercise of Series B Warrants and the revaluation of Series A warrants

has resulted in Stockholders’ Equity of $10,629 as of December 31, 2024, on a pro forma basis.

The decrease in

net loss is attributable primarily to the reduction in other expense discussed above.

and Going Concern

of December 31, 2025, we had $7,383 in cash and cash equivalents compared with $5,627 in cash, cash equivalents and restricted cash as

of December 31, 2024.

The net increase in cash and cash equivalents was attributable to the $17,043 of net proceeds received from financing

activities offset by cash used in operating and investing activities of $15,336.

have a history of recurring losses, and as of December 31, 2025, we have an accumulated deficit of $151,838.

During the fiscal year ended

December 31, 2025, we recorded a net loss of $19,388.

Our primary requirements for liquidity have been to fund product and clinical development

activities and to satisfy our general corporate and working capital needs.

on our operating plans, we do not expect that our current cash and cash equivalents as of December 31, 2025, will be sufficient to fund

our operating, investing, and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently

contemplated.

Based upon this review and our current financial condition, the Company has concluded that substantial doubt exists as

to our ability to continue as a going concern.

We have raised and believe we will continue to be able to raise additional capital through

debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies,

or other sources of financing.

However, there can be no assurances that such financing will be available or will be at terms acceptable

to us, or at all.

If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate

our clinical trials or other operations.

If any of these events occur, our ability to achieve our operational goals would be adversely

Our future capital requirements and the adequacy of available funds will depend on many factors, including those described

in the section titled “ Risk Factors .” Depending on the severity and direct impact of these factors on us, we may be

unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Concern Uncertainty

date, we have not yet commercialized the Glucotrack CBGM.

Further development and commercialization efforts are expected to

require substantial additional expenditure.

Therefore, we are dependent upon external sources for financing our operations.

As of December

31, 2024, we have incurred a stockholders’ deficiency of $13,000, which includes an accumulated deficit of $132,450.

we have generated operating losses and negative operating cash flow for all reported periods.

As of December 31, 2024, the balance of

cash and cash equivalents amounted to $5,617.

the year ended December 31, 2024, we received approximately $13,734 through public offerings and debt issuances which were

subsequently converted to equity.

In addition, subsequent to the balance sheet date, we received $6,349 through the sale of

shares of Common Stock.

We plan to finance our operations through the sale of debt or equity securities (including the shelf

registration statement on Form S-3 that was declared effective on October 3, 2024 by the SEC which allows us to register up to

$30,000 of certain equity and/or debt securities of the Company through prospectus supplement).

There can be no assurance that we

will succeed in obtaining the necessary financing or generating sufficient revenue from sale of the Glucotrack CBGM in order to

continue our operations as a going concern.

has considered the significance of such conditions in relation to our ability to meet current obligations and to achieve our business

targets and determined that these conditions raise substantial doubt about our ability to continue as a going concern.

our operating cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated.

Based upon this review and our current financial

condition, we have concluded that substantial doubt exists as to our ability to continue as a going concern.

We have raised and believe

we will continue to be able to raise additional capital through debt financings, private or public equity financings, license agreements,

collaborative agreements or other arrangements with other companies, or other sources of financing.

However, there can be no assurances

that such financing will be available or will be at terms acceptable to us, or at all.

If we are unable to raise capital when needed

or on attractive terms, we would be forced to delay, reduce, or eliminate our clinical trials or other operations.

If any of these events

occur, our ability to achieve our operational goals would be adversely affected.

Our future capital requirements and the adequacy of

available funds will depend on many factors, including those described in the section titled “ Risk Factors .” Depending

on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements

on commercially acceptable terms favorable to us, or at all.

Accounting Policies and Estimates

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Accounting Pronouncements

regarding recent accounting pronouncements is contained in Note 2 to the Consolidated

Financial Statements, included elsewhere in this report.

regarding recent accounting pronouncements is contained in Note 2 to the Consolidated Financial Statements, included elsewhere in this

report, and is incorporated by reference.

Balance Sheet Arrangements

3 unchanged sentences

Financial Statements and Supplementary Data

is made to pages F-1 through F-31 comprising a portion of this Annual Report on Form 10-K, which are incorporated by reference

under this Item.

is made to pages F-1 through F-25 comprising a portion of this Annual Report on Form 10-K, which are incorporated by reference under

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

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 7. Management’s Discussion and Analysis