What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-14 compared with 2025-11-13 · 137 added, 206 removed, 65 unchanged (84% of the section changed)

26 unchanged sentences

Risks and uncertainties, the occurrence of which could adversely affect our business, include the risks identified under the caption

“Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “Annual Report”).

The following discussion should be read in conjunction with the condensed consolidated financial statements and the notes thereto included

in Item 1 of this Quarterly Report.

“Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S.

and Exchange Commission (the “SEC”) on March 30, 2026 (the “Annual Report”).

The following discussion should

be read in conjunction with the condensed consolidated financial statements and the notes thereto included in Item 1 of this Quarterly

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

We are currently developing an implantable continuous

blood glucose monitor (“CBGM”).

The Glucotrack CBGM is a long-term fully implantable continuous glucose monitor (CGM), consisting

of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application.

It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid glucose monitors.

a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more convenient and less burdensome

solution for people with diabetes, with no on-body wearable component and minimal calibration requirements.

Glucotrack CBGM is being developed for use by diabetes patients who are dependent on daily glucose monitoring to manage their disease.

These include patients who have the following conditions:

Type 1 diabetes, Type 2 insulin-dependent diabetes, Type 2 diabetes using basal

insulin and Type 2 diabetes at risk for hypoglycemia.

have continued to evolve our sensor chemistry following the results of an initial in-vitro feasibility study.

In 2024, we announced that

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

We have also completed multiple animal studies with

initial prototype systems which demonstrated a simple implant procedure with good safety and functionality.

The results of both were

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

We believe that implant accuracy and longevity

is key to the success for long term use.

initiated a first-in-human (“FIH”) short-term clinical study outside of the United States in fourth quarter of 2024 and completed

the study in first quarter of 2025.

We recently presented results at the 2025 American Diabetes Association annual conference at the

Innovation Hub podium as well as a poster.

The ADA presentation reported that the FIH clinical study met all primary and secondary endpoints

with no procedure or device related serious adverse events reported from implant through seven days post-removal of the CBGM sensor lead.

The system also demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99%

data capture rate, and no procedure or device-related serious adverse events.

These findings validate the safety and performance of the

system which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional

continuous glucose monitoring systems.

The MARD value demonstrates very high accuracy and compares favorably to commercially available

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

Placement and removal procedures

were successfully performed by interventional cardiologists.

We have initiated a long-term

clinical study outside the United States to evaluate the CBGM product performance and safety over an initial period of one (1) year.

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

impact study eligibility.

Consequently, we are undertaking certain protocol amendments to refine participant selection criteria

before enrolling additional participants.

In parallel, we intend to implement certain product improvements.

committed to advancing our clinical program and intend to proceed swiftly with the relevant protocol amendments and product

enhancements, subject to approval by the institutional review board.

the second quarter 2025, we initiated discussions with the Food & Drug Administration (“FDA”) in preparations for a pre-investigational

device exemption (“IDE”) submission.

The discussions pertain to the protocol study design and related requirements to secure

IDE approval for future long-term human clinical trials in the United States.

We remain in active review with the FDA to accommodate

their requirements and expects to file the IDE submission to the FDA during the Spring of 2026.

believe our technology, if successful, has the potential to be a long-term, implantable system that continually measures blood glucose

levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration.

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

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 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 $3,643, after deducting fees owed to the Agent from such sale.

the three months ended June 30, 2025, we sold 414,785 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 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.

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.

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 $3,600,000 for a purchase price of $3,000,000.

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 nine months ended September 30, 2025, we repurchased 51,529 of its Series A Warrants form existing warrant holders for $166.

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

The Company is a medical device company focused on

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

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

Company was founded with a mission to develop Glucotrack®, a non-invasive glucose monitoring device designed to help people with

diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)

spot finger stick devices.

The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements

via a small sensor clipped onto one’s earlobe.

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

for an updated product with improved accuracy and human factors.

As the glucose monitoring landscape has since rapidly moved away from

point-in-time measurement to continuous measurement, the Company determined in 2023 that it would focus its efforts on developing the

Glucotrack CBGM.

As such, the Company withdrew the CE Mark for Glucotrack and is 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 patients using insulin

or at risk for hypoglycemia.

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

The Company has demonstrated that a 3-year longevity

is feasible leveraging both in-vitro and in-silico test results.

The Company has also completed multiple animal studies with initial

prototype systems which demonstrated a simple implant procedure with good safety and functionality.

The results of both were presented

in poster form at the 2024 American Diabetes Association annual conference.

During the period, two peer-reviewed scientific articles

were published related to the CBGM technology.

One article, published in the IEEE Sensors Journal, characterized the long-term in-vitro

stability of electrochemical glucose sensors of the type used in the CBGM system, including the first year-long measurements of glucose

oxidase enzyme decay reported in the literature.

A second peer-reviewed article, published in The Journal of Diabetes Research, evaluated

the long-term accuracy and stability of the CBGM system in an in-vivo ovine model, providing externally validated evidence supporting

the long-term performance of the technology.

The Company believes its 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, the Company has also successfully demonstrated continuous glucose sensing in the epidural

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

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.

to March 31, 2026, the Company submitted an Investigational Device Exemption (“IDE”) application to the U.S.

Food and Drug

Administration (“FDA”) to initiate a U.S.

clinical study of its CBGM technology.

The IDE submission represents an important

milestone for the Company and reflects progress in its preclinical development and underlying technical foundation.

The Company has also

engaged a clinical research organization and identified trial sites in preparation for study commencement.

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.

Reverse Stock Split and Increase in Authorized Common Stock

filed with the Delaware Secretary of State a Certificate of Amendment to its 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 “2025 Reverse Stock Split”) of the

shares of our Common Stock.

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

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

All shares and per share numbers in the consolidated financial statements have

been retroactively adjusted and are reflected on a post-reverse share split basis.

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).

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

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

March 12, 2026, the Company received stockholder approval to issue Purchase Shares in excess of the “Exchange Cap,” as defined

On March 27, 2026, the Company sold 580,000 shares of Common Stock at an average offering price of $1.03 per share pursuant

to the ELOC for net proceeds of $590, after deducting fees from such sale.

Wulff as Chief Financial Officer

Cardwell’s resigned as Chief Financial Officer of the Company, and on January 28, 2025, our board of directors (the “Board”)

appointed Peter C.

Wulff as Chief Financial Officer of the Company.

and Administrative

and administrative expenses consist primarily of professional services, salaries, travel expenses and other related expenses for executive,

finance and administrative personnel, including stock-based compensation expenses.

Other general and administrative costs and expenses

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

and accounting services.

Wulff resigned as Chief Financial Officer of the Company on March 31, 2026.

and Development

2 unchanged sentences

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 the Glucotrack CBGM;

primarily due to expanding clinical trial activities, hiring additional personnel, as well as 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, development of new Glucotrack CBGM models and other product candidates.

expenses consist primarily of personnel-related expenses and professional service costs.

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

and other product candidates.

and Administrative

and administrative expenses consist primarily of professional services, salaries, travel expenses and other related expenses for executive,

finance and administrative personnel, including stock-based compensation expenses.

Other general and administrative costs and expenses

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

accounting, media, and public and investor relation services.

(Income) Expense

income expense, consist primarily of the change in fair value of derivative liabilities, finance (income) expense and other (income)

income expense, consist primarily of the change in fair value of derivatives liabilities, loss on the issuance of equity, loss on settlement

of debt to equity and finance income.

of Operations

following discussion of our operating results explains material changes in our results of operations for the three and nine months ended

September 30, 2025 compared with the same periods ended September 30, 2024.

The discussion should be read in conjunction with the financial

statements and related notes included elsewhere in this report.

Results of Operations for the Three Months ended September 30, 2025 and 2024

following discussion of our operating results explains material changes in our results of operations for the three months ended March

31, 2026 compared with the same period ended March 31, 2025.

The discussion should be read in conjunction with the financial statements

and related notes included elsewhere in this report.

Results of Operations for the Three Months Ended March 31, 2026 and 2025

information below is stated in thousands of U.S.

and administrative expenses

and administrative expenses were approximately $1,024 for the three-month period ended September 30, 2025, as compared to

approximately $1,063, for the prior-year period.

The decrease is primarily attributable to reduced board of director and legal fees,

offset by increased professional fees, and personnel costs.

and development expenses

and development expenses were approximately $3,165 for the three-month period ended September 30, 2025, as compared to approximately

$2,063 for the prior-year period.

The increase is attributable to product and manufacturing development costs we accrued during the

period related to the development of the Glucotrack CBGM Product.

expenses were approximately $120 for the three-month period ended September 30, 2025, as compared to $125 for the prior-year period.

The decrease is primarily attributable to a reduction in market research fees.

in derivative liability

in derivative liability for the three months ended September 30, 2025, was less than $1.0.

(income) expense, net

income was $136 for the three-month period ended September 30, 2025, as compared to $12 for the prior-year period.

The increase was due

to the receipt of a non-recurring research grant.

income (expenses), net

income, net was approximately $2 for the three-month period ended September 30, 2025, as compared to financing expense of approximately

$1,848 for the prior-year period.

This increase was primarily due to $1,505 in revaluation expenses incurred from settlement of financial

liabilities and $330 in discount amortization and interest expenses recognized in the prior-year period.

loss was $4,171 for the three-month period ended September 30, 2025, as compared to $5,087 for the prior-year period.

The reduction in

net loss is primarily attributed to the prior year revaluation expenses, discussed above, offset by the current year increase in research

and Development Expense

Results of Operations for the Nine Months ended September 30, 2025 and 2024

and administrative expenses

and administrative expenses were approximately $3,987 for the nine-month period ended September 30, 2025, as compared to

approximately $2,598, for the prior-year period.

The increase is primarily attributable to increased legal and professional fees,

and personnel costs.

and development expenses

and development expenses were approximately $8,186 for the nine-month period ended September 30, 2025, as compared to approximately $7,800

for the prior-year period.

The increase is attributable to product and manufacturing development costs we accrued during the period related

to the development of the Glucotrack CBGM Product.

expenses were approximately $430 for the nine-month period ended September 30, 2025, as compared to $295 for the prior-year period.

increase is primarily attributable to increased market research fees.

in derivative liability

in derivative liability for the nine-month period ended September 30, 2025, was a $3,269.

The change is primarily due to adjustments

of the estimated fair value of the exchanged and repurchased warrants, as well as the outstanding 2,518 Series A and Series B Warrants.

and development expenses were $2,132 for the three months ended March 31, 2026, as compared to $1,871 for the prior-year period.

increase of $261 was primarily attributable to increased expenses related to product design, development and manufacturing activities

and pre-clinical animal studies.

and Administrative Expense

and administrative expenses were $2,071 for the three months ended March 31, 2026, as compared to $1,627 for the prior-year period.

increase of $444 is primarily attributable to increased professional fees and personnel costs.

(Income) Expense, net

income was $44 for the nine-month period ended September 30, 2025, as compared to $12 for the prior-year period.

income (expenses), net

income, net was approximately $68 for the nine-month period ended September 30, 2025, as compared to financing expense of approximately

$1,822 for the prior-year period.

This increase was primarily due to $1,505 in revaluation expenses incurred from settlement of financial

liabilities and $330 in discount amortization and interest expenses recognized in the prior-year period.

loss was $15,760 for the nine-month period ended September 30, 2025, as compared to $12,503 for the prior-year period.

The increase in

net loss is primarily attributed to the increase in general and administrative expenses and the fair value change of the derivative liability,

as described above.

expense was $131 for the three months ended March 31, 2026, as compared to $3,335 for the prior-year period.

The decrease in other expense

is primarily attributed to the current year reduction in the change of derivative liabilities.

loss was $4,334 for the three months ended March 31, 2026, as compared to a net loss of $6,833 for the prior-year period.

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

and Going Concern

of September 30, 2025, we had $7,869 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 $13,549 of net proceeds received from

financing activities offset by cash used in operating and investing activities of $11,380.

have a history of recurring losses, and as of September 30, 2025, we have an accumulated deficit of $148,210.

During the nine-months

ended September 30, 2025, we recorded a net loss of $15,760.

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 September 30, 2025, will be sufficient to fund

of March 31, 2026, we had $3,929 in cash and cash equivalents compared with $7,383 in cash and cash equivalents as of December 31, 2025.

The net decrease in cash and cash equivalents was attributable to $4,048 of cash used in operating activities offset by net proceeds

received from financing activities of $591.

have a history of recurring losses, and as of March 31, 2026, we have an accumulated deficit of $156,172.

During the three months ended

March 31, 2026, we recorded a net loss of $4,334.

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 March 31, 2026, will be sufficient to fund

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

estimates it will require approximately $15.0 million in cash to fund operations over this period.

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.

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.

this review and our current financial condition, we have concluded that substantial doubt exists as to our ability to continue as a going

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 on terms acceptable to us, or at all.

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.

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

22 unchanged sentences

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-Q

Item 2. Management’s Discussion and Analysis