What changed in this filing

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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-31 · 367 added, 257 removed, 463 unchanged (57% of the section changed)

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We are not profitable and have incurred losses since our inception.

date we have not generated material revenue from the sale of products, and we do not anticipate that we will report operating income

in the foreseeable future.

Our initial product, Glucotrack CBGM, has not been approved for marketing in the United States and is currently

under preclinical development.

We continue to incur research and development and selling, marketing and general and administrative expenses

related to our operations, development and commercialization of our first product.

Our operating losses for the years ended December

31, 2024 and 2023 were approximately $22.6 million and $7.1 million, respectively, and we had an accumulated deficit of approximately

$132.0 million as of December 31, 2024.

We expect to continue to incur losses for the foreseeable future, and these losses will likely

increase as we develop and prepare to commercialize Glucotrack CBGM.

If we are not successful in developing, manufacturing and distributing

Glucotrack CBGM, or if Glucotrack CBGM does not achieve market acceptance, we may never become profitable.

Even if we achieve profitability

in the future, we may not be able to sustain profitability in subsequent periods.

we continue to evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter

To date we have not generated material revenue from the sale of products, and we do not anticipate that we will report operating

income in the foreseeable future.

Our first product was removed from international markets as the Company withdrew its CE Mark by

As of 2023, all commercialization and development efforts ceased of the first product.

Our second and novel new product,

Glucotrack CBGM, has not been approved for marketing in the United States or internationally and is currently under preclinical

Our net losses for the years ended December 31, 2025 and 2024 were approximately $19.4 million and $22.6 million,

respectively, and we had an accumulated deficit of approximately $151.8 million as of December 31, 2025.

We expect to continue to

incur losses for the foreseeable future, and these losses will likely increase as we develop and prepare to commercialize Glucotrack

If we are not successful in developing, manufacturing and distributing Glucotrack CBGM, or if Glucotrack CBGM does not achieve

market acceptance, we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain

profitability in subsequent periods.

we evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter

difficulties in managing our growth and expanding our operations successfully.

anticipate that, as our operations expand and, assuming that our development, testing, studies and trials are successful, we will need

to expand our manufacturing, marketing and sales capabilities by contracting with third parties.

Maintaining these relationships and

managing our future growth will impose significant added responsibilities on members of our management team.

We must be able to manage

our development efforts effectively;

anticipate that, as our operations expand and, assuming that our development, testing, pre-clinical studies and human clinical trials

are successful, we will need to build and develop our marketing and sales capabilities.

Maintaining and managing our future growth will

impose significant added responsibilities on members of our management team.

We must be able to manage our development efforts effectively;

manage our clinical trials effectively;

hire, train and integrate additional management, development,

administrative and sales and marketing personnel;

hire, train and integrate additional management, development, administrative and sales and marketing

improve managerial, development, operational and finance systems;

and expand our facilities,

all of which may impose a strain on our administrative and operational infrastructure.

and expand our facilities, all of which may impose a strain

on our administrative and operational infrastructure.

may have future capital needs and may not be able to obtain additional financing on acceptable terms.

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our ability to continue as a “going concern.”

may not have sufficient liquidity to meet our anticipated obligations over the next year from the issuance of the financial

statements contained in this Annual Report.

We have incurred net losses and negative cash flows from our operations and

comprehensive loss since our inception and as of December 31, 2024, we had an accumulated deficit of $132.5 million.

conditions raise substantial doubt about the Company’s ability to continue as a going concern.

may not have sufficient liquidity to meet our anticipated obligations over the next year from the issuance of the financial statements

contained in this Annual Report.

We have incurred net losses and negative cash flows from our operations and comprehensive loss since

our inception and as of December 31, 2025, we had an accumulated deficit of $151.8 million.

As of December 31, 2025, we had cash and

cash equivalents of $7.4 million.

There are no assurances that we will be able to raise additional capital or do so on terms favorable

Our recurring losses from operations and projected future cash flow requirements raise substantial doubt about our ability to

continue as a going concern without sufficient capital resources and we have included explanatory information in the notes to our financial

statements for the year ended December 31, 2025, with respect to this uncertainty, and the report of our independent registered public

accounting firm with respect to our audited financial statements for the year ended December 31, 2025 included an emphasis

of matter for this as well.

Our consolidated financial statements do not include any adjustments that might result from the outcome of

this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which

contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

ability to continue as a going concern is dependent on our available cash, how well we manage that cash, and our operating requirements.

If we are unable to raise additional capital when needed, we could be forced to curtail operations or take other actions such as implementing

additional restructuring and cost reductions, disposing of one or more product lines and/or, selling or licensing intellectual property.

If we are unable to continue as a going concern, we may be forced to liquidate our assets, which would have an adverse impact on our

business and developmental activities.

In such a scenario, the values we receive for our assets in liquidation or dissolution could be

significantly lower than the values reflected in our financial statements.

crises and market instability may materially and adversely affect the demand for our products, as well as our ability to obtain credit

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fund our operations.

crises may reduce the demand for new and innovative medical devices, resulting in delayed market acceptance of our products, if and

when they are approved.

Such a delay could have a material adverse impact on our business, expected cash flows, results of

operations and financial condition.

Additionally, we have funded our operations to date primarily through public and private sales

of securities, including Common Stock and other securities convertible into or exercisable for shares of our Common Stock.

turmoil and instability in the world’s equity and credit markets may materially adversely affect our ability to sell

additional securities and/or borrow cash.

There can be no assurance that we will be able to raise additional working capital on

acceptable terms or at all, and any failure to do so may materially adversely affect our ability to continue operations.

crises may reduce the demand for new and innovative medical devices, resulting in delayed market acceptance of our products, if and when

they are approved.

Such a delay could have a material adverse impact on our business, expected cash flows, results of operations and

financial condition.

Additionally, we have funded our operations to date primarily through public and private sales of securities, including

Common Stock and other securities convertible into or exercisable for shares of our Common Stock.

Economic turmoil and instability in

the world’s equity and credit markets may materially adversely affect our ability to sell additional securities and/or borrow cash.

There can be no assurance that we will be able to raise additional working capital on acceptable terms or at all, and any failure to

do so may materially adversely affect our ability to continue operations.

CBGM is not approved for sale in the United States or other jurisdictions.

will likely be required to undertake significant clinical trials to demonstrate to the FDA that Glucotrack CBGM is safe and

effective for its intended use (refer to “ Business – Regulatory Considerations ”).

We may also be required to

undertake similar clinical trials by non-U.S.

will likely be required to undertake significant clinical trials to demonstrate to the FDA that Glucotrack CBGM is safe and effective

for its intended use (refer to “ Business – Regulatory Considerations ”).

We may also be required to undertake

similar clinical trials by non-U.S.

regulatory agencies, particularly for the European Union (CE Mark).

Clinical trials

for implantable medical devices are expensive and uncertain processes that take years to complete.

Failure can occur at any point in

the process and early positive results do not ensure that the entire clinical trial will be successful.

Product candidates in

clinical trials may fail to show desired efficacy and safety traits despite early promising results.

A number of companies in the

medical device industry have suffered significant setbacks in advanced clinical trials, even after their product candidates

demonstrated promising results at earlier points.

Clinical trials for implantable

medical devices are expensive and uncertain processes that take years to complete.

Failure can occur at any point in the process and

early positive results do not ensure that the entire clinical trial will be successful.

Product candidates in clinical trials may fail

to show desired efficacy and safety traits despite early promising results.

A number of companies in the medical device industry have

suffered significant setbacks in advanced clinical trials, even after their product candidates demonstrated promising results at earlier

results from the limited safety and performance pre-clinical trials and first-in-human acute clinical studies that we have conducted

should not be relied upon as evidence that early-stage or large-scale clinical trials will succeed.

Despite efforts to choose the

proper animal model reflecting our intended use, our pre-clinical animal trials and first-in-human acute clinical studies cannot be

a guarantee of clinical trial success because human physiology and anatomy are different.

Because of the sample size, possible

variation in methodology or differences in physiology, the results of these pre-clinical trials may not be indicative of future

We will be required to demonstrate through well-controlled clinical trials that Glucotrack CBGM or future product

candidates, if any, are safe and effective for their intended uses.

Despite efforts to choose the proper

animal model reflecting our intended use, our pre-clinical animal trials and first-in-human acute clinical studies cannot be a guarantee

of clinical trial success because human physiology and anatomy are different.

Because of the sample size, possible variation in methodology

or differences in physiology, the results of these pre-clinical trials may not be indicative of future results.

We will be required to

demonstrate through multiple well-controlled clinical trials that Glucotrack CBGM or future product candidates, if any, are safe and

effective for their intended uses.

the Glucotrack CBGM or our future product candidates, if any, may not be cleared or approved, as the case may be, even if the clinical

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In addition, any of these regulatory authorities may also clear or approve

a product candidate for fewer or more limited uses than we request or may grant clearance or approval contingent on the performance of

costly post-marketing clinical trials.

In addition, the FDA or other non-regulatory authorities may not approve the labeling claims necessary

or desirable for the successful commercialization of Glucotrack CBGM or our future product candidates, if any.

are highly dependent on the success of our product candidate, Glucotrack CBGM, and cannot give any assurance that it will receive regulatory

approval or clearance or be successfully commercialized.

are highly dependent on the success of our product candidate, Glucotrack CBGM.

We cannot give any assurance that the FDA will permit

us to clinically test the device, nor can we give any assurance that the clinical trials will be successful or that Glucotrack CBGM will

receive regulatory clearance or approval or be successfully commercialized, for a number of reasons, including, without limitation, the

potential introduction by our competitors of more clinically-effective or cost-effective alternatives, failure in our sales and marketing

a product candidate for fewer or more limited patient populations than we request or may grant clearance or approval contingent on the

performance of costly post-marketing clinical trials.

In addition, the FDA or other non-regulatory authorities may not approve the labeling

claims necessary or desirable for the successful commercialization of Glucotrack CBGM or our future product candidates, if any.

are highly dependent on the success of our primary product candidate, Glucotrack CBGM, and cannot give any assurance that it will receive

regulatory approval or clearance or be successfully commercialized.

are highly dependent on the success of our primary product candidate, Glucotrack CBGM.

We cannot give any assurance that the FDA will

permit us to clinically test the device, nor can we give any assurance that the clinical trials will be successful or that Glucotrack

CBGM will receive regulatory clearance or approval or be successfully commercialized, for a number of reasons, including, without limitation,

the potential introduction by our competitors of more clinically-effective or cost-effective alternatives, failure in our sales and marketing

efforts, or the failure to obtain positive coverage determinations or reimbursement.

Any failure to obtain approval to conduct

clinical trials, favorable clinical data, clearance or approval of or to successfully commercialize Glucotrack CBGM would have a material

adverse effect on our business.

Any failure to obtain approval to conduct clinical

trials, favorable clinical data, clearance or approval of or to successfully commercialize Glucotrack CBGM would have a material adverse

effect on our business.

our competitors develop and market products that are more effective, safer or less expensive than Glucotrack CBGM or our future product

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of product candidates by physicians and other health care providers;

the results of our clinical trials;

results of our clinical trials;

ability to recruit and enroll patients for our clinical trials;

efficacy, safety, performance and reliability of our product candidates;

the speed at which we develop product candidates;

speed at which we develop product candidates or required iterations thereon;

ability to obtain prompt and favorable FDA review and approval of an IDE to conduct our clinical trials;

ability to obtain prompt and favorable IRB review and approval at each of our clinical sites;

our ability to commercialize and market any of our product candidates that may receive regulatory clearance or approval;

our ability to design and successfully execute appropriate clinical trials;

ability to commercialize and market any of our product candidates that may receive regulatory clearance or approval;

ability to design and successfully execute appropriate clinical trials;

timing and scope of regulatory clearances or approvals;

appropriate coverage and adequate levels of reimbursement under private and governmental health insurance plans, including Medicare;

coverage and adequate levels of reimbursement under private and governmental health insurance plans, including Medicare;

ability to protect intellectual property rights related to our products.

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diabetes market is currently seeing increasing use of GLP-1 drugs for the treatment of obesity and Type 2 diabetes.

While we believe

that GLP-1s are a companion product and can be used in conjunction with CGM systems, such drugs could potentially compete with the Glucotrack

CBGM and impact successful commercialization.

While GLP-1s have

been used as a companion product in conjunction with CGM systems, such drugs could potentially compete with the Glucotrack CBGM and impact

successful commercialization particularly as it applies to patients with Type 2 diabetes not dependent on insulin as well as those with

pre-diabetes conditions.

product development activities could be delayed or stopped.

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commencement of future clinical trials could be substantially delayed or prevented by several factors, including:

the failure to obtain sufficient funding to pay for all necessary clinical trials;

failure to obtain sufficient funding to pay for all necessary clinical trials;

number of, and competition for, suitable patients that meet the protocol’s inclusion criteria and do not meet any of the exclusion

limited number of, and competition for, suitable sites to conduct the clinical trials, and delay or failure to obtain FDA approval, if necessary, to commence a clinical trial;

number of, and competition for, suitable sites to conduct the clinical trials, and delay or failure to obtain FDA approval, if necessary,

to commence a clinical trial;

or failure to obtain sufficient supplies of the product candidate for clinical trials;

requirements to provide the medical device required in clinical trials at cost, which may require significant expenditures that we are unable or unwilling to make;

delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or investigators;

to provide the medical device required in clinical trials at cost, which may require significant expenditures that we are unable

or unwilling to make;

or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or

investigators;

or failure to obtain IRB approval or renewal of such approval to conduct a clinical trial at a prospective or accruing site, respectively.

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several factors, including:

or failure to obtain FDA IDE approval or renewal of such approval to conduct a clinical trial;

than expected rates of patient recruitment and enrollment;

failure of patients to complete the clinical trial;

unforeseen safety issues;

of patients to complete the clinical trial;

safety issues;

of efficacy evidenced during clinical trials;

termination of clinical trials by one or more clinical trial sites;

of clinical trials by one or more clinical trial sites;

or unwillingness of patients or medical investigators to follow clinical trial protocols;

inability to monitor patients adequately during or after treatment.

clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, the IRB for any given site or us.

Any failure or significant delay in completing clinical trials for Glucotrack® or future product candidates, if any, could

to monitor patients adequately during or after the clinical study period;

to meet safety and efficacy endpoints required by the FDA for market clearance.

clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, and/or the IRB for any given site

Any failure or significant delay in completing clinical trials for the Glucotrack CBGM or future product candidates, if any, could

materially harm our financial results and the commercial prospects for our product candidates.

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of Glucotrack CBGM or our future product candidates, if any.

research, testing, manufacturing, labeling, approval, selling, marketing and distribution of medical devices are subject to

extensive regulation by the FDA and other non-U.S.

research, testing, manufacturing, labeling, approval, selling, marketing and distribution of medical devices are subject to extensive

regulation by the FDA and other non-U.S.

regulatory authorities, with regulations that differ from country to country.

are not permitted to market our product candidates in the United States until we receive a clearance letter under Section 515

premarket approval from the FDA.

We have not submitted an application or premarket notification for or received marketing clearance

or approval for our current product candidate.

Obtaining approval of any premarket approval can be a lengthy, expensive and

uncertain process, particularly for Class III devices under which our product candidate falls.

In lieu of acting on a premarket

notification, the FDA may seek additional information or additional data which would further delay our ability to market the

product candidate.

We are not permitted

to market our product candidates in the United States until we receive a clearance letter under Section 515 premarket approval from the

We have not submitted an application or premarket notification for or received marketing clearance or approval for our current product

Obtaining approval of any premarket approval can be a lengthy, expensive and uncertain process, particularly for Class III

devices under which our product candidate falls.

In lieu of acting on a premarket notification, the FDA may seek additional information

or additional data which would further delay our ability to market the product candidate.

In addition, failure to comply with FDA, non-U.S.

regulatory authorities or other applicable U.S.

requirements may, either before or after product clearance or approval, if any, subject us to administrative or judicially imposed

sanctions, including:

regulatory requirements may, either before or after product clearance or

approval, if any, subject us to administrative or judicially imposed sanctions, including:

on the products, manufacturers or manufacturing process;

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or mandatory product recalls and publicity requirements;

total or partial suspension of production;

or partial suspension of production;

of restrictions on operations, including costly new manufacturing requirements;

refusal to clear or approve pending applications or premarket notifications.

approval of a PMA or PMA supplement is not guaranteed, and the approval will take several years when factoring in clinical trial timelines.

to clear or approve pending applications or premarket notifications.

approval of a Class III medical device is not guaranteed, and the approval will take several years when factoring in clinical trial timelines.

The FDA also has substantial discretion in the medical device clearance or approval processes.

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of a medical device candidate for many reasons, including:

medical device candidate may not be deemed safe or effective;

device candidate may not be deemed safe or effective;

officials may not find the data from the clinical trials sufficient;

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judicially imposed sanctions, including:

restrictions on the products, manufacturers or manufacturing process;

on the products, manufacturers or manufacturing process;

inspectional observations (Form 483), warning letters, or non-warning letters incorporating inspectional observations;

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seizures, detentions or import bans;

voluntary or mandatory product recalls and publicity requirements;

suspension or withdrawal of regulatory clearances or approvals;

total or partial suspension of production;

imposition of restrictions on operations, including costly new manufacturing requirements;

or mandatory product recalls and publicity requirements;

or withdrawal of regulatory clearances or approvals;

or partial suspension of production;

of restrictions on operations, including costly new manufacturing requirements;

to clear or approve pending applications or premarket notifications.

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will depend on a number of factors, including:

timing of market introduction of competitive products;

of market introduction of competitive products;

and efficacy of our product;

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advantages or disadvantages over alternative treatments;

strength of marketing and distribution support;

price of our product candidates, both in absolute terms and relative to alternative treatments;

of marketing, sales, and distribution support;

of our product candidates, both in absolute terms and relative to alternative treatments;

of coverage and reimbursement from government and other third-party payors.

the Glucotrack CBGM or our future product candidates, if any, fail to achieve market acceptance, we may not be able to generate significant

revenue or achieve or sustain profitability.

coverage and reimbursement status of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage

the Glucotrack CBGM or our future product candidates, if any, fail to achieve sufficient reimbursement and coverage, we may not be able

to generate significant revenue or achieve or sustain profitability.

reimbursement status and coverage of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage

and adequate reimbursement could limit our ability to market Glucotrack CBGM or future product candidates, if any, and may inhibit our

ability to generate revenue from Glucotrack CBGM or our future product candidates, if any, that may be cleared or approved.

is significant uncertainty related to the third-party coverage and reimbursement of newly cleared or approved medical devices.

The commercial

success of Glucotrack CBGM or our future product candidates, if any, in both domestic and international markets will depend in part on

the availability of coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and

Medicaid programs, managed care organizations and other third-party payors.

Government and other third-party payors are increasingly

attempting to contain health care costs by limiting both coverage and the level of reimbursement for new products and, as a result, they

may not cover or provide adequate payment for Glucotrack CBGM or our future product candidates, if any.

These payors may conclude that

our products are not as safe or effective as existing devices or that the overall cost of using one of our devices exceeds the overall

cost of the competing device, and third-party payors may not approve Glucotrack CBGM or our future product candidates, if any, for coverage

and adequate reimbursement.

Furthermore, deficit reduction and austerity measures in the United States and abroad may put further pressure

on governments to limit coverage of, and reimbursement for, our products.

The failure to obtain coverage and adequate reimbursement for

Glucotrack CBGM or our future product candidates, if any, or health care cost containment initiatives that limit or restrict reimbursement

for such products, may reduce any future product revenue.

The commercial success

of Glucotrack CBGM or our future product candidates, if any, in both domestic and international markets will depend in part on the availability

of coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and Medicaid programs,

managed care organizations and other third-party payors.

Government and other third-party payors are increasingly attempting to contain

health care costs by limiting both coverage and the level of reimbursement for new products and, as a result, they may not cover or provide

adequate payment for Glucotrack CBGM or our future product candidates, if any.

These payors may conclude that our products are not as

safe or effective as existing devices or that the overall cost of using one of our devices exceeds the overall cost of the competing

device, and third-party payors may not approve Glucotrack CBGM or our future product candidates, if any, for coverage and adequate reimbursement.

Furthermore, deficit reduction and austerity measures in the United States and abroad may put further pressure on governments to limit

coverage of, and reimbursement for, our products.

The failure to obtain coverage and adequate reimbursement for Glucotrack CBGM or our

future product candidates, if any, or health care cost containment initiatives that limit or restrict reimbursement for such products,

may reduce any future product revenue.

may not obtain insurance coverage to adequately cover all significant risk exposures.

will be exposed to liabilities that are unique to the products we provide.

We currently maintain commercial general liability and property insurance, but there can be

no assurance that we will acquire or maintain insurance for certain risks, that the amount of our insurance coverage will be adequate

to cover all claims or liabilities or that we will not be forced to bear substantial costs resulting from risks and uncertainties of

We currently maintain commercial general liability and property

insurance, but there can be no assurance that we will acquire or maintain insurance for certain risks, that the amount of our insurance

coverage will be adequate to cover all claims or liabilities or that we will not be forced to bear substantial costs resulting from risks

and uncertainties of business.

It is also not possible to obtain insurance to protect against all operational risks and liabilities.

to obtain adequate insurance coverage on terms favorable to us, or at all, could have a material adverse effect on our business, financial

condition and results of operations.

The failure to obtain adequate insurance coverage on terms favorable to us, or at all, could have a material adverse effect on our business,

financial condition and results of operations.

product liability lawsuits are brought against us, we may incur substantial liabilities.

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merits or eventual outcome, liability claims may result in:

decreased demand for products that we may offer for sale;

demand for products that we may offer for sale;

to our reputation;

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monetary awards to trial participants or patients;

product recalls, withdrawals or labeling, marketing or promotional restrictions;

recalls, withdrawals or labeling, marketing or promotional restrictions;

decline in our stock price.

inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability

claims could prevent or inhibit the commercialization of products we develop.

We currently maintain product liability insurance up to

$5,000 per claim and in the aggregate.

Although we have product liability coverage, we may have to pay amounts awarded by a court or

negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be

able to obtain, sufficient capital to pay such amounts.

inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product

liability claims could prevent or inhibit the commercialization of products we develop.

We currently do not maintain product

liability insurance in the United States and maintain product liability insurance in Australia up to $10.0 Million AUS Dollars per

claim and in the aggregate.

Regardless of whether we maintain product liability insurance coverage in any jurisdiction, including

Australia or in the future the United States, we may be required to pay amounts awarded by a court or negotiated in a settlement that

exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient

capital to pay such amounts.

we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize Glucotrack

CBGM or our future product candidates, if any.

will need to expand and effectively manage our managerial, operational, financial, development and other resources in order to

successfully pursue our research, development and commercialization efforts for Glucotrack CBGM or our future product candidates, if

Our success depends on our continued ability to attract, retain and motivate highly qualified management and pre-clinical and

clinical personnel.

The loss of the services of any of our executive and senior management could delay or prevent the development or

commercialization of Glucotrack CBGM or our future product candidates, if any.

At present, we do not have executive insurance

policies with respect to any of our employees.

We will need to hire additional personnel as we continue to expand our research and

development activities and build a sales and marketing function.

may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for

qualified personnel among medical device and other businesses.

If we are not able to attract and retain the necessary personnel to

accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our research and

development objectives, our ability to raise additional capital and our ability to implement our business strategy.

In particular,

if we lose any members of our executive or senior management teams, we may not be able to find suitable replacements in a timely

fashion or at all and our business may be harmed as a result.

will need to expand and effectively manage our managerial, operational, financial, development and other resources in order to successfully

pursue our research, development and commercialization efforts for Glucotrack CBGM or our future product candidates, if any.

depends on our continued ability to attract, retain and motivate highly qualified management and pre-clinical and clinical personnel.

The loss of the services of any of our executive and senior management could delay or prevent the development or commercialization of

Glucotrack CBGM or our future product candidates, if any.

At present, we do not have executive insurance policies with respect to any

of our employees.

We will need to hire additional personnel as we continue to expand our research and development activities and build

a sales and marketing function.

may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for qualified

personnel among medical device and other businesses.

If we are not able to attract and retain the necessary personnel to accomplish our

business objectives, we may experience constraints that will significantly impede the achievement of our research and development objectives,

our ability to raise additional capital and our ability to implement our business strategy.

In particular, if we lose any members of

our executive or senior management teams, we may not be able to find suitable replacements in a timely fashion or at all and our business

may be harmed as a result.

rely on third parties to manufacture and supply our product.

do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a prototype lab.

We have no experience in medical device manufacturing and lack the resources and the capability to manufacture the Glucotrack CBGM on

a commercial scale.

do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a research and prototyping

We, therefore, lack the internal capability to manufacture the Glucotrack CBGM on a commercial scale.

our manufacturing partners are unable to produce our products in the amounts, timing or pricing that we require, we may not be able to

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products, cost overruns or other problems that could seriously harm our business.

performance failure on the part of our third-party manufacturers could delay clinical development or regulatory clearance or

approval of our product candidates or commercialization of our future product candidates, if any, depriving us of potential product

revenue and resulting in additional losses.

In addition, our dependence on a third-party for manufacturing may adversely affect our

future profit margins.

Our ability to replace an existing manufacturer may be difficult because the number of potential

manufacturers is limited and the FDA must approve any replacement manufacturer before it can begin manufacturing our product

Such approval would require additional non-clinical testing and compliance inspections.

It may be difficult or

impossible for us to identify and engage a replacement manufacturer on acceptable terms in a timely manner, or at all.

performance failure on the part of our third-party manufacturers could delay clinical development or regulatory clearance or approval

of our product candidates or commercialization of our future product candidates, if any, depriving us of potential product revenue and

resulting in additional losses.

In addition, our dependence on a third-party for manufacturing may adversely affect our future profit

Our ability to replace an existing manufacturer may be difficult because the number of potential manufacturers is limited and

the FDA must approve any replacement manufacturer before it can begin manufacturing our product candidates.

Such approval would require

additional non-clinical testing and compliance inspections.

It may be difficult or impossible for us to identify and engage a replacement

manufacturer on acceptable terms in a timely manner, or at all.

clinical investigators and contract research organizations that we may engage to conduct our clinical trials may not be diligent, careful

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regulations and customs;

changes in non-U.S.

currency exchange rates and currency controls;

changes in a specific country or region’s political or economic environment;

in a specific country or region’s political or economic environment;

protection measures, import or export licensing requirements or other restrictive actions by U.S.

negative consequences from changes in tax laws;

consequences from changes in tax laws;

associated with staffing and managing foreign operations, including differing labor relations.

funding that we received through the Israeli Innovation Authority (“IIA”) for research and development activities restricts

our ability to manufacture products or to transfer technology outside of Israel.

March 4, 2004, the IIA agreed to provide us with a grant of 420 New Israeli Shekels (“NIS”), or approximately $93 at an

exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood glucose

our ability to manufacture products or to transfer technology outside of Israel of its first product which we have taken off the market

and no longer have available for sale.

2023, the Company abandoned pursuit of its Israeli originated first generation product development programs, including the

abandonment of any associated intellectual property and intangible assets.

The Company is solely focused on its second product,

which is uniquely designed and patented, under product and clinical development efforts in the United States.

The Company’s Israeli subsidiary is in the process of dissolution and does not conduct any operating activities.

March 4, 2004, the IIA agreed to provide us with a grant of 420,000 New Israeli Shekels (“NIS”), or approximately $93 thousand

at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood glucose

monitor (the “development plan”).

This grant constituted 60% of our research and development budget for the development

plan at that time.

Due to our acceptance of this grant, we are subject to the provisions of the Israeli Law for the Encouragement of

Industrial Research and Development, 1984 (the “R&D Law”).

Among other things, the R&D Law restricts the ability

to sell or transfer rights in technology or know-how developed with IIA funding or transfer any Means of Control (as defined in the

R&D Law) of us to non-Israeli entities.

The Industrial Research and Development Committee at the IIA (the “research

committee”) may, under special circumstances, approve the transfer outside of Israel of rights in technology or know-how

developed with IIA funding subject to certain conditions, including the condition that certain payments be made to the IIA.

Additionally, products developed with IIA funding outside of Israel cannot be manufactured without the approval of a research

The restrictions regarding the sale or transfer of technology or manufacturing rights out of Israel could have a material

adverse effect on the ability to enter into strategic alliances or enter into merger or acquisition transactions in the future that

provide for the sale or transfer of technology or manufacturing rights.

late 2023, the Company abandoned pursuit of its Israeli originated first generation product development programs top focus solely on

its next generation CBGM product development efforts for FDA market approval.

This grant constituted 60% of our research and development budget for the development plan

at that time.

Due to our acceptance of this grant, we are subject to the provisions of the Israeli Law for the Encouragement of Industrial

Research and Development, 1984 (the “R&D Law”).

Among other things, the R&D Law restricts the ability to sell or

transfer rights in technology or know-how developed with IIA funding or transfer any Means of Control (as defined in the R&D Law)

of us to non-Israeli entities.

The Industrial Research and Development Committee at the IIA (the “research committee”) may,

under special circumstances, approve the transfer outside of Israel of rights in technology or know-how developed with IIA funding subject

to certain conditions, including the condition that certain payments be made to the IIA.

Additionally, products developed with IIA funding

outside of Israel cannot be manufactured without the approval of a research committee.

The restrictions regarding the sale or transfer

of technology or manufacturing rights out of Israel could have a material adverse effect on the ability to enter into strategic alliances

or enter into merger or acquisition transactions in the future that provide for the sale or transfer of technology or manufacturing rights.

results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.

such as geopolitical events (including the ongoing wars in Iran, Ukraine and Israel and the risk of increased tensions between China

and Taiwan), inflationary pressures, public health crises, and U.S.

election cycles, and changes in government administration and policies

have caused extreme volatility and disruptions in the capital and credit markets in recent years.

Uncertainty or unfavorable global economic

conditions could result in a variety of impacts to our business, including adversely impacting our ability to raise additional capital

when needed on acceptable terms, if at all.

Related to Owning our Common Stock

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we and our stockholders could face significant material adverse consequences.

In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we may not satisfy and therefore

could cause our Common Stock to be delisted by Nasdaq on an imminent basis, if approved by the SEC.

order to remain listed on Nasdaq, we must satisfy minimum financial and other continued listing requirements and standards, including

those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price,

and certain corporate governance requirements.

and certain corporate governance requirements (the “Nasdaq Listing Rules”).

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

equity for continued listing (the “Minimum Stockholders’ Equity Requirement”).

On May 21, 2024, the Nasdaq Qualifications Listing Staff (the “Staff”)

notified us that our Form 10-Q for the period ended March 31, 2024, indicated that we no longer met the Minimum Stockholders’ Equity

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

On May 21, 2024, the Nasdaq Qualifications

Listing Staff (the “Staff”) notified us that our 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 is a basis

for delisting our Common Stock.

we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq as

set forth in Nasdaq Listing Rule 5550(a)(2) (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 (the “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.

set forth in Nasdaq Listing Rule 5550(a)(2) (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.

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 (the “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 November Offering (defined blow), the

Panel has 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.

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

Price Rule, or other Nasdaq listing requirements.

If we are not able to comply with applicable listing standards, our shares of Common

Stock will be subject to delisting.

Nasdaq delists our Common Stock from trading on its exchange for failure to meet comply with the Bid Price Rule, or any other listing

standards, we and our stockholders could face significant material adverse consequences including, but not limited to:

a limited availability of market quotations for our securities;

a reduction in liquidity and market price of our Common Stock;

a reduction in the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise equity financing;

a determination that our Common Stock is a “penny stock,” which will require brokers trading in our Common Stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our Common Stock;

a limited amount of analyst coverage;

a decreased ability to issue additional securities or obtain additional financing in the future.

The Compliance Letter noted, that because the

Company’s bid price had closed below the minimum required by the Bid Price Rule following the November Offering (defined blow),

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 maintained long-term compliance with the Minimum Stockholders’

Equity Requirement, the Bid Price Rule, and all other Nasdaq Listing Rules.

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.

addition to the foregoing requirements, Nasdaq has recently proposed a new listing requirement that would require each Nasdaq listed

issuer to maintain a minimum market value of listed securities of at least $5 million.

Under this proposal, if the value of an issuer’s

listed securities, as measured by each applicable trading day’s closing price, continues to be less than $5 million for a period

of 30 consecutive trading days, the issuer’s securities would immediately be delisted, with no compliance or cure period.

rule would also preclude an issuer’s ability to seek stay of delisting during any appeals process, and would preclude Nasdaq hearings

panels from reversing the delisting determination to situations where there was an error and the company never actually failed to satisfy

the requirement.

The panel would also not be able to consider any facts indicating that issuer subsequently regained compliance with

the requirement or grant an issuer any additional time to regain compliance.

The proposed rule is subject to review and approval by the

SEC, and it is unknown whether the SEC will approve the proposal.

If approved by the SEC, the rule could become effective on an imminent

Our Common Stock currently trades at levels that are below the $5 million aggregate market value threshold proposed by Nasdaq.

As such, if this proposal is approved by the SEC, our Common Stock could be imminently delisted by Nasdaq on this basis.

may be required to monitor our market value of listed securities closely and, if necessary, take actions such as issuing additional securities,

raising additional capital or undertaking other corporate actions to seek to maintain compliance, any of which could dilute our existing

shareholders, increase our costs, or divert management’s attention.

The risk of a rapid loss of Nasdaq listing, or an actual delisting,

could adversely affect investor confidence, the liquidity and trading price of our Common Stock, and our ability to access the capital

markets, and could have a material adverse effect on our business, financial condition and results of operations.

can be no assurance that we will be able to continue to maintain compliance with the Nasdaq Listing Rules.

If we are not able to comply

with applicable Nasdaq Listing Rules, our shares of Common Stock will be subject to delisting.

Nasdaq delists our Common Stock from trading on its exchange for failure to meet comply with the Bid Price Rule, or any other Nasdaq

Listing Rules, we and our stockholders could face significant material adverse consequences including, but not limited to:

limited availability of market quotations for our securities;

reduction in liquidity and market price of our Common Stock;

reduction in the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise

equity financing;

determination that our Common Stock is a “penny stock,” which will require brokers trading in our Common Stock to adhere

to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our Common

limited amount of analyst coverage;

decreased ability to issue additional securities or obtain additional financing in the future.

had identified a material weakness in our internal control over financial reporting, and we may not be able to successfully implement

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and adequate financial reporting.

During the fiscal year ended December 31, 2025, management identified and began implementing corrective actions to remediate these material

These actions include implementing enhanced IT system access controls and data backup procedures, hiring additional accounting

personnel to improve segregation of duties, engaging third‑party valuation and technical accounting experts, and initiating the

implementation of an enterprise resource planning system designed to automate user roles, permissions, and approval workflows.

intends to continue these remediation efforts during fiscal year 2026;

however, these initiatives may not fully remediate all material

weaknesses in our internal control over financial reporting.

there can be no assurance that we will not suffer from other material weaknesses or significant deficiencies in the future.

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actions and cause us to incur substantial additional costs in future periods relating to the implementation of remedial measures.

market price of our Common Stock has been volatile and may continue to be volatile due to numerous circumstances beyond our control,

and stockholders could lose all or part of their investment.

market price of our Common Stock has been and may continue to be highly volatile.

Our stock price could be subject to wide fluctuations

in response to a variety of factors, including, without limitation:

results of trials or studies;

the announcement of new products or product enhancements by us or our competitors;

market price and trading volume of our Common Stock has been volatile and may continue to be volatile due to numerous circumstances beyond

our control, and stockholders could lose all or part of their investment.

market price and trading volume of our Common Stock has been and may continue to be highly volatile.

Our stock price and trading volume

could be subject to wide fluctuations in response to a variety of factors, including, without limitation:

of trials or studies;

announcement of new products or product enhancements by us or our competitors;

concerning intellectual property rights and regulatory approvals;

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in the medical device industry;

the results of product liability or intellectual property lawsuits;

results of product liability or intellectual property lawsuits;

or the perception that future sales may occur, of equity securities or issuance of debt;

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could cause a decline in the value of the Common Stock.

have a substantial number of convertible securities outstanding and the exercise of our outstanding warrants could have a dilutive

effect on our Common Stock.

We have a substantial number of convertible securities outstanding, including warrants exercisable for shares of our Common Stock.

issuance of shares upon the exercise of these warrants would result in dilution to our existing stockholders and could adversely affect

the market price of our Common Stock.

The trading price of our Common Stock fluctuates and may not be sufficient to induce warrant holders

to exercise their warrants.

If the warrants are “out of the money,” meaning the exercise price exceeds the market price of

our Common Stock, warrant holders are unlikely to exercise their warrants

charter documents, Delaware law, and our commercial contracts may contain provisions that may discourage an acquisition of us by others

and may prevent attempts by our stockholders to replace or remove our current management.

in our charter documents, as well as provisions of the Delaware General Corporation Law (“DGCL”), could have an impact on

the trading price of our Common Stock by making it more difficult for a third party to acquire us at a price favorable to our stockholders.

For example, our charter documents include provisions prohibiting the use of cumulative voting for the election of directors;

the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued by

our board of directors without stockholder approval to defend against a takeover attempt;

and establishing advance notice requirements

for nominations for election to our Board or for proposing matters that can be acted upon at stockholder meetings.

addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our Board or current management.

We are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of

business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an

interested stockholder, unless such transactions are approved by our Board.

This provision could have the effect of delaying or preventing

a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors

are willing to pay for our Common Stock.

commercial contracts that we enter into with our vendors and customers in the course of our business operations may contain provisions

with respect to changes in control that could provide for termination rights or otherwise have a negative impact on our business or results

of operations if a stockholder were to acquire a significant percentage of our outstanding stock.

Related to Intellectual Property

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pending patent applications may not result in issued patents.

The patent position of medical device companies, including us, is

generally uncertain and involves complex legal and factual considerations.

The standards that the USPTO and its foreign counterparts

use to grant patents are not always applied predictably or uniformly and can change.

There is also no uniform, worldwide policy regarding

the subject matter and scope of claims granted or allowable in medical device patents.

Accordingly, we do not know the degree of future

protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others.

systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our

rights to the same extent as the laws of the United States.

Therefore, the enforceability or scope of our patents in the United States

or in foreign countries cannot be predicted with certainty, and, as a result, any patents that we own may not provide sufficient protection

The patent position of medical device companies, including us, is generally

uncertain and involves complex legal and factual considerations.

The standards that the USPTO and its foreign counterparts use to grant

patents are not always applied predictably or uniformly and can change.

There is also no uniform, worldwide policy regarding the subject

matter and scope of claims granted or allowable in medical device patents.

Accordingly, we do not know the degree of future protection

for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others.

The legal systems

of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights

to the same extent as the laws of the United States.

Therefore, the enforceability or scope of our patents in the United States or in

foreign countries cannot be predicted with certainty, and, as a result, any patents that we own may not provide sufficient protection

against competitors.

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in the future.

cannot assure you that any patents that will issue, that may issue or that may be licensed to us will be enforceable or valid or will

not expire prior to the commercialization of our product candidates, thus allowing others to more effectively compete with us.

any patents that we own may not adequately protect our product candidates or our future products.

the Company has obtained issued patents, we cannot assure you that any patents that will issue, that may issue or that may be licensed

to us will be enforceable or valid or will not expire prior to the commercialization of our product candidates, thus allowing others

to more effectively compete with us.

Therefore, any patents that we own may not adequately protect our product candidates or our future

we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could

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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 1A. Risk Factors