What changed in this filing

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Item 1A. Risk Factors

2025-03-31 compared with 2024-03-28 · 293 added, 291 removed, 427 unchanged (58% of the section changed)

Risk Factors.

investment in our Common Stock involves a high degree of risk.

Before making an investment decision, you should carefully consider the

following risk factors.

If any of these risks actually occur, our business, financial condition and results of operations could be materially

In addition, risks and uncertainties not presently known to us or that we currently deem immaterial may also materially harm

our business, financial condition and results of operations.

If this were to happen, the value of our Common Stock could decline significantly,

and you could lose all or part of your investment.

You should carefully consider the following risks and all of the other

information contained in this Annual Report before deciding whether to invest in our Common Stock.

If any of the following risks are

realized, our business, financial condition and results of operations could be materially and adversely affected.

In that event, the

trading price of our Common Stock could decline, and you could lose all or part of your investment in our Common Stock.

Additional risks

of which we are not presently aware or that we currently believe are immaterial may also harm our business and results of operations.

Some statements in this Annual Report, including such statements in the following risk factors, constitute forward-looking statements.

See the section entitled “Cautionary Note Regarding Forward-Looking Statements.”

Related to our Business and Industry

have a history of operating losses, and there is no assurance that we will generate material revenues or become profitable in the near

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Maintaining these relationships and

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

We must be able to manage our

development efforts effectively;

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;

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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 Report.

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

and as of December 31, 2023, there is an accumulated deficit of $109,853.

These conditions raise substantial doubt about the Company’s

ability to continue as a going concern.

Related to Owning our Common Stock

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

the foreseeable future.

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

the foreseeable future.

Any cash that might be available for payment of dividends will be used to expand our business.

Payments of any

cash dividends in the future will depend on our financial condition, results of operation and capital requirements, as well as other

factors deemed relevant to our Board of Directors.

Common Stock may be delisted from Nasdaq if we fail to comply with continued listing standards.

Common Stock is currently traded on Nasdaq under the symbol “GCTK.” If we fail to meet any of the continued listing standards

of Nasdaq, for which we have one or more deficiencies, our Common Stock could be delisted from Nasdaq.

The continued listing standards

include specifically enumerated criteria, such as:

$1.00 minimum closing bid price;

Stockholders’

equity of $2,500;

shares of publicly held Common Stock with a market value of at least $1,000;

round-lot stockholders;

with Nasdaq’s corporate governance requirements, as well as additional or more stringent criteria that may be applied in the

exercise of Nasdaq’s discretionary authority.

May 26, 2023, we received a notice from the Staff of Nasdaq that we no longer complied with Nasdaq Listing Rule 5550(a)(2), which requires

listed securities to maintain a minimum bid price of $1.00 per share.

The Nasdaq letter stated that we had 180 days, or until November

22, 2023, to regain compliance with the Bid Price Rule.

On November 24, 2023, we received a letter from the Staff of Nasdaq notifying

us that we have been granted an additional 180 calendar days, or until May 20, 2024, to regain compliance with the Bid Price Rule.

at any time during the Extended Compliance Period, the closing bid price of our Common Stock is at least $1.00 per share for a minimum

of 10 consecutive business days, the Staff of Nasdaq will provide written confirmation that we have achieved compliance with the Bid

If we cannot demonstrate compliance during the Extended Compliance Period, then the Staff of Nasdaq will provide notice that

our Common Stock will be subject to delisting.

At that time, we may appeal the Staff’s determination to a hearings panel.

price on March 19, 2024 was $0.32, and, as such, we are not currently in compliance with the Bid Price Rule.

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

and our stockholders could face significant material adverse consequences including:

limited availability of market quotations for our securities;

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

remedial measures.

identified material weaknesses related to our internal control over financial reporting as of December 31, 2023 and concluded that internal

control over financial reporting as at December 31, 2023 were not effective.

The ineffectiveness of the Company’s internal control

over financial reporting was due to identification of material weaknesses related to lack of sufficient internal accounting personnel,

segregation of duties, and lack of sufficient internal controls (including IT general controls) that encompass the Company as a whole

with respect to entity and transactions level controls in order to ensure complete documentation of complex and non-routine transactions

and adequate financial reporting.

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

to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future,

such failure could result in a material misstatement of our annual or quarterly financial statements that would not be prevented or detected

on a timely basis and which could cause investors and other users to lose confidence in our financial statements, limit our ability to

raise capital and have a negative effect on the trading price of our Common Stock.

Additionally, failure to remediate the material weakness

or otherwise maintain effective internal controls over financial reporting may also negatively impact our operating results and financial

condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory

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 may fluctuate significantly.

market price of the Common Stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such

of trials or studies;

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

concerning intellectual property rights and regulatory approvals;

in our and our competitors’ results of operations;

in earnings estimates or recommendations by securities analysts, if the Common Stock is covered by analysts;

in the medical device industry;

results of product liability or intellectual property lawsuits;

issuances of Common Stock or other securities;

addition or departure of key personnel;

announcements

by us or our competitors of acquisitions, investments or strategic alliances;

market conditions and other factors, including factors unrelated to our operating performance.

in recent years, the stock market in general, and the market for medical device companies in particular, have experienced extreme price

and volume fluctuations.

Continued or renewed market fluctuations could result in extreme volatility in the price of our Common Stock,

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

Related to our Business and Industry

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.

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 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 and in the unstable world may materially adversely affect our ability to sell additional securities and/or

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.

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 “ Management Discussion and Analysis - Government Regulatory ”).

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).

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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.

results from the limited safety and performance pre-clinical trials 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 cannot be a guarantee of clinical trial success because human physiology and anatomy are different.

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 well-controlled clinical trials that Glucotrack CBGM or future

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

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.

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.

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

data are satisfactory and support, in our view, it’s or their clearance or approval.

data are satisfactory and support, in our view, its or their clearance or approval.

The FDA or other non-U.S.

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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 GluctTrack CBGM will

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

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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

candidates, if any, our commercial opportunities will be adversely affected.

life sciences industry is highly competitive;

and we face significant competition from many medical device companies that are researching

life sciences industry is highly competitive, and we face significant competition from many medical device companies that are researching

and marketing products designed to address the needs of people suffering from diabetes.

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of product candidates by physicians and other health care providers;

results of our clinical trials;

the results of our clinical trials;

ability to recruit and enroll patients for our clinical trials;

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

speed at which we develop product candidates;

the speed at which we develop product candidates;

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

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;

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;

timing and scope of regulatory clearances or approvals;

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

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

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

the 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

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;

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;

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

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;

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;

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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than expected rates of patient recruitment and enrollment;

of patients to complete the clinical trial;

safety issues;

failure of patients to complete the clinical trial;

unforeseen safety issues;

of efficacy evidenced during clinical trials;

of clinical trials by one or more clinical trial sites;

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

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

to monitor patients adequately during or after treatment.

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 materially

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

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

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

regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization

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.

regulatory authorities, which regulations differ from country to country.

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

We have not submitted an application or premarket notification for or received marketing clearance or approval for any of our

product candidates.

Obtaining approval of any premarket approval can be a lengthy, expensive and uncertain process, particularly those

for Class III devices under which our product 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.

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.

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

authorities or other applicable U.S.

regulatory requirements may, either before or after product clearance or approval,

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

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:

on the products, manufacturers or manufacturing process;

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or mandatory product recalls and publicity requirements;

or partial suspension of production;

total or partial suspension of production;

of restrictions on operations, including costly new manufacturing requirements;

to clear or approve pending applications or premarket notifications.

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.

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to address and the regulations applicable to any particular medical device candidate.

The FDA can delay, limit or deny clearance or

approval of a medical device candidate for many reasons, including:

The FDA can delay, limit or deny clearance or approval

of a medical device candidate for many reasons, including:

medical device candidate may not be deemed safe or effective;

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to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed.

may encounter delays if we are unable to recruit and enroll and retain enough patients to complete clinical trials.

Patient enrollment

depends on many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical

sites and the eligibility criteria for the trial.

may encounter delays if we are unable to recruit, enroll and retain enough patients to complete clinical trials.

Patient enrollment depends

on many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites

and the eligibility criteria for the trial.

Delays in patient enrollment are not unusual.

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We, and the manufacturers of our products

if other than us, also will be required to comply with the FDA’s Quality System Regulation, which includes requirements relating

to quality control and quality assurance, as well as the corresponding maintenance of records and documentation.

Moreover, device manufacturers

are required to report adverse events by filing Medical Device Reports with the FDA, which are publicly available.

Further, regulatory

agencies must approve our manufacturing facilities before they can be used to manufacture products, and these facilities are subject

to ongoing regulatory inspection.

also will be required to comply with the FDA’s Quality System Regulation, which includes requirements relating to quality control

and quality assurance, as well as the corresponding maintenance of records and documentation.

Moreover, device manufacturers are required

to report adverse events by filing Medical Device Reports with the FDA, which are publicly available.

Further, regulatory agencies must

approve our manufacturing facilities before they can be used to manufacture products, and these facilities are subject to ongoing regulatory

If we fail to comply with the regulatory requirements of the FDA and other non-U.S.

regulatory authorities,

or if previously unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be subject to

administrative or judicially imposed sanctions, including:

on the products, manufacturers or manufacturing process;

regulatory authorities, or if previously

unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or

judicially imposed sanctions, including:

restrictions 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;

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;

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;

to clear or approve pending applications or premarket notifications.

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regulatory authorities, including the EU and each of the EU member countries individually, may change

their policies and additional regulations may be enacted that could prevent or delay regulatory clearance or approval of our product

their policies and enact additional regulations that could prevent or delay regulatory clearance or approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative

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will depend on a number of factors, including:

of market introduction of competitive products;

timing of market introduction of competitive products;

and efficacy of our product;

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advantages or disadvantages over alternative treatments;

of marketing and distribution support;

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

strength of marketing and distribution support;

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

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

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

We currently maintain premises insurance and there can be

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

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

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.

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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dangers inherent in the product, negligence, strict liability and a breach of warranties.

Claims could also be asserted under state consumer

protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities.

successful defense would require significant financial and management resources.

Regardless of the merits or eventual outcome, liability

claims may result in:

demand for products that we may offer for sale;

Claims could also be asserted under state or

federal consumer protection laws or regulations.

If we cannot successfully defend ourselves against product liability claims, we may

incur substantial liabilities.

Even successful defense would require significant financial and managerial resources.

Regardless of the

merits or eventual outcome, liability claims may result in:

decreased demand for products that we may offer for sale;

to our reputation;

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monetary awards to trial participants or patients;

recalls, withdrawals or labeling, marketing or promotional restrictions;

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

decline in our stock price.

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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 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 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 key man 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

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

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.

rely on third parties to manufacture and supply our product.

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a commercial scale.

To date we have manufactured Glucotrack CBGM with a third-party manufacturer in Israel.

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 contract manufacturers could delay clinical development or regulatory clearance or approval of

our product candidates or commercialization of our future product candidates, 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 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.

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.

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

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These investigators and contract research organizations will not be our employees and we will

not be able to control, other than by contract, the amount of resources, including time that they devote to products that we develop.

If independent investigators fail to devote sufficient resources to the clinical trials, or if their performance is substandard, it will

delay the approval or clearance and commercialization of any products that we develop.

Further, the FDA requires that we comply with

standards, commonly referred to as good clinical practice, for conducting, recording and reporting clinical trials to assure that data

and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.

our independent clinical investigators and contract research organizations fail to comply with good clinical practice, the results of

our clinical trials could be called into question and the clinical development of our product candidates could be delayed.

clinical investigators or contract research organizations to meet their obligations to us or comply with federal regulations could adversely

affect the clinical development of our product candidates and harm our business.

not be able to control, other than by contract, the amount of resources spent on our endeavors, including time that they devote to products

that we develop.

If independent investigators fail to devote sufficient resources to the clinical trials, or if their performance is

substandard, it will delay the approval or clearance and commercialization of any products that we develop.

Further, the FDA requires

that we comply with standards, commonly referred to as good clinical practice, for conducting, recording and reporting clinical trials

to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects

are protected.

If our independent clinical investigators and contract research organizations fail to comply with good clinical practice,

the results of our clinical trials could be called into question and the clinical development of our product candidates could be delayed.

Failure of clinical investigators or contract research organizations to meet their obligations to us or comply with federal regulations

could adversely affect the clinical development of our product candidates and harm our business.

business may become subject to economic, political, regulatory and other risks associated with international operations, which could

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regulations and customs;

changes in non-U.S.

currency exchange rates and currency controls;

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

changes 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.

consequences from changes in tax laws;

negative consequences from changes in tax laws;

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

may not be able to enforce covenants not-to-compete under current Israeli law, which might result in added competition for our products.

have non-competition agreements or provisions with all of our employees and executive officers, all of which are governed by Israeli

These agreements or provisions prohibit our employees from competing with us or working for our competitors, generally during, and

for up to nine months after termination of, their employment with us.

However, Israeli courts are reluctant to enforce non-compete undertakings

of former employees and tend, if at all, to enforce those provisions for only relatively brief periods of time or in restricted geographical

In addition, Israeli courts typically require the presence of additional circumstances, such as a demonstration of an employer’s

legitimate interest which was damaged;

breach of fiduciary duties, loyalty and acting not in good faith;

a payment of a special consideration

for employee’s non-compete obligation;

material concern for disclosing employer’s trade secrets;

or a demonstration that

an employee has unique value to the employer specific to that employer’s business, before enforcing a non-competition undertaking

against such employee.

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 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 our 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, we may not manufacture products

developed with IIA funding outside of Israel without the approval of the research committee.

The restrictions regarding the sale or transfer

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

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

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

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.

Related to Owning our Common Stock

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

the foreseeable future.

have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in

the foreseeable future.

Any cash that might be available for payment of dividends will be used to expand our business.

Payments of any

cash dividends in the future will depend on our financial condition, results of operation and capital requirements, as well as other

factors deemed relevant to our Board of Directors.

we are unable to continue to satisfy the applicable continued listing requirements of Nasdaq, our Common Stock could be delisted, and

we and our stockholders could face significant material adverse consequences.

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.

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.

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.

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.

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

remedial measures.

identified material weaknesses related to our internal control over financial reporting as of December 31, 2024 and concluded that internal

control over financial reporting as at December 31, 2024 were not effective.

The ineffectiveness of the Company’s internal control

over financial reporting was due to identification of material weaknesses related to lack of sufficient internal accounting personnel,

segregation of duties, and lack of sufficient internal controls (including IT general controls) that encompass the Company as a whole

with respect to entity and transaction level controls in order to ensure complete documentation of complex and non-routine transactions

and adequate financial reporting.

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

to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future,

such failure could result in a material misstatement of our annual or quarterly financial statements that would not be prevented or detected

on a timely basis and which could cause investors and other users to lose confidence in our financial statements, limit our ability to

raise capital and have a negative effect on the trading price of our Common Stock.

Additionally, failure to remediate the material weakness

or otherwise maintain effective internal controls over financial reporting may also negatively impact our operating results and financial

condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory

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;

concerning intellectual property rights and regulatory approvals;

in our and our competitors’ results of operations;

in earnings estimates or recommendations by securities analysts, if the Common Stock is covered by analysts;

in the medical device industry;

the results of product liability or intellectual property lawsuits;

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

issuances of Common Stock or other securities;

addition or departure of key personnel;

in state, provincial, or federal regulations affecting us and our industry;

political, and other external factors;

announcements

by us or our competitors of acquisitions, investments or strategic alliances;

market conditions and other factors, including factors unrelated to our operating performance.

addition, the stock market in general, and the market for medical device companies in particular, have experienced extreme price and

volume fluctuations.

Continued or renewed market fluctuations could result in extreme volatility in the price of our Common Stock, which

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

Related to Intellectual Property

27 unchanged sentences

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.

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

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

against competitors.

58 unchanged sentences

If we fail to obtain

a required license and are unable to design around a patent, we may be unable to effectively market some of our technology and products,

which could limit our ability to generate revenues or achieve profitability and possibly prevent us from generating revenue sufficient

to sustain operations.

a required license and are unable to design technology that does not infringe upon a patent belonging to a third party, we may be unable

to effectively market some of our technology and products, which could limit our ability to generate revenues or achieve profitability

and possibly prevent us from generating revenue sufficient to sustain operations.

threats to our information technology infrastructure could expose us to liability and damage our reputation and business.

19 unchanged sentences

the final omnibus rule adopted in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health

information has been inappropriately accessed or disclosed, notification requirements to individuals, federal regulators, and in some

cases, notification to local and national media.

information has been inappropriately accessed or disclosed as well as notification requirements to individuals, federal regulators and

in some cases, notification to local and national media.

Notification is not required under HIPAA if the health information that is improperly

5 unchanged sentences

data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.

Activities outside of the U.S.

implicate local and national data protection standards, impose additional compliance requirements, and

generate additional risks of enforcement for non-compliance.

We may be required to expend significant capital and other resources to

ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate

Activities outside of the United States implicate local and national data protection standards, impose additional compliance requirements,

and generate additional risks of enforcement for non-compliance.

We may be required to expend significant capital and other resources

to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate

problems caused by such breaches.

27 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-K

Item 1A. Risk Factors