What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-16 compared with 2021-11-15 · 168 added, 241 removed, 74 unchanged (85% of the section changed)

40 unchanged sentences

We operate primarily through Integrity Israel.

Israel was founded in 2001 with a mission to develop, produce and market non-invasive glucose monitors for home use by diabetics.

have developed a non-invasive glucose monitor, the GlucoTrack® glucose monitoring device, which is designed to help people with diabetes

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

finger stick devices.

The first generation GlucoTrack (“GlucoTrack 1.0”) utilizes a patented combination of ultrasound,

electromagnetic and thermal technologies to obtain glucose measurements in less than one minute via a small sensor that is clipped onto

one’s earlobe and connected to a small, handheld control and display unit, all without drawing blood or interstitial fluid.

are currently developing our own companion applications and a cloud-based solution, as well as conducting ongoing discussions with potential

partners, to offer an effective platform to provide real time, data driven personalized tools to effectively help a user manage their

In addition to being a critical and effective management tool for the end user, we believe that third parties such as insurers,

pharmaceutical companies and advertisers would be willing to pay for the de-identified data that we will obtain through our platform,

and that this is an opportunity for us to develop an additional revenue source.

a home-based short calibration process of approximately thirty minutes consisting of three typical blood glucose reference

measurements, GlucoTrack 1.0 can be used to non-invasively measure glucose levels for six months before a user is required to repeat

the calibration process.

The entire calibration process can be performed by the user themselves without the need for a trained calibrator.

We believe the simple-to-perform calibration, as well as the infrequency of the required re-calibration are significant advantages over

our competition.

1.0 has received the initial Conformité Européene (CE) Mark (indicating the conformity of the Company’s product

with health, safety, and environmental protection standards for products sold within the European Economic Area) approval for the

GlucoTrack 1.0 from DEKRA Certification B.V., our European notified body (the “Notified Body”), which is an entity that

has been accredited by a member state of the European Union (“EU”) to assess whether a product to be placed on the

market meets certain preordained standards.

The intended use for GlucoTrack 1.0 received by the Notified Body is for both those subjects

with Type 2 diabetes as well as those suffering from pre-diabetes.

of the CE Mark allows us to market and sell GlucoTrack 1.0 glucose monitoring device in EU member countries that have adopted the

European Medical Device Directive (the “MDD”) without being subject to additional national regulations with regard to demonstration

of performance and safety.

However, although the MDD is applicable throughout the EU, in practice it does not ensure uniform regulation

throughout the EU.

Accordingly, member countries may apply and enforce the MDD’s terms differently, and certain EU member countries

may request or require performance and/or safety data in addition to the MDD’s requirements from time to time, on a case-by-case

The CE Mark also permits the sale in countries that have an MDD Mutual Recognition Agreement with the EU.

This would include some

countries in South East Asia as well as in Latin America, opening new potential markets for Integrity on a global basis.

and quality are non-negotiables in the medical devices industry.

Regulatory requirements are increasingly stringent throughout every

step of a product’s life cycle, including service and delivery.

More and more, organizations in the industry are expected to demonstrate

their quality management processes and ensure best practice in everything they do.

ISO 13485 is an internationally agreed standard that

sets out the requirements for a quality management system specific to the medical devices industry.

On March 1, 2019 we received

an extension of our ISO 13485:2016 certificate and Annex II certification from the EU.

The ISO 13485:2016 certification

signifies that we have met the standards required for company-wide implementation of device quality management system(s).

the certification is design, development, manufacture and service of non-invasive glucose monitoring systems for home use.

Annex II also

addresses quality control systems.

The certification allows us to self-certify certain modifications and changes and simplifies some

of the reporting to and review by the relevant Notified Body.

This can shorten the CE-mark review process of future GlucoTrack enhancements

or revisions, including software updates and other improvements of the device that do not affect the intended use and/or safety performance.

The ISO 13485:2016 and Annex II certifications enable us to potentially reduce the time to market for product sales on new, enhanced

or modified GlucoTrack devices.

trials conducted in Germany by Pfutzner Science & Health Institute, GmbH, headed by Prof.

Andreas Pfutzner, on subjects with

Type 2 diabetes and pre-diabetes, as well as at Soroka University Medical Center, Beer-Sheva, Israel, demonstrated favorable results.

Results from the trials show 99.3% of the study data points were within the clinically accepted A and B zones of the Clarke Error Grid

(which is a tool used to quantify the clinical accuracy of blood glucose estimates generated by meters as compared to a reference value),

and 17.0% Mean Absolute Relative Difference.

In addition, the German trial concluded

that the data confirms the performance of the GlucoTrack among its intended users, including pre-diabetic patients.

In addition, the Company has

demonstrated (1) GlucoTrack 1.0 demonstrates consistent glucose measurement repeatability between different GlucoTrack devices

and on each earlobe of the same subject;

(2) the repeatability of different GlucoTrack 1.0 devices is similar at all tested

glucose ranges and post-prandial time periods;

and (3) the GlucoTrack 1.0 mean precision absolute relative difference (PARD)

of 8.2% is equivalent or better than the independently reported PARD values of commercially available continuous glucose monitoring systems.

Company conducted an additional study that evaluated GlucoTrack accuracy in 172 adults with type 2 diabetes who were prescribed

one or more medications for major medical conditions associated with diabetes and presented key findings of this study at the European

Association for the Study of Diabetes Congress (EASD) in Lisbon, Portugal.

The experiment stratified participants into five medication

groups, focusing on anti-cholesterolemia, anti-hypertension, anti-thrombotic, and anti-diabetic (prolonged duration and short and mixed

duration) medications.

The study demonstrated that the use of these common concomitant medications in diabetes had no effect on the performance

of GlucoTrack 1.0.

Company had begun the implementation of a proof-of-concept pilot program for GlucoTrack 1.0 in the Netherlands, a country chosen

based on the relatively smaller size of the marketplace to allow us to rapidly assess our performance and make adjustments as necessary.

We have been working closely with our exclusive distributor in the Netherlands, Medireva B.V., and have accomplished product and disease

area training across the organization and segmentation of the local target audiences including key opinion leaders, treating physicians,

and diabetes nurses.

The most important aspect of our pilot program in the Netherlands are the discussions held with many health insurance

Approval of full or partial reimbursement by the health insurance companies will be a key factor in enabling us to achieve

significant sales volume.

The Company has made progress with several of these companies on initial programs with GlucoTrack 1.0 as an

important step towards reimbursement approval.

Talent development, recruiting

and organizational health have been a critical focus of the Company.

A number of high-quality individuals have joined the Company, each

of whom bring extensive experience in their respective fields.

We have bolstered our Senior Management with the recruitment of Erez Ben-Zvi,

a highly experienced MedTech development professional who joined us last year as Vice President of Product, and recently took on the

additional role of General Manager, and Shalom Shushan, a seasoned executive who joined us as Chief Technology Officer.

PhD, who has a decorated career developing innovative medical technologies, including at DexCom and MiniMed and was a member of the Board

of Directors of the Company, was appointed as President and Chief Operating Officer.

Malavé, formerly of Insulet Corp,

Medtronic and MiniMed has joined as an independent board member.

Several highly talented and accomplished executives joined the Company

as senior advisors to the Board.

These include Yair Briman, the former CEO of Philips Healthcare Informatics, Daniel McCaffrey MBA MA,

a world-renowned behavioral scientist and digital health expert currently at Samsung Health and formerly of Dexcom, Dr.

Alexander Raykhman

PhD, a measurement and artificial intelligence expert and Dr.

Klonoff, world renowned endocrinologist and diabetes technology

thought leader.

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

are a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for

use by people with diabetes.

Integrity Israel was founded in 2001 with a mission to develop, produce and market non-invasive glucose

monitors for home use by diabetics.

We have developed a non-invasive blood glucose monitor, GlucoTrack®, which is designed to help

people with diabetes obtain blood glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)

spot finger stick devices.

Our first generation product, GlucoTrack® 1.0 utilizes a patented combination of ultrasound, electromagnetic

and thermal technologies to obtain blood glucose measurements in less than one minute via a small sensor that is clipped onto one’s

earlobe and connected to a small, handheld control and display unit, all without drawing blood.

Our next generation product, GlucoTrack®

2.0 which is currently under development, utilizes substantially identical underlying sensor technology, and is expected to be a completely

wireless sensor to be clipped on the earlobe.

GlucoTrack eliminates the handheld unit and will transmit results directly to a user’s

development, recruiting and organizational health have been a critical focus of the Company.

A number of high-quality individuals have

joined the Company, each of whom bring extensive experience in their respective fields.

Goode PhD, who has a decorated career

developing innovative medical technologies, including at DexCom and MiniMed and was a member of the Board of Directors of the Company,

was appointed as President and Chief Operating Officer.

In addition, James P.

Thrower PhD, a seasoned executive formerly of Sterling

Medical Devices, Mindray DS USA and DexCom, Inc.

joined as Vice President of Engineering.

Malavé, formerly of Insulet

Corp, Medtronic and MiniMed has joined as an independent board member.

Several highly talented and accomplished executives joined the

Company as senior advisors to the Board.

These include Yair Briman, the former CEO of Philips Healthcare Informatics, Daniel McCaffrey

MBA MA, a world-renowned behavioral scientist and digital health expert currently VP of Digital Health and Software at OMRON Healthcare,

and formerly at Samsung Health and Dexcom, Inc., Dr.

Alexander Raykhman PhD, a measurement and artificial intelligence expert and

Klonoff, world renowned endocrinologist and diabetes technology thought leader.

We intend to continue to invest in our talent

and to expand and strengthen all areas within the Company.

the Company performed a top-down analysis of the GlucoTrack 1.0 model to identify areas of potential enhancement, as it relates to the

platform, integrations, sensor technologies, accuracy as well as manufacturing costs.

The result of this

comprehensive review is an accelerated development plan for GlucoTrack 2.0.

GlucoTrack 2.0 will be a completely wireless and rechargeable

earclip to be paired with a smartphone, with more capabilities and features, increased accuracy, significantly greater margins for the

Company and lower cost to the end-user as compared to GlucoTrack 1.0.

previously reported, the Company has made significant progress towards receiving insurance reimbursement in the Netherlands.

new accelerated development plan for GlucoTrack 2.0, and all of the expected advantages over GlucoTrack 1.0, it became

clear to the Company that introducing GlucoTrack 2.0 rather than the GlucoTrack 1.0 would serve the diabetes market and the Company more

We are currently working with our European partners on the roadmap for distribution of GlucoTrack 2.0 when completed and

ready to market.

addition to the European markets, the Company is now focused on the U.S.

market as well, including building out its U.S.

strategy and planning the required FDA clinical trials and field testing to support its entrance into the market.

The Company is currently

in the process of identifying clinical sites in the U.S., interviewing Contract Research Organizations (CRO’s), and forming its

Scientific and Medical Advisory Boards.

The result of this comprehensive review is an accelerated

development plan for GlucoTrack 2.0.

GlucoTrack 2.0 will be a completely wireless and rechargeable earclip to be paired with a smartphone,

with more capabilities and features, increased accuracy, significantly greater margins for the Company and lower cost to the end-user

as compared to GlucoTrack 1.0.

previously reported, the Company made significant progress towards receiving insurance reimbursement in the Netherlands.

accelerated development plan for GlucoTrack 2.0, and all of the expected advantages over GlucoTrack 1.0, it became clear to the Company

that introducing GlucoTrack 2.0 rather than the GlucoTrack 1.0 would serve the diabetes market and the Company more effectively.

currently working with our European partners on the roadmap for distribution of GlucoTrack 2.0 when completed and ready to market.

In addition to the European markets, the Company is now focused on the U.S.

market as well, including building

go-to-market strategy and planning the required FDA clinical trials and field testing to support its entrance into the market.

The Company is currently in the process of identifying clinical sites in the U.S., interviewing Contract Research Organizations (CRO’s),

and forming its Scientific and Medical Advisory Boards.

We intend to build out a team to support the U.S.

activities while continuing our technology

development in our R&D facility located in Israel.

activities while continuing

our technology development in our R&D facility located in Israel.

Recent Events

June 22, 2021, Luis J.

Malavé has been appointed to the Company’s Board of Directors.

Malavé brings more than

30 years of leadership experience in the MedTech industry, primarily in diabetes management, spanning all company stages, from private

startups to large-cap publicly listed companies.

He has extensive expertise in product development, operations, marketing, strategic

partnerships, and US FDA regulatory strategy.

October 2017, Mr.

Malavé has served as President of EOFLOW CO.

Ltd., a company listed on the Korea Stock Exchange that has developed

a wearable disposable insulin pump.

From October 2014 to June 2016, he was COO of Mikroscan Technologies.

Prior to that, Mr.

was the President and CEO of Palyon Medical, maker of an implantable drug-delivery system that spun out from German medical-technology

giant Fresenius SE.

Prior to Palyon, he spent nearly a decade at insulin pump maker Insulet Corp., including as its Senior Vice President

of Research, Development and Engineering, and as Chief Operating Officer.

He also held various senior positions at Medtronic and MiniMed,

overseeing product development of various diabetes management devices.

Malavé earned his Bachelor’s degree in Mathematics

and Computer Science from the University of Minnesota, a Master’s degree in Software Engineering from the University of St.

and an MBA from the University of Maryland.

October 19, 2021, Paul V.

Goode was appointed as President and Chief Operating Officer of Integrity Applications, Inc.

(the “Company”),

effective November 1, 2021 (“Effective Date”).

Goode was appointed as President and Chief Operating Officer of the Company, effective November 1, 2021 (“Effective

He has served as a member of Integrity’s Board of Directors since December 17, 2020.

Concurrent with his new appointment, Mr.

Concurrent with his new appointment,

Goode will be stepping down from the Board.

In this role, Goode will lead the company’s

operations, overseeing strategy, design, manufacturing, business and product development and begin to build the U.S.

infrastructure in

preparation for the U.S.

clinical trials of GlucoTrack.

He will devote such time as necessary to perform his duties but shall be able

to pursue other professional opportunities at the same time.

His base salary shall be $175,000 per year, and he shall be entitled to

a cash bonus of up to 20% of his annual base salary as determined by the Company’s Compensation Committee and shall be granted

options to purchase up to One and half Percent (1.5%) of the fully diluted common stock, par value $0.001 per share, of the Company (“Common

Stock”) as of the Effective Date, with a per share exercise price equal to the greater of (A) $5.20 per share or (B) the closing

price of a share of Common Stock on the Effective Date, as reported by Bloomberg L.P., which shall vest in equal monthly installments

over a three year period following the Effective Date.

The bonus and equity incentives shall be subject to clawback rights if there is

a misstatement of financials which changes any metrics upon which a bonus or incentives are based and the clawback will be pro rata based

upon the changes in the financials with respect to the effect on any underlying metrics.

may be at risk as a result of the current COVID-19 pandemic.

Risks that could affect our business include the duration and scope of the

COVID-19 pandemic and the impact on the demand for our products;

actions by governments, businesses and individuals taken in response

to the pandemic;

the length of time of the COVID-19 pandemic and the possibility of its reoccurrence;

the timing required to develop

effective treatments and a vaccine in the event of future outbreaks;

the eventual impact of the pandemic and actions taken in response

to the pandemic on global and regional economies;

and the pace of recovery when the COVID-19 pandemic subsides.

In this role, Goode will lead the company’s operations, overseeing strategy, design,

manufacturing, business and product development and begin to build the U.S.

infrastructure in preparation for the U.S.

clinical trials

of GlucoTrack.

He will devote such time as necessary to perform his duties but shall be able to pursue other professional opportunities

at the same time.

His base salary shall be $175,000 per year, and he shall be entitled to a cash bonus of up to 20% of his annual base

salary as determined by the Company’s Compensation Committee and shall be granted options to purchase up to One and half Percent

(1.5%) of the fully diluted common stock, par value $0.001 per share, of the Company (“Common Stock”) as of the Effective

Date, with a per share exercise price equal to the greater of (A) $5.20 per share or (B) the closing price of a share of Common Stock

on the Effective Date, as reported by Bloomberg L.P., which shall vest in equal monthly installments over a three year period following

the Effective Date.

The bonus and equity incentives shall be subject to clawback rights if there is a misstatement of financials which

changes any metrics upon which a bonus or incentives are based and the clawback will be pro rata based upon the changes in the financials

with respect to the effect on any underlying metrics.

connection with our application to list our shares of common stock on Nasdaq Capital Market (“NASDAQ”), on August 13,

2021, we effected a reverse split of our common stock in a ratio of 1 for 13 (the “Reverse Share Split”).

September 27, 2021, our shelf registration statement on Form S-3 (file no.

333-259664) was declared effective by the SEC.

The shelf registration

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

December 8, 2021, we announced that our shares of common stock were approved for listing on the NASDAQ.

Trading on NASDAQ commenced on

December 10, 2021 under its existing trading symbol, IGAP.

March 14, 2022, we changed our name to GlucoTrack, Inc.

with Nasdaq and our trading symbol to GCTK.

March 22, 2022, Shalom Shushan, Chief Technology Officer, provided notice of his resignation from the Company, effective May 22, 2022,

for personal reasons.

In connection with the Company’s previously announced plans to migrate certain aspects of product development

to the United States, James P.

Thrower PhD, Vice President of Engineering, will be assuming Mr.

Shushan’s responsibilities.

connection with the Company’s previously announced plans to migrate certain aspects of the product development of GT 2.0 to the

United States, as well as in preparation for U.S.

clinical trials, on May 15, 2022 Erez Ben-Zvi, VP of Product in Israel, provided notice

of his resignation from the Company, to be effective June 26, 2022.

summary of our significant accounting policies is included under Item 7 – Management’s Discussion and Analysis of Financial

Condition and Results of Operations of our fiscal 2021 Form 10-K.

An accounting policy is deemed to be critical if it requires an accounting

estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates

reasonably could have been used, or if changes in the estimate that are reasonably possible could materially impact the financial statements.

There have been no material changes to the critical accounting policies and estimates as filed in such report.

Accounting Policies

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and such differences could be material.

As applicable to the consolidated financial statements included elsewhere in this report, the

most significant estimates and assumptions relate to determination of net realizable value of inventory.

As applicable to the consolidated financial statements included elsewhere in this report, the most significant estimates

and assumptions relate to the going concern assumptions.

of Operations

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

ended September 30, 2021 compared with the same period ended September 30, 2020.

The discussion should be read in conjunction with the

financial statements and related notes included elsewhere in this report.

Months ended September 30, 2021 compared to Three Months ended September 30, 2020

the three-month period ended September 30, 2021, we had no revenues.

following discussion of our operating results explains material changes in our results of operations for the three-month period ended

March 31, 2022 compared with the same period ended March 31, 2021.

The discussion should be read in conjunction with the financial statements

and related notes included elsewhere in this report.

Months ended March 31, 2022 compared to Three Months ended March 31, 2021

the three-month period ended March 31, 2022 and 2021, we had no revenues.

and development expenses

and development expenses were $447 thousand for the three-month period ended September 30, 2021, as compared to $476 thousand

for the prior-year period.

The decrease is immaterial.

and development expenses were $460 thousand for the three-month period ended March 31, 2022, as compared to $309 thousand for the comparative

The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.

and development expenses consist primarily of salaries and other personnel-related expenses, materials, clinical trials and other expenses.

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development of new GlucoTrack® models and others.

and marketing expenses

and marketing expenses were $113 thousand for the three-month period ended September 30, 2021, as compared to $93 thousand for

the prior-year period.

The decrease is immaterial.

and marketing expenses consist primarily of professional services, salaries, travel expenses and other related expenses.

and administrative expenses

and administrative expenses were $207 thousand for the three-month period ended September 30, 2021, as compared to $318 thousand

for the prior-year period.

The increase is primarily attributable to hiring of new and augmented personnel to move forward our business

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

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

Other general and administrative costs and expenses

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

and accounting services.

income, net was approximately $9 thousand for the three-month period ended September 30, 2021, as compared to financing income of $40

thousand for the prior-year period.

The decrease is immaterial.

loss was $804 thousand for the three-month period ended September 30, 2021, as compared to $509 thousand for the prior-year period.

increase in net loss is attributable primarily to one-time income in the amount of $ 338 recorded in the three-month period

ended September 30, 2020 resulting from an agreement signed with one of our suppliers.

Months ended September 30, 2021 compared to Nine Months ended September 30, 2020

the nine-month period ended September 30, 2021, we had no revenues.

and development expenses

and development expenses were $1,077 thousand for the nine-month period ended September 30, 2021, as compared to $1,268 thousand

for the prior-year period.

The decrease is attributable to a decrease in research and development as the change in management evaluates

the Company’s direction and potential move to clinical trials in the U.S.

and development expenses consist primarily of salaries and other personnel-related expenses, materials, clinical trials and other expenses.

We expect research and development expenses to increase in 2021 and beyond, primarily due to hiring additional personnel and developing

our next generation product line;

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

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

development of new GlucoTrack models and others.

and marketing expenses

and marketing expenses were $136 thousand for the nine-month period ended September 30, 2021, as compared to $274 thousand for

the prior-year period.

The decrease is attributable to the occurrence of minimal sales and

marketing activities in 2021 .

and marketing expenses consist primarily of professional services, salaries, travel expenses and other related expenses.

and administrative expenses

and administrative expenses were $1,323 thousand for the nine-month period ended September 30, 2021, as compared to $712 thousand

for the prior-year period.

The increase is primarily attributable to hiring of new and augmented personnel to move forward our business

Marketing expenses

expenses were $0 thousand for the three-month period ended March 31, 2022, as compared to $23 thousand for the comparative

The decrease is primarily attributable to the Company’s decision to reduce/stop its

Selling and marketing expenses until the completion of the development of the GlucoTrack® 2.0.

Marketing expenses during the

three-month period ended March 31, 2021, consisted in primarily of professional services, salaries, travel expenses and other related

General and administrative expenses

were $633 thousand for the three-month period ended March 31, 2022, as compared to $564 thousand for the comparative period.

The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.

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

3 unchanged sentences

and accounting services.

income, net was approximately $21 thousand for the nine-month period ended September 30, 2021, as compared to financing income of $99

thousand for the prior-year period.

The decrease is due to lower interest rates on savings accounts.

loss was $2,561 thousand for the nine-month period ended September 30, 2021, as compared to $1,817 thousand for the prior-year period.

The increase in net loss is attributable primarily to one-time income in the amount of $ 338 recorded in the nine-month period

ended September 30, 2020 resulting from an agreement signed with one of our suppliers.

and Capital Resources

of September 30, 2021, cash on hand was approximately $7 million as a result of our $15 million private placement which closed during

February 2020, for which we received net cash of approximately $13 million.

Based on our current cash burn rate, strategy and operating

plan, we believe that our cash and cash equivalents will enable us to operate for a period in excess of one year from the date of this

In order to fund our anticipated liquidity needs beyond such period (or possibly earlier if our current cash burn rate, strategy

or operating plan change in a way that accelerates or increases our liquidity needs), we will need to raise additional capital.

September 27, 2021, the Company’s shelf registration statement on Form S-3 (file no.

333-259664) was declared effective by the

The shelf registration statement permits the Company to register up to $100,000,000 of certain equity and debt securities

of the Company via prospectus supplement.

Cash Used in Operating Activities for the Nine-Month Periods Ended September 30, 2021 and September 30, 2020

cash used in operating activities was $2,796 thousand and $2,657 thousand for the nine-month periods ended September 30, 2021 and 2020,

respectively.

Net cash used in operating activities primarily reflects the net loss for those periods of $2,561 thousand and $1,817 thousand,

respectively.

Cash Used in Investing Activities for the Nine-Month Periods Ended September 30, 2021 and September 30, 2020

cash used (provided) in investing activities was $(3) and $46 thousand for the nine-month periods ended September 30, 2021 and 2020,

respectively, and was used mostly to purchase equipment (such as computers, research and development, and office equipment).

Cash Provided by Financing Activities for the Nine-Month Periods Ended September 30, 2021 and September 30, 2020

cash provided by financing activities was $0 and $13,009 thousand for the nine-month periods ended September 30, 2021 and 2020, respectively.

Cash provided by financing activities for the nine-month period ended September 30, 2020 reflected net capital raised from the February

2020 private placement and issuance of our common stock.

expenses, net

Financing expenses, net were

approximately $0 thousand for the three-month period ended March 31, 2022, as compared to $8 thousand for the comparative

The change is immaterial.

Net loss was $1,093 thousand

for the three-month period ended March 31, 2022, as compared to $904 thousand for the comparative period.

The Increase in net

loss is attributable primarily to hiring of new and augmented personnel to move forward our business agenda.

Concern Uncertainty

of March 31, 2022, cash on hand was approximately $4.8 million.

The development and commercialization of non-invasive glucose monitoring

devices for use by people, are expected to require substantial further expenditures.

We remain dependent upon external sources for financing

our operations.

Since inception, we have incurred substantial accumulated losses and negative operating cash flow, and have a significant

accumulated deficit.

These factors raise substantial doubt about our ability to continue as a going concern.

The financial statements

do not include any adjustments that might result from the outcome of this uncertainty.

We plan to finance our operations through the

sale of equity (including shelf registration statement on Form S-3 was declared effective on September 27, 2021 by the Securities and

Exchange Commission (SEC) which allows the Company to register up to $100,000 thousand of certain equity and/or debt securities of the

Company through prospectus supplement).

There can be no assurance that we will succeed in obtaining the necessary financing to continue

our operations.

Cash Used in Operating Activities for the Three-Month Periods Ended March 31, 2022 and March 31, 2021

cash used in operating activities was $1,265 thousand and $933 thousand for the three-month periods ended March 31, 2022 and 2021, respectively.

Net cash used in operating activities primarily reflects the net loss for those periods of $1,093 thousand and $904 thousand, respectively.

Sheet Arrangements

of September 30, 2021, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.

of March 31, 2022, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.

Quantitative and Qualitative Disclosures About Market Risk.

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis