What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-11-14 compared with 2022-08-15 · 133 added, 108 removed, 135 unchanged (64% of the section changed)

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Following the Reorganization,

the former equity holders of Integrity Israel were entitled to the same proportional ownership in us as they had in Integrity Israel prior

to the Reorganization.

the former equity holders of Integrity Israel were entitled to the same proportional ownership in us as they had in Integrity Israel

prior to the Reorganization.

As a result of the Reorganization, Integrity Israel became a wholly owned subsidiary of ours.

We operate primarily

through Integrity Israel.

a medical device company focused on the design, development and commercialization of innovative technologies for use by people with diabetes

and prediabetes.

Our first product focus is GlucoTrack®, a non-invasive blood glucose monitor designed to help people with diabetes

and prediabetes obtain blood glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot

primarily through Integrity Israel.

are a medical device company focused on the design, development and commercialization of innovative technologies for use by people with

diabetes and prediabetes.

Our first product focus is GlucoTrack®, a non-invasive blood glucose monitor designed to help people with

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

finger stick devices.

Our first-generation device, GlucoTrack® 1.0 utilized 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

and thermal technologies to obtain blood glucose measurements in approximately 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.

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Mark approval, underwent a limited release beta test in Europe and the Middle East.

The Company is now focused on the development of its

next generation non-invasive glucose monitor, GlucoTrack® 2.0.

The Company is now focused on the development of

its next generation non-invasive glucose monitor, GlucoTrack® 2.0.

In addition, following the recent acquisition of certain related

IP, the Company has commenced an R&D program to develop a long-term implantable glucose management technology to address the growing

Type 1 and insulin dependent Type 2 diabetes market.

2.0 utilizes a different and significantly simplified and less costly sensor technology than our 1.0 technology.

We are designing a form

factor that will shed the wired handheld unit from the GlucoTrack 1.0 design to be a completely wireless earclip with Bluetooth connectivity

factor that will shed the wired handheld unit from the GlucoTrack 1.0 design to be a completely wireless clip with Bluetooth connectivity

for pairing directly with the user’s own mobile device (smartphone and/or tablet).

The earclip will be rechargeable and stored

in a small carrying case for storage and recharging when not in use, similar to wireless earbuds.

This facilitates the smallest earclip

design by reducing battery size requirements.

The device will be pocket-sized and rechargeable,

facilitating easy and convenient portability.

Eliminating the cabled main unit hardware is also expected to significantly lower our manufacturing

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In addition, we believe

that this new sensor technology will lead to a substantially faster measurement than our 1.0 version.

early Q2 the Company completed lab testing of its 2.0 clinical prototype system.

that the new sensor technology will lead to a substantially faster measurement than our 1.0 version.

Q2 of this year, the Company completed lab testing of its 2.0 clinical prototype system.

This process included testing of multiple iterations

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During this in-house

testing, the Company achieved better than expected accuracy and performance.

Initial data collected indicates that the GlucoTrack® 2.0 system may

achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in the market when conducting

the upcoming first in-human clinical study.

Company has recently received Ethics Committee and clinical center approvals to conduct its first in-human study at the Rabin Medical

Center in Israel.

The initial results from this study will drive a follow-up multi-center study in the United States, led by Dr.

Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula Medical

testing of multiple iterations, the Company achieved better than expected accuracy and performance.

Initial data collected indicates

that the Gen 2 system may achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in

the market when conducting the upcoming first in-human clinical study.

Further to that, the testing validated a dramatically faster speed

of measurement is possible, which will significantly improve the patient use experience.

The in-house testing also exposed some clip-based

human factors considerations that appear to impact consistent device performance.

Further improvements are being investigated to improve

device performance consistency prior to launching the first-in-human clinical study, which is expected to be conducted at the Rabin

Medical Center in Israel.

The initial results from this study will drive a follow-up multi-center study in the United States, led by

Klonoff, Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula

Medical Center.

study is intended to be a precursor to the eventual pivotal trial for FDA clearance.

The Company aims to begin its first

in-human study in Israel in Q3 and in U.S.

centers in Q4.

are also developing a wireless mobile platform that will support capturing anonymized data that can leverage novel machine learning (AI)

and data analytic techniques to facilitate device iterations and glucose sensing accuracy improvements.

In addition, mobile device pairing

will facilitate data transfer to electronic medical records (EMRs) used by managing physicians to effectively treat their patients.

this data can provide a potential revenue stream for valuable T2DM and pre-T2DM de-identified patient data that can be used by third-party

organizations such as pharma, insurance, and others.

historically the Company has operated out of its Israel location, the Company is now transitioning all operations and development to

the United States.

A number of high-quality individuals have joined the Company, each of whom bring extensive experience in their respective

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, has been appointed as President and Chief Executive Officer.

In addition, James

are also developing a wireless mobile platform that will support capturing anonymized data that can leverage novel machine learning

(AI) and data analytic techniques to facilitate device iterations and glucose sensing accuracy improvements.

In addition, mobile

device pairing to this platform will facilitate data transfer to electronic medical records (EMRs) used by managing physicians to

effectively treat their patients.

Moreover, this data can provide a potential revenue stream for valuable T2DM and pre-T2DM

de-identified patient data that can be used by third-party organizations such as pharma, insurance, and others.

historically the Company has operated out of its Israel location, the Company has transitioned all operations and development to the

United States as of the end of Q3.

Remaining activities in Israel include accounting and as-needed contract resources to support the

first-in-human clinical trial.

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, has been appointed as President and Chief Executive 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

Malavé, formerly of Insulet Corp, Medtronic and MiniMed has joined as an independent board member.

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, Inc.

Mark Tapsak PhD, a medical research scientist, joined as Vice President of Sensor Technology, bringing over 25 years of

experience in the diabetes industry, including previous senior roles at DexCom and Medtronic, Inc.

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, Inc.

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

Alexander Raykhman PhD,

a measurement and artificial intelligence expert and Dr.

Klonoff, world renowned endocrinologist and diabetes technology thought

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.

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Shushan’s responsibilities.

in connection with the Company’s previously announced plans to migrate certain aspects of product development to the United States,

as well as in preparation for U.S.

clinical trials, on May 11, 2022 Erez Ben-Zvi, VP of Product in Israel, provided notice of his resignation

from the Company, to be effective June 12, 2022.

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, Erez Ben-Zvi, VP of Product in Israel, resigned from the Company,

effective June 12, 2022.

October 10, 2022, the Company announced that it has acquired certain IP related to a long-term implantable continuous glucose monitor

and that it intends to develop the technology to address the growing Type 1 and insulin dependent Type 2 diabetes market.

October 14, 2022, the Company announced the hiring of Dr.

Mark Tapsak as Vice President of Sensor Technology.

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

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of Operations

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

ended June 30, 2022 compared with the same period ended June 30, 2021.

The discussion should be read in conjunction with the financial

statements and related notes included elsewhere in this report.

Months ended June 30, 2022 compared to Three Months ended June 30, 2021

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

ended September 30, 2022 compared with the same period ended September 30, 2021.

The discussion should be read in conjunction with the

financial statements and related notes included elsewhere in this report.

Months ended September 30, 2022 compared to Three Months ended September 30, 2021

and development expenses

and development expenses were $469 thousand for the three-month period ended June 30, 2022, as compared to $321 thousand for the prior-year

The increase is primarily attributable to developing and validating our next generation product line.

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

We expect research and development expenses to increase in 2022 and beyond, primarily due to hiring additional personnel

and developing and validating 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 development expenses were $434 thousand for the three-month period ended September 30, 2022, as compared to $447 thousand for the

prior-year period.

The Decrease is immaterial.

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 2022 and beyond, primarily due to hiring additional personnel and developing

and validating 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.

expenses were $0 thousand for the three-month period ended September 30, 2022, as compared to $113 thousand for the prior-year period.

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

expenses until the completion of the development of the GlucoTrack® 2.0.

expenses during the three-month period ended September 30, 2021, consisted in primarily of professional services, salaries, travel expenses

and other related expenses.

and administrative expenses

and administrative expenses were $654 thousand for the three-month period ended June 30, 2022, as compared to $552 thousand for the prior-year

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,

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 (expenses), net

income (expenses), net was approximately $(4) thousand for the three-month period ended June 30, 2022, as compared to financing income

of $20 thousand for the prior-year period.

The decrease in the financing income is mainly attributed

to the decrease in interest income resulting from the reduction in the company’s cash balance over the year.

loss was $1,127 thousand for the three-month period ended June 30, 2022, as compared to $853 thousand for the prior-year period.

and administrative expenses were $495 thousand for the three-month period ended September 30, 2022, as compared to $207 thousand for

the prior-year period.

The increase is primarily attributable to the additional expenses that the company accrued due to its listing

on the Nasdaq Capital Market (“NASDAQ”).

and administrative expenses consist primarily of professional services, salaries, insurance, 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 $2 thousand for the three-month period ended September 30, 2022, as compared to financing income of $9

thousand for the prior-year period.

The decrease in the financing income is mainly attributed to

the decrease in interest income resulting from the reduction in the company’s cash balance over the year.

loss was $928 thousand for the three-month period ended September 30, 2022, as compared to $804 thousand for the prior-year period.

increase in net loss is attributable primarily to the increase in our operating expenses, as described above.

Months ended June 30, 2022 compared to Six Months ended June 30, 2021

Months ended September 30, 2022 compared to Nine Months ended September 30, 2021

and development expenses

and development expenses were $929 thousand for the six-month period ended June 30, 2022, as compared to $630 thousand for the prior-year

and development expenses were $1,363 thousand for the nine-month period ended September 30, 2022, as compared to $1,077 thousand for

the prior-year period.

The increase is primarily attributable to developing and validating our next generation product line.

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

We expect research and development expenses to increase in 2022 and beyond, primarily due to hiring additional personnel

and developing and validating 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 $0 thousand for the six-month period ended June 30, 2022, as compared to $23 thousand for the prior-year

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.

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

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 2022 and beyond, primarily due to hiring additional personnel and developing

and validating 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.

expenses were $0 thousand for the nine-month period ended September 30, 2022, as compared to $136 thousand for the prior-year period.

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.

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

and administrative expenses

and administrative expenses were $1,287 thousand for the six-month period ended June 30, 2022, as compared to $1,116 thousand for the

prior-year period.

and administrative expenses were $1,782 thousand for the nine-month period ended September 30, 2022, as compared to $1,323 thousand for

the prior-year 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,

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.

and to additional expenses that the company accrued due to its listing on the Nasdaq Capital

Market (“NASDAQ”).

and administrative expenses consist primarily of professional services, salaries, insurance, 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 (expenses), net

income (expenses), net was approximately $(4) thousand for the six-month period ended June 30, 2022, as compared to financing income

income (expenses), net was approximately $(2) thousand for the nine-month period ended September 30, 2022, as compared to financing income

of $21 thousand for the prior-year period.

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the decrease in interest income resulting from the reduction in the company’s cash balance over the year.

loss was $2,220 thousand for the six-month period ended June 30, 2022, as compared to $1,757 thousand for the prior-year period.

increase in net loss is attributable primarily to the increase in our operating expenses, as described above.

loss was $3,148 thousand for the nine-month period ended September 30, 2022, as compared to $2,561 thousand for the prior-year period.

The increase in net loss is attributable primarily to the increase in our operating expenses, as described above.

Concern Uncertainty

of June 30, 2022, cash on hand was approximately $3.8 million.

of September 30, 2022, cash on hand was approximately $3.2 million.

The development and commercialization of non-invasive glucose monitoring

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our operations.

Cash Used in Operating Activities for the Six-Month Periods Ended June 30, 2022 and June 30, 2021

cash used in operating activities was $2,181 thousand and $1,902 thousand for the six-month periods ended June 30, 2022 and 2021, respectively.

Net cash used in operating activities primarily reflects the net loss for those periods of $2,220 thousand and $1,757 thousand, respectively.

Cash Used (provided ) in Investing Activities for the Six-Month Periods Ended June 30, 2022 and June 30, 2021

cash used (provided) in investing activities was $4 and $(3) thousand for the six-month periods ended June 30, 2022 and 2021, respectively,

and was used (provided) mostly to purchase and sale equipment.

Cash Used in Operating Activities for the Nine-Month Periods Ended September 30, 2022 and September 30, 2021

cash used in operating activities was $2,789 thousand and $2,796 thousand for the nine-month periods ended September 30, 2022 and 2021,

respectively.

Net cash used in operating activities primarily reflects the net loss for those periods of $3,148 thousand and $2,561 thousand,

respectively.

Cash Used (provided ) in Investing Activities for the Nine-Month Periods Ended September 30, 2022 and September 30, 2021

cash used (provided) in investing activities was $4 and $(3) thousand for the nine-month periods ended September 30, 2022 and 2021, respectively,

and was used (provided) mostly to purchase and sale of equipment.

Sheet Arrangements

of June 30, 2022, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K .

of September 30, 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.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis