What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2021-06-29 compared with 2020-06-29 · 295 added, 279 removed, 227 unchanged (72% of the section changed)

Our fiscal year

ends on March 31 of each calendar year.

Each reference to a fiscal year in this Report, refers to the fiscal year ended March

31 of the calendar year indicated (for example, fiscal 2021 refers to the fiscal year ended March 31, 2021).

Unless the context

requires otherwise, references to “we,”

“us,”

“our,”

and the “Company”

Modular Medical, Inc.

and its consolidated subsidiary.

We are a development

stage medical device company focused on the design, development and eventual commercialization of an innovative insulin pump to

address shortcomings and problems represented by the relatively limited adoption of currently available pumps for insulin-requiring

stage, medical device company focused on the design, development, and eventual commercialization of an innovative insulin pump

to address shortcomings and problems represented by the relatively limited adoption of currently available pumps for insulin-requiring

people with diabetes.

typically classified as either type 1 or type 2:

1 diabetes is characterized by the body’s nearly complete inability to produce

· Type 1 diabetes is characterized

by the body’s nearly complete inability to produce insulin.

It is frequently diagnosed during childhood or adolescence.

Individuals with

type 1 diabetes require daily insulin therapy to survive.

2 diabetes represents over 90% of all individuals diagnosed with diabetes and is characterized

by the body’s inability to either properly utilize insulin or produce enough insulin.

Individuals with type 1 diabetes require daily insulin therapy to survive.

· Type 2 diabetes represents

over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize

insulin or produce enough insulin.

Initially, many people with type 2 diabetes attempt to manage their diabetes with improvements

in diet and exercise and/or the use of oral medications and/or injection of glucagon-like

peptide-1, or GLP-1, drugs.

However, as their diabetes advances, patients progress to

requiring insulin therapies, such as once-daily long-acting insulin, and, ultimately,

mealtime rapid-acting insulin therapy.

in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1, or GLP-1, drugs.

as their diabetes advances, patients progress to require insulin therapies, such as once-daily long-acting insulin, and, ultimately,

intensified mealtime rapid-acting insulin therapy.

the primary source of energy for cells, must be maintained at certain levels in the blood in order to permit optimal cell function

2 unchanged sentences

Hyperglycemia can lead to serious long-term complications, including blindness, kidney

disease, nervous system disease, occlusive vascular diseases, lower-limb amputation, stroke and cardiovascular disease, or death.

disease, nervous system disease, occlusive vascular diseases, lower-limb amputation, stroke and cardiovascular disease, and death.

Hypoglycemia can lead to confusion or loss of consciousness, often requiring a visit to the emergency room or, in certain cases,

result in death.

result in seizures, coma, and death.

The International

1 unchanged sentence

this number will increase to 700 million people.

According to the U.S.

Centers for Disease Control and Prevention, or CDC, 2020

National Diabetes Statistics Report, approximately 27 million people in the United States have diagnosed diabetes, of which type

1 diabetes accounts for approximately 5%, or approximately 1.4 million people.

All people with type 1 diabetes, which is our primary

market, require daily insulin.

According to the CDC, approximately 14% of people with type 2 diabetes in the United States, or

3.2 million people, require insulin to manage their diabetes.

In this Report, we refer to people with type 1 diabetes and people

with type 2 diabetes who require mealtime insulin as “insulin-requiring people with diabetes.”

According to the Seagrove 2021 Diabetes Blue Book, approximately 27 million people

in the United States have diagnosed diabetes, of which type 1 diabetes accounts for approximately 7%, or approximately 1.8 million

All people with type 1 diabetes, which is our primary market, require daily insulin.

According to the Seagrove 2021 Diabetes

Blue Book, approximately 18% of people with type 2 diabetes in the United States, or 4.7 million people, require insulin (basal

alone represent 3.1 million and basal plus mealtime represent 1.6 million) to manage their diabetes.

In this Report, we refer

to people with type 1 diabetes and people with type 2 diabetes who require mealtime insulin as “insulin-requiring people

with diabetes.”

Currently, there

1 unchanged sentence

multiple daily insulin injections directly into

the body through syringes or insulin pens, referred to as Multiple Daily Injection, or MDI, therapy, or the use of an insulin

pump to deliver a continuous subcutaneous insulin infusion, or CSII, into the body.

Generally, CSII therapy is considered to provide

a number of advantages over MDI therapy, primarily an improvement in glycemic control, as measured by certain diabetes management

Use of CSII has proven to improve clinical outcomes while, importantly, reducing emergency room visits associated with

the body through syringes or insulin pens, referred to as Multiple Daily Injection, or MDI therapy, or the use of an insulin pump

to deliver a continuous subcutaneous insulin infusion, or CSII therapy, into the body.

Generally, CSII therapy is considered to

provide a number of advantages over MDI therapy, primarily an improvement in glycemic control, as measured by certain diabetes

management tests.

Use of CSII has proven to improve clinical outcomes while, importantly, reducing emergency room visits associated

with low glucose.

Notwithstanding

5 unchanged sentences

of the shortcomings, cost, and complexity-of-use problems prevalent in available insulin pumps, continue to receive their daily

insulin through MDI.

insulin through MDI therapy.

target market for our insulin pump is the almost pumper population located in the United States.

2 unchanged sentences

classify as almost pumpers.

The remainder of the population treat their diabetes via MDI.

and development team is led by Paul DiPerna, our chairman, chief executive officer and a 40% shareholder.

DiPerna has over

30 years of high-level experience in developing, designing and obtaining U.S.

Food and Drug Administration, or FDA, approval for

and managing the commercialization of medical devices, including consumer and hospital-based insulin pumps, while working for

such industry leading medical device companies as Baxter Healthcare, Inc., a supplier of drug therapies and associated pumping

technologies, and Tandem Diabetes Care, Inc., or Tandem, a leading supplier of pumping technology to the existing insulin pumping

marketplace, Mr.

The remainder of the population treat their diabetes via MDI therapy.

and development team is led by Paul DiPerna, our chairman, chief executive officer, and our largest shareholder.

over 30 years of high-level experience in developing, designing, and obtaining U.S.

Food and Drug Administration, or FDA, approval

for and managing the commercialization of medical devices, including consumer and hospital-based insulin pumps, while working

for such industry leading medical device companies as Baxter Healthcare, Inc., or Baxter, a supplier of drug therapies and associated

pumping technologies, and Tandem Diabetes Care, Inc., or Tandem, a leading supplier of pumping technology to the existing insulin

pumping marketplace, Mr.

DiPerna was the founder of Tandem and designer of its initial product.

Insulin Pump Prototype

the past five years, we have designed and developed working prototypes of our low-cost insulin pump that are now undergoing the

testing required to submit for FDA approval.

During this period, we have and continue to devote substantial time and resources

to better understand the needs and preferences of almost pumpers to enable us to modify and refine our insulin pump to the needs

and preferences of this target market.

To help us better understand their needs and preferences, we obtained information about

our target market and their care givers through one on one interviews, human factors testing, on-line and in person surveys, and

focus groups at industry related tradeshows and conferences.

designed and developed working prototypes of our low-cost insulin pump that are now undergoing the testing required to submit

for FDA approval.

During this period, we have, and continue to devote, substantial time and resources to better understand the

needs and preferences of almost pumpers to enable us to modify and refine our insulin pump to the needs and preferences of this

target market.

To help us better understand their needs and preferences, we obtained information about our target market and their

care givers through one on one interviews, human factors testing, on-line and in person surveys, and focus groups at industry

related tradeshows and conferences.

Pre-Commercialization

we have substantially completed the general engineering and mechanical aspects of our current insulin pump prototype, prior to

commercializing, we still must successfully complete a number of material steps including:

to modify, refine and finalize our prototype so that it meets:

general needs and preferences of our almost-pumper target market based upon our knowledge

of the diabetes industry and information available and/or obtained by us from almost

pumpers and their caregivers;

general guidelines of third-party payors, private and public insurance companies, preferred

provider organizations and other managed care providers with particular focus on the

guidelines established by the Center for Medicare and Medicaid Services, or CMS which

administrates the United States Medicare program, or Medicare.

To assist us in making

such modifications and refinements, we have retained independent consultants to focus

on ensuring that our product satisfies the existing coverage and reimbursement criteria

of such third-party payors.

to work closely with our regulatory consultants to complete, finalize and file our submission

to the FDA for 510(k) clearance and all other documentation necessary to obtain approval

of our insulin pump.

While we have

substantially completed the general engineering and mechanical aspects of our insulin pump prototype, prior to commercializing,

we still must successfully complete a number of material steps including:

· Continue to modify, refine

and finalize our prototype so that it meets:

o the general needs and preferences

of our almost-pumper target market based upon our knowledge of the diabetes industry and information available and/or obtained

by us from almost pumpers and their caregivers;

o the general guidelines of

third-party payors, private and public insurance companies, preferred provider organizations and other managed care providers

with particular focus on the guidelines established by the Center for Medicare and Medicaid Services, or CMS which administrates

the United States Medicare program, or Medicare.

To assist us in making such modifications and refinements, we have retained independent

consultants to focus on ensuring that our product satisfies the existing coverage and reimbursement criteria of such third-party

· Continue to work closely

with our regulatory consultants to complete, finalize and file our submission to the FDA for 510(k) clearance and all other documentation

necessary to obtain approval of our insulin pump.

This will include:

the FDA in a pre-submission conference to ensure that we understand and meet the FDA’s requirements, expectations and

standards with regard to approval of our product.

At this meeting, our team, including our FDA regulatory consultant, will

receive FDA comments and guidance regarding our proposed submission during the pre-market notification period for 510(k) clearance

(including any suggested modifications to the device description, indications for use or summary of supporting data contained

in the notification);

and ensuring that our pre-market notification, which will be part of our FDA submission, demonstrates that our insulin pump,

which is substantially equivalent to an insulin pump previously cleared by the FDA and legally marketed to the public;

our submission to the FDA, to include all of the appropriate results of tests (relating

to, among other things, user effectiveness, sterility, pump efficiency and shipping compatibility)

demonstrating safety and efficacy of our insulin pump in satisfaction of the mandates

of the Federal Food, Drug and Cosmetics Act, or the FDCA, including requirements with

regard to registration and listing, labeling, medical device reporting and good manufacturing

We currently expect to make this submission in the fourth calendar quarter

manufacturing process will progress during the submission process to select a manufacturer of our insulin pump through a competitive

bidding process and prepare for our introduction.

· Refining our manufacturing

o engaging the FDA in a pre-submission

conference to ensure that we understand and meet the FDA’s requirements, expectations and standards with regard to approval

of our product.

At this meeting, our team, including our FDA regulatory consultant, received FDA comments and guidance regarding

our proposed submission during the pre-market notification period for 510(k) clearance (including any suggested modifications

to the device description, indications for use or summary of supporting data contained in the notification);

o preparing and ensuring that

our pre-market notification, which will be part of our FDA submission, demonstrates that our insulin pump, which is substantially

equivalent to an insulin pump previously cleared by the FDA and legally marketed to the public;

o preparing our submission

to the FDA, to include all of the appropriate results of tests (relating to, among other things, user effectiveness, sterility,

pump efficiency and shipping compatibility) demonstrating safety and efficacy of our insulin pump in satisfaction of the mandates

of the Federal Food, Drug and Cosmetics Act, or the FDCA, including requirements with regard to registration and listing, labeling,

medical device reporting and good manufacturing practices.

We currently expect to make this submission in the fourth calendar

quarter of 2021.

· Refine our manufacturing

process during the submission process to identify and select a manufacturer of our insulin pump through a competitive bidding

2 unchanged sentences

as may be required by the FDA as a condition to granting approval and providing 510(k) clearance for our insulin pump;

· Retain appropriate sales

and marketing personnel to develop, implement and launch a promotional campaign for our insulin pump substantially focused on

our target market.

As with any medical device attempting

to enter and successfully compete with existing products in an established and competitive marketplace, we will face significant

hurdles to accomplish the above steps to commercialization including:

· Hire and retain appropriate

sales and marketing personnel to develop, implement and launch a promotional campaign for our insulin pump substantially focused

on our target market.

medical device attempting to enter and successfully compete with existing products in an established and competitive marketplace,

we will face significant hurdles to accomplish the above steps to commercialization including:

· Obtaining FDA 510(k) clearance

2 unchanged sentences

approvals with regard to our product, as required by the FDCA;

endocrinologists, physician’s assistants, nurse practitioners and nurse educators, who typically prescribe pump usage,

and certified diabetes educators and dieticians, who provide education and guidance to diabetes patients, as to what we believe

to be the superior qualities of our product;

Demonstrating to general practitioners,

who have historically been skeptical of the heightened support inherent in insulin pumps, our product’s ease of use

and convenience;

· Educating endocrinologists,

physician’s assistants, nurse practitioners and nurse educators, who typically prescribe pump usage, and certified diabetes

educators and dieticians, who provide education and guidance to diabetes patients, as to what we believe to be the superior qualities

of our product;

· Demonstrating to select general

practitioners, who have historically been skeptical of the heightened support inherent in insulin pumps, our product’s ease

of use and convenience;

· Ensuring that our final product

2 unchanged sentences

and reluctance of almost-pumpers to using insulin pumps to treat their diabetes;

Ensuring that third party payors

agree to cover all or a substantial portion of the purchase price and recurring costs of the use of our insulin pump.

· Ensuring that third party

payors agree to cover all or a substantial portion of the purchase price and recurring costs of the use of our insulin pump.

that there are a number of shortcomings and issues with currently available insulin pumps that prevent a substantial number of

people requiring insulin on a daily basis from adjusting an insulin pump to treat their diabetes.

people who require insulin on a daily basis from choosing an insulin pump to treat their diabetes.

We believe, that by tailoring

1 unchanged sentence

We believe that to

achieve broader market acceptance, an insulin pump must be easier to learn how to use, be less time consuming to operate, more

intuitive to both patients and physicians and meet the standards for coverage by insurance providers, including so that

co-payments required from patients are affordable and the hurdles to insurance coverage are significantly reduced.

Among the more prominent issues are:

Many existing pumps are highly complex and require significant technical expertise to use effectively.

We believe such pumps

were designed for “super users,”

whom have high levels of motivation and technical competence.

The complexity

of pumps proves daunting to less technically inclined users.

We believe that a majority of existing pumps are bulky and difficult to manage, in many cases requiring additional equipment

to introduce a catheter to the patient’s body and up to 48 inches of tubing, which must be replaced frequently to connect

this catheter to a pump.

This requires users to carry spare parts and other equipment adding to the encumbrance of using the

Costs associated with insulin pump therapy are high and can be prohibitive, especially for those on fixed or limited incomes.

These costs vary by pump, but multi-thousand-dollar upfront payments often with substantial co-payments in addition to possible

daily co-payments on consumables can easily place current pumps out of reach for patients.

This makes insurance providers

hesitant to pay for them, leading to limited or absent reimbursement/coverage.

team has substantial knowledge of the diabetes space and experience in developing, winning approval for, and bringing insulin

pumps to market.

Based on this experience, we believe that our innovative insulin pump, using a new and proprietary method of

pumping insulin, can address most or all of these shortcomings.

It provides a state-of-the-art insulin pump capable of both basal

(steady flow) and bolus (mealtime dosing) insulin disbursement and with a natural migration path to multi-chamber/multi liquid

pumps with exciting array of new therapies being available to patients.

Our goal is to become the leader in expanding access to

insulin pump technology to a wider portion of diabetes sufferers and provide not just care for the super users, but “diabetes

care for the rest of us.”

DiPerna, our founder, chairman and chief executive officer, chief financial officer, secretary and treasurer began his career

in approximately 1980 as a mechanical design engineer in the automated test equipment industry before moving in approximately

1989 to a start-up company in the blood separation sciences industry.

achieve broader market acceptance, an insulin pump must be easier to learn to use, be less time consuming to operate, more intuitive

to both patients and physicians, and meet the standards for coverage by insurance providers so that co-payments required

from patients are affordable and the hurdles to insurance coverage are significantly reduced.

the more prominent issues are:

· Complexity :

Many existing

pumps are highly complex and require significant technical expertise to use effectively.

We believe such pumps were designed for

“super users,”

who have high levels of motivation and technical competence.

The complexity of pumps proves

daunting to less technically inclined users.

· Cumbersome :

that a majority of existing pumps are bulky and difficult to manage, in many cases requiring additional equipment to introduce

a catheter to the patient’s body and up to 48 inches of tubing, which must be replaced frequently, to connect the catheter

This requires users to carry spare parts and other equipment adding to the encumbrance of using the pump.

Costs associated

with insulin pump therapy are high and can be prohibitive, especially for those on fixed or limited incomes.

These costs vary

by pump, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to possible daily co-payments

on consumables, can easily place current pumps out of reach for patients.

This makes insurance providers hesitant to pay for them,

leading to limited or absent reimbursement/coverage and high hurdles for patients to gain access.

has substantial knowledge of the diabetes space and experience in developing, winning approval for, and bringing insulin pumps

Based on this experience, we believe that our innovative insulin pump, using a new and proprietary method of pumping

insulin, can address most or all of these shortcomings.

It provides a state-of-the-art insulin pump capable of both basal (steady

flow) and bolus (mealtime dosing) insulin disbursement.

It also has been designed considering a natural migration path to multi-chamber/multi-liquid

pumps, potentially offering an exciting array of new therapies to patients with diabetes and other conditions.

Our goal is to

become the leader in expanding access to insulin pump technology to a wider portion of diabetes sufferers and provide not just

care for the super users, but “diabetes care for the rest of us.”

our founder, chairman and chief executive officer, chief financial officer, secretary and treasurer, began his career in approximately

1980 as a mechanical design engineer in the automated test equipment industry before moving in approximately 1989 to a start-up

company in the blood separation sciences industry.

This company was acquired in approximately 1991 by Baxter.

Healthcare, or Baxter.

Following such acquisition, Mr.

DiPerna became employed by Baxter and held various positions during his

approximate 12 years at Baxter.

Following such acquisition,

he became employed by Baxter and held various positions for approximately 12 years.

While at Baxter, Mr.

DiPerna led significant projects and initiatives including leading a team

of approximately 50 engineers in developing equipment in the blood separation sciences industry.

In approximately 1996, Mr.

was promoted to General Manager of Baxter’s business development group to identify expansion opportunities in the medical

device industry for Baxter.

DiPerna led significant

projects and initiatives, including leading a team of approximately 50 engineers in developing equipment in the blood separation

sciences industry.

In approximately 1996, he was promoted to General Manager of Baxter’s business development group to identify

expansion opportunities in the medical device industry for Baxter.

While holding such position, Mr.

DiPerna led a team of approximately 20 personnel responsible for

researching custom orthopedics, digital dentistry and rapid prototyping.

In such role, one of Mr.

DiPerna’s assignments

was identifying opportunities in the diabetes industry.

DiPerna led a team of approximately

20 personnel responsible for researching custom orthopedics, digital dentistry, and rapid prototyping.

In such role, one of his

assignments was identifying opportunities in the diabetes industry.

As a result, Mr.

DiPerna developed an expertise and knowledge and became

well known in the diabetes industry and led attempts by Baxter to acquire three then-leading insulin pump manufacturers.

DiPerna developed an expertise and knowledge

and became well known in the diabetes industry and led attempts by Baxter to acquire three then-leading insulin pump manufacturers.

DiPerna, using his knowledge and experience acquired at Baxter in the diabetes industry and in the “pump”

business in particular, left Baxter and founded what subsequently became Tandem Diabetes Care, Inc., or Tandem.

While at Tandem,

DiPerna held various positions, including member of the board of directors, chief executive officer and chief technology officer.

Tandem is a medical device company that designs, develops and commercializes products for people with insulin-dependent diabetes.

Tandem’s common stock is listed on the NASDAQ Stock Market under the symbol “TNDM.”

Tandem was founded by Mr.

product business in particular, left Baxter and founded what subsequently became Tandem.

While at Tandem, Mr.

DiPerna held various

positions, including member of the board of directors, chief executive officer, and chief technology officer.

Tandem is a medical

device company that designs, develops and commercializes products for people with insulin-dependent diabetes.

Tandem was founded

DiPerna to design, develop and commercialize a “state of the art”

user-friendly insulin pump.

Under the leadership

DiPerna, Tandem raised approximately $52,000,000 from well-known venture-capital firms.

DiPerna was the person primarily

responsible for the design concept and development of Tandem’s insulin pump, which, after commercial introduction, it is

estimated by Mr.

He was the person

primarily responsible for the design concept and development of Tandem’s insulin pump, which, after commercial introduction,

it is estimated by Mr.

DiPerna such insulin pump had a quick ramp up to 5,000 purchasers.

DiPerna resigned from his executive

officer position and board seat at Tandem and continued to advise the company through 2013.

He co-invented a medical device used

for blood-borne infection control called the “Curos Cap.”

Curos Cap was owned by a private company which was acquired

by 3M Corporation in 2015 for $150,000,000.

DiPerna resigned from his

executive officer position and board seat at Tandem and continued to advise the company through 2013.

He co-invented a medical

device used for blood-borne infection control called the “Curos Cap.”

Curos Cap was owned by a private company which

was acquired by 3M Corporation in 2015 for $150,000,000.

Thereafter, Mr.

DiPerna founded a company Fuel Source Partners, LLC to incubate early

stage medical device products and accumulate technical talent.

One of such proposed products was spun-out to Quasuras in March

2015, which we acquired in July 2017.

DiPerna holds a number of issued and pending patents and is a member of the American

Diabetes Association.

DiPerna received a Master’s in Engineering Management from Northeastern University and a BS in

Mechanical Engineering from the University of Lowell.

DiPerna founded Fuel Source Partners, LLC to incubate

early stage medical-device products and accumulate technical talent.

One of such proposed products was spun-out to Quasuras, Inc.,

or Quasuras, in March 2015, which we acquired in July 2017.

DiPerna holds a number of issued and pending patents and is a

member of the American Diabetes Association.

DiPerna received a Master’s in Engineering Management from Northeastern

University and a BS in Mechanical Engineering from the University of Lowell.

From January 2017 until July 2019, Mr.

DiPerna joined National Cardiac Incorporated

as its Chief Executive Officer and as a board member to leverage their technology in the cardiac monitoring space.

DiPerna served

at National Cardiac Incorporated as its Chief Executive Officer and as a board member to leverage their technology in the cardiac

monitoring space.

Generally, there

3 unchanged sentences

to supplement or replace the insulin-producing function of the pancreas.

Insulin injections are often referred to as multiple

daily injection, or MDI, and involve the use of syringes or insulin pens to inject insulin into the body, as required.

pumps are used to provide a steady flow of insulin (often referred to as continuous subcutaneous insulin infusion or basal rate

insulin) and bursts of mealtime insulin (boluses).

Insulin pump therapy has been shown to provide people with insulin-requiring

diabetes with numerous advantages compared to MDI.

The steady flow of insulin and the easier application of mealtime boluses has

been shown by numerous clinical studies to result in lower HbA1c (a measure of the amount of glucose in the bloodstream) when

compared to MDI therapy.

This results in lower rates of hospitalization and a reduction in overall adverse events for people with

believe that the greater efficacy of pumps compared to MDI makes insulin pumps a more optimal choice for persons in managing diabetes,

MDI therapy involves the use of syringes or insulin pens

to inject insulin into the body, as required.

Insulin pumps are used to provide a steady flow of insulin (often referred to as

continuous subcutaneous insulin infusion or basal rate insulin) and bursts of mealtime insulin (boluses).

Insulin pump therapy

has been shown to provide people with insulin-requiring diabetes with numerous advantages compared to MDI therapy.

flow of insulin and the easier application of mealtime boluses has been shown by numerous clinical studies to result in lower

HbA1c (a measure of the amount of glucose in the bloodstream) when compared to MDI therapy.

This results in lower rates of hospitalization

and a reduction in overall adverse events for people with diabetes.

that the greater efficacy of pumps compared to MDI makes insulin pumps a more optimal choice for persons in managing diabetes,

but that the shortcomings and challenges around existing pumps have held back adoption rates.

the CDC, in the United States, in 2020, 88 million people, or 1 out of 3 adults, had pre-diabetes, approximately 27 million people

had been diagnosed with diabetes and an additional 7 million people had diabetes that was undiagnosed.

The CDC also indicated

that diabetes was the seventh leading cause of death in the United States in 2017, which according to the CDC, may be

underreported.

Diabetes was the leading cause of kidney failure, lower-limb amputations, and adult-onset blindness and represented

more than $327 billion in medical costs in 2017.

Centers for Disease Control and Prevention, or CDC, 2020 National Diabetes Statistics Report in the United States, in

2018, 88 million people, or 1 out of 3 adults, had pre-diabetes, approximately 27 million people had been diagnosed with diabetes

and an additional 7 million people had diabetes that was undiagnosed.

The CDC also indicated that diabetes was the seventh leading

cause of death in the United States in 2017, which according to the CDC, may be underreported.

Diabetes was the leading cause

of kidney failure, lower-limb amputations, and adult-onset blindness and represented more than $327 billion in medical costs in

We believe that

due to a number of factors, including the large consumption of processed foods and the growing obesity problem in the United States,

the number of persons requiring daily administration of insulin is and will continue to grow at rapid rates.

of persons with diabetes requiring daily insulin administration is our target market and we believe our proposed product has the

potential to substantially improve the day to day quality of life of such persons.

the number of persons requiring daily administration of insulin will continue to grow at rapid rates.

of persons with diabetes requiring daily insulin administration is our target market, and we believe our proposed product has

the potential to substantially improve the day to day quality of life of such persons.

The Opportunity

34 unchanged sentences

We believe this makes insurers hesitant to pay for pumps

for any but their best and most compliant patients and places them out of reach for many patients who cannot afford such out of

pocket expenses.

pump is being designed and developed to address the above shortcomings and to appeal to (i) the substantial group of “almost-pumpers”

for any but their best and most compliant patients and places pumps out of reach for many patients who cannot afford such out

of pocket expenses.

pump is being designed and developed to address the above shortcomings and to appeal to:

(i) the substantial group of “almost-pumpers”

who are currently interested in using an insulin pump, but have not done so because of the complexity, cost or cumbersome nature

2 unchanged sentences

product on the market and the easiest for providers to prescribe.

current pump prototype of our proposed pump has been built to test what we believe to be our novel approach to insulin pumps.

By providing a pump that we believe will establish industry standards in terms of technology, simplicity to understand, ease

of use and price, we believe our proposed pump will offer the vast majority of benefits afforded by more expensive and

complex pumps but while accessible to a substantially greater percentage of diabetes sufferers requiring daily insulin

pump prototype of our proposed pump has been built to test what we believe to be our novel approach to insulin pumps.

a pump that we believe will establish industry standards in terms of technology, simplicity to understand, ease of use and price,

we believe our proposed pump will offer the vast majority of benefits afforded by more expensive and complex pumps but remain

accessible to a substantially greater percentage of diabetes sufferers requiring daily insulin therapy.

We believe people

6 unchanged sentences

complex features and are “user friendly”

to only the most technically astute and are becoming more complex and difficult

to only the most technically astute.

goal is to successfully design, develop and obtain all required regulatory approvals for our proposed insulin pump, and, thereafter,

commercialize, market and sell the finished product.

Our long-term goal is to become a leading provider of insulin pump therapy

by focusing on both consumer and clinical needs.

commercialize the finished product.

Our long-term goal is to become a leading provider of insulin pump therapy by focusing on

both consumer and clinical needs.

To achieve our above stated immediate

and current goals, we intend to pursue the following business strategies:

of innovative proprietary technology.

DiPerna’s substantial experience in engineering design and innovative technology in the medical device industry

and, in particular, with insulin pumps, we have generated proprietary technology that will be incorporated into our proposed insulin

innovative proprietary technology.

Based upon Mr.

DiPerna’s substantial experience in engineering design and innovative technology in the medical device industry and, in

particular, with insulin pumps, we have generated proprietary technology that has been incorporated into our proposed insulin

Generally, this technology is involved in the delivery of insulin to the user at the appropriate and necessary times.

1 unchanged sentence

We believe the proposed design, engineering

and technology being incorporated into our proposed pump, will make our proposed pump substantially simpler and more affordable

than those currently available.

These features, together with the safety and reliability of our proposed pump, are designed to

create the next generation of insulin pumps that will be superior to those currently available and make it available to consumers

across mostly all socioeconomic groups in the United States and around the world.

and technology being incorporated into our proposed pump will make it substantially simpler and more affordable than those currently

These features, together with the safety and reliability of our proposed pump, are designed to create the next generation

of insulin pumps that will feature important and well-differentiated attributes compared to those currently available and make

it available to consumers across mostly all socioeconomic groups in the United States and around the world.

low during our design and development process.

to ensure that we have sufficient funds to design, develop and obtain all required regulatory approvals for our proposed insulin

To attempt to

ensure that we have sufficient funds to design, develop, and obtain all required regulatory approvals for our proposed insulin

pump without having to sacrifice quality and efficiency, we intend to maintain a tight budget and limit expenditures where possible.

3 unchanged sentences

other medical devices and his ability to manage a small, focused development team.

We currently expect various other expenses

such as product scale up, sales and marketing costs will not be incurred until such time as development work is completed and

regulatory approvals obtained.

experienced engineers picked, supervised and led by Mr.

DiPerna, a highly experienced and respected engineer and executive in

the insulin pump industry.

attempt to ensure our proposed insulin pump is “state of the art,”

functional, and efficient, as well as to conserve

funds, significantly all of our employees will initially be hand-picked engineers under the leadership of Mr.

that there is a strong pool of engineers with significant applicable experience and knowledge who we will be able to initially

employ on a contract and/or outsource basis to help us design and develop our proposed insulin pump.

We believe by hiring such

persons on an out-source basis, we will save substantial resources and by having Mr.

DiPerna lead and focus the team on technological

and mechanical aspects of our proposed insulin pump, we believe our team will be well guided, focused, cost efficient, and able

to efficiently design and develop our product that we believe can eventually be an industry standard.

medical device industry is regulated extensively by governmental authorities, principally the FDA and corresponding state regulatory

We currently expect that various other expenses,

such as product scale up, and sales and marketing costs, will not be incurred until such time as development work is completed

and regulatory approvals obtained.

experienced engineers selected, supervised, and led by Mr.

DiPerna, a highly experienced and respected engineer and executive

in the insulin pump industry.

To attempt to

ensure our proposed insulin pump is “state of the art,”

functional, and efficient, as well as to conserve funds, substantially

all of our employees will initially be hand-picked engineers under the leadership of Mr.

We believe that there is a strong

pool of engineers with significant applicable experience and knowledge who we will be able to initially employ on a contract and/or

outsource basis to help us design and develop our proposed insulin pump.

We believe by hiring such persons on an out-source basis,

we will save substantial resources and by having Mr.

DiPerna lead and focus the team on technological and mechanical aspects of

our proposed insulin pump, we believe our team will be well guided, focused, cost efficient, and able to efficiently design and

develop our product that we believe can eventually be a competitive and popular choice for people with insulin requiring diabetes.

device industry is regulated extensively by governmental authorities, principally the FDA and corresponding state regulatory agencies.

The regulations are very complex and are subject to rapid change and varying interpretations.

Regulatory restrictions

or changes could limit our ability to bring our proposed product to the commercialization stage as a result of higher than anticipated

costs to obtain regulatory approval.

Regulatory restrictions or changes

could limit our ability to bring our proposed product to the commercialization stage as a result of higher than anticipated costs

to obtain regulatory approval.

The FDA and other U.S.

36 unchanged sentences

basis or at all for our proposed product.

FDA requires us to go through a more rigorous examination for our proposed product than we currently expect, we will require substantial

additional funding sooner than anticipated and/or our product could be severely delayed, or our efforts ceased.

We anticipate

that our proposed product will require the more costly, lengthy and uncertain PMA approval process.

If the FDA requires

us to go through a more rigorous examination for our proposed product than we currently expect, we will require substantial additional

funding sooner than anticipated and/or our product could be severely delayed, or our efforts ceased.

We anticipate that our proposed

product will require the 510(k) clearance process.

delay, limit or deny clearance or approval of our proposed pump device for many reasons, including:

4 unchanged sentences

actions which may prevent or delay approval or clearance of our proposed product.

delay in, or failure to receive or maintain, clearance or approval for our products under development could prevent us from generating

Any delay in,

or failure to receive or maintain, clearance or approval for our proposed product under development could prevent us from generating

revenue therefrom or achieving profitability.

9 unchanged sentences

have a material adverse effect on our reputation, business and financial condition.

As of March 31, 2020, we had

13 employees all of whom are located in the United States, consisting of 10 in research and development and manufacturing operations

and 3 in marketing and general and administrative functions

As of March 31,

2021, we had 20 employees all of whom are located in the United States, consisting of 16 in research and development and manufacturing

operations and 4 in marketing and general and administrative functions.

Medtronic, Inc.,

3 unchanged sentences

We do not intend to directly

compete for those patients, instead we intend to offer a simple to use more cost-effective solution to attract the more mainstream

compete for those individuals with diabetes, instead we intend to offer a simple to use more cost-effective solution to attract

the more mainstream patients.

Intellectual Property

Our success depends in part on our

ability to obtain patents and trademarks, maintain trade secret and know-how protection, enforce our proprietary rights against

infringers, and operate without infringing on the proprietary rights of third parties.

Because of the length of time and expense

associated with developing new products and bringing them through the regulatory approval process, the health care industry places

considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes,

know-how, and methods.

As of March 31, 2020, we had

four pending U.S.

utility patent applications and three foreign pending patent applications related to our proprietary fluid movement

technology and the configuration of our product offering.

There can be no assurance that the pending patent applications

will result in the issuance of patents, that patents issued to or licensed by us will not be challenged or circumvented by competitors,

or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive

depends in part on our ability to obtain patents and trademarks, maintain trade secret and know-how protection, enforce our proprietary

rights against infringers, and operate without infringing on the proprietary rights of third parties.

Because of the length of

time and expense associated with developing new products and bringing them through the regulatory approval process, the health

care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies,

products, processes, know-how, and methods.

31, 2021, we had six pending U.S.

utility patent applications, two pending foreign patent applications and

two pending international PCT patent applications on various aspects of our technology, including our proprietary fluid

movement technology.

There can be no assurance that the pending patent applications will result in the issuance of patents,

that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that these patents will be

found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage.

Corporate History and Background

30 unchanged sentences

Besser, Frank and DiPerna, collectively,

the 3 Quasuras Shareholders), and Quasuras, we acquired all of the issued and outstanding shares of Quasuras owned by the 3 Quasuras,

resulting in Quasuras becoming our wholly-owned subsidiary (the Acquisition).

Simultaneously with the closing of the Acquisition,

Manchester Explorer cancelled the 2,900,000 shares of our common stock purchased in the Control Block Acquisition, Mr.

resigned as our president and a director and Mr.

Frank resigned as our chief executive officer, chief financial officer, secretary,

and treasurer, but remained a director, and Mr.

DiPerna was appointed our chairman of the board of directors, chief executive

officer, chief financial officer, secretary and treasurer.

the 3 Quasuras Shareholders), and Quasuras (the Share Exchange Agreement), we acquired all of the issued and outstanding shares

of Quasuras owned by the 3 Quasuras Shareholders, resulting in Quasuras becoming our wholly-owned subsidiary (the Acquisition).

Simultaneously with the closing of the Acquisition, Manchester Explorer cancelled the 2,900,000 shares of our common stock purchased

in the Control Block Acquisition, Mr.

Besser resigned as our president and a director and Mr.

Frank resigned as our chief executive

officer, chief financial officer, secretary, and treasurer, but remained a director, and Mr.

DiPerna was appointed our chairman

of the board of directors, chief executive officer, chief financial officer, secretary and treasurer.

In anticipation

4 unchanged sentences

to “MODD.”

Following the

closing of the Acquisition, on July 28, 2017, we filed a Current Report on Form 8-K, as amended (the Super 8-K), with the Securities

and Exchange Commission (the SEC) to disclose the Acquisition and related transactions, and upon the filing of the Super 8-K we

ceased being a shell company.

Smaller Reporting

2017, we filed a Current Report on Form 8-K, as amended (the Super 8-K), with the Securities and Exchange Commission (the SEC)

disclosing the Acquisition and related transactions, and, upon such filing, we ceased being a shell company.

Smaller Reporting Company

We are subject

to the reporting requirements of Section 13 of the Exchange Act, and we are subject to the disclosure requirements of Regulation

S-K of the SEC, as a “smaller reporting company.”

That designation relieves us of some of the disclosure requirements

of Regulation S-K.

to the reporting requirements of Section 13 of the Exchange Act and to the disclosure requirements of Regulation S-K of the SEC,

as a “smaller reporting company.”

Such designation relieves us of some of the disclosure requirements of Regulation

Available Information

and copy any materials that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C.

You may also find all of the reports or registration statements that we have previously filed electronically with the SEC

at its Internet site at www.sec.gov.

Please call the SEC at 202-551-8090 for further information on this or other Public Reference

Our SEC reports and registration statements are also available from commercial document retrieval services, such as CCH

Washington Service Bureau, whose telephone number is 1-800-955-0219.

Our website address is www.modular-medical.com.

The information in our website is not incorporated by reference into this report.

We file reports

with the SEC and make available, free of charge, on or through our website, our annual reports on Form 10-K, quarterly reports

on Form 10-Q, current reports on Form 8-K, proxy and information statements and amendments to these reports filed or furnished

pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material

with, or furnish it to, the SEC.

All SEC filings are also available at the SEC’s website at www.sec.gov.

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 1. Business