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Item 1. Business

2026-06-29 compared with 2025-06-20 · 790 added, 826 removed, 104 unchanged (94% of the section changed)

We are a pre-revenue, medical device company focused on the design,

development, and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace.

Through the creation of an innovative two-part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and

access to the higher standards of care that presently require considerable motivation from the patient to use the available insulin pumps.

We are a medical device company focused on the design, development,

and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace.

the creation of an innovative two-part patch pump, we seek to fundamentally alter the trade-offs between cost and complexity and access

to the higher standards of care that presently require considerable motivation from the patient to use the available insulin pump offerings.

By simplifying and streamlining the user experience from the initial introduction of the patient to our product, prescription assistance,

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to market and sell our MODD1 pump in the United States.

We are actively working to manufacture and commercialize our MODD1 product and

commence initial shipments during the quarter ending September 30, 2025.

We are currently preparing a second 510(k) premarket notification

application to the FDA for an updated version of the MODD1, called the Pivot, which is a tubeless version of the product that integrates

the set into a true tubeless patch.

The Pivot will provide us with cost and usability improvements and improved manufacturability, allowing

our marketing to be focused on low cost and ease of use and learnability.

We believe we will submit the notification for the Pivot by

October 31, 2025, and we believe we could obtain regulatory clearance to market and launch Pivot during the three months ending March

We intend to replace the MODD1 with the Pivot, as soon as the required regulatory approval from the FDA is received.

We also intend

to obtain Conformite Europeenne , or CE, mark clearance for both our MODD1 and Pivot products, which would allow us to market and

sell in European markets.

We expect to obtain CE mark clearance in the first quarter of 2026.

In August 2025, we announced the first human use of our MODD1 pump delivering

insulin to a human patient.

In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot™, and began

converting our cartridge manufacturing line to Pivot production.

Our Pivot product is a tubeless insulin delivery system that integrates

the infusion set under the removable pump into a true tubeless patch.

The Pivot is expected to provide us with cost and usability improvements

and improved manufacturability, allowing our marketing to be focused on low cost, ease of use and learnability.

We submitted a 510(k)

premarket notification to the FDA for our Pivot product in November 2025, and, in April 2026, we received FDA clearance to market and

sell our Pivot pump in the United States.

We do not intend to commercialize our MODD1 product.

In June 2026, we announced commercial availability,

and commenced initial shipments of, our Pivot insulin delivery system in the United States.

We intend to expand commercial activities

across metropolitan markets by late 2026.

We also intend to obtain Conformite Europeenne , or CE, mark clearance for our Pivot product,

which would allow us to market and sell in Europe and certain other international markets.

We expect to obtain CE mark clearance by the

second quarter of 2027.

Differentiation

We believe that there are a number of shortcomings and issues with

currently available insulin pumps that prevent a substantial number of people who require insulin on a daily basis from choosing an insulin

pump to treat their diabetes.

We believe that, by tailoring our insulin pump to address such factors, we can expand the scope and adoption

rate of insulin pump usage by the less capable, less motivated sector of the market.

We believe that to 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.

Among the more prominent issues are:

currently available insulin pumps that prevent a substantial number of people, estimated to be almost two-thirds of individuals with diabetes,

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

We believe that, by tailoring our insulin

pump to address such factors, we can expand the scope and adoption rate of insulin pump usage by the less capable, less motivated sector

of the market.

We believe that to 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 can be daunting to less technically

inclined, less motivated users.

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 can be daunting to

less technically inclined, less motivated users.

● Cumbersome :

that a majority of existing pumps are bulky and difficult to manage, requiring a means of carrying the pump around and up to 48 inches

of tubing to the injection site to connect the catheter to a pump.

The tubing and the cartridge, which holds the insulin, must be replaced

every few days.

We believe that a majority of existing pumps are bulky and difficult to manage, requiring a means of carrying the pump around and up

to 48 inches of tubing to the injection site to connect the catheter to a pump.

The tubing and the cartridge, which holds the insulin,

must be replaced every few days.

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

comparison, our product only requires a cartridge change every few days.

In comparison, our product only requires a cartridge change every few days.

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

These costs vary by pump and insurance coverage, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to possible additional co-payments on consumables, can easily place current pumps out of reach for many patients.

The leading patch pump on the market today also discards all the electronics required for pumping and communication every three days, creating a higher cost architecture and significant waste.

We believe the reusability of our product will provide us with a significant cost advantage in the marketplace with our reusable pumping system.

Outdated style :

vary by pump and insurance coverage, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to possible

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

The leading patch pump on the market

today also discards all the electronics required for pumping and communication every three

days, creating a higher cost architecture and significant waste.

We believe the reusability of our product will provide us with a significant

cost advantage in the marketplace with our reusable pumping system.

Consumer electronics devices have evolved in both form and function.

Diabetes pumps have not experienced similar progress.

We believe that consumers will be more receptive of products designed with the user experience in mind and that many have low tolerance for complex, difficult procedures for use and maintenance of products.

Pump mechanism limitations :

We believe that consumers will be more receptive of products designed with the user experience in mind and that many have low tolerance

for complex, difficult procedures for use and maintenance of products.

mechanism limitations :

Traditional pumps generally utilize a syringe and plunger mechanism to deliver insulin.

We believe this design limits the ability to reduce the size of the pump, and also potentially exposes the user to the unintended delivery of the full volume of insulin within the pump, which can cause hypoglycemia or death.

We believe that the fear of adverse health events due to technical malfunctions related to traditional pump mechanism limitations deters the adoption of insulin pump therapy.

Our team has substantial knowledge of the diabetes

industry and experience in developing, obtaining marketing authorization 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.

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.”

We believe this design

limits the ability to reduce the size of the pump, and also potentially exposes the user to the unintended delivery of the full volume

of insulin within the pump, which can cause hypoglycemia or death.

We believe that the fear of adverse health events due to technical

malfunctions related to traditional pump mechanism limitations deters the adoption of insulin pump therapy.

team has substantial knowledge of the diabetes industry and experience in developing, obtaining marketing authorization 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.

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.

With the commercial launch of our Pivot pump, our goal is to become

the leader in expanding access to insulin pump technology to a wider portion of people with diabetes by delivering an affordable, easy-to-use

solution — not just for the highly motivated “super users,” but “diabetes care for the rest of us.”

While our initial target market is people with Type 1 diabetes, we

believe there is a substantial opportunity to penetrate the type 2 marketplace, first through our initial MODD1 pump, and then with the

future introduction of Pivot, which would be the only 3 milliliter, tubeless removable patch pump on the market.

The MODD1 and its successor product the Pivot

are high-precision pumps that we believe represent the best choice for new pump patients because they are affordable, easy to learn and

use, and has a revolutionary design and internal technology that enable precision with low-cost manufacture and high reproducibility.

Key features include:

Three parts - one reusable, two disposable (the cartridge and the set) - snap together to form the working system;

One button interface, easy to learn and use;

● Phone software for those who want to access more information

on the product;

● 90-day reusable, 3-day disposable;

Removable system;

No external controller required, no charging, no battery replacement;

Slim profile, lighter weight.

A proprietary survey of American healthcare payors

representing 50 million covered lives (approximately one-third of total U.S.

covered lives) performed for us by industry leading survey

firm ISA in 2019 has demonstrated that payors are willing to grant equivalent or preferential coverage for a product with this feature

set at launch in exchange for discounts of approximately 20%.

Diabetes Classifications and Therapies

Diabetes is typically classified as either type

Type 1 diabetes, or T1D, is an auto-immune condition characterized by the body’s nearly complete inability to produce insulin.

It is frequently diagnosed during childhood or adolescence, although it can sometimes have onset in adulthood.

Individuals with T1D require daily insulin therapy to survive.

Type 2 diabetes, or T2D, represents over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce sufficient insulin.

Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1 (GLP-1) drugs.

However, as their diabetes advances, patients often progress to requiring insulin therapies such as once-daily long-acting insulin and ultimately to intensified mealtime rapid-acting insulin therapy.

This represents an important portion of the diabetes market with an estimated 1.6 million individuals with T2D intensively treated with insulin currently in the United States.

Glucose, the primary source of energy for cells,

must be maintained at certain levels in the blood in order to permit optimal cell function and health.

The brain works on pure glucose,

and, when sufficient glucose is available, the brain allows insulin to be released that allows the cells to absorb glucose.

with diabetes, blood glucose levels are not well controlled by the brain due to the shortage of insulin.

Frequently, blood glucose levels

become very high, a condition known as hyperglycemia, or very low, a condition called hypoglycemia.

Hyperglycemia can lead to serious

long-term complications, including blindness, kidney disease, nervous system disorders, occlusive vascular diseases, lower-limb amputation,

stroke, 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 seizures, coma, and/or death.

believe there is a substantial opportunity to penetrate the Type 2 marketplace, through our Pivot product, which would be the only 3 milliliter,

tubeless removable patch pump on the market.

People with Type 2 diabetes tend to use more insulin than the present pump offerings can

hold, requiring more frequent changes of the pump and incurring higher expense.

Pivot is a high-precision pump, which we believe represent the best choice for new pump patients because it is affordable, easy to learn

and use, and has a revolutionary design and internal technology that enable precision with low-cost manufacture and high reproducibility.

features include:

parts — one reusable, two disposable (the cartridge and the set) — snap together to form the working system;

button interface, easy to learn and use;

software for those who want to access more information on the product;

reusable, 3-day disposable;

external controller required, no charging, no battery replacement;

profile, lighter weight.

Classifications and Therapies

Diabetes is typically classified as either Type 1 or Type 2:

1 diabetes, or T1D, is an auto-immune condition characterized by the body’s nearly complete inability to produce insulin.

frequently diagnosed during childhood or adolescence, although it can sometimes have onset in adulthood.

Individuals with T1D require

daily insulin therapy to survive.

2 diabetes, or T2D, represents over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability

to either properly utilize insulin or produce sufficient insulin.

Initially, many people with T2D attempt to manage their condition with

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

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

to intensified mealtime rapid-acting insulin therapy.

This represents an important portion of the diabetes market with an estimated 1.6

million individuals with T2D intensively treated with insulin currently in the United States.

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

The brain works on pure glucose, and, when sufficient glucose is available, the brain allows insulin to be released that allows

the cells to absorb glucose.

In people with diabetes, blood glucose levels are not well controlled by the brain due to the shortage of

Frequently, blood glucose levels become very high, a condition known as hyperglycemia, or very low, a condition called hypoglycemia.

Hyperglycemia can lead to serious long-term complications, including blindness, kidney disease, nervous system disorders, occlusive vascular

diseases, lower-limb amputation, stroke, 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 seizures, coma, and/or death.

All people with T1D, which is our primary market,

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as “insulin-requiring people with diabetes.”

Currently, there are two primary therapies available

for insulin-requiring people with diabetes:

multiple daily insulin injections directly into the body through syringes or insulin pens

(a type of syringe), referred to as Multiple Daily Injection, or MDI therapy, or the use of an insulin pump to deliver mealtime insulin

boluses to help with glucose absorption after carbohydrate consumption and 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 such as hemoglobin A1c (HbA1c) measure and more recently Time in Range (TIR)

where a continuous glucose measuring device is used to calculate this test.

Among other clinical benefits, a study conducted by Tandem

Diabetes Care, Inc., or Tandem, in 2021, demonstrated that insulin pump use can decrease glucose variability, reduce the number of hypoglycemia

events, and reduce the fear of hypoglycemia.

Notwithstanding these advantages, we believe the

difficulty in use resulting from the complexity and cumbersome design of available insulin pumps, as well as high and often prohibitive

costs for both the patient and insurance provider, has resulted not only in dissatisfaction among many existing pump users.

the cost and complexity to the user has severely limited the adoption rate of insulin pumps by a large segment of the diabetes population

using MDI therapy, whom we refer to in this Report as “Almost Pumpers.”

We define Almost Pumpers as insulin-requiring

people with diabetes who are aware of pumps and their potential benefits but because of past experiences, pump shortcomings, cost, complexity,

there are two primary therapies available for insulin-requiring people with diabetes:

multiple daily insulin injections directly into

the body through syringes or insulin pens (a type of syringe), referred to as Multiple Daily Injection, or MDI therapy, or the use of

an insulin pump to deliver mealtime insulin boluses to help with glucose absorption after carbohydrate consumption and 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 such as hemoglobin A1c (HbA1c) measure

and more recently Time in Range (TIR) where a continuous glucose measuring device is used to calculate this test.

Notwithstanding

these advantages, we believe the difficulty in use resulting from the complexity and cumbersome design of available insulin pumps, as

well as high and often prohibitive costs for both the patient and insurance provider, has resulted not only in dissatisfaction among

many existing pump users.

We believe the cost and complexity to the user has severely limited the adoption rate of insulin pumps by a

large segment of the diabetes population using MDI therapy, whom we refer to in this Report as “Almost Pumpers.”

We define “Almost Pumpers” as insulin-requiring people

with diabetes who are aware of pumps and their potential benefits but because of past experiences, pump shortcomings, cost, complexity,

and time and learning required to adopt and utilize currently available insulin pumps, continue to receive their daily insulin through

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the design and include features that would motivate them to be able to use this technology to better care for their diabetes.

pump has been well received by these individuals and our clinical advisors, as applicable for this sector of the marketplace.

Our research, along with marketplace data provided

by Seagrove in 2023, estimates that 33% of Americans with T1D have an insulin pump and 28% of Americans with T1D (44% of those who currently

utilize MDI) can be classified as having an interest in pump adoption and meeting the American Diabetes Association guidelines of glucose

control if their objections to the currently available suite of products can be overcome.

They do not want to closely manage their glucose

levels and incur the associated time and effort involved;

however, they understand, or are advised by their clinical care team, that they

need to do more to achieve a reasonable level of glucose.

offering has been well received by these individuals and our clinical advisors, as applicable for this sector of the marketplace.

Our research, along with marketplace data provided by Seagrove in 2026,

estimates that 43% of Americans with T1D have an insulin pump and 28% of Americans with T1D (44% of those who currently utilize MDI) can

be classified as having an interest in pump adoption and meeting the American Diabetes Association guidelines of glucose control if their

objections to the currently available suite of products can be overcome.

They do not want to closely manage their glucose levels and incur

the associated time and effort involved;

however, they understand, or are advised by their clinical care team, that they need to do more

to achieve a reasonable level of glucose.

They are the Almost Pumpers.

We have developed what we believe to be the most

technologically advanced delivery system overcome the objections and provide motivation for this market.

We believe that there are four

addressable hurdles to adoption:

We have developed what we believe to be the most technologically

advanced delivery system overcome the objections and provide motivation for this market.

We believe that there are four addressable hurdles

the device needs to be easy to learn and to operate;

● Affordability:

we will focus on overcoming copay and insurance hurdles rather than leaving the “insurance journey” to the clinician and patient;

Accessibility and Education:

we will seek to engage patients to sample this new technology by supplying clinicians with free samples and simple training to allow people to see first-hand the typical barriers to adoption that have been overcome;

Service and Support:

we will focus on overcoming copay and insurance hurdles rather than leaving the “insurance journey” to the clinician and

● Accessibility

and Education:

we will seek to engage patients to sample this new technology by supplying clinicians with free samples and simple training

to allow people to see first-hand the typical barriers to adoption that have been overcome;

where we will answer their questions and concerns during this diabetes experience.

We believe this conversion process, engaging people

to try and thereby receive the benefits of our technology will substantially increase adoption of insulin pumps among with patients with

T1D and T2D who remain reliant upon multiple daily injections.

We believe this conversion process, engaging people to try and thereby

receive the benefits of our technology will substantially increase adoption of insulin pumps among with patients with T1D and T2D who

remain reliant upon MDI.

Diabetes is a disease that appears randomly throughout the world.

we cannot segment the market by socioeconomics, education or level of care.

We intend to create an insulin pump that appeals to all Almost

Therefore, we cannot segment the market by

socioeconomics, education or level of care.

We intend to create an insulin pump that appeals to all Almost Pumpers.

The International Diabetes Federation estimated

that, in 2021, approximately 537 million people were living with diabetes worldwide, and by 2045, this number will increase to approximately

that, in 2025, approximately 357 million people were diagnosed with diabetes worldwide, and, by 2045, this number will increase to approximately

456 million people.

An estimated 34 million people in the United States

live with diabetes.

An estimated 34 million people in the United

States live with diabetes.

Within this group, T1D accounts for approximately 2.1 million people with the remainder being T2D.

All people with

T1D require daily insulin.

However, of the approximately 32.2 million people with T2D, about 1.6 million of them require MDI therapy to

manage their diabetes.

with T1D require daily insulin.

However, of the approximately 32.2 million people with T2D, about 2.1 million of them require MDI therapy

to manage their diabetes.

This represents a large and growing market with the effects of diabetes accounting for roughly 25% of all healthcare

dollars spent annually in the United States.

According to the National Diabetes Health Care

Provider Survey conducted by Seagrove Partners, LLC, or Seagrove, in 2021, approximately 25% of the 1.6 million highly insulin intensive

individuals with T2D have considered going “on pump.”

Insulin pumps have been shown to provide a higher

level of care for insulin-dependent people with diabetes and result in better glycemic control, fewer comorbidities, fewer trips to the

emergency room, and higher overall quality of life.

They also result in lower overall costs to the healthcare system, reducing typical

expense per patient year from approximately $27,000 to $17,000.

Despite these benefits, only 1 in 3 (33%) of the

1.8 million Americans with T1D and very few of the 1.6 million T2D intensively treated with insulin currently use an insulin pump, for

a total of approximately 670,000 current users, with only a slow increase of insulin pump use.

The remaining 68% of individuals with T1D

and virtually all with T2D rely on MDI therapy for glucose control.

Decades of advances in technology advances have left these non-pumpers

at a significant disadvantage from a control perspective versus their “pumping” counterparts.

We have identified a large segment of the market

that we refer to as “Almost Pumpers.” Almost Pumpers are those insulin-requiring people with diabetes (T1D or T2D) who feel

that they would adopt the pump if it were less expensive, less time consuming, less technically intimidating, and if there was no separate

We believe that they represent approximately 32% of the T1D market correlating to a $1.9 billion growth opportunity.

Insulin pumps on the market today require a substantial

amount of time to manage the therapy, have high out-of-pocket costs that place these technologies out of reach for a large part of the

population, and are feature-heavy with complex systems, which we believe have hampered adoption and intimidated many users.

The most commonly

used insulin pumps today require extensive training and hours of daily management.

The average pump user must go through 42 steps of setup

and refill process every 72 hours to “stay on track.” Our product only requires nine steps for setup and refill every 72 hours.

pumps have been shown to provide a higher level of care for insulin-dependent people with diabetes and result in better glycemic control,

fewer comorbidities, fewer trips to the emergency room, and higher overall quality of life.

They also result in lower overall costs to

the healthcare system, reducing typical expense per patient year from approximately $27,000 to $17,000.

these benefits, only 1 in 3 (33%) of the 1.8 million Americans with T1D and very few of the 1.6 million T2D intensively treated with

insulin currently use an insulin pump, for a total of approximately 670,000 current users, with only a slow increase of insulin pump

The remaining 68% of individuals with T1D and virtually all with T2D rely on MDI therapy for glucose control.

Decades of advances

in technology advances have left these non-pumpers at a significant disadvantage from a control perspective versus their “pumping”

counterparts.

have identified a large segment of the market that we refer to as “Almost Pumpers.” Almost Pumpers are those insulin-requiring

people with diabetes (T1D or T2D) who feel that they would adopt the pump if it were less expensive, less time consuming, less technically

intimidating, and if there was no separate controller.

We believe that they represent approximately 32% of the T1D market correlating

to a $1.9 billion market opportunity.

pumps on the market today require a substantial amount of time to manage the therapy, have high out-of-pocket costs that place these

technologies out of reach for a large part of the population, and are feature-heavy with complex systems, which we believe have hampered

adoption and intimidated many users.

The most commonly used insulin pumps today require extensive training and hours of daily management.

The average pump user must go through 42 steps of setup and refill process every 72 hours to “stay on track.” Our product

only requires nine steps for setup and refill every 72 hours.

The current reluctance to adopt the insulin pump

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In the United States, people living with T1D have struggled to attain glycemic

A 2019 analysis of the large T1D Exchange clinical registry found that only 21% of U.S.

adults with T1D achieved the ADA A1c

goal (<7.0%).

According to the American Diabetes Association, only 23% of U.S.

adults and 17% of children with T1D achieved the ADA A1c goal

Further, according to a study published in JAMA Internal Medicine, researchers found no significant improvements in diabetes

care between 2005 and 2016, with persistent gaps in care related to socioeconomic status.

Another transition in the care of diabetes is

the measuring of glucose from finger-stick tests to continuous glucose monitoring, or CGM, sensors, which are wearable devices.

sensors are placed under the skin and give a reading every five minutes of the user’s glucose level.

While Dexcom has been a market

leader in this field, the introduction and rapid adoption of the Freestyle Libre by Abbott Labs has made CGM easier and more affordable,

expanded the product category, and doubled the market size.

The Freestyle Libre product is a more affordable, easier to use and smaller

version of the popular Dexcom, Inc.

Another transition in the care of diabetes is the measuring of glucose

from finger-stick tests to continuous glucose monitoring, or CGM, sensors, which are wearable devices.

These sensors are placed under

the skin and give a reading every five minutes of the user’s glucose level.

While Dexcom has been a market leader in this field,

the introduction and rapid adoption of the Freestyle Libre by Abbott Labs has made CGM easier and more affordable, expanded the product

category, and doubled the market size.

The Freestyle Libre product is a more affordable, easier to use and smaller version of the popular

(Dexcom) CGM product.

Now, for the first time, there is an easy, less painful, i.e., no more finger

sticks, way for patients to have the data they need to understand more about their glucose levels and their insulin requirements.

to such data has motivated patients to ask their diabetes clinician how they can achieve better glycemic control and made them more comfortable

with using technology and wearables to treat their diabetes.

Now, for the first time, there is an easy, less painful, i.e., no more finger sticks, way for patients

to have the data they need to understand more about their glucose levels and their insulin requirements.

Access to such data has motivated

patients to ask their diabetes clinician how they can achieve better glycemic control and made them more comfortable with using technology

and wearables to treat their diabetes.

Pumps offer a clear pathway to better control and better overall care.

believe that the insulin pump market is ready for a similar transition as that experienced in the CGM space.

Our MODD1 pump represents

a new and better offering to assist and induce a wide variety of patients to make the transition and overcome the objections to superior

control by becoming a “pumper.”

We believe that the insulin

pump market is ready for a similar transition as that experienced in the CGM space.

We believe our Pivot pump represents a new and better

offering, which can assist and induce a wide variety of patients to make the transition and overcome the objections to superior control

by becoming a “pumper.”

We believe the present pump marketplace is approximately

a $1.9 billion market, comprising 33% of T1D pumpers and a small group of T2D pumpers.

Seagrove surveyed clinicians, and, in its 2021

report, estimated that 28% of T1D patients and 25% of T2D patients would adopt technology that was easier to use, learn and access and

eligible for insurance reimbursement.

We believe this represents a total addressable market of approximately $3 billion for us, assuming

Seagrove surveyed clinicians, and, in a 2021 report,

estimated that 28% of T1D patients and 25% of T2D patients would adopt technology that was easier to use, learn and access and eligible

for insurance reimbursement.

We believe this represents a total addressable market of approximately $3 billion for us, assuming prescription

cartridge revenue of approximately $4,100 per patient, per year.

We are dedicated to helping all people with diabetes

gain access to high quality care.

We aim to help people with diabetes - especially Almost Pumpers and the historically underserved communities

- gain access to insulin pump technology by making it affordable and easy to use.

Diabetes Care is at an Inflection Point

We believe that the insulin pump market stands

at a crossroads as a confluence of events makes the timing for a new product introduction ideal.

At the same time, reimbursement for patch pumps

has been increasingly moving to a pharmacy benefits manager (PBM) model, which simplifies reimbursement and will further aid in a “frictionless

launch.” This represents a fundamental shift in the insulin pump market, making onboarding rapid and simplifying a previously complex

and time-consuming “insurance journey.”

We believe these CGM device users are increasingly

interested in adopting technology and wearables to manage their diabetes.

We believe CGM device users are a natural market for a new type

of pump, if it can meet their needs and address their objections and that the conjunction of the above trends represents a unique opportunity

in the insulin pump market’s history.

The CGM device provides glucose-level data, and, as necessary, the user can respond to address

any issues with a simple button push on a pump to deliver their insulin versus taking out a syringe and injecting glucose.

Diabetes technology companies understand that

we are at a turning point with new markets (T2D, T1D that are currently not using technologies).

This can be seen with increased discussion

around this topic during recent national diabetes conferences, as well as an increase in marketing promotion.

All these recent changes support the high proportion

of T1D and T2D intensively treated with insulin that we consider to be Almost Pumpers, and we expect the number of Almost Pumpers to grow

in the coming years and be more reachable with appropriate marketing strategies.

Our Insulin Pump

Instead of building complex, bespoke, and difficult to manufacture

and maintain pumping and control systems, we began with the technology and the user in mind.

Using proprietary methods of insulin measurement,

we were able to eschew complex mechanisms and instead built a product, our MODD1, using only parts from high volume consumer electronics

manufacturing lines, breaking the cost vs functionality curve that has existed in the insulin pump space and representing the first truly

modern insulin pump design.

We consider this to be a new kind of product for a new kind of patient.

In September 2024, we received clearance from

the FDA to market and sell our MODD1 product in the United States.

We plan to launch this pump in a single region during the quarter ending

September 30, 2025.

We expect to submit our successor product, our Pivot pump, which is a tubeless pump product, for clearance by October

A good part of our focus has shifted to managing the process of preparing to move our initial production line to our manufacturing

partner, Phillips Medisize, a Molex company, a large tier-one medical device manufacturer, which will manage and operate our production

to produce products for human use.

We believe that Phillips Medisize will be able to rapidly scale our production to higher volumes at

We continue to devote substantial time and resources, including exhibiting at major diabetes conferences, to better understand

the needs and preferences of Almost Pumpers and the specific patient/provider/payor requirements to motivate change from MDI therapy.

are dedicated to helping all people with diabetes gain access to high quality care.

We aim to help people with diabetes — especially

Almost Pumpers and the historically underserved communities — gain access to insulin pump technology by making it affordable and

Care is at an Inflection Point

believe that the insulin pump market stands at a crossroads as a confluence of events makes the timing for a new product introduction

the same time, reimbursement for patch pumps has been increasingly moving to a pharmacy benefits manager (PBM) model, which simplifies

reimbursement and will further aid in a “frictionless launch.” This represents a fundamental shift in the insulin pump market,

making onboarding rapid and simplifying a previously complex and time-consuming “insurance journey.”

believe these CGM device users are increasingly interested in adopting technology and wearables to manage their diabetes.

CGM device users are a natural market for a new type of pump, if it can meet their needs and address their objections and that the conjunction

of the above trends represents a unique opportunity in the insulin pump market’s history.

The CGM device provides glucose-level

data, and, as necessary, the user can respond to address any issues with a simple button push on a pump to deliver their insulin versus

taking out a syringe and injecting glucose.

technology companies understand that we are at a turning point with new markets (T2D, T1D that are currently not using technologies).

This can be seen with increased discussion around this topic during recent national diabetes conferences, as well as an increase in marketing

these recent changes support the high proportion of T1D and T2D intensively treated with insulin that we consider to be Almost Pumpers,

and we expect the number of Almost Pumpers to grow in the coming years and be more reachable with appropriate marketing strategies.

of building complex, bespoke, and difficult to manufacture and maintain pumping and control systems, we began with the technology and

the user in mind.

Using proprietary methods of insulin measurement, we were able to eschew complex mechanisms and instead built a product,

our MODD1, using only parts from high volume consumer electronics manufacturing lines, breaking the cost vs functionality curve that

has existed in the insulin pump space and representing the first truly modern insulin pump design.

We consider this to be a new kind

of product for a new kind of patient.

In September 2024, we received clearance from the FDA to market and

sell our MODD1 product in the United States, and, in August 2025, we demonstrated the first human use of our MODD1 pump delivering insulin

to a human patient.

We announced our next-generation patch pump, branded as Pivot, in August 2025, and we began converting our cartridge

manufacturing line to Pivot production.

Our Pivot product is a tubeless insulin delivery system that integrates the set into a true tubeless

The Pivot is expected to provide us with cost and usability improvements and improved manufacturability, allowing our marketing

to be focused on low cost, ease of use and learnability.

In April 2026, we received FDA clearance to market and sell our Pivot pump in

the United States.

We do not intend to commercialize our MODD1 product.

In June 2026, we announced commercial availability of, and commenced

initial shipments of, our Pivot insulin delivery system in the United States, and we intend to expand commercial activities across metropolitan

markets by late 2026.

have established our initial production line with our manufacturing partner, Phillips Medisize, a Molex company, a large tier-one medical

device manufacturer, which will manage and operate our production for human use.

We believe that Phillips Medisize will be able to rapidly

scale our production to higher volumes at lower cost.

We continue to devote substantial time and resources, including exhibiting at major

diabetes conferences, to better understand the needs and preferences of Almost Pumpers and the specific patient/provider/payor requirements

to motivate change from MDI therapy.

By making the bolus delivery at meals simple, we believe we will drive improved health outcomes.

Our Pivot product has several distinguishing features:

(1) The pump has a simple button to press to deliver insulin as the patient

The electronic pump uses a simple motor for rotating a cam to motivate the insulin into the patient along with low power

Bluetooth and near-field communication (NFC) chips to optionally allow the patient to communicate with a smart phone, tablet, or other

mobile computing device.

(2) The pump snaps together with a three-day disposable cartridge, which

the patient fills with insulin for delivery.

It includes a simple coin cell, which allows it to run through the 80-hour life of the cartridge.

(3) The infusion set is built into the adhesive pad that the pump attaches

to and the needle can be safely removed and discarded by the user after application.

Despite this true patch form factor, the pump is

removable by the user during the three days of wear.

The system will deliver a small continuous rate called a basal that

will provide approximately 50% of the total daily dose required, and the user will use the on-pump button to administer boluses, typically

before and after meals.

The objective is to make the product simple to acquire and take home, simple to learn and most importantly, simple

to use and live with, to expand the pump market, drive adoption and, ultimately, improve clinical outcomes.

Technological Advantages

The adoption of new ultra-high volume technologies will result in far

easier manufacturing scale up, as parts sourcing and assembly processes are far easier.

The MODD1 was designed from the beginning for

mass manufacturing, and we have partnered with a tier-one medical device manufacturer, Phillips Medisize, to establish processes and “lights

out” or near lights out production assembly lines whereby a minimal number of workers will be required in the production facility.

This advantage is compounded by the high availability and already optimized cost reduction in its components.

When we achieve production

scale, we believe this should result in a cost of goods for MODD1, estimated on the competitors’ announced margins and sales, of

approximately 50% lower than our closest patch pump competitor.

The adoption of modern, miniaturized technologies

has led to numerous other advantages, as well.

For example, our MODD1 pump is smaller in overall volume than Insulet’s popular Omnipod

product and has a lower profile to the skin.

Despite this, the MODD1 holds a full 3 milliliter, or mL, (300 units) of insulin, in line

with full sized pumps such as those offered by Tandem and Medtronic, 50% more than the 2mL reservoir in the Omnipod.

We believe that this

volume advantage over other patch pumps will be significant as 24% of type 1 and over 50% of the rapidly growing type 2 market require

more than 2mL of insulin every three days (the expected wear time of patch pumps).

In addition, our new pumping modality will provide

what we believe is the most even (and thus closest to the function of a healthy pancreas) delivery of basal insulin in the industry.

intend to demonstrate the impact of our system on glycemic control in a clinical study specifically focused on improved adherence, more

bolus deliveries per day and providing the clinicians with clear data on patient use.

The technology allows the patient to simply add

insulin and operate.

The battery is included in each cartridge, and the device is operated without a controller.

As a result, no charging

MODD1 has also been made push-button simple to deliver insulin to appeal to a wider audience of users.

This new technology has made the MODD1 lighter

than existing offerings.

Compared to the Insulet Omnipod, MODD1 weighs 20 grams (vs.

Pivot product has several distinguishing features:

pump has a simple button to press to deliver insulin as the patient requires it.

The electronic pump uses a simple motor for rotating

a cam to motivate the insulin into the patient along with low power Bluetooth and near-field communication (NFC) chips to optionally

allow the patient to communicate with a smart phone, tablet, or other mobile computing device.

pump snaps together with a three-day disposable cartridge, which the patient fills with insulin for delivery.

It includes a simple coin

cell, which allows it to run through the 80-hour life of the cartridge.

infusion set is built into the adhesive pad that the pump attaches to and the needle can be safely removed and discarded by the user

after application.

Despite this true patch form factor, the pump is removable by the user during the three days of wear.

system will deliver a small continuous rate called a basal that will provide approximately 50% of the total daily dose required, and

the user will use the on-pump button to administer boluses, typically before and after meals.

The objective is to make the product simple

to acquire and take home, simple to learn and most importantly, simple to use and live with, to expand the pump market, drive adoption

and, ultimately, improve clinical outcomes.

Technological

The adoption of new ultra-high volume manufacturing technologies will

result in far easier production scale up, as parts sourcing and assembly processes are far easier.

Our pump products have been designed

from the beginning for mass manufacturing, and we have partnered with Phillips Medisize to establish processes and “lights out”

or near lights out production assembly lines whereby a minimal number of workers will be required in the production facility.

This advantage

is compounded by the high availability and already optimized cost reduction in its components.

When we achieve production scale, we believe

this should result in a cost of goods for our Pivot pump, estimated on the competitors’ announced margins and sales, of approximately

50% lower than our closest patch pump competitor.

The adoption of modern, miniaturized technologies has led to numerous

other advantages, as well.

For example, our Pivot pump is smaller in overall volume than Insulet’s popular Omnipod product and has

a lower profile to the skin.

Despite this, our Pivot pump holds a full 3 milliliter, or mL, (300 units) of insulin, in line with full

sized pumps such as those offered by Tandem and Medtronic, 50% more than the 2 mL reservoir in the Omnipod.

We believe that this volume

advantage over other patch pumps will be significant as 24% of type 1 and over 50% of the rapidly growing Type 2 market require more than

2mL of insulin every three days (the expected wear time of patch pumps).

addition, our new pumping modality will provide what we believe is the most even (and thus closest to the function of a healthy pancreas)

delivery of basal insulin in the industry.

We intend to demonstrate the impact of our system on glycemic control in a clinical study

specifically focused on improved adherence, more bolus deliveries per day and providing the clinicians with clear data on patient use.

technology allows the patient to simply add insulin and operate.

The battery is included in each cartridge, and the device is operated

without a controller.

As a result, no charging is required.

The Pivot pump has also been made push-button simple to deliver insulin to

appeal to a wider audience of users.

This new technology has made our Pivot pump lighter than existing offerings.

Compared to the Insulet Omnipod, our Pivot pump weighs 20 grams (vs.

26 grams) empty and 23 grams (vs.

28 grams) fully

filled (despite carrying 50% more insulin), reductions of 23% and 18%, respectively.

Also, unlike existing patch pumps, the MODD1 can

be removed from the needle and taken off and replaced later if the user desires.

This avoids loss of insulin in a pump due to accidental

dislodging of the soft canula, an issue for other patch pumps with which users have expressed considerable dissatisfaction.

Our approach to the care of diabetes can be further

enhanced by leveraging the MODD1 single-pumping chamber technology and reusable pump approach to apply to dual (or more) chamber pumping

We believe that such multi-chamber pumps will be integral to the realization of high time-in-range artificial pancreas solutions

that require no human intervention because of the application of, for instance, drugs to raise glucose levels coupled with drugs to lower

They will be the next step forward from the cumbersome and awkward solutions today that require the user to announce meals, count

and input carbohydrates, and adjust delivery for exercise and sleep to prevent overdosing of insulin.

Instead, if a user overdosed insulin,

the user would simply pump in a drug to release sugar stores to raise it up.

We believe that a pre-filled peel and stick patch pump with

the ability to function in a fully autonomous closed loop system with a CGM device, which is measuring and transmitting glucose-level

information, represents the next generation of diabetes care.

We believe that we have demonstrated our technology and have secured, and

will continue securing, intellectual property protection on our approach.

We believe this technology, especially applied

in a dual chamber capacity, will open up numerous applications outside of diabetes where medication compliance of complex therapy regimes

is difficult.

Example applications would include weight loss, fertility, and simplifying the delivery of complex multi-drug cocktails,

especially those with diverse and challenging dosing schedules.

Our proposed pump has been designed and developed

to address the aforementioned shortcomings of the existing pump market and to appeal to:

(i) the substantial group of Almost-Pumpers,

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

products and (ii) people who are using one of the currently available insulin pumps but are dissatisfied with such products.

that, owing to our new proprietary technology, our proposed insulin pump will be the simplest and least expensive product on the market

and the easiest for providers to prescribe.

Our current 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 MODD 1 pump will offer the vast majority of benefits afforded by more

expensive and complex pumps, but it will remain accessible to a substantially greater percentage of diabetes sufferers requiring daily

insulin therapy.

We believe people generally will not use technology

that intimidates them, especially for a life-sustaining therapy.

In addition, we believe that physicians are hesitant to prescribe such

technology due to the level of training and support required with the present pump product offerings.

It is our belief that broadly-needed

medical products, such as is intended with our proposed pump, must be user-friendly and affordable.

We believe this approach is fundamentally

different from that applied to the existing pump market today, where most pumps are continuously adding complex features appealing to

super users and leaving the other people with diabetes further behind.

Our current goal is to commercialize our MODD1pump product and successfully

obtain all required regulatory approvals for our Pivot pump 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:

● Use of innovative proprietary

Based on the substantial experience

of Paul DiPerna, our President, Chief Financial Officer, Treasurer and Chairman of our board of directors, in engineering design and innovative

technology in the medical device industry and, in particular, with the invention, market vision and technical development of insulin pumps,

we have generated proprietary technology that has been incorporated into our proposed insulin pump.

We believe this technology allowing

for a two-part, yet small enough to wear, pump product, along with simplified mechanics for pumping, has greatly assisted us in creating

a simpler, user-friendly pump.

We believe the completed design, engineering and technology being incorporated into our pump will make

it 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 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.

Use of go-to market commercialization technology.

We plan to commercialize our MODD1 product line

using a highly differentiated go-to-market strategy.

Generally, current pumps are marketed by a large, direct sales force to end users

directly, and the manufacturer provides all training and support, as the current training reimbursement offered by insurance providers

is inadequate to motivate clinicians to provide such training to patients.

We intend to employ a different strategy and utilize i) distributors

to target the daily insulin users who are still managed by a primary care physician and ii) a small direct sales force to directly engage

with diabetes educator practices.

Specifically, our direct sales force will engage with larger diabetes educator practices, which currently

prescribe a high volume of pumps and deliver a consultative message focused on those users that indicate a desire to use a pump but have

rejected all of the currently available options.

We engaged Seagrove to conduct a survey of physicians and diabetes educators, and the

resulting data suggested that approximately 25% of multiple daily injectors could be receptive to our offering.

We believe that the modest

30-minute training requirement for our product, combined with the more limited feature set for our MODD1, will incentivize nurse practitioners

to identify and train new users who have not been offered pumps before.

This would also allow us to offer virtual or second level training

support and not require us to be the primary training provider.

We plan to launch our MODD1 product during the

quarter ending September 30, 2025 in a single region in the United States with a select group of providers to gain user experience.

October 31, 2025, we plan to submit a 510(k) premarket notification to the FDA for a new and improved version of the MODD1, the Pivot,

which will use our proprietary, integrated insulin-delivery set manufactured by us.

We believe the new integrated insulin-delivery set

will offer improved user experience, while reducing our production costs.

This new version of our product, the Pivot, is the version that

we plan to launch nationally in the United States after we receive FDA clearance, which we expect could occur sometime in the first quarter

We have also begun the process of obtaining Conformite

Europeenne , or CE, mark clearance for our Pivot design, which would allow us to market and sell in European markets.

obtain CE mark clearance in the first quarter of 2026.

28 grams) fully filled (despite

carrying 50% more insulin), reductions of 23% and 18%, respectively.

Also, unlike existing patch pumps, our Pivot pump can be removed

from the needle and taken off and replaced later if the user desires.

This avoids loss of insulin in a pump due to accidental dislodging

of the soft canula, an issue for other patch pumps with which users have expressed considerable dissatisfaction.

approach to the care of diabetes can be further enhanced by leveraging our single-pumping chamber technology and reusable pump approach

to apply to dual (or more) chamber pumping solutions.

We believe that such multi-chamber pumps will be integral to the realization of

high time-in-range artificial pancreas solutions that require no human intervention because of the application of, for instance, drugs

to raise glucose levels coupled with drugs to lower glucose.

They will be the next step forward from the cumbersome and awkward solutions

today that require the user to announce meals, count and input carbohydrates, and adjust delivery for exercise and sleep to prevent overdosing

Instead, if a user overdosed insulin, the user would simply pump in a drug to release sugar stores to raise it up.

that a pre-filled peel and stick patch pump with the ability to function in a fully autonomous closed loop system with a CGM device,

which is measuring and transmitting glucose-level information, represents the next generation of diabetes care.

We believe that we have

demonstrated our technology and have secured, and will continue securing, intellectual property protection on our approach.

believe this technology, especially applied in a dual chamber capacity, will open up numerous applications outside of diabetes where

medication compliance of complex therapy regimes is difficult.

Example applications would include weight loss, fertility, and simplifying

the delivery of complex multi-drug cocktails, especially those with diverse and challenging dosing schedules.

Our Pivot pump has been designed and developed to address the aforementioned

shortcomings of the existing pump market and to appeal to:

(i) the substantial group of Almost-Pumpers, who may be interested in using

an insulin pump, but have not done so because of the complexity, cost or cumbersome nature of existing products and (ii) people who are

using one of the currently available insulin pumps but are dissatisfied with such products.

We believe that, owing to our new proprietary

technology, our Pivot pump is the simplest and least expensive product on the market and the easiest for providers to prescribe.

current 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 Pivot pump will

offer the vast majority of benefits afforded by more expensive and complex pumps, but it will remain accessible to a substantially greater

percentage of diabetes sufferers requiring daily insulin therapy.

We believe people generally will not use technology that intimidates

them, especially for a life-sustaining therapy.

In addition, we believe that physicians are hesitant to prescribe such technology due

to the level of training and support required with the present pump product offerings.

It is our belief that broadly-needed medical products,

such as our Pivot pump, must be user-friendly and affordable.

We believe this approach is fundamentally different from that applied to

the existing pump market today, where most pumps are continuously adding complex features appealing to super users and leaving the other

people with diabetes further behind.

Our current goal is to expand commercialization of our Pivot pump product

across metropolitan markets in the United States and obtain all required regulatory approvals to offer the product for sale in multiple

international markets.

long-term goal is to become a leading provider of insulin pump therapy by focusing on both consumer and clinical needs.

achieve our above stated immediate and current goals, we intend to pursue the following business strategies:

of innovative proprietary technology.

Based on the substantial experience of Paul DiPerna, our President,

Chief Financial Officer, Treasurer and Chairman of our board of directors, in engineering design and innovative technology in the medical

device industry and, in particular, with the invention, market vision and technical development of insulin pumps, we have generated proprietary

technology that has been incorporated into our Pivot insulin pump.

We believe this technology allowing for a two-part, yet small enough

to wear, pump product, along with simplified mechanics for pumping, has greatly assisted us in creating a simpler, user-friendly pump.

We believe the completed design, engineering and technology being incorporated into our pump will make it substantially simpler and more

affordable than those currently available.

These features, together with the safety and reliability of our Pivot 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.

of go-to market commercialization technology.

plan to commercialize our Pivot product line using a highly differentiated go-to-market strategy.

Generally, current pumps are marketed

by a large, direct sales force to end users directly, and the manufacturer provides all training and support, as the current training

reimbursement offered by insurance providers is inadequate to motivate clinicians to provide such training to patients.

employ a different strategy and utilize i) distributors to target the daily insulin users who are still managed by a primary care physician

and ii) a small direct sales force to directly engage with diabetes educator practices.

Specifically, our direct sales force will engage

with larger diabetes educator practices, which currently prescribe a high volume of pumps and deliver a consultative message focused

on those users that indicate a desire to use a pump but have rejected all of the currently available options.

We engaged Seagrove to

conduct a survey of physicians and diabetes educators, and the resulting data suggested that approximately 25% of multiple daily injectors

could be receptive to our offering.

We believe that the modest 30-minute training requirement for our product, combined with the more

limited feature set for our Pivot pump, will incentivize nurse practitioners to identify and train new users who have not been offered

pumps before.

This would also allow us to offer virtual or second level training support and not require us to be the primary training

In addition, in June 2026, we launched PivotPump.com, a patient-focused website designed to support individuals seeking a simpler

path to insulin pump therapy.

The PivotPump.com website provides accessible, educational content on insulin pump therapy and highlights

our focus on real-world usability and supporting patients in evaluating and adopting pump-based diabetes care.

In June 2026, we announced commercial availability of our Pivot product

in the United States and commenced initial patient shipments.

We intend to expand commercial activities across metropolitan markets by

We have also begun the process of obtaining Conformite Europeenne ,

or CE, mark clearance for our Pivot product, which would allow us to market and sell in European and certain other international markets.

We expect to obtain clearance by the second quarter of 2027.

Our initial strategy to address European markets is to partner with distributors

to bring the Pivot to market in those countries that accept the CE mark and have acceptable reimbursement.

We believe that the combination

of our patch pump form factor, lower cost at scale and lower training burden is well suited for European markets where there are very

few physicians or nurses available to provide training.

This would allow the Pivot to gain rapid adoption in areas where pump penetration

is currently much lower than in the United States.

We will target other select international markets using the same approach.

We believe the combination of these differentiated

approaches will enable us to take reasonable initial market share, while not incurring the significant overhead cost of existing commercialization

strategies employed by the incumbents, where competition for users is intense.

During fiscal 2026, we hired

a head of international operations in Switzerland, who has significant experience in launching competitive insulin pump systems in Europe.

We believe that the combination of our patch pump form factor, lower cost at scale and lower training burden is well suited for European

markets where there are very few physicians or nurses available to provide training.

This would allow the Pivot to gain rapid adoption

in areas where pump penetration is currently much lower than in the United States.

We will target other select international markets using

the same approach.

believe the combination of these differentiated approaches will enable us to take reasonable initial market share, while not incurring

the significant overhead cost of existing commercialization strategies employed by the incumbents, where competition for users is intense.

Manufacturing

Our pump product comprises the pump, a disposable

cartridge that holds the insulin reservoir, a baseplate that affixes the pump product to the user’s body and the infusion set, which

includes a cannula to infuse the insulin into the body.

We intend to manufacture the pump, the cartridge and the baseplate and purchase

the infusion set from third parties.

Prior to shipment, our pump product will be packaged with an infusion set.

pump product comprises the pump, a disposable cartridge that holds the insulin reservoir, a baseplate that affixes the pump product to

the user’s body and the infusion set, which includes a cannula to infuse the insulin into the body.

We intend to manufacture the

pump, the cartridge and the baseplate and purchase the infusion set from third parties.

Prior to shipment, our pump product will be packaged

with an infusion set.

In connection therewith:

● We have installed automation machines in our facility that will be

capable of assembling the cartridges at a rate sufficient to supply 6,000 patients (60,000 cartridges per month), and we plan to have

this capacity moved to the Pivot product in 2026.

We also have ordered production molding for more than three

times this number of users, so we can quickly scale up with demand.

● Product packaging will initially

be performed manually by our personnel, while the cartridge automation is being refined.

We expect to purchase and implement packaging

automation equipment as the second phase of automation of the cartridge.

We have engaged Phillips Medisize as our manufacturing

partner, and we are in the final stages of validating our manufacturing at Phillips Medisize’s facilities.

Once the validation is

complete, Phillips Medisize will then perform all manufacturing operations to ensure compliance with FDA regulations.

FDA Clearance

The FDA requires us to meet all applicable regulations

for insulin pumps, a subcategory of infusion pumps, which are generally considered Class II devices by the FDA.

In January 2024, we submitted

a 510(k) premarket notification to the FDA for our initial insulin pump product, the MODD1, and, in September 2024, we received FDA clearance

to market and sell our MODD1 pump in the United States.

We plan to submit our Pivot successor product to the FDA by October 31, 2025,

and we expect to receive FDA clearance by March 31, 2026.

Commercialization Steps

To commercialize our product, we must successfully

complete a number of material steps, including:

● Continue to ensure it

o FDA requirements for 510(k)

clearance, including taking such actions, if any, as may be required by the FDA as a condition to granting approval and providing 510(k)

clearance for our insulin pump;

o the general needs and preferences

of our Almost-Pumper target market based on our knowledge of the diabetes industry, information gathered from our soft launch and other

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 administers

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 products and product candidates satisfy the existing coverage and reimbursement criteria of

such third-party payors.

● Transfer our manufacturing

equipment and process to Phillips Medisize prior to product launch;

● 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.

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:

● Obtaining FDA 510(k) clearance

to market and sell our insulin pump to the public;

● Obtaining any other FDA-required

authorizations with regard to our product, as required by the Federal Food, Drug, and Cosmetic Act, or FDCA, which is administered

have installed automation machines in our facility that will be capable of assembling the cartridges at a rate sufficient to supply 6,000

patients (60,000 cartridges per month), and we plan to have this capacity moved to the Pivot product in 2026.

We also have ordered production

molding for more than three times this number of users, so we can quickly scale up with demand.

packaging will initially be performed manually by our personnel, while the cartridge automation is being refined.

We expect to purchase

and implement packaging automation equipment as the second phase of automation of the cartridge.

Medisize, our manufacturing partner, performs all manufacturing operations to ensure compliance with FDA regulations.

FDA requires us to meet all applicable regulations for insulin pumps, a subcategory of infusion pumps, which are generally considered

Class II devices by the FDA.

As discussed above, we have obtained the required FDA clearance for our MODD1 and Pivot insulin pump products.

Commercialization

commercialize our product, we must successfully complete a number of material steps, including:

to ensure it meets:

requirements for 510(k) clearance, including taking such actions, if any, as may be required by the FDA as a condition to granting approval

and providing 510(k) clearance for our insulin pump;

general needs and preferences of our Almost-Pumper target market based on our knowledge of the diabetes industry, information gathered

from our soft launch and other information available and/or obtained by us from Almost Pumpers and their caregivers;

● 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 administers 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 products and product candidates

satisfy the existing coverage and reimbursement criteria of third-party payors.

our manufacturing equipment and process to Phillips Medisize prior to product launch;

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.

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:

any other FDA-required authorizations, in addition to FDA 510(K) clearance, with regard to our product, as required by the Federal Food,

Drug, and Cosmetic Act, or FDCA, which is administered by the FDA;

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

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qualities of our products.

We expect to continue to exhibit at the Association of Diabetes Care & Education Specialists, or

ADCES, conference annually;

We attend and exhibit at multiple diabetes industry conferences and trade shows;

● Demonstrating

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ease of use and convenience;

● Ensuring that our products do, in fact, meet the needs of Almost Pumpers;

● Overcoming the historic obstacles

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 products.

Looking Forward

Going forward, we expect to continue to evolve our MODD1 pump and its

capabilities and functionality both in response to patient needs and as part of our current platform roadmap.

● With future Pivot products,

we intend to seek to add phone-based control and Alternative Controller Enabled (“ACE”) and Automated Insulin Deliver (“AID”)

capability to allow integration with popular continuous glucose monitors.

We believe this will expand our available market to include

many existing pumpers.

The new model has the same modular design and low-cost components as MODD1 and provides a much desired breakthrough

for patients - two-factor command authentication that allows the wearer to use an application on his/her cell phone as the controller.

● AID-control functionality is being developed and will be added via

an ACE designation on the pump.

● Any approved AID controller

can drive insulin delivery in “auto” mode, when appropriate.

● CGM integration allows the

controller to potentially adjust basal insulin rate for meals and exercise with an approved algorithm.

● With our future Pivot product, we will seek to move to a full-featured,

multi-chamber pump optimized for high time-in-range fully autonomous close loop insulin delivery utilizing the form factor and cost advantages

of its pumping designs to create an affordable, easy to use drug delivery system to realize the aspiration of true “artificial pancreas”

We envision moving to a drug prefill model, such that cartridges can be filled with insulin or other drugs and shipped cold chain

to patients, further simplifying the use process.

Today, in the United States, only three companies

are commercializing insulin pumps to T1D patients and insulin treated T2D patients and have significant market share:

● Medtronic - commercializes

the durable Minimed 770G and also offers older durable pumps (670G, 630G etc.).

In 2020, they held approximately 51% of the US insulin

● Tandem - commercializes the

durable t:slim X2 pump (with or without algorithms - Basal-IQ and Control-IQ).

that our products do, in fact, meet the needs of Almost Pumpers;

the historic obstacles and reluctance of Almost Pumpers to using insulin pumps to treat their diabetes;

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 products.

forward, we expect to continue to evolve our Pivot pump and its capabilities and functionality both in response to patient needs and

as part of our current platform roadmap.

future Pivot products, we intend to seek to add phone-based control and Alternative Controller Enabled (“ACE”) and Automated

Insulin Deliver (“AID”) capability to allow integration with popular continuous glucose monitors.

We believe this will expand

our available market to include many existing pumpers.

The new model has the same modular design and low-cost components as MODD1 and

provides a much desired breakthrough for patients — two-factor command authentication that allows the wearer to use an application

on his/her cell phone as the controller.

● AID-control

functionality is being developed and will be added via an ACE designation on the pump.

approved AID controller can drive insulin delivery in “auto” mode, when appropriate.

integration allows the controller to potentially adjust basal insulin rate for meals and exercise with an approved algorithm.

our future Pivot product, we will seek to move to a full-featured, multi-chamber pump optimized for high time-in-range fully autonomous

close loop insulin delivery utilizing the form factor and cost advantages of its pumping designs to create an affordable, easy to use

drug delivery system to realize the aspiration of true “artificial pancreas” systems.

We envision moving to a drug prefill

model, such that cartridges can be filled with insulin or other drugs and shipped cold chain to patients, further simplifying the use

Today, in the United States, five companies are commercializing insulin

pumps to T1D patients and insulin treated T2D patients and only three have significant market share:

● Insulet — commercializes a disposable patch pump, which held approximately 43% of the US market in 2026.

● Tandem — commercializes a durable pump available with or without automated dosing algorithms.

In 2026, they held approximately 34% of the US insulin

● Insulet - commercializes the

disposable Omnipod patch pump with approximately 19% of the US market in 2020.

Medtronic pump and infusion set

Tandem pump and infusion set

These three insulin pump offerings are vying for the attention of the

most motivated and well insured in hope of converting them away from their reliance on MDI.

We believe the t:slim X2 and Minimed 770G

pump products each receive in excess of $4,000 through durable medical equipment (DME) and daily consumable insurance coverage reimbursements.

Daily consumable reimbursement would also cover on an ongoing basis cartridge, tubing and sets for each three-day period, as well.

products have controllers integrated into the pump, making them cumbersome and bulky, along with long (greater than 20 inch) tubing between

the pump and the cannular site.

The Omnipod is the third offering;

a patch pump that attaches to your body for 72 hours and uses a separate

controller to manage the insulin delivery process.

Insurance coverage for Omnipod can be provided via DME but also via Pharmacy Benefit

The Omnipod patch pump is more expensive per day and less accurate than other insulin pumps, according to a Mende 2022 study.

33% of people living with T1D are currently using insulin pumps;

of these, the vast majority are using one of these three offerings, a

statistic that has not changed significantly over the last five years.

● Minimed — commercializes a durable insulin delivery pump and continues to offer a range of older durable pumps.

In 2026, they held approximately

21% of the US insulin pump market.

These three insulin pump offerings are vying for

the attention of the most motivated and well insured in hope of converting them away from their reliance on MDI.

We believe the each of

the two leading durable pump products receive in excess of $4,000 through durable medical equipment (DME) and daily consumable insurance

coverage reimbursements.

Daily consumable reimbursement would also cover on an ongoing basis cartridge, tubing and sets for each three-day

period, as well.

These products have controllers integrated into the pump, making them cumbersome and bulky, along with long (greater

than 20 inch) tubing between the pump and the cannular site.

The third offering is a patch pump that attaches to the body for 72 hours

and uses a separate controller to manage the insulin delivery process.

Insurance coverage for patch pumps of this type can be provided

via DME but is primarily provided through the Pharmacy Benefit (PB).

These patch pumps can be more expensive per day and less accurate

than other insulin pumps, according to a Mende 2022 study.

Around 38% of people living with T1D are currently using insulin pumps;

these, the vast majority are using one of these three offerings, a statistic that has not changed significantly over the last five years.

All of these pump products require extensive training

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with the cost and awkwardness of these products contribute to the limited uptake.

Although there are purely mechanical pumps available

to patients with a small percentage of T2D patients using the Mannkind V-Go patch pump, a fixed basal rate and a button to deliver small

This pump is simple to use, though gives little performance decision to the user (e.g., no possibility to change the basal rate,

no possibility to stop bolus doses, small reservoir, pump that needs to be changed every day, etc.).

The last available patch pump is

provided by Cequr, called Simplicity, a bolus only delivery option without basal delivery or any electronic reporting.

There are purely mechanical pumps available to

patients, and a modest percentage of T2D patients use Mannkind’s mechanical patch pump, which provides a fixed basal rate and a

button to deliver small boluses.

This pump is simple to use, though gives little performance decision to the user (e.g., no possibility

to change the basal rate, no possibility to stop bolus doses, small reservoir, pump that needs to be changed every day, etc.).

Cequr offers another patch pump, providing a bolus only delivery option without basal delivery or any electronic reporting.

Cequr recently

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Beta Bionics, Inc.

launched its I-Let pump in October 2023 and reported approximately

launched its durable pump in October 2023 and reported approximately

35,000 users at the end of 2025.

Deka Research and Development Corp.

received clearance for its Sequel Twist pump in July of 2023, but,

to our knowledge, has not yet made its product available for sale.

Medtronic has launched a new version of its insulin

pump, the Minimed 780G, already available in some European countries with an advanced algorithm, but no obvious change in hardware.

is now selling a small, no display pump called Mobi.

The Mobi has a small 2mL reservoir and is controlled by a separate unit, similar

to the current Omnipod product.

Insulet has also launched the Omnipod 5, a similar patch pump to its current offering, that includes an

AID algorithm.

Approximately 79% of the people who rely upon

MDI therapy choose to not administer a shot outside of their house, which creates a poorly controlled group.

Our pump products are designed

to focus upon a segment of these people and mobilize them via a simple, easy to use, affordable product.

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, 2025, we held five U.S.

and two foreign patents, and we also held 20 pending applications in the United States and abroad.

The patents and patent applications

cover various aspects of our technology, including our proprietary fluid movement technology and associated features of our insulin delivery

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.

Government Regulation

Our operations are subject to comprehensive federal,

state, and local laws and regulations in the jurisdictions in which we or our research and development partners do business.

and regulations governing our business and interpretations of those laws and regulations and are subject to frequent change.

to operate profitably will depend in part upon our ability, and that of our research and development partners and affiliates, to operate

in compliance with applicable laws and regulations.

The laws and regulations relating to medical products and healthcare services that

apply to our business and that of our partners and affiliates continue to evolve, and we must, therefore, devote significant resources

to monitoring developments in legislation, enforcement, and regulation in such areas.

As the applicable laws and regulations change, we

are likely to make conforming modifications in our business processes from time to time.

We cannot provide assurance that a review of

our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations or that

the regulatory environment will not change in a way that restricts our operations.

FDA Regulation

In the United States, medical devices are strictly

regulated by the FDA.

Under the FDCA, a medical device is defined as “an instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar or related article, including a component, part or accessory which is, among other things:

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in

man or other animals;

or intended to affect the structure or any function of the body of man or other animals, and which does not achieve

its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being

metabolized for the achievement of any of its primary intended purposes.” This definition provides a clear distinction between a

medical device and other FDA regulated products such as drugs.

If the primary intended use of a medical product is achieved through chemical

action or by being metabolized by the body, the product is usually a drug or biologic.

(Deka) received clearance for its durable pump in July of 2023.

has launched broadly with a large sales force in the United States, but it has not yet publicly disclosed the number of users.

Minimed’s flagship durable pump is available

in some European countries with an advanced algorithm, but there has not been an obvious change in hardware.

Tandem is now selling a small,

no display pump with a small 2mL reservoir that is controlled by a separate unit, similar in concept to existing patch pump controllers.

Insulet has also launched a new version of its patch pump that includes an AID algorithm and improved low-power Bluetooth.

Approximately

79% of the people who rely upon MDI therapy choose to not administer a shot outside of their house, which creates a poorly controlled

Our pump products are designed to focus upon a segment of these people and mobilize them via a simple, easy to use, affordable

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 June 29, 2026, we held eight U.S.

and six foreign patents, and we have numerous applications pending and in various stages of review by the USPTO and foreign patent agencies.

The patents and patent applications cover various aspects of our technology, including our proprietary fluid movement technology and associated

features of our insulin delivery methodology.

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.

operations are subject to comprehensive federal, state, and local laws and regulations in the jurisdictions in which we or our research

and development partners do business.

The laws and regulations governing our business and interpretations of those laws and regulations

and are subject to frequent change.

Our ability to operate profitably will depend in part upon our ability, and that of our research

and development partners and affiliates, to operate in compliance with applicable laws and regulations.

The laws and regulations relating

to medical products and healthcare services that apply to our business and that of our partners and affiliates continue to evolve, and

we must, therefore, devote significant resources to monitoring developments in legislation, enforcement, and regulation in such areas.

As the applicable laws and regulations change, we are likely to make conforming modifications in our business processes from time to

We cannot provide assurance that a review of our business by courts or regulatory authorities will not result in determinations

that could adversely affect our operations or that the regulatory environment will not change in a way that restricts our operations.

the United States, medical devices are strictly regulated by the FDA.

Under the FDCA, a medical device is defined as “an instrument,

apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part

or accessory which is, among other things:

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,

treatment, or prevention of disease, in man or other animals;

or intended to affect the structure or any function of the body of man

or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other

animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” This definition

provides a clear distinction between a medical device and other FDA regulated products such as drugs.

If the primary intended use of

a medical product is achieved through chemical action or by being metabolized by the body, the product is usually a drug or biologic.

If not, it is generally a medical device.

We have developed an insulin pump delivery system,

which is regulated by the FDA as a medical device under the FDCA, as implemented and enforced by the FDA.

The FDA regulates the development,

testing, manufacturing, labeling, packaging, storage, installation, servicing, advertising, promotion, marketing, distribution, import,

export, and market surveillance of medical devices.

Device Premarket Regulatory Requirements

Before being introduced into the U.S.

each medical device must obtain marketing clearance or approval from the FDA through the premarket notification (or 510(k)) process, the

de novo classification process, or the premarket approval, or PMA, process, unless they are determined to be Class I devices or

to otherwise qualify for an exemption from one of these available forms of premarket review and authorization by the FDA.

Under the FDCA,

medical devices are classified into one of three classes - Class I, Class II or Class III - depending on the degree of risk associated

with each medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness.

Classification

of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA

review required prior to marketing the device.

Class I devices are those for which reasonable assurance of safety and effectiveness can

be maintained through adherence to general controls which include compliance with the applicable portions of the FDA’s Quality System

Regulation (the “QSR”), as well as regulations requiring facility registration and product listing, reporting of adverse medical

events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

have developed an insulin pump delivery system, which is regulated by the FDA as a medical device under the FDCA, as implemented and

enforced by the FDA.

The FDA regulates the development, testing, manufacturing, labeling, packaging, storage, installation, servicing,

advertising, promotion, marketing, distribution, import, export, and market surveillance of medical devices.

Premarket Regulatory Requirements

being introduced into the U.S.

market, each medical device must obtain marketing clearance or approval from the FDA through the

premarket notification (or 510(k)) process, the de novo classification process, or the premarket approval, or PMA, process,

unless they are determined to be Class I devices or to otherwise qualify for an exemption from one of these available forms of

premarket review and authorization by the FDA.

Under the FDCA, medical devices are classified into one of three classes —

Class I, Class II or Class III — depending on the degree of risk associated with each medical device and the extent of control

needed to provide reasonable assurance of safety and effectiveness.

Classification of a device is important because the class to

which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the

Class I devices are those for which reasonable assurance of safety and effectiveness can be maintained through adherence to

general controls which include compliance with the applicable portions of the FDA’s Quality System Regulation (the

“QSR”), as well as regulations requiring facility registration and product listing, reporting of adverse medical events,

and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

The Class I designation also applies

to devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable assurance

of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not life-supporting

or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a

potential, unreasonable risk of illness or injury.

Class II devices are those for which general controls

alone are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish “special

controls.” These special controls can include performance standards, post-market surveillance requirements, patient registries and

FDA guidance documents describing device-specific special controls.

While most Class I devices are exempt from the premarket notification

requirement, most Class II devices require a premarket notification prior to commercialization in the United States;

however, the FDA

has the authority to exempt Class II devices from the premarket notification requirement under certain circumstances.

As a result, manufacturers

of most Class II devices must submit premarket notifications to the FDA under Section 510(k) of the FDCA (21 U.S.C.

order to obtain the necessary clearance to market or commercially distribute such devices.

To obtain 510(k) clearance, manufacturers must

submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate

device” that is already on the market.

A predicate device is a legally marketed device that is not subject to PMA, meaning, (i)

a device that was legally marketed prior to May 28, 1976 (“pre-amendments device”) and for which a PMA is not required, (ii)

a device that has been reclassified from Class III to Class II or I or (iii) a device that was found substantially equivalent through

the 510(k) process.

If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant

in a premarket notification submission, the agency will grant 510(k) clearance for the new device, permitting the applicant to commercialize

Premarket notifications are subject to user fees, unless a specific exemption applies.

If there is no adequate predicate to which a manufacturer

can compare its proposed device, the proposed device is automatically classified as a Class III device.

In such cases, a device manufacturer

must then fulfill the more rigorous PMA requirements or can request a risk-based classification determination for its device in accordance

with the de novo classification process.

Devices that are intended to be life sustaining

or life supporting, devices that are implantable, devices that present a potential unreasonable risk of harm or are of substantial importance

in preventing impairment of health, and devices that are not substantially equivalent to a predicate device and for which safety and effectiveness

cannot be assured solely by the general controls and special controls are placed in Class III.

Such devices generally require FDA approval

through the PMA process, unless the device is a pre-amendments device not yet subject to a regulation requiring premarket approval.

PMA process is more demanding than the 510(k) process.

For a PMA, the manufacturer must demonstrate through extensive data, including

data from preclinical studies and one or more clinical trials, that the device is safe and effective for its proposed indication.

PMA must also contain a full description of the device and its components, a full description of the methods, facilities and controls

used for manufacturing, and proposed labeling.

Following receipt of a PMA submission, the FDA determines whether the application is sufficiently

complete to permit a substantive review.

If the FDA accepts the application for review, it has 180 days under the FDCA to complete its

review and determine whether the proposed device can be approved for commercialization, although in practice, PMA reviews often take significantly

longer, and it can take up to several years for the FDA to issue a final decision.

Before approving a PMA, the FDA generally also performs

an on-site inspection of manufacturing facilities for the product to ensure compliance with the QSR.

The de novo classification process

allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its device to Class

I or Class II, on the basis that the device presents low or moderate risk, as an alternative to following the typical Class III device

pathway requiring the submission and approval of a PMA application.

The FDA has confirmed our MODD1 product qualifies as a 510(k) eligible

device and does not require a de novo classification.

Clinical trials are almost always required to

support PMAs and are sometimes required to support 510(k) and de novo classification submissions.

In our case, usability

studies of our intended users are required and have been completed.

All clinical investigations of devices to determine safety and effectiveness

must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational

device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of

study sponsors and study investigators.

If the device presents a “significant risk,” as defined by the FDA, the agency requires

the study sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the sponsor

that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies

the agency’s concerns.

If the FDA determines that there are deficiencies or other concerns with an IDE that require modification

of the study, the FDA may permit a clinical trial to proceed under a conditional approval.

The FDA may also notify the sponsor that the

study is approved as proposed or approved with specific requested modification.

Furthermore, the agency may withdraw approval of an IDE

under certain circumstances.

In addition, the study must be approved by, and conducted under the oversight of, an institutional review

board, or IRB, for each clinical site.

If the device presents a non-significant risk to the patient according to criteria established

by the FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more

IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation,

ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

Post-Marketing Restrictions and Enforcement

After a device is placed on the market, numerous

regulatory requirements apply.

to devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable

assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not

life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and

that do not present a potential, unreasonable risk of illness or injury.

II devices are those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness and

there is sufficient information to establish “special controls.” These special controls can include performance standards,

post-market surveillance requirements, patient registries and FDA guidance documents describing device-specific special controls.

most Class I devices are exempt from the premarket notification requirement, most Class II devices require a premarket notification prior

to commercialization in the United States;

however, the FDA has the authority to exempt Class II devices from the premarket notification

requirement under certain circumstances.

As a result, manufacturers of most Class II devices must submit premarket notifications to the

FDA under Section 510(k) of the FDCA (21 U.S.C.

§ 360(k)) in order to obtain the necessary clearance to market or commercially distribute

such devices.

To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device

is “substantially equivalent” to a “predicate device” that is already on the market.

A predicate device is a

legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976 (“pre-amendments

device”) and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or I or (iii)

a device that was found substantially equivalent through the 510(k) process.

If the FDA agrees that the device is substantially equivalent

to the predicate device identified by the applicant in a premarket notification submission, the agency will grant 510(k) clearance for

the new device, permitting the applicant to commercialize the device.

Premarket notifications are subject to user fees, unless a specific

exemption applies.

there is no adequate predicate to which a manufacturer can compare its proposed device, the proposed device is automatically classified

as a Class III device.

In such cases, a device manufacturer must then fulfill the more rigorous PMA requirements or can request a risk-based

classification determination for its device in accordance with the de novo classification process.

that are intended to be life sustaining or life supporting, devices that are implantable, devices that present a potential unreasonable

risk of harm or are of substantial importance in preventing impairment of health, and devices that are not substantially equivalent to

a predicate device and for which safety and effectiveness cannot be assured solely by the general controls and special controls are placed

in Class III.

Such devices generally require FDA approval through the PMA process, unless the device is a pre-amendments device not yet

subject to a regulation requiring premarket approval.

The PMA process is more demanding than the 510(k) process.

For a PMA, the manufacturer

must demonstrate through extensive data, including data from preclinical studies and one or more clinical trials, that the device is

safe and effective for its proposed indication.

The PMA must also contain a full description of the device and its components, a full

description of the methods, facilities and controls used for manufacturing, and proposed labeling.

Following receipt of a PMA submission,

the FDA determines whether the application is sufficiently complete to permit a substantive review.

If the FDA accepts the application

for review, it has 180 days under the FDCA to complete its review and determine whether the proposed device can be approved for commercialization,

although in practice, PMA reviews often take significantly longer, and it can take up to several years for the FDA to issue a final decision.

Before approving a PMA, the FDA generally also performs an on-site inspection of manufacturing facilities for the product to ensure compliance

with the QSR.

de novo classification process allows a manufacturer whose novel device is automatically classified into Class III to request

down-classification of its device to Class I or Class II, on the basis that the device presents low or moderate risk, as an alternative

to following the typical Class III device pathway requiring the submission and approval of a PMA application.

The FDA has confirmed our

MODD1 product qualifies as a 510(k) eligible device and does not require a de novo classification.

trials are almost always required to support PMAs and are sometimes required to support 510(k) and de novo classification

In our case, usability studies of our intended users are required and have been completed.

All clinical investigations

of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device

exemption, or IDE, regulations that govern investigational device labeling, prohibit promotion of investigational devices, and

specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

If the device presents a

“significant risk,” as defined by the FDA, the agency requires the study sponsor to submit an IDE application to the

FDA, which must become effective prior to commencing human clinical trials.

The IDE will automatically become effective 30 days

after receipt by the FDA, unless the FDA denies the application or notifies the sponsor that the investigation is on hold and may

not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns.

the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may

permit a clinical trial to proceed under a conditional approval.

The FDA may also notify the sponsor that the study is approved as

proposed or approved with specific requested modification.

Furthermore, the agency may withdraw approval of an IDE under certain

circumstances.

In addition, the study must be approved by, and conducted under the oversight of, an institutional review board, or

IRB, for each clinical site.

If the device presents a non-significant risk to the patient according to criteria established by the

FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more

IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the

investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

Post-Marketing

Restrictions and Enforcement

a device is placed on the market, numerous regulatory requirements apply.

These include, but are not limited to:

● submitting and updating establishment

registration and device listings with the FDA;

● compliance with the QSR, which

requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint

and related investigation files, and other quality assurance controls during the manufacturing process;

● unannounced routine or for-cause

device facility inspections by the FDA, which may include our suppliers’ facilities;

● labeling regulations, which

prohibit the promotion of products for uncleared or unapproved (or “off-label”) uses and impose other restrictions relating

to promotional activities;

● corrections and removal reporting

regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health

posed by a device or to remedy a violation of the FDCA that may present a risk to health;

● post-market surveillance regulations,

which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness

data for the device.

In addition, under the FDA medical device reporting,

or MDR, regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or

contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury

if the malfunction of the device or a similar device of such manufacturer were to recur.

The decision to file an MDR involves a judgment

by the manufacturer.

If the FDA disagrees with the manufacturer’s determination, the FDA can take enforcement action.

The MDR requirements also extend to health-care

facilities that use medical devices in providing care to patients, or “device user facilities,” which include hospitals, ambulatory

surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities, but not physician offices.

device user facility must report any device-related death to both the FDA and the device manufacturer, or any device-related serious injury

to the manufacturer (or, if the manufacturer is unknown, to the FDA) within 10 days of the event.

Device user facilities are not required

to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur but may

voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

The FDA also has the authority to require the

recall of commercialized medical device products in the event of material deficiencies or defects in design or manufacture.

The authority

to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious adverse

health consequences or death.

Manufacturers may, under their own initiative, recall a product if any distributed devices fail to meet

established specifications, are otherwise misbranded or adulterated under the FDCA, or if any other material deficiency is found.

FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated.

The failure to comply with applicable regulatory

requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

warning letters, fines, injunctions or civil penalties;

recalls, detentions or seizures of products;

operating restrictions;

delays in the introduction of products into the market;

total or partial suspension of production;

delay or refusal of the FDA or other regulators to grant 510(k) clearance, PMA approvals, or other marketing authorization to new products;

withdrawals of marketing authorizations;

in the most serious cases, criminal prosecution.

To ensure compliance with regulatory requirements,

medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA, and

these inspections may include the manufacturing facilities of subcontractors.

Federal Trade Commission Regulatory Oversight

Our advertising for our products and services

will be subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (the “FTC”) as well as comparable

state consumer protection laws.

Under the Federal Trade Commission Act (the “FTC Act”), the FTC is empowered, among other

things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce;

(b) seek monetary

redress and other relief for conduct injurious to consumers;

and (c) gather and compile information and conduct investigations relating

to the organization, business, practices, and management of entities engaged in commerce.

The FTC has very broad enforcement authority,

and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or

judicial penalties, including civil penalties, injunctions affecting the manner in which we would be able to market services or products

in the future, or criminal prosecution.

Healthcare Law and Regulation

United States

We will have to comply with various U.S.

and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral

laws, rules and regulations.

Violations of the fraud and abuse laws are punishable by criminal and civil sanctions, including, in some

instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid.

These laws include

the following:

the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;

the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

the federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners and physician ownership and investment interests;

analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

Some state laws require pharmaceutical or medical

device companies to comply with the relevant industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated

by the federal government in addition to requiring drug and device manufacturers to report information related to payments to physicians

and other health care providers or marketing expenditures.

State and foreign laws also govern the privacy

and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted

by HIPAA, thus complicating compliance efforts.

We also may be subject to, or may in the future become subject to, U.S.

federal and state,

and foreign laws and regulations imposing obligations on how we collect, use, disclose, store and process personal information.

or perceived failure to comply with such obligations could result in liability or reputational harm and could harm our business.

compliance with such laws could also impair our efforts to maintain and expand our customer base and thereby decrease our future revenues.

The European Union approves the use of medical

devices in a very different way.

They have similar regulations and requirements to adhere to, however, a Notified Body, in the form of

a private company, will represent their interests and is required to have sufficient expertise to review all applications and the company’s

internal processes to ensure the safety of the product for which approval is being requested.

We have identified a Notified Body to represent

us, and we are following our FDA submission process with regard to preparing the materials and processes required to meet the regulations

and gain clearance.

European Union

and updating establishment registration and device listings with the FDA;

with the QSR, which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including

maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;

● unannounced

routine or for-cause device facility inspections by the FDA, which may include our suppliers’ facilities;

regulations, which prohibit the promotion of products for uncleared or unapproved (or “off-label”) uses and impose other

restrictions relating to promotional activities;

● corrections

and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to

reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health;

● post-market

surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional

safety and effectiveness data for the device.

addition, under the FDA medical device reporting, or MDR, regulations, medical device manufacturers are required to report to the FDA

information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would

likely cause or contribute to death or serious injury if the malfunction of the device or a similar device of such manufacturer were

The decision to file an MDR involves a judgment by the manufacturer.

If the FDA disagrees with the manufacturer’s determination,

the FDA can take enforcement action.

MDR requirements also extend to health-care facilities that use medical devices in providing care to patients, or “device user

facilities,” which include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient

treatment facilities, but not physician offices.

A device user facility must report any device-related death to both the FDA and the

device manufacturer, or any device-related serious injury to the manufacturer (or, if the manufacturer is unknown, to the FDA) within

10 days of the event.

Device user facilities are not required to report device malfunctions that would likely cause or contribute to

death or serious injury if the malfunction were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s

Safety Information and Adverse Event Reporting Program.

FDA also has the authority to require the recall of commercialized medical device products in the event of material deficiencies or

defects in design or manufacture.

The authority to require a recall must be based on an FDA finding that there is a reasonable

probability that the device would cause serious adverse health consequences or death.

Manufacturers may, under their own initiative,

recall a product if any distributed devices fail to meet established specifications, are otherwise misbranded or adulterated under

the FDCA, or if any other material deficiency is found.

The FDA requires that certain classifications of recalls be reported to the

FDA within ten working days after the recall is initiated.

failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following

letters, fines, injunctions or civil penalties;

detentions or seizures of products;

restrictions;

in the introduction of products into the market;

or partial suspension of production;

or refusal of the FDA or other regulators to grant 510(k) clearance, PMA approvals, or other marketing authorization to new products;

● withdrawals

of marketing authorizations;

the most serious cases, criminal prosecution.

ensure compliance with regulatory requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled

and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of subcontractors.

Trade Commission Regulatory Oversight

advertising for our products and services will be subject to federal truth-in-advertising laws enforced by the Federal Trade Commission

(the “FTC”) as well as comparable state consumer protection laws.

Under the Federal Trade Commission Act (the “FTC

Act”), the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices

in or affecting commerce;

(b) seek monetary redress and other relief for conduct injurious to consumers;

and (c) gather and compile information

and conduct investigations relating to the organization, business, practices, and management of entities engaged in commerce.

has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection

laws can result in administrative or judicial penalties, including civil penalties, injunctions affecting the manner in which we would

be able to market services or products in the future, or criminal prosecution.

Law and Regulation

will have to comply with various U.S.

federal and state laws, rules and regulations pertaining to healthcare fraud and abuse, including

anti-kickback laws and physician self-referral laws, rules and regulations.

Violations of the fraud and abuse laws are punishable by

criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including

Medicare and Medicaid.

These laws include the following:

federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or

providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or

the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare

program such as Medicare and Medicaid;

federal False Claims Act imposes civil penalties, and provides for civil whistleblower or

qui tam actions, against individuals or entities for knowingly presenting, or causing to

be presented, to the federal government, claims for payment that are false or fraudulent

or making a false statement to avoid, decrease or conceal an obligation to pay money to the

federal government;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal

and civil liability for executing a scheme to defraud any healthcare benefit program or making

false statements relating to healthcare matters;

as amended by the Health Information Technology for Economic and Clinical Health Act and

its implementing regulations, also imposes obligations, including mandatory contractual terms,

with respect to safeguarding the privacy, security and transmission of individually identifiable

health information;

federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any

materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics

and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information

related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners

and physician ownership and investment interests;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements

and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

state laws require pharmaceutical or medical device companies to comply with the relevant industry’s voluntary compliance guidelines

and the relevant compliance guidance promulgated by the federal government in addition to requiring drug and device manufacturers to

report information related to payments to physicians and other health care providers or marketing expenditures.

and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other

in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

We also may be subject to, or may in

the future become subject to, U.S.

federal and state, and foreign laws and regulations imposing obligations on how we collect, use, disclose,

store and process personal information.

Our actual or perceived failure to comply with such obligations could result in liability or

reputational harm and could harm our business.

Ensuring compliance with such laws could also impair our efforts to maintain and expand

our customer base and thereby decrease our future revenues.

European Union approves the use of medical devices in a very different way.

They have similar regulations and requirements to adhere

to, however, a Notified Body, in the form of a private company, will represent their interests and is required to have sufficient expertise

to review all applications and the company’s internal processes to ensure the safety of the product for which approval is being

We have identified a Notified Body to represent us, and we are following our FDA submission process with regard to preparing

the materials and processes required to meet the regulations and gain clearance.

In the European Economic Area, or EEA, which is

26 unchanged sentences

and that any claims made about the performance and safety of the device are supported by suitable evidence.

All manufacturers placing medical devices into

the market in the EEA must comply with the EU Medical Device Vigilance System.

Under this system, incidents must be reported to the relevant

authorities of the member states of the EEA, and manufacturers are required to take Field Safety Corrective Actions, or FSCAs, to reduce

a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on

An incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well

as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death

of a patient or user or of other persons or to a serious deterioration in their state of health.

An FSCA may include the recall, modification,

exchange, destruction or retrofitting of the device.

FSCAs must be communicated by the manufacturer or its legal representative to its

customers and/or to the end users of the device through Field Safety Notices.

Where appropriate, our products commercialized in Europe

are CE marked and classified as either Class I or Class II.

In 2017, the European Parliament passed the Medical

Devices Regulation, which repeals and replaces the EU Medical Devices Directive.

Unlike directives, which must be implemented into the

national laws of the EEA member states, the regulations would be directly applicable (i.e., without the need for adoption of EEA member

State laws implementing them) in all EEA member states and are intended to eliminate current differences in the regulation of medical

devices among EEA member States.

The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent,

predictable and sustainable regulatory framework across the EEA for medical devices and in vitro diagnostic devices and ensure a high

level of safety and health while supporting innovation.

The Medical Device Regulation became applicable

on May 26, 2021.

Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally

continue to be made available on the market or put into service until May 26, 2026.

The Medical Devices Regulation, among other things:

● strengthens the rules on placing

devices on the market and reinforces surveillance once they are available;

● establishes explicit provisions

on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

● improves the traceability of

medical devices throughout the supply chain to the end-user or patient through a unique identification number;

● sets up a central database

to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

● strengthens rules for the assessment

of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the

Available Information

Our annual reports on Form 10-K, quarterly reports

on Form 10-Q, current reports on Form 8-K and amendments to such reports filed or furnished pursuant to section 13(a) or 15(d) of the

Securities Exchange Act of 1934, as well as section 16 reports on Form 3, 4, or 5, are available free of charge on our website at www.modular-medical.com.

as soon as it is reasonably practicable after they are filed or furnished with the SEC.

Our Code of Business Conduct and Ethics and the

charters for the Audit Committee, Compensation Committee and Nominating and Governance Committee are also available on our website.

Code of Business Conduct and charters are also available in print to any stockholder upon request without charge.

Requests for such documents

should be directed to Modular Medical, Inc., 10740 Thornmint Road, San Diego CA 92127, Attn.

Our Internet website and the information

contained on it or connected to it are not part of, or incorporated by, reference into this Report.

Our filings with the SEC are also

available on the SEC’s website at http://www.sec.gov.

Corporate Information

We are a Nevada corporation, and Quasuras, Inc.,

a Delaware corporation, is our only subsidiary.

Our corporate headquarters and operating facilities are located at 10740 Thornmint Road,

San Diego, CA 92127.

manufacturers placing medical devices into the market in the EEA must comply with the EU Medical Device Vigilance System.

system, incidents must be reported to the relevant authorities of the member states of the EEA, and manufacturers are required to take

Field Safety Corrective Actions, or FSCAs, to reduce a risk of death or serious deterioration in the state of health associated with

the use of a medical device that is already placed on the market.

An incident is defined as any malfunction or deterioration in the characteristics

and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly,

might lead to or might have led to the death of a patient or user or of other persons or to a serious deterioration in their state of

An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device.

FSCAs must be communicated

by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices.

Where appropriate, our products commercialized in Europe are CE marked and classified as either Class I or Class II.

2017, the European Parliament passed the Medical Devices Regulation, which repeals and replaces the EU Medical Devices Directive.

directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable (i.e.,

without the need for adoption of EEA member State laws implementing them) in all EEA member states and are intended to eliminate current

differences in the regulation of medical devices among EEA member States.

The Medical Devices Regulation, among other things, is intended

to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and in vitro

diagnostic devices and ensure a high level of safety and health while supporting innovation.

Medical Device Regulation became applicable on May 26, 2021.

Devices lawfully placed on the market pursuant to the EU Medical Devices

Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2026.

Medical Devices Regulation, among other things:

● strengthens

the rules on placing devices on the market and reinforces surveillance once they are available;

● establishes

explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed

on the market;

the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available

rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before

they are placed on the market.

annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to such reports filed or

furnished pursuant to section 13(a) or 15(d) of the Securities Exchange Act of 1934, as well as section 16 reports on Form 3, 4, or

5, are available free of charge on our website at www.modular-medical.com .

as soon as it is reasonably practicable after they

are filed or furnished with the SEC.

Our Code of Business Conduct and Ethics and the charters for the Audit Committee, Compensation

Committee and Nominating and Governance Committee are also available on our website.

The Code of Business Conduct and charters are

also available in print to any stockholder upon request without charge.

Requests for such documents should be directed to Modular

Medical, Inc., 10740 Thornmint Road, San Diego CA 92127, Attn.

Our Internet website and the information contained on it or

connected to it are not part of, or incorporated by, reference into this Report.

Our filings with the SEC are also available on the

SEC’s website at http://www.sec.gov .

are a Nevada corporation, and Quasuras, Inc., a Delaware corporation, is our only subsidiary.

Our corporate headquarters and operating

facilities are located at 10740 Thornmint Road, San Diego, CA 92127.

Our telephone number is (858) 800-3500.

We maintain a website at www.modular-medical.com.

As of March 31, 2025, we had 54 employees, all of whom are located

in the United States and 53 of whom are full-time, consisting of 49 in research and development and manufacturing operations and 5 in

general and administrative functions.

We maintain a website at

www.modular-medical.com .

As of March 31, 2026, we had 51 employees, all located in the United States

of which 50 of are full-time, consisting of 42 in research and development and manufacturing operations, six in general and administrative

functions and three in sales and marketing.

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