MODD US Equity☆

modd-20260331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: March 31, 2026

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to

__________

Commission file number: 001-41277

MODULAR MEDICAL, INC.

(Exact name of registrant as specified in its charter)

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (858)800-3500

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.001 per share MODD The Nasdaq Stock Market, LLC

Securities registered pursuant to Section 12(g) of the Act:

(Title

of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒

Indicate by check mark if the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated Filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common stock held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on the Nasdaq Stock Market on September 30, 2025 was $37,453,403.

The number of shares of the registrant’s common stock outstanding, par value $0.001 per share, as of June 22, 2026, was 5,413,160.

ANNUAL

REPORT ON FORM 10-K

FOR THE YEAR ENDED MARCH 31, 2026

TABLE

OF CONTENTS

Page

Special Note Regarding Forward Looking Statements and Other Information ii

Part I

Item 1 Business 1

Item 1A Risk Factors 19

Item 1B Unresolved Staff Comments 39

Item 1C Cybersecurity 39

Item 2 Properties 40

Item 3 Legal Proceedings 40

Item 4 Mine Safety Disclosures 40

Part II

Item 6 Reserved 42

Item 7A Quantitative and Qualitative Disclosures about Market Risk 45

Item 8 Financial Statements and Supplementary Data F-1

Item 9A Controls and Procedures 46

Item 9B Other Information 47

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 47

Part III

Item 10 Directors, Executive Officers and Corporate Governance 48

Item 11 Executive Compensation 54

Item 14 Principal Accountant Fees and Services 61

Part IV

Signatures 65

i

SPECIAL

NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION

This

Annual Report on Form 10-K (this “Report”) contains “forward-looking statements” within the meaning of Section

27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,

as amended (the “Exchange Act”), that relate to future events or to our future operations or financial performance. Any forward-looking

statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance

or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by

such forward-looking statement.

Words

such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,”

“intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,”

“likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled”

and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements,

although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis

for each forward-looking statement contained in this report, we caution you that these statements are based on our estimates or projections

of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results,

level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking

statement. Actual results, level of activity, performance, experience or achievements may differ materially from those expressed

or implied by any forward-looking statement as a result of various important factors, including our critical accounting policies and

risks and uncertainties relating to:

● our strategies, prospects, plans, expectations, forecasts or objectives;

● our ability to expand, protect and maintain our intellectual property rights;

● our analysis of the target market for our insulin pump;

● regulatory developments in the United States and other countries;

ii

● general economic, business, political and social conditions;

● our ability to generate significant revenues and achieve profitability;

● our ability to manage the growth of our business;

● the success of competing third-party products;

● various other matters, many of which are beyond our control.

Our fiscal year ends on March 31 of each calendar year. Each reference

to a fiscal year in this Report refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2026 refers

to the fiscal year ended March 31, 2026). Unless the context requires otherwise, references to “we,” “us,” “our,”

and the “Company” refer to Modular Medical, Inc. and its consolidated subsidiary.

Note

Regarding Reverse Stock Split

We

effected a reverse stock split of our outstanding common stock at a ratio of 1-for-30, effective as of March 31, 2026, for the purpose

of complying with Nasdaq Listing Rule 5550(a)(2). We have reflected the reverse stock split herein, unless otherwise indicated.

iii

PART

I

ITEM 1.BUSINESS

Overview

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. 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 pump offerings.

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

establishing insurance reimbursement, streamlined training and day-to-day use with strong clinical support, we seek to expand the wearable

insulin delivery device market beyond the highly motivated “super users” to expand the category into the mass market. Our

product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets for those

individuals requiring multiple daily doses of insulin. In January 2024, we submitted a 510(k) premarket notification to the United States

Food and Drug Administration, or 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. 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 PivotTM, 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, 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.

Among

the more prominent issues are:

1

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. 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, 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.

The

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.

Key

features include:

● 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; and

● Slim profile, lighter weight.

2

Diabetes

Classifications and Therapies

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

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. In people 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.

All people with T1D, which is our primary market,

require daily insulin. According to the Seagrove 2026 Diabetes Blue Book, there are approximately 4.2 million potential users for insulin

pumps, split evenly between type 1 and type 2. In this Report, we refer to people with T1D and people with T2D who require mealtime insulin

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.

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

MDI therapy. We undertook one-on-one interviews with over 200 of these individuals to understand their past experiences on or considering

pumps, existing pump shortcomings, the cost and insurance challenges, complexity to learn and time and complexity to operate that drives

them to remain on MDI. With this detailed understanding, we brought a series of prototype models to them to react to, so we could refine

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

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

3

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:

● Usability: the device needs to be easy to learn and to operate;

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. 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.

Market

The International Diabetes Federation estimated

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. 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 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.

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

to a $1.9 billion market opportunity.

4

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.

The current reluctance to adopt the insulin pump

has had serious consequences on the healthcare system. In the United States, people living with T1D have struggled to attain glycemic

targets. According to the American Diabetes Association, only 23% of U.S. adults and 17% of children with T1D achieved the ADA A1c goal

(<7.0%). 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. 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, Inc. (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. 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. 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 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.

5

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, 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

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. 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.

We

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.

6

Our

Pivot product has several distinguishing features:

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 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).

7

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. 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.

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 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, 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.

Our

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

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

Solution

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.

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 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.

Our

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

8

To

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

● Use 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.

● Use of go-to market commercialization technology.

We

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. 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 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

provider. 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

late 2026.

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. 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.

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.

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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. In connection therewith:

Phillips

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

Commercialization

Steps

To

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

● Continue to ensure it meets:

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:

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

Looking

Forward

Going

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.

Competition

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:

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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; of

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

to initiate and two to four hours per day to use and manage on an ongoing basis. We believe this level of sophistication and effort combined

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

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.). Lastly,

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

disclosed it has slightly more than 15,000 users. Beta Bionics, Inc. launched its durable pump in October 2023 and reported approximately

35,000 users at the end of 2025. Deka Research and Development Corp. (Deka) received clearance for its durable pump in July of 2023. Deka

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

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.

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

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.

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. 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

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.

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. 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

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. 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.

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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. § 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.

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. 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,