NASDAQ: BMRA

BIOMERICA INC

CIK 0000073290 · SIC 2835 · In Vitro Diagnostics

Micro Revenue $4M Assets $7M as of Sep 1, 2026

We are a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products. Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients to aid in the diagnosis of diseases, food intolerances, and… About this business →

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10-K Filed Aug 31, 2026 · Period ending May 31, 2026

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8-K Filed Aug 26, 2026 · Period ending Aug 20, 2026

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8-K Filed Jun 4, 2026 · Period ending May 29, 2026

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10-Q Filed Apr 13, 2026 · Period ending Feb 28, 2026

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10-Q Filed Jan 14, 2026 · Period ending Nov 30, 2025

Summary not yet generated.

8-K Filed Dec 16, 2025 · Period ending Dec 12, 2025

Summary not yet generated.

10-K/A Filed Sep 26, 2025 · Period ending May 31, 2025

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10-K Filed Aug 29, 2025 · Period ending May 31, 2025

Summary not yet generated.

424B5 Filed May 10, 2024

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424B5 Filed Mar 7, 2023

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424B5 Filed Mar 2, 2023

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10-Q/A Filed Jan 17, 2018 · Period ending Nov 30, 2017

Summary not yet generated.

Latest financial statements

From 10-K filed Aug 31, 2026 (period ending May 31, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.

As filed

Consolidated Statements of Operations and Comprehensive Loss

Description Years ended May 31, 2026 Years ended May 31, 2025
Net sales 4,453,000 5,311,000
Cost of sales (4,091,000) (4,813,000)
Gross profit 362,000 498,000
Operating expenses:
Selling, general and administrative 4,894,000 4,612,000
Research and development 788,000 1,023,000
Total operating expenses 5,682,000 5,635,000
Loss from operations (5,320,000) (5,137,000)
Other income:
Dividend, interest, and other income 1,233,000 165,000
Unrealized holding gain on equity investment 335,000 -
Total other income 1,568,000 165,000
Loss before income taxes (3,752,000) (4,972,000)
Provision for income taxes (23,000) (1,000)
Net loss (3,775,000) (4,973,000)
Basic net loss per common share (1.30) (2.16)
Diluted net loss per common share (1.30) (2.16)
Weighted average number of common shares outstanding:
Basic 2,914,923 2,297,057
Diluted 2,914,923 2,297,057
Net loss (3,775,000) (4,973,000)
Other comprehensive loss, net of tax:
Foreign currency translation adjustment (3,000) (3,000)
Comprehensive loss (3,778,000) (4,976,000)

Consolidated Balance Sheets

Description May 31, 2026 May 31, 2025
Assets
Current Assets:
Cash and cash equivalents 1,308,000 2,399,000
Accounts receivable, net 785,000 731,000
Inventories, net 1,707,000 1,490,000
Prepaid expenses and other current assets 216,000 255,000
Total current assets 4,016,000 4,875,000
Property and equipment, net 78,000 135,000
Right-of-use assets, net 1,873,000 429,000
Investments 500,000 165,000
Intangible assets, net of accumulated amortization of $89,000 and $69,000 as of May 31, 2026 and May 31, 2025, respectively 209,000 228,000
Other assets 83,000 113,000
Total Assets 6,759,000 5,945,000
Liabilities and Shareholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses 1,171,000 672,000
Secured promissory note payable related party 500,000 -
Accrued compensation 492,000 655,000
Advances from customers 83,000 55,000
Lease liabilities, current portion 235,000 358,000
Total current liabilities 2,481,000 1,740,000
Lease liabilities, net of current portion 1,648,000 100,000
Total Liabilities 4,129,000 1,840,000
Commitments and contingencies (Note 9)
Shareholders’ Equity:
Preferred stock, Series A 5% convertible, $0.08 par value, 571,429 shares authorized, none issued and outstanding as of May 31, 2026 and May 31, 2025 - -
Preferred stock, undesignated, no par value, 4,428,571 shares authorized, none issued and outstanding as of May 31, 2026 and May 31, 2025 - -
Common stock, $0.08 par value, 25,000,000 shares authorized as of May 31, 2026 and 2025, respectively, and 3,195,263 and 2,546,216 shares issued and outstanding as of May 31, 2026 and 2025, respectively 255,000 203,000
Additional paid-in capital 59,426,000 57,175,000
Accumulated other comprehensive loss (108,000) (105,000)
Accumulated deficit (56,943,000) (53,168,000)
Total shareholders’ equity 2,630,000 4,105,000
Total Liabilities and Shareholders’ Equity 6,759,000 5,945,000

Consolidated Statements of Cash Flows

Description Years ended May 31, 2026 Years ended May 31, 2025
Cash flows from operating activities:
Net loss (3,775,000) (4,973,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 77,000 87,000
Provision for allowance for credit losses 12,000 8,000
(Recovery) provision for inventory reserves (77,000) 4,000
Share-based compensation 476,000 460,000
Amortization of right-of-use asset 344,000 313,000
Unrealized holding gain on equity investment (335,000) -
Changes in assets and liabilities:
Accounts receivable (66,000) 209,000
Inventories (140,000) 882,000
Prepaid expenses and other current assets 39,000 (17,000)
Other assets 23,000 9,000
Accounts payable and accrued expenses 499,000 (467,000)
Accrued compensation (163,000) -
Advances from customers 28,000 (30,000)
Reduction in lease liabilities (363,000) (327,000)
Net cash used in operating activities (3,421,000) (3,842,000)
Cash flows from investing activities:
Expenditures related to intangibles (1,000) (37,000)
Net cash used in investing activities (1,000) (37,000)
Cash flows from financing activities:
Gross proceeds from sale of common stock 1,874,000 2,143,000
Deferred offering costs - (3,000)
Costs from sale of common stock (40,000) (44,000)
Proceeds from exercise of stock options - 15,000
Proceeds from secured promissory note payable related party 500,000 -
Net cash provided by financing activities 2,334,000 2,111,000
Effect of exchange rate changes on cash (3,000) (3,000)
Net decrease in cash and cash equivalents (1,091,000) (1,771,000)
Cash and cash equivalents at beginning of year 2,399,000 4,170,000
Cash and cash equivalents at end of year 1,308,000 2,399,000
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Income taxes 22,000 10,000
Non-cash investing and financing activities:
Deferred offering costs 7,000 84,000
Right-of-use assets obtained in exchange for operating lease liabilities 1,788,000 -
Write-off of fully depreciated property and equipment 14,000 -

Amounts as printed on the EDGAR/iXBRL face. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗

About BIOMERICA INC

Source: Item 1 (Business) from the 10-K filed August 31, 2026. Description as filed by the company with the SEC.

ITEM
1. BUSINESS

BUSINESS
OVERVIEW

THE
COMPANY

We are a global biomedical technology company that
develops, patents, manufactures and markets advanced diagnostic and therapeutic products. Our diagnostic test kits are used to analyze
blood, urine, nasal, or fecal material from patients to aid in the diagnosis of diseases, food intolerances, and other medical conditions.
These tests detect and measure the presence and levels of specific bacteria, hormones, antibodies, antigens and other substances that
may exist in the human body at extremely low concentrations. Our products are designed to enhance patient outcomes and well-being while
reducing total healthcare costs.

We sell our portfolio of diagnostic products worldwide,
primarily to clinical laboratories and in point-of-care settings, including physicians’ offices and over-the-counter channels. We
also provide contract development and manufacturing services to third parties that utilize the technology underlying our products. In
addition, we are commercializing our inFoods® IBS product through physician-directed and laboratory-based channels, including third-party
reimbursement pathways. Most of our products carry Conformité Européenne (“CE”) marking and/or are registered
with regulatory agencies in various countries for diagnostic use, with several also cleared by the United States Food and Drug Administration (“FDA”) for sale in the United States.

TECHNOLOGICAL
ADVANCEMENTS AND PRODUCT DEVELOPMENT

Technological
advances in medical diagnostics have enabled diagnostic tests to be performed not only in clinical laboratories but also at home and
at the point-of-care in physicians’ offices. We strive to develop and market diagnostic products that are accurate, utilize easily
obtained patient specimens and, where appropriate, can be performed without complex instrumentation. Our home use (over-the-counter)
and professional use (physicians’ office, clinics, etc.) rapid diagnostic test products help manage existing medical
conditions and may save lives through early detection and diagnosis of specific diseases. Traditionally, such tests required the
expertise of medical technologists and sophisticated equipment, with results often not available for days. We believe our rapid
point-of-care tests, when properly used, can be as accurate as laboratory tests.

Read full description ↓

RESEARCH
AND DEVELOPMENT

We
invest resources in the research and development of new diagnostic products and technologies designed to address a range of medical conditions
and unmet clinical needs. Our research and development activities include the development and optimization of immunoassays, enzyme-linked
immunosorbent assays (“ELISAs”), rapid diagnostic tests, and related diagnostic technologies. These products
are either internally developed, licensed from third parties, or developed under contract for customers.

Our
experienced and highly trained technical personnel, including Ph.D. level scientists and other scientific and technical professionals,
are engaged in new product development, product improvement, contract development projects, and technology transfer activities. Many
members of our technical staff have extensive experience in diagnostic product development and manufacturing, including prior experience
at large diagnostic companies. We also utilize our Scientific Advisory Board, which includes physicians and clinicians with relevant
areas of expertise, to provide scientific and clinical input regarding certain product development programs and clinical studies.

For
the fiscal years ended May 31, 2026 and 2025, consolidated research and development expenses totaled approximately $788,000 and
$1,023,000, respectively. The decrease was primarily attributable to lower research and development personnel costs and related
development expenses, including reduced research and development activity as hp+detect™ transitioned from development to
commercialization and inFoods® IBS continued its transition toward commercialization.

We
intend to pursue additional applications for the inFoods® technology for other disease states, including Functional Dyspepsia,
Crohn’s Disease, Ulcerative Colitis, Gastroesophageal Reflux Disease (“GERD”), Migraine Headaches, Depression, and
Osteoarthritis. We have filed patents globally to protect the use of inFoods® IBS diagnostic technology for these indications, with
patents issued in the United States and multiple foreign jurisdictions, and others in review or prosecution.

Our
research and development efforts have also led to the FDA 510(k) clearance of hp+detect™, a proprietary diagnostic test for detecting
Helicobacter pylori (“H. pylori”) and monitoring treatment. H. pylori is a leading cause of peptic ulcers and a significant
risk factor for gastric cancer. In addition to our internally developed products, we intend to continue leveraging our scientific, product
development, regulatory, and manufacturing capabilities to pursue contract assay development and Contract Development and Manufacturing Organization (“CDMO”) opportunities for third-party
diagnostic and life science companies. These activities may include development of new assays and diagnostic products, optimization or
modification of existing products, analytical and clinical testing support, technology transfer, and manufacturing services.

KEY
PRODUCT LAUNCHES

A
key outcome of our research and development efforts is our patented diagnostic-guided therapy (“DGT”) product, developed
on the inFoods® technology platform. This innovative technology is designed to aid in the management of gastrointestinal conditions
such as irritable bowel syndrome (“IBS”) and other inflammatory diseases. The DGT product targets chronic inflammatory illnesses
that are widespread and prevalent across large markets. We have launched our inFoods® IBS product, which leverages this patented
technology. The inFoods® IBS product utilizes a simple blood test to identify patient-specific foods that, when eliminated from the
diet, may help reduce IBS symptoms such as pain, bloating, diarrhea, cramping, and constipation. Unlike broad and difficult-to-manage
dietary restrictions, the inFoods® IBS product pinpoints a patient’s heightened immunoreactivity to specific foods known to
frequently trigger IBS symptoms. By removing the foods identified as problematic, patients can achieve relief from IBS symptoms.

1

We
have introduced the inFoods® IBS product to gastroenterology (“GI”) physician groups in multiple states and regions,
including collaboration with one of the largest GI groups in the United States. The initial phase focused on gathering real world feedback,
optimizing physician engagement, and validating operational processes. GI physician feedback has been generally positive, and we are
continuing to expand our presence in the GI segment while exploring opportunities to bring the inFoods® technology to other medical
specialties. The outcome of our clinical study was published in the June 2025 issue of Gastroenterology. We are also evaluating distribution,
partnership, and licensing opportunities with U.S. companies to support a scalable, broader market launch. We pursued reimbursement for the inFoods® IBS product through the Medicare
system which resulted in CMS establishing a national Medicare payment rate of $300 for the test effective January 1, 2026. We intend to
pursue broader reimbursement opportunities.

As
we continue to pursue commercial opportunities in both the United States and international markets, we remain attentive to evolving global
economic conditions, including uncertainties related to international trade policies, tariffs, supply chain dynamics, wars and other
geopolitical developments. Although these factors have not had a material impact on our operations to date, future changes in trade regulations,
tariff structures, or logistical constraints could influence the cost, availability, or timing of materials and components used in our
manufacturing processes and our ability to sell finished products into international markets. We continue to monitor these developments
closely and are implementing contingency plans, including alternative sourcing strategies and supplier diversification, to support supply
chain continuity, maintain operational efficiency, and help mitigate potential future impacts. We are also focusing on alternative manufacturing
and shipping strategies through BioEurope GmbH, our European subsidiary, and Biomerica de Mexico, our Mexican subsidiary, to mitigate
some of the risks these policies may have on our revenues and operations.

In
addition, in December 2023 we received FDA clearance for hp+detect™, a diagnostic test designed to detect Helicobacter pylori (H.
pylori) bacteria in the gastrointestinal tract. H. pylori is a prevalent infection, affecting approximately 35% of the United States
population and 45% of the population in Europe’s largest countries. This bacterium is recognized as the strongest known risk factor
for gastric cancer, which remains one of the leading causes of cancer-related deaths globally. The hp+detect™ test is marketed
directly to laboratories and is intended to provide physicians and medical centers with a reliable tool for diagnosing H. pylori infections
and monitoring treatment effectiveness. During fiscal 2026, we received our first commercial order for hp+detect™ from one of the
largest clinical laboratory chains operating across Europe. The initial order was for the United Kingdom market, where hp+detect™
received registration from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) in February 2026.

STRATEGIC
INITIATIVES AND COST MANAGEMENT

As
part of our ongoing commitment to disciplined capital management, we continued to evaluate and prioritize our operating expenditures
during fiscal 2026. These efforts included reducing research and development spending as certain development programs progressed
toward commercialization, reallocating resources toward commercial, regulatory and reimbursement activities, managing working
capital and maintaining disciplined capital expenditures. Total operating expenses increased approximately 1% during fiscal 2026
compared with fiscal 2025, while net cash used in operating activities improved by approximately 11%. In addition, we raised
approximately $1,827,000 in net proceeds under our existing at-the-market (“ATM”) offering program during fiscal 2026,
providing additional liquidity to support our operations. We continue to evaluate opportunities to manage costs, preserve liquidity
and allocate resources toward initiatives that we believe have the greatest potential to create shareholder value.

OPERATIONS
AND GLOBAL PRESENCE

Biomerica
is headquartered in Irvine, California, where it centralizes administration, finance, regulatory compliance, product development, sales,
marketing, customer service, and primary manufacturing operations. To enhance global competitiveness, we maintain manufacturing and assembly
operations in Mexicali, Mexico, which support our manufacturing capacity and cost structure. Additionally, Biomerica operates BioEurope
GmbH in Europe, which supports sales, distribution and other commercial activities in international markets.

Additional
information about our products is available on our website at www.biomerica.com. The content on any website referred to in this Form 10-K
is not a part of or incorporated by reference in this Form 10-K unless expressly noted. Our Annual Report on Form 10-K, Quarterly Reports
on Forms 10-Q, Current Reports on Forms 8-K, Proxy Statements and all other filings we make with the Securities and Exchange Commission
(“SEC”) are available on our website, free of charge, as soon as reasonably practicable after we file them with or furnish
them to the SEC and are also available online at the SEC’s website at www.sec.gov.

PRODUCTION

Our
diagnostic test kits are manufactured and/or assembled at our facilities in Irvine, California, and in Mexicali, Mexico. We established
our manufacturing facility in Mexicali, Mexico, in fiscal 2003 and moved a significant portion of our diagnostic packaging and assembly
operations to that facility.

Production
of diagnostic tests can involve formulating component antibodies and antigens in specified concentrations, attaching a tracer to the
antigen, filling components into vials, packaging and labeling. We continually engage in quality control procedures to help ensure the
consistency and quality of our products and compliance with applicable FDA and international regulatory requirements.

2

Our
manufacturing operations and facilities are regulated by the FDA quality system requirements applicable to medical device manufacturers.
We have an internal quality department that monitors and evaluates product quality and output. We also have an internal Quality Systems
department whose goal is to ensure that our operating procedures are in compliance with current FDA requirements, applicable CE marking
requirements and International Organization for Standardization (“ISO”) standards. We either produce our own antibodies and
antigens or purchase these materials from qualified vendors. We have alternate, approved sources for most critical raw materials and
are working to procure alternate sources for the few for which alternate sources are not currently available. These manufacturing and
quality capabilities also support our contract development and manufacturing activities.

MARKETS
AND METHODS OF DISTRIBUTION

The
majority of our revenues come from the sale of products we manufacture in the United States and Mexico, with certain raw materials sourced
from the United States, Asia, and other regions. Our diagnostic business serves a diverse customer base that includes both domestic and
international distributors, as well as hospitals, clinical laboratories, medical research institutions, pharmaceutical companies, drugstores,
wholesalers, physicians’ offices, and e-commerce customers. A significant portion of our revenues are derived from international
sales.

We
employ a Director of International Sales, based in Germany, who has over 25 years of experience in diagnostics and life sciences. This
individual’s international business experience and multilingual capabilities have facilitated strong relationships across Europe,
Eastern Europe, the Middle East, Latin America, Canada, and the United States. We are also pursuing new opportunities through the addition
of distributors and product lines in these regions.

We
market our diagnostic products through distributors, advertising in medical and trade journals, trade show exhibitions, direct mailings,
and through a small internal sales team. The two primary markets we target are clinical laboratories and patient point-of-care testing.

Our
net sales were approximately $4,453,000 for the fiscal year ended May 31, 2026, compared to $5,311,000 for the fiscal year ended May
31, 2025. For the fiscal years ended May 31, 2026, and 2025, we had one distributor each year that accounted for 31% of our net sales.

3

Total
gross receivables were approximately $823,000 and $757,000 as of May 31, 2026 and 2025, respectively. As of those dates, three and four
distributors accounted for approximately 59% and 69% of gross accounts receivable, respectively. Of the 59% concentration as of May 31,
2026, 34% was attributable to two distributors located in North America.

BACKLOG

As
of May 31, 2026, and 2025, Biomerica’s backlog of unshipped orders was approximately $604,000 and $1,324,000, respectively. As
of May 31, 2026, the majority of this backlog consisted of orders intended for shipment to Asia.

RAW
MATERIALS

Biomerica
utilizes a range of principal raw materials including chemicals, serums, reagents, and packaging supplies. The majority of these materials
are sourced from multiple suppliers, ensuring we are not reliant on any single source. However, for certain critical materials such as
antibodies, where suppliers are limited, there exists a risk of potential supply challenges or increased costs in the future.

Our
inventory includes antibodies, antigens, bottles, boxes, chemicals, and reagents essential for manufacturing our test kits, along with
products in various stages of completion.

For
the fiscal year ended May 31, 2026, purchases from one vendor accounted for approximately 12% of our total raw material procurement,
primarily related to commodity plastic products. For the fiscal year ended May 31, 2025, purchases from one vendor accounted for approximately
12% of our total raw material procurement, also primarily related to commodity plastic products.

COMPETITION

We offer several proprietary products with notable
competitive advantages, including our EZ Detect colon disease home test, Aware Breast Self-Exam product, inFoods® IBS product, and
hp+detect™ for H. pylori detection.

Our competitors include divisions and subsidiaries
of well-established medical and pharmaceutical companies that are much larger than Biomerica and expend substantially greater amounts
for research and development, manufacturing, advertising, and marketing. We also provide contract development and manufacturing services,
where we compete on the basis of technical capabilities, quality, pricing, service and project execution.

The competitive landscape for diagnostic products
is shaped by several factors, including product uniqueness, technology, quality, performance, pricing, and service. We believe our competitive
position is strengthened by the distinctiveness of our product offerings, the quality and speed of our test results, and our patent portfolio,
despite our limited marketing resources.

GOVERNMENT
REGULATION OF OUR DIAGNOSTIC BUSINESS

Our
primary business consists of selling products that are generally legally defined as medical devices and in vitro diagnostic (“IVD”)
medical devices. As a result, we are a manufacturer of medical devices and in vitro diagnostic medical devices, and as such, we are
subject to the regulations issued and enforced by numerous governmental entities. These agencies include the FDA, Environmental
Protection Agency, Federal Trade Commission, Occupational Safety and Health Administration, United States Department of Agriculture
(“USDA”), and Consumer Product Safety Commission, as well as certain European Government agencies. Our activities are
also regulated by various agencies of the states and localities in which our products are sold. These regulations govern the
introduction of new IVD medical devices and other medical devices, the observance of certain standards with
respect to the manufacture and labeling of medical devices, the maintenance of certain records, the reporting of potential product
problems, and other related matters.

The
Food, Drug & Cosmetic Act of 1938 (the “FDCA”) regulates medical devices in the United States by classifying them
into one of three classes based on the extent of regulation believed necessary to ensure safety and effectiveness. Class I devices
are those devices for which safety and effectiveness can reasonably be assured through general controls, such as device listing,
adequate labeling, and adherence to the Quality Management System Regulation (“QMSR”) as well as Medical Device
Reporting (“MDR”), labeling and other regulatory requirements. Some Class I medical devices are exempt from the
requirement of Pre-Market Notification or clearance. Class II devices are those devices for which safety and effectiveness can
reasonably be ensured through using special controls, such as performance standards, post-market surveillance and patient
registries, as well as adherence to the general controls’ provisions applicable to Class I devices. Class III devices are
devices that generally must receive clearance by the FDA pursuant to a pre-market approval prior to marketing to ensure their
safety and effectiveness. Generally, Class III devices are limited to life-sustaining, life-supporting, or implantable devices.
However, this classification can also apply to novel technology or new intended uses or applications for existing devices. Our
products are primarily either Class I or Class II medical devices.

4

Pursuant
to FDA requirements, we have registered our manufacturing facility with the FDA as a medical device manufacturer and
listed the medical devices we manufacture. We are also subject to inspection on a routine basis for compliance with FDA
regulations. This includes the Quality Management System Regulation (“QMSR”), which requires that we manufacture our
products and maintain our documents in a prescribed manner with respect to issues such as design controls, manufacturing, testing,
and validation activities. Further, we are required to comply with other FDA requirements with respect to labeling and MDR
regulations which requires that we provide information to the FDA on deaths or serious injuries alleged to have been associated
with the use of our products, as well as any product malfunctions that are likely to cause or contribute to death or serious injury
if the malfunction were to recur. We believe that we are currently in material compliance with all relevant QMSR and MDR
requirements.

In
addition, our facility is required to have a California Medical Device Manufacturing License. The license is not transferable and
must be renewed biannually. Our current license is valid until November 19, 2026. Through compliance with FDA and California
regulations, we can market some of our medical devices throughout the United States. International sales of medical devices are also
subject to the regulatory requirements of each country where the product is sold. In Europe, the directives of the European Union
(“EU”) require that a device has a CE Mark in order to be sold in EU countries. We comply with In Vitro Diagnostic
Medical Devices Directive (“IVDD”) 98/79/EC, Medical Devices Regulation (EU) 2017/745 MDR and In Vitro Diagnostic
Medical Devices Regulation (EU) 2017/746) (“IVDR”). We also comply with ISO 13485:2016 Medical Devices Quality
Management Systems – Requirements for Regulatory Purposes and EN ISO 14971:2019 Medical devices – Application of Risk Management to Medical Devices.

At
present, outside of the EU, the international regulatory review process varies from country to country. We work with our distributors
and sales representatives in the foreign countries in which we market our products to ensure that we comply with the regulatory laws
of those countries. We believe that our international sales to date have been in compliance with the laws of all foreign countries in
which we have made sales. Exports of most medical devices are also subject to certain FDA regulatory controls.

The designing, development, manufacturing,
marketing, post-market surveillance, distribution, advertising, and labeling of our immunoassay IVD medical device products are
subject to regulation in the United States by the Center for Devices and Radiological Health of the FDA and state agencies. FDA
regulations require that some new products have pre-marketing clearance or approval by the FDA and require these products to be
manufactured in accordance with the FDA’s current Good Manufacturing Practice (“cGMP”) regulations, to be
extensively tested and to be properly labeled to disclose test results and performance claims and limitations. After a product that
is subject to FDA regulation is placed on the market, numerous regulatory requirements apply, including, for example, the
requirement that we comply with recordkeeping and reporting requirements, such as the FDA’s medical device reporting
regulations and reporting of corrections and removals. The FDA enforces these requirements by inspection and post-market
surveillance. The last FDA-announced inspection was in May 2024 and no observations were noted. We believe that all our
products sold in the United States comply with the FDA and applicable state regulations.

We
are a FDA-regulated and ISO 13485:2016-certified IVD Medical Devices company. Our goal is to provide
high quality medical diagnostic products that generally meet or exceed customer requirements and comply with all applicable
regulatory requirements: FDA 21 CFR Part 820 Quality Management System Regulation, ISO 13485:2016/A11:2021, Medical Devices Quality
Management Systems – Requirements for Regulatory Purposes, In Vitro Diagnostic Medical Devices Directive 98/79/EC IVDD, Medical
Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746) IVDR, Guidelines related to
Medical Devices Directive/Regulation Guidance on CE Marking, among others. We involve our employees in a continuous improvement
process to increase productivity, improve quality, and maintain the suitability, adequacy, and effectiveness of our quality
management system.

The
IVDR (EU) 2017/746 was effective on May 26, 2022. Manufacturers need to update their technical documentation and processes to meet the
more stringent regulatory requirements of the European Union. Notified Bodies can begin certifying devices to the new IVDR requirements
once they have been designated under IVDR by their Competent Authority. Our Notified Body is officially designated under the IVDR and
listed in the European Commission NANDO database since August 19, 2021. We are working closely with our Notified Body to update our technical
documentation to comply with these more stringent IVDR requirements. We received 1st IVDR Certificate (IVDR_40108 rev. 0)
on January 13, 2025 for the scope of “In Vitro Diagnostic Medical Devices: Reagent Test Kits intended to be used for the screening
of Intolerances.”

5

Per
IVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices with a CE certificate that was issued
in accordance with IVDD may be placed on the market or put into service until December 31, 2027, providing a formal application to the
notified body has been made by May 26, 2026.

In
accordance with these requirements, we submitted the IVDR Technical Documentation and made a formal application to our Notified Body
for our Self-Testing Rapid Test products (Class B and Class C) prior to May 26, 2025. For our ELISA Professional products (Class B),
we plan to submit the IVDR Technical Documentation and make the corresponding formal application to the Notified Body prior to May 26,
2027.

Per
IVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices without a CE certificate that was issued
in accordance with IVDD, for which a declaration of conformity was drawn up prior to May 26, 2022, per IVDD and for which the conformity
assessment procedure pursuant to IVDR requires the involvement of a Notified Body, may be placed on the market, or put into service until
the following dates. We also have until the following dates to update the technical documentation and processes to meet these regulatory
requirements of IVDR 2017/746 providing a formal application to the notified body has been made:

(1)
December
31, 2027, for Class D devices, formal application to notified body by May 26, 2025;

(2)
December
31, 2028, for Class C devices, formal application to notified body by May 26, 2026. Our Class C Self-Testing Rapid Test products
meet this requirement through submission prior to May 26, 2025;

(3)
December
31, 2029, for Class B devices, formal application to notified body by May 26, 2027; Our Class B Self-Testing Rapid Test products
were submitted prior to May 26, 2025, and our Class B ELISA Professional products are planned for submission prior to May 26, 2027;
and

(4)
December
31, 2029, for Class A devices placed on the market in sterile condition, formal application to notified body by May 26, 2027.

We
continue to update our technical documentation, quality management system, and associated processes to ensure compliance with the requirements
of IVDR (EU) 2017/746 within the applicable transition timelines.

SEASONALITY
OF BUSINESS

Our
business has not been subject to significant seasonal fluctuations.

INTERNATIONAL
BUSINESS

The
following table sets forth the dollar volume of revenue attributable to sales to domestic customers and foreign customers during our
last two fiscal years:

For The Year Ended May 31,

2026
2025

Revenues from sales to unaffiliated customers:

North America
$ 1,466,000
33 %
$ 1,658,000
31 %

Asia
1,409,000
32 %
1,718,000
32 %

Europe
1,117,000
25 %
1,297,000
24 %

Middle East
446,000
10 %
630,000
12 %

South America
15,000
0 %
8,000
0 %

Total
$ 4,453,000

$ 5,311,000

Our
international operations face distinct risks that differ from those encountered in the United States. These risks include economic
fluctuations, regulatory changes, geopolitical instability (such as terrorism and trade disputes), tariffs, embargoes,
import/export restrictions, and potential disruptions in shipping and distribution channels. Such factors can significantly impact
our foreign sales and may complicate our ability to collect accounts receivable in international markets during economic
downturns.

Each
country has its own licensing requirements for diagnostic products, which can differ considerably from the United States regulations
and may change unexpectedly. Currently, our international sales rely on 38 independent distributors across around 30 countries.
These diverse factors contribute to the complexities and uncertainties associated with our international business operations.

INTELLECTUAL
PROPERTY

We
consider the protection of our methodologies, designs, product formulations, manufacturing processes, diagnostic procedures, copyrights,
service marks, trademarks, and trade secrets essential for our future success. To safeguard our proprietary rights in products and services,
we utilize copyright, trademark, patent, service mark, and trade secret laws, alongside contractual restrictions. Our efforts include
confidentiality and invention assignment agreements with employees and contractors, as well as nondisclosure agreements with most fulfilment
and strategic partners to restrict access to and disclosure of proprietary information. However, these measures may not entirely prevent
unauthorized use or disclosure of our technology.

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In
the past, we have licensed and may continue to license certain proprietary rights, such as trademarks, patents, trade secrets, or copyrighted
material, to third parties. While we strive to maintain the quality of our product brands through these license agreements, we cannot
guarantee that licensees will always act in a manner that preserves the value of our proprietary rights or reputation.

LICENSE
OF THIRD-PARTY INTELLECTUAL PROPERTY

On
occasion, we have in-licensed both exclusive and non-exclusive rights to trade secrets,
intellectual property, and patents owned by third parties. These license agreements typically require royalties and other
payments, or are use by us to perform contract work for others.

We
have a royalty agreement in which we obtained rights to manufacture and market an Adrenocorticotropic Hormone test (“ACTH test”)
(used to detect chronic metabolic conditions). Royalty expenses of approximately $7,000, respectively, are included in cost of sales
for this agreement for the fiscal years ended May 31, 2026 and 2025. Sales of products manufactured under this agreement are not material
to total sales for the fiscal years ended May 31, 2026 and 2025. We may license other products or technology in the future
as it is deemed necessary or opportunistic for conducting business.

Some
of the products that we manufacture, sell, or use may be covered by claims in issued patents held by other persons or entities, and as
such, upon notice from such persons or entity we may be required to pay a license fee or may be required to cease all manufacture, sale
or use of such products, which could negatively impact us. While we have not been notified of any such claims by third parties, we cannot
guarantee that such claims will not be made in the future.

BRANDS
AND TRADEMARKS

We
occasionally register our tradenames with the United States Patent and Trademark Office (“USPTO”). Of note, we registered
the tradename “inFoods” on December 24, 2016. Our unregistered tradenames are “EZ Detect,” “EZ-H.P.,”
and “EZ-PSA”. A trademark for “Aware” was issued and assigned in 2001, renewed in 2011 and 2021. On January 11,
2020, the USPTO renewed our “FORTEL” trademark for another ten years.

The
laws of some foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States. Effective
copyright, trademark, and trade secret protection may not be available in such jurisdictions.

PATENTS
AND INFOODS TECHNOLOGY

We
have filed dozens of international patent applications and applications under the Patent Cooperation Treaty (“PCT”) and have
multiple provisional and patent applications pending with the USPTO. A substantial portion of our issued and pending patents relate to
the inFoods® technology platform.

Our
most important family of patent applications pertains to our inFoods® technology platform, which is a method of diagnosing and
treating symptoms of many different inflammatory diseases. Our first product launch using this technology is the inFoods® IBS product
which is designed to diagnose and treat IBS. Using a patient blood sample, a physician or lab can run our test to identify specific foods
(e.g., pork, milk, onions, sugar, chickpeas) that, if eliminated from an IBS patient’s diet, can alleviate or reduce the individual’s
IBS symptoms, including, but not limited to, constipation, diarrhea, bloating, cramping, severe pain, and indigestion. We have filed
many patent applications with the USPTO and with other such similar agencies in other countries outside of the United States pertaining
to this inFoods® technology. These patent applications include claims that address the diagnosis and treatment of several disease
states including IBS, functional dyspepsia, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease, osteoarthritis,
psoriasis, migraine headaches, and depression. The first inFoods® IBS patents filed by us pertained to IBS. Several of these patents
pertaining to the inFoods® technology have been issued and others are in active review and prosecution.

In
August 2018, we received our first patent pertaining to the inFoods® technology platform from the Korean Intellectual Property Office,
covering IBS. Since then, we have been granted a total of 36 patents. The USPTO has issued two patents with claims relating to our inFoods®
technology for testing and treating patients with
IBS. Patents relating to IBS have also been issued in Australia, Canada (two patents), Japan (three patents), Korea (three patents),
Mexico, Panama, Peru and Singapore, covering our inFoods® technology. Additional patent applications pertaining to the inFoods®
IBS product are in prosecution and review at the USPTO and with the patent issuance authorities in other countries.

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We
are also developing and have filed patents with claims that cover products that target other diseases utilizing the inFoods®
technology platform. We have dozens of patents that are issued, in prosecution or review, pertaining to these other diseases,
including: Functional Dyspepsia, Crohn’s disease, Ulcerative Colitis, GERD, Migraine Headaches, Depression, and
Osteoarthritis. In addition, we have a family of patents that cover the use of certain information technology (“IT”)
platforms and artificial intelligence/machine learning (“AI/ML”) tools that could assist patients in identifying and
avoiding packaged or processed food that contain specific foods that they are trying to eliminate from their diet.

In
addition to our inFoods® IBS related issued patents, we have also been issued inFoods® technology patents pertaining to the following
diseases in the following jurisdictions:


Attention
Deficit Disorder (“ADD”) and Attention Deficit Hyperactivity Disorder (“ADHD”): Australia, European Patent
Office (EP), Unitary Patent (“UP”), Japan, and Mexico.


Crohn’s
Disease: Mexico, EP, United Kingdom (UK), UP


GERD
Disease: Australia, EP, UP, UK


Migraine
Disease: Japan, EP, UK and UP


Osteoarthritis
Disease: Mexico, Japan


Psoriasis
Disease: AU, EP, UK, UP


Psychological
depression: US, EP, Japan, Mexico, UK, UP


Ulcerative
Colitis: EP, Japan, UK, UP


IT
based food monitoring and elimination technology: Japan

Due to the high cost of prosecuting new patents, and
maintaining issued patents, we have begun to abandon certain patent applications in select countries, as these applications have been
deemed less strategic to the Company’s future business plan. These actions have significantly lowered ongoing intellectual property related legal expenses.

We
believe the claims in our currently issued inFoods® IBS patents and claims in our pending patents that protect the use of the
inFoods® technology to diagnose and treat various other diseases, provide us with certain protections from other companies
making or selling competing products in this highly disruptive new field of medicine.

In
addition to the use of our own patents, we have been granted from third parties the rights to use, manufacture and sell certain products
that are protected by patents or other intellectual property owned by these third parties. In some cases, royalties are paid on the sales
of these products. In other cases, we generate revenues from others by manufacturing on their behalf, the products that are covered by their
intellectual property. We anticipate that we will license or purchase the rights to other products or technologies in the future.

We
also engage in contract research and development and contract manufacturing for third party companies. The technologies that relate to
this contract research and development and manufacturing are protected by patents and other intellectual property. In these situations,
this intellectual property is typically licensed to us under a limited license agreement enabling us to perform the services being contracted.

With
the launch of inFoods® IBS, our business model for this product includes the potential out-licensing of the product and related patents
to a large international life sciences or technology company that could commercialize it or support us in its commercialization. Additionally,
we may explore out-licensing opportunities for the patents or intellectual property associated with other products, including our H.
pylori product.

EMPLOYEES

As
of May 31, 2026 and 2025, we employed a total of 50 and 54 employees, respectively, in the United States, Mexico, UK and Germany, of
which 50 and 53 were full-time employees, respectively.

We
engage a range of external experts. including Ph.D.’s, M.D.’s, and other industry specialists, as well as medical institutions,
to support various aspects of our operations. These services include technical support, regulatory guidance, marketing and public relations,
financial advisory, and contract product development and manufacturing. To safeguard our proprietary information and intellectual property,
we implement confidentiality agreements, intellectual property ownership clauses, and indemnification provisions with these external
parties. Despite these measures, we cannot guarantee complete protection against third-party claims or potential intellectual property
theft.

CORPORATE
HISTORY

Biomerica,
Inc. is a Delaware corporation. We operate through two wholly owned subsidiaries: Biomerica de Mexico, which serves as an assembly and
manufacturing facility, and BioEurope GmbH, which functions as a distributor of our products in international markets.

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