What changed in this filing

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Item 1. Business

2025-08-29 compared with 2024-08-28 · 246 added, 264 removed, 194 unchanged (72% of the section changed)

(“Biomerica,” the “Company,” “we,” “us,” or “our”) was incorporated

in Delaware in September 1971 as Nuclear Medical Systems, Inc., and later changed its name to Biomerica, Inc.

The Company has two wholly

owned subsidiaries, Biomerica de Mexico, which is used for assembly/manufacturing, and BioEurope GmbH, which acts as a distributor of

Biomerica products in certain markets.

are a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products.

Our diagnostic test kits are utilized in the analysis of blood, urine, nasal, or fecal samples for the diagnosis of various diseases,

food intolerances, and other medical conditions.

These kits also measure levels of specific hormones, antibodies, antigens, and other substances,

which may exist in the human body at extremely low concentrations.

Our products are designed to enhance health

and well-being while reducing overall healthcare costs.

Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis of various diseases,

food intolerances, and other medical complications.

They can also be used to measure or detect the presence and levels of specific bacteria,

hormones, antibodies, antigens and other substances, which may exist in the human body in extremely small concentrations.

are designed to enhance the health and well-being of people, while reducing total healthcare cost.

extensive range of medical diagnostic products is sold worldwide, primarily in two markets:

clinical laboratories and point-of-care settings,

including physicians’ offices and over-the-counter sales at major retailers such as Walmart, CVS Pharmacy, and Amazon.

our products are Conformite Europeenne (“CE”) marked and/or registered with regulatory agencies in various countries for diagnostic use, with several also cleared

for sale in the United States by the FDA.

IMPACT OF COVID-19 ON REVENUES

In response to the global COVID-19 pandemic, we began developing, marketing, and selling COVID-19 diagnostic tests

in March 2020.

These tests contributed significantly to our revenues during fiscal years 2021 and 2022.

However, demand sharply declined

in fiscal 2023, leading to no sales of COVID-19-related products in fiscal 2024.

As a result, our COVID-19 product sales have caused significant

fluctuations in our revenues over the past four years.

contrast, our non-COVID-19 products, have accounted for approximately 100% and 96% of our revenues during the fiscal years ended May

31, 2024, and 2023, respectively, and have remained our core focus.

TECHNOLOGICAL ADVANCEMENTS AND PRODUCT

clinical laboratories and point-of-care

Most of our products are Conformite Europeenne (“CE”) marked and/or registered with regulatory agencies in various

countries for diagnostic use, with several also cleared by the U.S.

Food and Drug Administration (“FDA”) for sale in the

United States.

TECHNOLOGICAL

advances in medical diagnostics have enabled the performance of diagnostic tests not only in clinical laboratories but also at home

and in point-of-care settings, such as physicians’ offices.

A key objective for us has been the development and marketing of

rapid diagnostic tests that are accurate, utilize easily obtained patient specimens, and can be performed without the need for

complex instrumentation.

Our over-the-counter (home use) 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 that properly developed and utilized rapid point-of-care tests can match the accuracy of laboratory tests, delivering reliable results in

minutes with minimal or no instrumentation.

RESEARCH AND DEVELOPMENT

invest considerable resources in the research and development of new products designed to diagnose and, in some cases, treat several

major medical diseases.

These products are both internally developed and obtained through licensing agreements.

Our experienced and

highly trained technical personnel, including Ph.D.

holders and other scientists, are dedicated to developing new products and

managing technology transfer activities.

Many of our technical staff have extensive industry experience from previous employment at

large diagnostic manufacturing companies.

We also rely on our Scientific Advisory Board, comprised of leading medical doctors and

clinicians, to guide our clinical studies and product development efforts.

KEY PRODUCT LAUNCHES

key outcome of our recent research and development efforts is our patented diagnostic-guided therapy (“DGT”) product, developed on the

inFoods® technology platform.

This innovative product is designed to treat gastrointestinal conditions such as irritable bowel syndrome

(“IBS”) and other inflammatory diseases, targeting chronic inflammatory conditions prevalent in large markets.

The inFoods® IBS product,

which we have already launched, uses a simple blood test to identify patient-specific foods that, when eliminated, may alleviate IBS

symptoms such as pain, bloating, diarrhea, cramping, and constipation.

Unlike broad dietary restrictions, the inFoods® IBS product

pinpoints a patient’s heightened immunoreactivity to specific foods known to frequently trigger IBS symptoms, providing targeted

have launched our inFoods® product across numerous gastroenterology (“GI”) physician groups in various states and regions, including

collaboration with one of the largest GI groups in the U.S.

Feedback from GI specialty physicians has been positive, and we are actively

expanding our network by onboarding additional physician practices.

Our dedicated sales team is focused on deepening relationships within

the GI segment and targeting opportunities to introduce inFoods® to other medical specialties, including integrated health practices

and concierge physicians.

We are also evaluating distribution, partnership, and licensing opportunities with U.S.

and multinational

companies to accelerate the commercialization and growth of inFoods® products both domestically and internationally.

our inFoods ® product line, our additional efforts have led to a significant milestone by receiving FDA clearance in December

2023 for hp+detect ™ , a new diagnostic test for detecting Helicobacter pylori (H.

pylori) bacteria in the gastrointestinal

pylori is a widespread infection, affecting an estimated 35% of the U.S.

population and 45% of the population in Europe’s

five largest countries.

This bacterium is recognized as the strongest known risk factor for gastric cancer, which is the third most common

cause of cancer-related deaths globally.

hp+detect™ test provides physicians and medical centers with a reliable tool for diagnosing H.

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.

One of our key objectives has been to develop and market rapid diagnostic tests that

are accurate, utilize easily obtained patient specimens, and are simple to perform without the need for complex instrumentation.

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.

Our products require limited to no instrumentation,

deliver reliable results in minutes, and can be performed with confidence at home or in a physician’s office.

AND DEVELOPMENT

invest resources in the research and development of new products designed to diagnose and, in some cases, treat several major medical

These products are either internally developed or licensed from others.

Our experienced and highly trained technical personnel,

including Ph.D.

holders and other scientists, are dedicated to developing new products and managing technology transfer activities.

technical staff, many of whom, have extensive experience from previous employment at large diagnostic manufacturing companies, bring

a wealth of industry knowledge.

Additionally, we rely on our Scientific Advisory Board, comprised of leading medical doctors and clinicians,

to guide our clinical studies and product development efforts.

the fiscal years ended May 31, 2025 and 2024, consolidated research and development expenses totaled approximately $1,023,000 and $1,491,000,

respectively.

The decrease reflects our transition from intensive product development to the commercialization phase of inFoods®

IBS and hp+detect™, as well as our broader efforts to manage costs and preserve cash.

IBS, we are pursuing 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® diagnostic technology for these indications, with patents

issued in the United States and multiple foreign jurisdictions, and others in review or prosecution.

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.

pylori is a leading cause of peptic ulcers and a significant risk factor

for gastric cancer.

While commercialization activities for hp+detect™ are at an early stage, we continue to position the product

as a reliable diagnostic option for laboratories and physicians.

PRODUCT LAUNCHES

key outcome from 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 in large markets.

We have launched inFoods® IBS product, which leverages this pateneted 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

By removing the foods identified as problematic, patients can achieve relief from IBS symptoms.

have introduced our inFoods® product to gastroenterology (“GI”) physician groups in multiple states and regions,

including collaboration with one of the largest GI groups in the U.S.

The initial phase was 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 Gastroenteroloy.

assessing distribution, partnership, and licensing opportunities with large U.S.

distributors to support broader

availability and sale/marketing.

We are actively pursuing insurance reimbursement for the InFoods IBS product in conjunction with

our CLIA laboratory partner.

we continue pursue commercial opportunities in both U.S.

and international markets, we remain attentive to evolving global economic conditions,

including uncertainties related to international trade policies, tariffs, and supply chain dynamics.

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.

We continue to monitor these

developments closely and are actively 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 of our products through our European subsidiary (BioEurope), and our Mexican subsidiary

(BioMexico), to mitigate some of the risk these policies may have on our revenues and operations.

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.

pylori is a prevalent infection, affecting approximately 35% of the U.S.

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

the effectiveness and safety of treatments.

The diagnostic test is marketed directly to laboratories, where patient samples are analyzed.

We are actively promoting hp+detect™ to large end-customer labs to support its launch and distribution, aiming to enhance patient

care through timely and accurate detection of H.

pylori infections.

treatment effectiveness.

We are currently in

discussions with large end-customer laboratories for our hp+detect™ to position it for commercial adoption.

INITIATIVES AND COST MANAGEMENT

to slower-than-expected launches of our key products, inFoods ® IBS and hp+detect ™ , we have initiated significant cost-cutting measures to extend our cash runway and work towards increasing revenues to cover overhead

These measures include a workforce reduction of nearly 15% and a significant reduction in expenses.

Additionally, we are actively exploring strategic opportunities

to enhance shareholder value.

OPERATIONS AND GLOBAL PRESENCE

part of our ongoing commitment to operational efficiency and disciplined capital management, we have taken proactive steps to optimize

our cost structure and extend our cash runway.

These actions, which include a workforce reduction of approximately 15% during this fiscal

year, which incurred costs such as severance, impacting typical cost trends and margins.

Additionally, we raised $2,015,000 in net proceeds

from the ATM offering filed in May 2024 ,

providing additional liquidity to support our operations.

We are actively exploring strategic opportunities to enhance and create shareholder

AND GLOBAL PRESENCE

is headquartered in Irvine, California, where it centralizes administration, finance, regulatory compliance, product development, sales,

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and quality of our products and to comply with applicable FDA and international regulations.

manufacturing operations and facilities are regulated by the FDA Good Manufacturing Practices for medical devices.

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, CE Mark and International Organization for Standardization

(“ISO”) regulations.

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 that we

AND DEVELOPMENT

employ a team of highly qualified technical personnel, including Ph.D.

holders and experts with extensive experience in the

development and production of diagnostic tests, to support our research and development (“R&D”) initiatives.

Our team is actively

engaged in enhancing existing products and driving ongoing innovation.

R&D expenses encompass materials, supplies, personnel,

consultants, facilities, outside clinical trial sites, equipment, and contract services.

For the fiscal years ended May 31, 2024,

and 2023, consolidated R&D expenses totaled approximately $1,491,000 and $1,584,000, respectively.

We anticipate that R&D

expenses will decrease significantly in the upcoming quarters as we are in the commercialization phase of inFoods ®

and hp+detect ™ and in an effort to preserve cash.

cornerstone of our R&D efforts is the development of our proprietary

diagnostic-guided therapy, known as the inFoods® technology.

This platform enables physicians to identify patient-specific foods (e.g.,

pork, milk, onions, sugar, chickpeas) that, when eliminated from the patient’s diet, may alleviate or improve symptoms of IBS and other conditions.

We have filed patents globally related to the use of inFoods® diagnostic technology for

detecting abnormal immune responses in patients with various diseases.

Many of these patents have been recently issued, while others are

in the review and prosecution phase.

The United States Patent and Trademark Office (“USPTO”) has granted us two patents with broad claims

protecting the inFoods® IBS product.

Additionally, patents have been issued in Australia, Japan, Korea, Mexico, and Singapore.

patent applications related to the inFoods® IBS product are pending or under review in the United States and other countries.

We are also developing and have filed patents for additional products targeting

other diseases using the inFoods® technology platform.

These diseases include Functional Dyspepsia, Crohn’s Disease, Ulcerative

Colitis, Gastroesophageal Reflux Disease (“GERD”), Migraine Headaches, Depression, and Osteoarthritis.

In addition to our issued U.S.

we now hold 3 6 foreign patents that have either been issued or for which we have received

a notice of allowance, covering over 50 countries.

These patents protect the use of inFoods® technology for IBS and several other

Notably, our first patent allowed for a disease other than IBS was granted in Japan in August 2021, covering the use of inFoods®

technology for diagnosing and treating depression.

additional R&D efforts have led to the 510(k) clearance of our proprietary H.

pylori test, hp+detect ™ , which is

designed to provide highly accurate sensitivity and specificity for detecting H.

pylori and monitoring treatment.

manufacturing operations and facilities are regulated by the FDA Current Good Manufacturing Practices for medical devices.

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, CE Mark and International Organization for

Standardization (“ISO”) regulations.

We either produce our own antibodies and antigens or purchase these materials from qualified

We have alternate, approved sources for most critical raw materials and are working to procure alternate sources for the few

that we do not have.

AND METHODS OF DISTRIBUTION

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She also has strong relationships with key strategic entities in Europe,

Eastern Europe, Latin America, Canada, and the United States and we expect that she will continue to help Biomerica add new distributors

Eastern Europe, Latin America, Canada, and the United States and we expect that she will continue to help us add new distributors

for existing products and add new product-lines for future distribution by us.

rely on affiliated and unaffiliated distributors, advertising in medical and trade journals, exhibitions at trade shows, direct mailings,

rely on distributors, advertising in medical and trade journals, exhibitions at trade shows, direct mailings,

and an internal sales staff to market our diagnostic products.

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testing (physicians’ offices and over-the-counter drug stores).

net sales were approximately $5,415,000 for fiscal 2024, compared to $5,339,000 for fiscal 2023.

For the fiscal years ended May 31, 2024,

and 2023, the Company had one distributor each year that accounted for 33% and 35% of our net sales, respectively.

gross receivables as of May 31, 2024, and 2023 were approximately $966,000 and $751,000, respectively.

As of May 31, 2024, and 2023,

the Company had four and one distributor, respectively, that accounted for a total of 64% and 36% of gross accounts receivable.

64% as of May 31, 2024, 37% was owed by a distributor in Asia.

net sales were approximately $5,311,000 for fiscal year ended May 31, 2025, compared to $5,415,000 for fiscal year ended May 31,

For the fiscal years ended May 31, 2025, and 2024, the Company had one distributor each year that accounted for 31%

and 33% of our net sales, respectively.

gross receivables were approximately $757,000 and $966,000 as of May 31, 2025 and 2024, respectively.

As of those dates, four distributors

accounted for approximately 69% and 64% of gross accounts receivable, respectively.

Of the 69% concentration as of May 31, 2025, 27%

was attributable to a distributor located in North America.

of May 31, 2025, and 2024, Biomerica’s backlog of unshipped orders was approximately $1,324,000 and $755,000, respectively.

May 31, 2024, the majority of this backlog consisted of orders intended for a distributor in Asia.

of May 31, 2025, the majority of this backlog consisted of orders intended for shipment to Asia.

utilizes a range of principal raw materials including chemicals, serums, reagents, and packaging supplies.

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products in various stages of completion.

the fiscal year ended May 31, 2024, purchases from one vendor accounted for 16% of our raw material procurement, primarily related to

In contrast, for the fiscal year ended May 31, 2023, the Company did not experience significant vendor concentration in raw material

offer several proprietary products with notable competitive advantages, including our EZ Detect colon disease home test, the Aware Breast

Self-Exam product, our inFoods ® IBS product, and hp+detect ™ for H.

the fiscal year ended May 31, 2025, 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, 2024, purchases from one vendor accounted for approximately

16% of our total raw material procurement, also primarily related to commodity plastic products.

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.

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primary business consists of selling products that are generally legally defined as medical devices and in vitro diagnostic medical devices.

As a result, we are considered to be a medical devices and in vitro diagnostic medical devices manufacturer, and as such, we are subject

to the regulations issued and enforced by of numerous governmental entities.

These agencies include the FDA, Environmental Protection

Agency, Federal Trade Commission, Occupational Safety and Health Administration, U.S.

Department of Agriculture (“USDA”),

and Consumer Product Safety Commission, as well as 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 in vitro diagnostic medical

devices and 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 matters.

As a result, we are a medical devices and in vitro diagnostic medical devices manufacturer, and as such, we are subject to the regulations

issued and enforced by of numerous governmental entities.

These agencies include the FDA, Environmental Protection Agency, Federal Trade

Commission, Occupational Safety and Health Administration, U.S.

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 in vitro diagnostic 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.

Food, Drug & Cosmetic Act of 1938 (the “FDCA”) regulates medical devices in the United States by classifying them into

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devices for which safety and effectiveness can reasonably be assured through general controls, such as device listing, adequate labeling,

and adherence to the Quality System Regulation (“QSR”) 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 the use of special controls,

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

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 prior to marketing by the FDA pursuant

to a pre-market approval to ensure their safety and effectiveness.

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,

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We are also subject to inspection on a routine basis for compliance with FDA regulations.

This includes the QSR,

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 QSR and MDR requirements.

This includes the Quality

System Regulation (“QSR”), 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 QSR and MDR requirements.

addition, our facility is required to have a California Medical Device Manufacturing License.

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In Europe, the directives of the European Union (“EU”)

require that a device have a CE Mark in order to be sold in EU countries.

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 and Medical Devices Regulation 2017/745 (“MDR”).

We also comply with ISO 13485:2016 Medical

Devices Quality Management Systems – Requirements for Regulatory Purposes.

(“IVDD”) 98/79/EC, Medical Devices Regulation (EU) 2017/745 MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746)

We also comply with ISO 13485:2016 Medical Devices Quality Management Systems – Requirements for Regulatory

Purposes and EN ISO 14971:2019.

present, outside of the EU, the international regulatory review process varies from country to country.

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Exports of most medical devices are also subject to certain FDA regulatory controls.

designing, development, manufacturing, marketing, post-market surveillance, distribution, advertising, and labeling of Biomerica’s

immunoassay in vitro diagnostic (“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

designing, development, manufacturing, marketing, post-market surveillance, distribution, advertising, and labeling of our immunoassay

in vitro diagnostic (“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,

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The last FDA-announced inspection was in May 2024 and no observations were noted.

We believe that all Biomerica products sold in the

United States comply with the FDA and state regulations.

We believe that all our products sold in the United

States comply with the FDA and applicable state regulations.

are an FDA-regulated and ISO 13485:2016-certified In Vitro Diagnostic Medical Devices company.

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CFR Part 820 Quality Management System, ISO 13485:2016, Medical Devices Quality Management Systems – Requirements for Regulatory

Purposes, In Vitro Diagnostic Medical Devices Directive 98/79/EC & and Medical Device Regulation 2017/745, Guidelines related to

Medical Devices Directive/Regulation Guidance on CE Marking, among others.

Biomerica involves its employees in a continuous improvement

process to increase productivity, improve quality and maintain the suitability, adequacy, and effectiveness of our quality management

EU In Vitro Diagnostic Medical Device Regulation (“IVDR”) 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.

Notified Body is officially designated under the IVDR and listed in the European Commission NANDO database since August 19, 2021.

are working closely with our Notified Body to update our technical documentation to comply with these more stringent IVDR requirements.

Purposes, In Vitro Diagnostic Medical Devices Directive 98/79/EC, 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.

EU In Vitro Diagnostic Medical Device Regulation (“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

Notified Bodies can begin certifying devices to the new IVDR requirements once they have been designated under IVDR by their Competent

Our Notified Body is officially designated under the IVDR and listed in the European Commission NANDO database since August

We are working closely with our Notified Body to update our technical documentation to comply with these more stringent IVDR

requirements.

IVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices with a CE certificate that was issued

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notified body has been made by May 26, 2025.

Renewal of CE Certificate for IVDD Quality System was granted to Biomerica.

Biomerica received an extended CE Certificate on May 24,

2022, which remains effective until May 26, 2025.

accordance with the regulation, we submitted a formal application to the notified body by May 26, 2025.

IVDR 2017/746 Amendment Regulation (EU) 2022/112, and published proposal 2024/0021 (COD), devices without a CE certificate that was issued

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the following dates.

Biomerica also has until the following dates to update the technical documentation and processes to meet these regulatory

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:

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31, 2029, for class B devices, formal application to notified body by May 26, 2027;

31, 2029, for class A devices placed on the market in sterile condition, formal application

to notified body by May 26, 2027.

31, 2029, for class A devices placed on the market in sterile condition, formal application to notified body by May 26, 2027.

business has not been subject to significant seasonal fluctuations.

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Our efforts include

confidentiality and invention assignment agreements with employees and contractors, as well as nondisclosure agreements with most fulfillment

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.

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agreements typically require royalties and other payments.

have a royalty agreement in which we obtained rights to manufacture and market an ACTH test (used to detect chronic metabolic conditions).

Royalty expenses of approximately $10,000 and $13,000, respectively, are included in cost of sales for this agreement for the fiscal

years ended May 31, 2024 and 2023.

Sales of products manufactured under this agreement are not material to total sales for the fiscal

years ended May 31, 2024 and 2023, respectively.

We may license other products or technology in the future as it is deemed necessary

or opportunistic for conducting business.

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 and $10,000, respectively, are included in cost of sales for this agreement for the fiscal years

ended May 31, 2025 and 2024.

Sales of products manufactured under this agreement are not material to total sales for the fiscal years

ended May 31, 2025 and 2024, respectively.

We may license other products or technology in the future as it is deemed necessary or opportunistic

for conducting business.

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

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AND TRADEMARKS

occasionally register our tradenames with the USPTO.

Of note, we registered the tradename

“InFoods” on December 24, 2016.

Our unregistered tradenames are “EZ Detect,” “EZ-H.P.,” and “EZ-PSA”.

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.

On January 11,

2020, the USPTO renewed our “FORTEL” trademark for another ten years.

laws of some foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States.

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AND INFOODS TECHNOLOGY

have filed over 100 international and Patent Corporation Treaty patents (“PCT”) and have multiple provisional and non-provisional

have filed dozens of international and Patent Corporation Treaty patents (“PCT”) and have multiple provisional and non-provisional

patents currently filed with the USPTO.

Substantially all of our patents that are pending or registered pertain to the inFoods ®

Substantially 15 of our patents that are pending or registered pertain to the inFoods ®

technology platform.

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osteoarthritis, psoriasis, migraine headaches, and depression.

These applications include the use of this technology in both humans and

The first inFoods ® patents filed by us pertained to IBS.

Several of these patents pertaining to the inFoods ®

IBS technology have been issued and many more are in active review and prosecution.

Several of these patents pertaining to the inFoods ® IBS technology have been issued and many more are in active review

and prosecution.

August 2018, we received our first patent pertaining to the inFoods ® technology platform from the Korean Intellectual

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Since then, we have been granted a total of 15 patents.

The USPTO has issued the Company two patents with broad claims that protect our inFoods ® technology in testing

and treating patients with IBS.

Patents have also been issued in the countries of Australia (two patents), Canada, Japan (two patents),

Korea (two patents), Mexico, Panama, Peru, and Singapore, covering our inFoods ® IBS 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.

The USPTO has issued the Company two patents

with broad claims that protect our inFoods ® technology in testing and treating patients with IBS.

Patents have also

been issued in the countries of Australia, Canada, Japan (two patents), Korea (two patents), Mexico, Panama, Peru, and Singapore,

covering our inFoods ® IBS 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.

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 in prosecution or review pertaining to these other diseases, including:

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.

addition to our IBS related issued patents, we have also been issued inFoods ® technology patents in the following countries

pertaining to the following diseases:

Australia – Attention Deficit Disorder (“ADD”) and Attention Deficit Hyperactivity

Disorder (“ADHD”);

Australia – GERD;

Japan - psychological depression, IT based food monitoring and elimination technology;

China – IT based food monitoring and elimination technology.

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.

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.

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:

Deficit Disorder (“ADD”) and Attention Deficit Hyperactivity Disorder (“ADHD”):

Australia, European Patent

Office (EP), Unitary Patent Office (UP) for certain EU countries, Mexico

Mexico, EP, United Kingdom (UK), UP

Australia, EP, UP, UK

Osteoarthritis

Mexico, Japan

AU, EP, UK, UP

Psychological

US, EP, Japan, Mexico, UK, UP

EP, Japan, UK, UP

based food monitoring and elimination technology:

believe the claims in these issued inFoods ® IBS patents and claims in our pending patents that protect the use of the

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making or selling competing products in this highly disruptive new field of medicine.

addition to the use of our own patents, we have acquired from third parties the rights to manufacture and sell certain products that

are protected by patents or intellectual property owned by these third parties.

In some cases, royalties are paid on the sales of these

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.

We anticipate that we will license or purchase the rights to other products or technologies in the future.

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The technologies that relate to

this contract R&D 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.

have recently launched the inFoods ® IBS product.

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.

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.

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

pylori product.

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which 53 and 63 were full-time employees, respectively.

Various employees listed in the production department also perform research and

development duties as a routine function of their job.

We occasionally employ temporary employees when needed.

following is a breakdown of employees by departments:

Administrative

Research & Development

Sales & Marketing

Production & Operations

do engage in a range of external experts, including Ph.D.’s, M.D.’s, and other industry specialists, as well as medical institutions,

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.

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guarantee complete protection against third-party claims or potential intellectual property theft.

is a Delaware corporation.

The Company operates 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 the Company’s products in international markets.

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

What changed 10-K

Item 1. Business