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Biomerica, Inc. (BMRA): Business Model Canvas [Dec-2025 Updated] |
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Biomerica, Inc. (BMRA) Bundle
You're looking at a company in a clear pivot, and frankly, the numbers from Fiscal Year 2025 tell the story: Biomerica, Inc. booked $5.3 million in net sales while keeping R&D tight at just $1.0 million and SG&A at $4.6 million. This isn't just tinkering; they are shifting hard away from older kits toward their patented inFoods® Irritable Bowel Syndrome test and growing their Contract Development and Manufacturing Organization (CDMO) work. As an analyst who's seen this game before, understanding how they plan to drive revenue from this new focus-especially with planned expense cuts of up to $1.4 million-is defintely the key to seeing where the value is hiding. Dive into the full Business Model Canvas below to see the nine blocks that support this strategic bet.
Biomerica, Inc. (BMRA) - Canvas Business Model: Key Partnerships
You're looking at the structure that helps Biomerica, Inc. get its diagnostic products to market and validated, so let's break down the key players they rely on as of late 2025.
Henry Schein for U.S. Marketing of inFoods® IBS Test
Biomerica, Inc. announced a marketing services arrangement with Henry Schein, Inc. on October 16, 2025, to market the inFoods® Irritable Bowel Syndrome (IBS) test across the United States, specifically excluding New York State. This partnership taps into Henry Schein's established infrastructure to reach primary care and gastroenterology specialty practices nationwide.
Here are the concrete details on the partner's scale:
| Metric | Data Point |
| Henry Schein Annual Sales (2024) | Over $12 billion |
| Henry Schein U.S. Sales Representatives | More than 400 medical field sales and telesales representatives |
| Marketing Agreement Date | October 16, 2025 |
| Geographic Scope | United States, excluding New York State |
This reach is intended to accelerate adoption of the non-drug, personalized solution for IBS management.
International Distributors for EZ Detect and Fortel® Tests in MENA Region
Biomerica, Inc. is actively expanding its footprint in the Middle East and North Africa (MENA) region, focusing on regulatory clearances and distribution partnerships for its at-home tests. A key milestone in this area was the regulatory approval for the Fortel® PSA Screening Test in the United Arab Emirates (UAE).
- UAE Ministry of Health and Prevention approved Fortel® Ulcer Test for home use following the fiscal year-end (May 31, 2025).
- The Fortel® PSA Screening Test also received approval from the Saudi Food and Drug Authority (SFDA).
- Biomerica, Inc.'s net sales for the first quarter of fiscal 2026 (ended August 31, 2025) were $1.4 million, down from $1.8 million the prior year, with timing of international orders being a noted factor.
- For the third quarter of fiscal 2025, revenue grew 10% year-over-year to $1.10 million.
Major U.S. Clinical Research Centers for inFoods® Validation
The scientific foundation for the inFoods® IBS test is built upon a randomized, multicenter, double-blind, placebo-controlled trial. This pivotal study, with results published in the June 2025 issue of Gastroenterology, involved a specific number of patients across several prominent institutions.
The trial included 238 patients across eight U.S. academic centers. The following centers were explicitly named as participants in the validation process:
| Clinical Research Center | Affiliation/Note |
| Mayo Clinic | Participated in the pivotal trial. |
| Cleveland Clinic | Participated in the pivotal trial. |
| University of Michigan | Participated in the pivotal trial. |
| Beth Israel Deaconess Medical Center Inc. | Participated in the pivotal trial. |
The study demonstrated that 59.6% of patients eliminating identified trigger foods met the FDA-defined target for abdominal pain reduction, compared to 42.2% in the control group.
Third-Party Diagnostic and Biotech Companies for CDMO Services
Biomerica, Inc. is formalizing and expanding its Contract Development and Manufacturing Organization (CDMO) services to meet accelerating market demand from diagnostic innovators. The company's CEO noted a meaningful increase in interest from both large and small organizations seeking to leverage their expertise.
The CDMO services are explicitly stated as a growing contributor to revenue and an opportunity for growth. For the first quarter of fiscal 2026 (ended August 31, 2025), the gross profit increase was driven in part by a greater contribution from higher-margin contract manufacturing services, despite net sales declining to $1.4 million from $1.8 million year-over-year. The company's fiscal year 2025 revenue was $5.3 million.
Laboratory Partners for Processing inFoods® IBS Test Claims
The inFoods® IBS test is a Laboratory Developed Test (LDT) used within a single laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. A crucial partnership element is the recent receipt of a Proprietary Laboratory Analyses (PLA) code from the American Medical Association CPT Editorial Panel. This PLA code is the unique identifier that allows healthcare providers and Biomerica's laboratory partner to submit claims to Medicare and private insurers once a reimbursement price is set by the Centers for Medicare & Medicaid Services.
Biomerica, Inc. (BMRA) - Canvas Business Model: Key Activities
You're looking at the core actions Biomerica, Inc. is taking to drive its business forward as of late 2025. It's all about getting their advanced diagnostics, especially the inFoods® platform, through the regulatory maze and into the hands of clinicians and patients.
Manufacturing and marketing advanced in-vitro diagnostic products
Biomerica, Inc. manufactures and markets its portfolio of advanced diagnostic and therapeutic products for point-of-care and hospital/clinical laboratory use. The overall financial performance for the fiscal year ended May 31, 2025 (Fiscal 2025) showed net sales of $5.3 million, a slight decrease from $5.4 million the prior year. The gross profit for Fiscal 2025 was $498,000, resulting in a gross margin of 9%, down from 11% in the prior year. This compression was attributed to macroeconomic events affecting revenue and product mix. The company is actively managing its cost structure, having reduced Selling, General and Administrative expenses to $4.6 million in Fiscal 2025, down from $5.5 million the year before. Cash used in operating activities improved significantly to $3.8 million in Fiscal 2025, compared to $5.3 million in the prior year. This disciplined approach helped improve the operating loss by 19% year-over-year to $5.1 million.
Here's a quick look at the key financial outcomes for Fiscal 2025:
| Metric | Fiscal Year Ended May 31, 2025 | Fiscal Year Ended May 31, 2024 |
| Net Sales (Revenue) | $5.3 million | $5.4 million |
| Gross Profit | $498,000 | $611,000 |
| Gross Margin | 9% | 11% |
| Operating Loss | ($5.1 million) | ($6.4 million) |
| Cash Used in Operating Activities | $3.8 million | $5.3 million |
Commercializing the inFoods® IBS test and securing reimbursement
A major activity involves pushing the inFoods® IBS test through commercial channels. For the second quarter of fiscal 2025, gross margins improved to 27% from 21% year-over-year, partly due to a favorable sales mix shift toward higher-margin sectors. Following the fiscal year-end, Biomerica, Inc. launched direct-to-consumer availability for inFoods® IBS, significantly broadening patient reach via telehealth and digital channels. A key commercial step was the October 2025 marketing services agreement with Henry Schein, Inc., to market the test across the United States, excluding New York State. Henry Schein, Inc. reported over $12 billion in annual sales in 2024, giving Biomerica, Inc. significant national reach support. Furthermore, advancing reimbursement is critical; the American Medical Association CPT Editorial Panel issued a Proprietary Laboratory Analyses (PLA) code for the inFoods® IBS test, which advances the pathway for Medicare and Medicaid reimbursement and broader patient access.
Expanding Contract Development and Manufacturing Organization (CDMO) services
The company is actively working to expand its Contract Development and Manufacturing Organization (CDMO) services. This segment contributed to improved margins in recent quarters. For instance, in the second quarter of fiscal 2025, gross margins improved significantly, reflecting a favorable shift in the sales mix toward the Contract Manufacturing sectors. While the overall net sales for the first quarter of fiscal 2026 were $1.4 million, down from $1.8 million in the prior year's quarter, this decrease was partially offset by rising inFoods® IBS product sales, but the gross profit still increased due to a greater contribution from higher-margin contract manufacturing services.
Research and development on the inFoods® platform for new GI indications
Research and development (R&D) is a necessary activity, though Biomerica, Inc. has been actively managing these costs. R&D expenses for the full Fiscal 2025 year were reduced to $1.0 million, compared to $1.5 million in the prior year, as part of a broader cost-reduction goal. The company secured three new international patents covering applications of its inFoods® technology platform for various gastrointestinal conditions. The inFoods® IBS clinical study results were published in the June 2025 issue of Gastroenterology, showing statistically significant outcomes:
- 59.6% of patients eliminating identified trigger foods achieved the FDA's endpoint for abdominal pain reduction, versus 42.1% in the control group.
- For IBS-C patients, the treatment group saw 67.1% achieve the endpoint, compared to 35.8% in the control group.
- For IBS-M patients, the treatment group saw 66% achieve the endpoint, compared to 29.5% in the control group.
Obtaining global regulatory clearances, like EU IVDR certification
Securing global regulatory clearances is a non-negotiable activity for market expansion. A significant milestone was achieved on February 26, 2025, when Biomerica, Inc. announced it secured CE-marking under the European Union's new In Vitro Diagnostic Medical Devices Regulation (IVDR - 2017/746) for its food intolerance diagnostic tests targeting Crohn's Disease and Ulcerative Colitis. This certification ensures compliance with stringent European Union standards and allows sales in the EU. Furthermore, following the Fiscal 2025 year-end, the United Arab Emirates Ministry of Health and Prevention approved Biomerica, Inc.'s Fortel® PSA rapid screening test for home use, expanding its footprint in the Middle East. The company also noted that the EU IVDR certification can serve as a basis for easier market access in other international markets with stringent regulatory approval processes. Finance: draft 13-week cash view by Friday.
Biomerica, Inc. (BMRA) - Canvas Business Model: Key Resources
You're looking at the core assets Biomerica, Inc. (BMRA) relies on to execute its diagnostic and therapeutic strategy. These aren't just line items; they are the proprietary engine driving their personalized medicine approach, especially around gastrointestinal conditions.
The Patented inFoods® Technology Platform is central. Specifically, the inFoods® IBS product is currently protected by 15 different patents globally. Furthermore, Biomerica, Inc. secured key intellectual property for expansion into broader GI markets, receiving three European patent notices of allowance covering technology and methods for treating GERD, Crohn's Disease, and Ulcerative Colitis. These patents cover major markets under the European Patent Organization (EPO), including Germany, the UK, France, Italy, and Spain, plus over 30 other nations within the EPO.
The company's foundation is built on deep experience. Biomerica, Inc. was founded in 1971, which underpins the 40+ years of assay development expertise you mentioned. This history supports their manufacturing capabilities, though specific facility counts aren't public, their ability to develop and market advanced diagnostic products is a key asset.
A significant recent operational milestone supporting the inFoods® IBS test is the granting of a Proprietary Laboratory Analysis (PLA) Code by the American Medical Association CPT Editorial Panel. This code acts as a unique identifier, which is a critical step for enabling insurance reimbursement and broader access for the test.
Here's a quick look at some of the quantifiable elements of Biomerica, Inc.'s Key Resources as of late 2025:
| Key Resource Metric | Value/Status as of Late 2025 |
| Employee Base (as of May 31, 2025) | 54 people |
| inFoods® IBS Global Patents | 15 |
| European Patent Coverage (Nations) | Major markets plus over 30 other EPO nations |
| inFoods® Technology Patent Protection (Noted Expiration) | Through 2036 (as of 2021 filing data) |
| Company Founding Year | 1971 |
| PLA Code Status for inFoods® IBS | Granted by AMA CPT Editorial Panel |
The intellectual property portfolio extends beyond IBS. The patents for GERD, Crohn's, and Ulcerative Colitis position Biomerica, Inc. to target markets with substantial annual values in Europe alone:
- GERD market value: over $4 billion annually in Europe.
- Crohn's Disease market value: $2.5 billion annually in Europe.
- Ulcerative Colitis market value: $1.9 billion annually in Europe.
Also, remember that the inFoods® IBS test itself is a key resource, supported by clinical validation, with a multicenter trial published in the June 2025 issue of Gastroenterology showing 59.6% of the treatment group achieving the FDA's endpoint for abdominal pain reduction.
Finance: draft a memo detailing the IP portfolio's status against the 2026 budget by next Tuesday.
Biomerica, Inc. (BMRA) - Canvas Business Model: Value Propositions
You're looking at the core value Biomerica, Inc. (BMRA) delivers across its product lines, which is heavily centered on personalized, data-driven diagnostics to guide therapy. Honestly, the numbers from Fiscal Year 2025 show a company focused on operational discipline while pushing clinical validation for its key GI products.
Personalized, non-drug dietary guidance for IBS symptom relief
The inFoods® IBS test is a cornerstone value proposition, offering a personalized, non-drug approach by identifying specific food triggers for Irritable Bowel Syndrome (IBS) symptoms. This moves patients away from broad elimination diets to targeted ones. For instance, the inFoods® IBS test identifies, on average, two to four specific foods that trigger a patient's symptoms.
The real-world impact is compelling. Initial data from over 360 patients in an ongoing study showed an average:
- 48.5% reduction in gastrointestinal (GI) pain.
- 49.8% reduction in bloating over an 8-week period.
This is supported by the launch of the AI-backed inFoods® IBS Trigger Food Navigator, a digital tool to help ensure patient compliance with their personalized dietary plan.
Simple, at-home diagnostic tests for early disease detection (e.g., EZ Detect)
Biomerica, Inc. provides convenience through at-home screening tools. The EZ Detect™ Colorectal Disease Screening Test is a prime example, offering a simple, at-home method to detect hidden blood in the stool, a key indicator for colorectal disease. This product has seen distribution through major retailers, including placement on shelves in over 4,600 Walmart Stores nationwide at one point.
Looking at the full Fiscal Year 2025, which ended May 31, 2025, the company reported total net sales of $5.3 million, which included sales from the EZ Detect™ and other at-home tests, though this figure was modestly lower than the prior year due to global tariff uncertainties and a shift in the product mix away from Over-the-Counter (OTC) retail sales in the fourth quarter.
Rapid, point-of-care diagnostic solutions for H. pylori and PSA
The value here is speed and accessibility for critical markers. Biomerica, Inc. has secured regulatory milestones for its rapid tests in international markets. For example, the Fortel® Prostate (PSA) Screening Test received approval from the Saudi Food and Drug Authority (SFDA) for at-home use, providing results in just 10 minutes from a simple finger-prick blood sample.
Furthermore, the Fortel® Ulcer Test, which detects H. pylori antibodies, received approval for home use from the United Arab Emirates (UAE) Ministry of Health and Prevention. The company is also in discussions for evaluations of the Hp Detect™ Stool Antigen ELISA test in the U.S. and Europe.
Comprehensive CDMO services for diagnostic innovators
Contract Development and Manufacturing Organization (CDMO) services provide a high-margin revenue stream that supports the overall financial structure. In the second quarter of fiscal 2025 (ended November 30, 2024), gross margins improved to 27%, partly reflecting a favorable sales mix that included a greater contribution from higher-margin contract manufacturing services. This trend continued into the first quarter of fiscal 2026 (ended August 31, 2025), where gross profit increased despite lower net sales, driven by a more favorable product mix and greater contribution from higher-margin contract manufacturing services.
Clinically validated results published in Gastroenterology journal
Scientific validation is a key part of the value proposition, lending credibility to the personalized guidance approach. The pivotal inFoods® IBS clinical trial was published in the June 2025 issue of Gastroenterology, the official journal of the American Gastroenterological Association. This was the largest study of its kind, demonstrating statistically significant outcomes when patients eliminated identified trigger foods.
Here's a look at the primary endpoint comparison from that peer-reviewed publication:
| Patient Group | Treatment Group (Eliminated Triggers) | Control Group (Placebo Diet) |
| Achieved FDA Endpoint for Abdominal Pain Reduction (All Subclasses) | 59.6% | 42.2% |
| IBS-C Patients Reaching Benchmark | 67.1% | 35.8% |
| IBS-M Patients Reaching Benchmark | 66.0% | 29.5% |
The company also secured three key patents for its inFoods® technology covering GERD, Crohn's Disease, and Ulcerative Colitis, which address markets valued at over $4.0 billion+, $2.5 billion+, and $1.9 billion+, respectively.
Finance: draft 13-week cash view by Friday.
Biomerica, Inc. (BMRA) - Canvas Business Model: Customer Relationships
You're looking at how Biomerica, Inc. (BMRA) connects with the people who buy and use its diagnostic products, especially the inFoods® IBS test, as of late 2025. The relationship strategy splits clearly between direct patient engagement and professional healthcare provider support, plus a growing focus on business-to-business (CDMO) partnerships.
Direct-to-Consumer (DTC) self-service via the inFoods® IBS website
Biomerica, Inc. (BMRA) has established a direct channel for patients seeking answers about their Irritable Bowel Syndrome (IBS) triggers. Patients can now order the inFoods® IBS test directly from www.infoodsIBS.com. This self-service model bypasses the traditional requirement for a doctor's visit just to initiate the test, relying instead on a simple, at-home finger-prick blood sample. This direct access is a key component of their customer relationship strategy for this product line. For context on the company's scale, Biomerica, Inc. (BMRA) reported total net sales of $1.64 million for the second quarter of fiscal 2025, which showed a 5% year-over-year increase.
AI-backed digital companion tool for patient compliance and support
While specific adoption metrics for an internal AI companion tool aren't public, the DTC launch of inFoods® IBS implies a necessary digital support structure to guide patients through the at-home testing process and subsequent dietary changes. The relationship here is mediated by digital tools designed to help patients maintain compliance with the personalized diet plan following the test. This aligns with the broader trend where AI companion platforms are projected to grow from a market valuation of USD 35.39 billion in 2025 globally.
Dedicated sales and account management for physician groups and CDMO clients
For professional clients, Biomerica, Inc. (BMRA) employs dedicated engagement through its Contract Development and Manufacturing Organization (CDMO) services. These services are noted as a growing contributor to revenue, indicating active account management and sales efforts toward diagnostic innovators. The relationship here is a high-touch, B2B partnership, leveraging Biomerica, Inc. (BMRA)'s 40 years of expertise in assay development, manufacturing, and regulatory compliance to provide end-to-end support from concept through commercial manufacturing. The company's disciplined cost management saw Selling, General and Administrative expenses reduced to $4.6 million in Fiscal 2025, down from $5.5 million the prior year, suggesting a focus on efficient, high-value client interactions.
Educational content and clinical data for healthcare providers
Building trust with healthcare providers (HCPs) relies heavily on robust clinical evidence. Biomerica, Inc. (BMRA) supports its relationship with the medical community by publishing strong clinical trial data. The inFoods® IBS test recently had a multicenter, double-blinded sham-controlled trial published in the June 2025 issue of Gastroenterology. Furthermore, the American Medical Association CPT Editorial Panel issued a Proprietary Laboratory Analysis ('PLA') Code for the test, which is a critical step for establishing a formal reimbursement pathway with payers and providers.
Here is a summary of the key clinical validation points used to engage the provider segment:
| Clinical Endpoint/Metric | Treatment Group Result | Control Group Result | Statistical Significance |
| Abdominal Pain Intensity (API) Responder Endpoint (>30% Improvement) | Achieved by 59.6% of patients | Achieved by 42.1% of patients | p-value of 0.0246 |
| IBS-C Patients Achieving API Endpoint | 67.1% | 35.8% | Implied Significant Difference |
| IBS-M Patients Achieving API Endpoint | 66% | 29.5% | Implied Significant Difference |
The company is also securing intellectual property that broadens the educational scope, having secured three key patents for inFoods® technology applications in Gastroesophageal Reflux Disease (GERD), Crohn's Disease, and Ulcerative Colitis, markets valued at over $4.0 billion+, $2.5 billion+, and $1.9 billion+, respectively.
The relationship strategy for HCPs centers on these facts:
- Publication in the peer-reviewed journal Gastroenterology in June 2025.
- Receipt of the AMA PLA Code for the inFoods® IBS test.
- Clinical study performed at centers including Mayo Clinic and Harvard Medical School Teaching Hospital affiliates.
- Secured international patents covering major European markets.
Finance: draft 13-week cash view by Friday.
Biomerica, Inc. (BMRA) - Canvas Business Model: Channels
You're looking at how Biomerica, Inc. gets its diagnostic and therapeutic products into the hands of patients and providers as of late 2025. The channel strategy is clearly segmenting between professional/lab channels and direct patient access, especially for the newer inFoods® IBS offering.
Direct-to-Consumer (DTC) digital distribution and telehealth platforms represent a significant expansion for the inFoods® IBS test. Following the Fiscal Year End (FYE) of May 31, 2025, Biomerica, Inc. introduced direct-to-consumer availability, allowing patients to order from www.infoodsIBS.com. This channel utilizes a new patient self-collection system where patients collect their own blood samples at home via a simple finger-stick device, which then enables nationwide access through telehealth and online medical providers.
The professional channel is being significantly bolstered by Strategic distribution partners like Henry Schein in the U.S. Biomerica, Inc. announced a marketing services arrangement with Henry Schein, Inc. on October 16, 2025, specifically to market the inFoods® IBS test across the United States, with the exception of New York State. Henry Schein's distribution network is powerful, comprised of more than 400 medical field sales and telesales representatives who target primary care and gastroenterology specialty practices. For context, Henry Schein, Inc. reported over $12 billion in annual sales in 2024.
For Clinical laboratories and physician offices for inFoods® IBS, the pathway to broader adoption and reimbursement is being formalized. The inFoods® IBS test received a Proprietary Laboratory Analysis (PLA) Code from the American Medical Association CPT Editorial Panel, which advances the pathway for Medicare and Medicaid reimbursement. Clinical validation supports this channel, as a study published in June 2025 in Gastroenterology showed that 59.6% of patients in the treatment group (eliminating identified trigger foods) achieved the FDA's endpoint for abdominal pain reduction, compared to 42.1% in the control group.
The International distribution network, particularly in the MENA region, shows targeted expansion for specific products. Following the FYE August 29, 2025 report, the United Arab Emirates Ministry of Health and Prevention approved Biomerica, Inc.'s Fortel® PSA rapid screening test, confirming continued growth in the Middle East. Furthermore, the company achieved EU IVDR certification for its food-intolerance diagnostic tests, supporting future European commercialization.
Regarding Over-the-Counter (OTC) retail channels for legacy products, there has been a noted shift in product mix impacting recent revenue figures. Net sales for the full Fiscal Year 2025 (ended May 31, 2025) were $5.3 million, down from $5.4 million the prior year, with the decrease partially attributed to fewer over-the-counter (OTC) retail sales in the fourth quarter. Similarly, for the first quarter of Fiscal 2026 (ended August 31, 2025), net sales were $1.4 million, compared to $1.8 million in Q1 FY2025, reflecting reduced retail market activity.
Here's a quick look at the scale of some of these channel components based on recent reporting:
| Channel/Metric | Associated Product(s) | Key Figure/Scope | Date/Period Reference |
| Henry Schein Sales Force Reach | inFoods® IBS | Over 400 representatives | October 2025 Agreement |
| DTC Digital Platform | inFoods® IBS | Order via www.infoodsIBS.com | Post-FYE May 2025 |
| OTC Retail Sales Impact (FY2025) | Legacy Products | Shift caused modest revenue decline from $5.4M | Fiscal Year 2025 |
| International Regulatory Approval (MENA) | Fortel® PSA | Approved by UAE Ministry of Health and Prevention | Post-FYE May 2025 |
| Reimbursement Pathway Advancement | inFoods® IBS | Received PLA Code | Post-FYE August 2025 |
The company's overall net sales for Fiscal 2025 were $5.3 million, while Q1 Fiscal 2026 sales were $1.4 million. Gross profit for FY2025 was $498,000.
You can see the reliance on professional channels for the newer diagnostic is clear, especially with the PLA code and the Henry Schein deal. The DTC route offers a direct patient line, but the legacy OTC channel seems to be shrinking as a revenue contributor.
- inFoods® IBS clinical trial treatment group pain responder rate: 59.6%.
- inFoods® IBS clinical trial control group pain responder rate: 42.1%.
- Operating expenses for Q1 Fiscal 2026: $1.5 million.
- Operating expenses for Q1 Fiscal 2025: $1.7 million.
Biomerica, Inc. (BMRA) - Canvas Business Model: Customer Segments
You're looking at the core groups Biomerica, Inc. (BMRA) serves as of late 2025. This isn't just about who buys the product; it's about who needs the diagnostic insight.
Irritable Bowel Syndrome (IBS) patients seeking non-drug treatment
This segment is targeted directly via the inFoods® IBS test, which allows patients to identify trigger foods through a simple at-home blood sample. Clinical study results for inFoods® IBS were published in the June 2025 issue of Gastroenterology, confirming statistically significant improvements in abdominal pain and bloating with patient-specific dietary guidance. The company noted that increased sales from inFoods® IBS partially offset revenue headwinds in Fiscal 2025. Post year-end (after May 31, 2025), the American Medical Association CPT Editorial Panel issued a Proprietary Laboratory Analysis (PLA) code for the inFoods® IBS test, advancing the pathway for broader patient access.
- Potential patient pool referenced: 4,000,000 IBS Patients.
- inFoods® IBS treatment group saw 59.6% achieve the FDA's endpoint for abdominal pain reduction.
- For IBS-C patients on the treatment diet, 67.1% saw improvement versus 35.8% in the control group.
Gastroenterologists and primary care physicians in the U.S.
These professionals are the gatekeepers for prescription and lab-ordered testing, though the inFoods® IBS test also has a direct-to-consumer channel. The company is actively introducing the inFoods® IBS product to select gastroenterology physician groups across multiple states and regions. A key commercial step was the Henry Schein and Biomerica Marketing Services Agreement for the inFoods® IBS Test in the U.S., announced in October 2025. Biomerica reduced its Selling, General and Administrative expenses to $4.6 million in Fiscal 2025, down from $5.5 million the prior year, reflecting streamlined commercial efforts.
International distributors and healthcare providers in the MENA region
International sales faced headwinds in Fiscal 2025 due to global tariff-related uncertainties causing certain customers to delay orders. The company's overall net sales for Fiscal 2025 were $5.3 million. The geographic revenue breakdown for Fiscal 2025 indicated specific contributions from the Middle East region.
| Region | Fiscal 2025 Revenue Amount (USD) | Fiscal 2025 Revenue Percentage |
| Asia | $1.72M | 32.35% |
| North America | $1.66M | 31.22% |
| Europe | $1.3M | 24.42% |
| Middle East | $630K | 11.86% |
| South America | $8K | 0.15% |
Further penetration in the MENA region is supported by regulatory milestones; the United Arab Emirates Ministry of Health and Prevention approved Biomerica's Fortel® Kidney Test for home use in September 2025 and the Fortel® Ulcer Test in August 2025.
Third-party diagnostic and biotechnology companies (CDMO)
Biomerica, Inc. announced an expansion of its Contract Development and Manufacturing Organization (CDMO) services in November 2025 to meet accelerating market demand from diagnostic innovators. The company stated that its CDMO services are a growing contributor to revenue. This segment benefits from Biomerica's 40+ years of expertise in assay development and manufacturing, backed by an ISO 13485 certification and an FDA registered cGMP manufacturing facility. The gross margin improvement to 27% in Q2 Fiscal 2025 was partially attributed to a favorable sales mix with greater contribution from the Contract Manufacturing sectors.
Consumers utilizing at-home screening tests (e.g., EZ Detect, Fortel®)
This segment includes sales of over-the-counter (OTC) products. The shift in product mix included fewer OTC retail sales during the fourth quarter of Fiscal 2025, contributing to the modest year-over-year revenue decline to $5.3 million for the full fiscal year. The company's Fortel® line saw regulatory progress in the UAE for home use testing. Biomerica's overall gross profit for Fiscal 2025 was $498,000, down from $611,000 the prior year, reflecting the impact of the macro-economic events on revenue and product mix, which includes the OTC channel.
Finance: finalize the Q2 FY2026 revenue contribution breakdown by product line for the next board review by Wednesday.
Biomerica, Inc. (BMRA) - Canvas Business Model: Cost Structure
You're looking at the core spending areas for Biomerica, Inc. as of late 2025, focusing on where the cash is going to support their diagnostic and therapeutic product development and sales efforts. The company has been aggressively managing its spend, which is a key focus area.
The cost structure is heavily influenced by focused spending on research and development and the necessary overhead to run a medical device/diagnostic business. Biomerica, Inc. achieved its cost-reduction goals for Fiscal Year 2025, which ended May 31, 2025.
The total operating expenses declined by more than $1.3 million in FY2025, driven by disciplined management across the board. This disciplined approach helped improve the operating loss by 19% year-over-year to $5.1 million.
Here is a breakdown of the major reported operating expense components for the fiscal year ended May 31, 2025:
| Cost Category | FY2025 Amount (in Millions USD) | Prior Year Amount (in Millions USD) |
| Selling, General, and Administrative (SG&A) expenses | $4.6 million | $5.5 million |
| Research and Development (R&D) expenses | $1.0 million | $1.5 million |
The planned annual expense reductions targeted a total savings of $1.0 million to $1.4 million, and the company delivered on this, with the actual reduction in R&D and SG&A alone accounting for a $1.4 million decrease ($0.5 million in R&D and $0.9 million in SG&A).
Regarding other significant cost drivers, you see the following:
- Manufacturing and labor costs for diagnostic kit production are a variable cost component. The company noted reduced direct labor costs in Q2 FY2025 due to strategic workforce reductions, which contributed to margin improvement in that quarter.
- Costs associated with clinical trials and regulatory compliance are inherent to advancing products like the inFoods® line and securing international certifications, such as the EU IVDR certification mentioned for food-intolerance diagnostic tests. Specific dollar amounts for these activities for the full FY2025 are embedded within the R&D and SG&A figures, but are not separately itemized in the year-end summary.
Cash management also saw a positive shift, with Cash Used in Operating Activities improving significantly to $3.8 million, down from $5.3 million in the prior year, reflecting this strong operating discipline.
Finance: review Q1 FY2026 operating expense breakdown against the $1.5M to $1.4M reduction target for the current year by end of next week.
Biomerica, Inc. (BMRA) - Canvas Business Model: Revenue Streams
Biomerica, Inc. (BMRA) generated total net sales of $5.3 million for the fiscal year ended May 31, 2025 (Fiscal 2025). This represented a modest decrease from the $5.4 million reported in the prior fiscal year.
The revenue streams for Biomerica, Inc. (BMRA) in Fiscal Year 2025 can be broken down by product line contribution and service type:
| Revenue Component | Fiscal Year 2025 Amount | Prior Year Amount |
| Total Net Sales | $5.3 million | $5.4 million |
| Gross Profit | $498,000 | $611,000 |
| Selling, General & Administrative Expenses | $4.6 million | $5.5 million |
| Research & Development Expenses | $1.0 million | $1.5 million |
Sales of the inFoods® IBS test were noted as an increasing contributor to revenue, partially offsetting other headwinds experienced during Fiscal Year 2025. For the first quarter of Fiscal Year 2026 (ending August 31, 2025), inFoods® IBS product sales were noted as a partial offset to a decrease in net sales.
Revenue from Contract Development and Manufacturing Organization (CDMO) services is an active component. Growth in the first quarter of Fiscal 2025 was driven by new contract manufacturing agreements. Furthermore, the gross profit in the first quarter of Fiscal 2026 was driven by a greater contribution from higher-margin contract manufacturing services.
Sales of legacy OTC products, such as EZ Detect and Fortel® tests, faced headwinds. The modest lower revenue in Fiscal 2025 was attributed, in part, to fewer over-the-counter (OTC) retail sales during the fourth quarter. Similarly, net sales in the first quarter of Fiscal 2026 reflected reduced retail market activity.
Future revenue potential is tied to insurance reimbursement for inFoods® IBS following a key regulatory step. The American Medical Association CPT Editorial Panel issued a Proprietary Laboratory Analyses (PLA) code for the inFoods® IBS test, effective October 1, 2025.
The PLA code allows for the submission of claims to Medicare and private insurers once a reimbursement price is set by the Centers for Medicare & Medicaid Services. This code represents a next step on the pathway to expand patient access through a billable reimbursement code.
Key elements related to the revenue-driving inFoods® IBS product include:
- Clinical study results published in June 2025 Gastroenterology.
- 59.6% of patients in the treatment group achieved the FDA's endpoint for abdominal pain reduction versus 42.1% in the control group.
- Direct-to-consumer availability launched, broadening patient reach.
- Three new international patents issued covering applications of the technology platform.
Finance: draft 13-week cash view by Friday.
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