BIOMERICA INC

Biomerica, Inc.

What the company does

• Global biomedical technology company that develops, patents, manufactures, and markets diagnostic and therapeutic products.
• Core offerings include diagnostic test kits for blood, urine, nasal, and fecal samples to aid diagnosis of diseases, food intolerances, and other conditions.
• Tests detect and measure bacteria, hormones, antibodies, antigens, and other substances at low concentrations to improve patient outcomes and reduce healthcare costs.
• Business model components:
  • Direct sales to clinical laboratories and point-of-care channels (physician offices, clinics, over-the-counter).
  • Contract development and manufacturing services (CDMO) using its underlying technologies.
  • Commercialization of inFoods® IBS through physician-directed and laboratory-based channels with established reimbursement pathways.

Key products and platforms

• inFoods® IBS: Diagnostic-guided therapy platform using a blood test to identify patient-specific foods that trigger IBS symptoms and support targeted dietary elimination.
• hp+detect™: FDA-cleared test for detecting Helicobacter pylori and monitoring treatment; commercial orders and European registration activity (UK MHRA, Feb 2026).
• EZ Detect colon disease home test, Aware Breast Self-Exam product, and other tests within the inFoods platform.
• inFoods pipeline includes applications for Functional Dyspepsia, Crohn’s Disease, Ulcerative Colitis, GERD, Migraine, Depression, Osteoarthritis, and related IT/AI-enabled food-monitoring tools.

Regulatory milestones

• FDA 510(k) clearance for hp+detect™ (Dec 2023).
• IVDR engagement in the EU; first IVDR certificate issued Jan 13, 2025 for “In Vitro Diagnostic Medical Devices: Reagent Test Kits for intolerance screening.”
• Submissions and transition plans in place to meet IVDR timelines for self-testing rapid tests and ELISA professional products.
• Medicare national payment rate for inFoods® IBS established at $300 (effective Jan 1, 2026).

Global operations and manufacturing

• Headquarters: Irvine, California (administration, finance, regulatory, product development, sales, customer service).
• Manufacturing/assembly: Irvine, CA and Mexicali, Mexico (approx. 8,100 sq ft Mexicali manufacturing facility with a 10-year lease and renewal option; additional smaller unit in Mexicali for a specific manufacturing process).
• Europe: BioEurope GmbH in Lindau, Germany serves as distributor and regional hub and supports international sales.
• Additional facilities support a global distribution network.

Markets, customers, and distribution

• Primary markets: clinical laboratories and point-of-care settings (physician offices, clinics, pharmacies).
• Distribution network: 38 independent distributors across approximately 30 countries.
• Regional revenue mix (fiscal year ended May 31, 2026):
  • North America: $1,466,000 (33%)
  • Asia: $1,409,000 (32%)
  • Europe: $1,117,000 (25%)
  • Middle East: $446,000 (10%)
  • South America: $15,000 (0%)
• Customer and receivable concentrations:
  • One distributor accounted for 31% of net sales in both 2026 and 2025.
  • Three distributors (2026) and four distributors (2025) accounted for 59% and 69% of gross accounts receivable, respectively.
  • Of the 59% AR concentration in 2026, 34% was owed by two distributors in North America.
• Backlog: Unshipped orders as of May 31, 2026 were approximately $604,000 (vs. $1,324,000 as of May 31, 2025), with the 2026 backlog primarily for Asia shipments.
• There is reliance on a limited number of distributors; changes in those relationships or their financial condition could materially affect sales and collections.

Financial highlights

• Net sales (fiscal year ended May 31):
  • 2026: approximately $4,453,000
  • 2025: approximately $5,311,000
• Research and development (R&D) expenses:
  • 2026: approximately $788,000
  • 2025: approximately $1,023,000
  • R&D declined in 2026 as hp+detect and inFoods® IBS transitioned from development to commercialization.
• Operating results and liquidity:
  • The company has a history of operating losses and negative cash flows from operations.
  • Cash and cash equivalents are insufficient to meet operating plans for the next 12 months, creating substantial doubt about continued operations; independent auditors noted a going concern.
  • Total operating expenses increased about 1% in 2026 vs. 2025; net cash used in operating activities improved by about 11% in 2026.
  • Financing: raised net proceeds of approximately $1,827,000 under an at-the-market (ATM) program during fiscal 2026.

Tax attributes

• Federal net operating losses (NOLs) carried forward of approximately $32.381 million; California state NOLs approximately $30.381 million (as of May 31, 2026). Use of NOLs is subject to regulatory limitations and expiration provisions.

Intellectual property and licensing

• Dozens of international patent applications, with a focus on inFoods® technology.
• Issued patents for inFoods IBS in the U.S. and several foreign jurisdictions; claims cover IBS and other related indications.
• Licensing arrangements exist for certain third-party IP and royalties (e.g., ACTH royalty payments of about $7,000/year).
• The company plans to pursue additional licenses or acquisitions to support product development and manufacturing as needed.

Regulatory and quality compliance

• Products regulated as medical devices and in vitro diagnostics (IVDs).
• FDA registration and quality system compliance (QMSR); ongoing compliance with MDR/MDR-like requirements in the EU.
• ISO 13485:2016 certification and adherence to applicable ISO and EN standards (e.g., EN ISO 14971).
• Notified Body engagement for IVDR compliance; ongoing updates to technical documentation and processes.

Corporate and staffing

• Employees:
  • May 31, 2026: 50 full-time employees
  • May 31, 2025: 54 employees (53 full-time)
• The company relies on internal staff and external experts (PhDs, MDs, clinicians) for product development, regulatory, and contract services.

Strategic and operating initiatives

• Cost management: ongoing evaluation of operating expenditures and disciplined capital spending.
• Growth plan: expand inFoods® applications, evaluate distribution, partnerships, and licensing for broader U.S. and international launches.
• Reimbursement and market access: pursue broader reimbursement beyond Medicare; CMS established a national rate for inFoods® IBS.
• Supply chain and manufacturing: dual manufacturing locations (U.S. and Mexico) with contingency planning and supplier diversification to mitigate trade and regulatory risks.

Representative milestones

• hp+detect™ FDA clearance (Dec 2023) and initial large European order (2026) with UK MHRA registration (Feb 2026).
• IVDR certification activity and first IVDR certificate for intolerance screening (Jan 2025); ongoing Notified Body engagement to support product transitions.
• Medicare national payment rate established for inFoods® IBS (Jan 2026).

Corporate history and structure

• Delaware corporation with two wholly owned subsidiaries:
  • Biomerica de Mexico (assembly and manufacturing)
  • BioEurope GmbH (international distribution)
• Corporate site: www.biomerica.com; company filings and reports are also available on the SEC website.