Biomerica Inc (NASDAQ: BMRA) is a medical diagnostics company that develops, manufactures, and sells rapid diagnostic test products for use in clinical laboratories and point-of-care settings worldwide. Revenue is transactional, generated through product sales to distributors and sales representatives who then sell into foreign markets, as well as direct sales in the United States. The company holds CE marks and FDA clearances across portions of its product portfolio, with additional country-specific registrations managed in cooperation with local distributors. As of the fiscal year ended May 31, 2025, the company reported a net loss of approximately $4,973,000 and cash used in operating activities of approximately $3,841,000. Its auditors have raised substantial doubt about the company's ability to continue as a going concern. The public float was approximately $9,945,252 as of July 24, 2025, placing Biomerica among the smallest publicly traded diagnostics companies on the Nasdaq Capital Market. The company operates a manufacturing facility in California, which holds a California Medical Device Manufacturing License valid until November 19, 2026.

Revenue model

Transactional product sales of rapid diagnostic tests sold through distributors and direct channels into clinical laboratory and point-of-care markets in the U.S. and internationally.

Products and services

Rapid diagnostic tests for home use (over-the-counter) and professional use (physicians' offices, clinics, clinical laboratories). Products are CE marked and/or registered with the FDA and regulatory agencies in various countries for in vitro diagnostic use. Products require limited to no instrumentation.

Customers and end markets

Clinical laboratories and point-of-care settings including physicians' offices and clinics. Products sold worldwide through distributors and sales representatives. End markets include healthcare providers and consumers using home diagnostic products.

Value-chain role

Developer and manufacturer of in vitro diagnostic medical devices. Sells finished products through distribution channels. Relies on third-party distributors in international markets for regulatory compliance and local sales.

Geographic exposure

Products sold worldwide. U.S. sales subject to FDA and California regulatory requirements. International sales subject to EU CE marking requirements (IVDD 98/79/EC, MDR 2017/745, IVDR 2017/746) and country-specific regulatory requirements. Manufacturing based in California.

Source: SEC 10-K, filed 2025-08-29

Industry: In Vitro & In Vivo Diagnostic Substances Peers: Abbott Laboratories Aspira Women's Health Inc Modular Medical Inc Eargo, Inc. Kewaunee Scientific Corp Lucira Health, Inc. Milestone Scientific Inc VAPOTHERM INC