Biomerica Announces CE Mark for Its H. pylori Diagnostic Test, hp+detect™

Rhea-AI Summary

Biomerica, Inc. (BMRA) announced that its hp+detect™ diagnostic test for Helicobacter pylori has received the CE Mark, allowing commercialization in the European Union and other international markets. This test identifies H. pylori, a significant cause of gastric cancer, affecting 45% of the population in Europe's largest countries. CEO Zack Irani confirmed plans to market the product while awaiting FDA clearance for U.S. sales. The CE Mark represents a critical step in expanding Biomerica's reach in the diagnostics market.

Positive

• CE Mark received for hp+detect™, enabling sales in the EU.
• High incidence of H. pylori increases market potential.
• Diagnostic test addresses serious health risks associated with gastric cancer.

Negative

• Awaiting FDA clearance for U.S. market could delay potential revenue.
• Competition from established players may impact market entry.

- Attaining CE Mark is a major step toward commercialization –

- World Health Organization (WHO) lists H. pylori among the 16 antibiotic-resistant bacteria that pose the greatest threat to human health and designated H. pylori as a Class 1 carcinogen, meaning that it is a known cause of cancer -

- 45% of the population in Europe’s five largest countries are afflicted with H. pylori -

IRVINE, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products, announces CE Mark for its hp+detect™ diagnostic test that detects Helicobacter pylori (H. pylori) bacteria. The Company will begin to market and sell its hp+detect™ diagnostic test in the European Union (EU) and other international countries following registration of the product in each country in which it is sold.

About hp+detect™
The Biomerica hp+detect™ product detects H. pylori bacteria which is estimated to infect 35% of the U.S. population and 45% of the population in Europe’s five largest countries. H. pylori infection is the strongest known risk factor for gastric cancer and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers will be able use hp+detect™ to diagnose H. pylori infection and monitor the safety and efficacy of treatment.

Biomerica’s Chairman and Chief Executive Officer Zack Irani stated, “As we await clearance from the FDA for hp+detect™ to be sold in the U.S., following our recent 510(k) submission, we are working to begin selling this product in the EU and other international countries. Attaining this CE Mark is a key step in the company’s commitment to bringing our diagnostic solution to the broader EU market.”

About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica’s primary focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

Safe Harbor Statement
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s estimated future financial results, demand for the Company's products, the Company's ability to fulfill orders, regulatory clearance of the Company’s tests and products, and possible success of our products once introduced into the market. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the safety and efficacy of the Company’s H. pylori hp-detect® test and actual safety and efficacy in patients of the Company’s hp-detect® test and other products and tests; expected completion of clinical studies and trials; the rapidity of testing results; uniqueness of the Company’s products; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® tests and other products and tests, including FDA clearance, attaining CE Mark and approvals from other international regulatory agencies; availability of the Company’s test kits and other products; capacity, resource and constraints on our suppliers; safety and efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; dependence on our suppliers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that could make it difficult or impossible for the company to maintain current operations; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection and freedom to operate on any aspects of its rapid test technologies; future production costs and overhead, sales and administrative costs, R&D expenditures, materials costs, needed inventory reserves, collectability of receivables, legal costs and other extraordinary costs. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.

Corporate Contact:

John Nesbett /Jennifer Belodeau 
IMS Investor Relations 
203.972.9200 
biomerica@imsinvestorrelations.com

FAQ

What is the significance of the CE Mark for Biomerica's hp+detect™?

The CE Mark allows Biomerica to market and sell its hp+detect™ diagnostic test in the European Union and internationally.

How prevalent is H. pylori in Europe based on Biomerica's press release?

Approximately 45% of the population in Europe’s five largest countries is affected by H. pylori.

What does the hp+detect™ test diagnose?

The hp+detect™ test is designed to detect Helicobacter pylori, a bacterium strongly linked to gastric cancer.

What are Biomerica's plans for the hp+detect™ test in the U.S.?

Biomerica is awaiting FDA clearance to sell the hp+detect™ test in the U.S. market after submitting a 510(k) application.

Who is the CEO of Biomerica?

Zack Irani is the Chairman and CEO of Biomerica.