Biomerica Announces FDA Submission For a Test to Detect Helicobacter pylori (H. pylori), a Bacteria That Infects Approximately 35% of the US Population

Rhea-AI Summary

Biomerica, Inc. (Nasdaq: BMRA) announced the submission of a 510(k) premarket notification to the FDA for its new product, hp+detect™, which detects H. pylori infection, a major contributor to gastric cancer and peptic ulcers affecting about 35% of the U.S. population. The FDA aims to provide a decision within 90 days. Biomerica is also preparing a CE Mark filing for European sales. CEO Zack Irani highlighted the product's accuracy and low-cost manufacturing process, indicating potential for high gross margins.

Positive

• Submission of 510(k) notification for hp+detect™ to detect H. pylori infection, targeting a significant market.
• Potential for high gross margins due to efficient manufacturing process.
• Product addresses a critical health issue, with over 115 million U.S. individuals affected by H. pylori.

Negative

• Dependence on FDA approval process, which may delay product availability.
• Competitive market for diagnostic products may pose challenges.

Gastric cancer is the third most common cause of cancer related death in the world and over 80% of gastric cancers are attributed to H. pylori bacterial infection

H. pylori infection is also a major cause of peptic ulcers

IRVINE, Calif., April 26, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for hp+detect™, a new product that detects the presence of the H. pylori bacteria, which infects approximately 35% of the U.S. population.

Under the current FDA 510(k) Premarket Notification Process, the FDA’s goal is to provide a decision within 90 days to the submitting company, unless further information is requested.

Biomerica is also preparing to submit a CE Mark filing, which will enable the product to be sold in most EU countries and other regions around the world.

Biomerica’s Chairman and Chief Executive Officer Zack Irani stated, “This FDA submission is a milestone in our commitment to bringing a diagnostic solution for the over 115 million people suffering from H. pylori infection across the U.S. today. We’re particularly excited about this product as it has shown to be highly accurate as compared to other products in the market. We’ve also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”

About hp+detect™

The Biomerica hp+detect™ product detects the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Once cleared, physicians and medical centers will be able use the results from the hp+detect™ test to diagnose the presence of H. pylori and monitor the efficacy of treatment.

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 primarily 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, and possible success of our clinical trials. 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 efficacy of the Company’s InFoods® products, H. pylori hp-detect® test and other products and tests; actual efficacy of the Company’s InFoods® products, 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, approval by Health Canada, 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; efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® 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 Biomerica's new product hp+detect™?

hp+detect™ is a diagnostic test that detects H. pylori infection, which can lead to gastric cancer and ulcers.

When did Biomerica submit the 510(k) notification for hp+detect™?

Biomerica submitted the 510(k) notification on April 26, 2022.

What is the significance of <em>H. pylori</em> infection?

H. pylori infection affects about 35% of the U.S. population and is linked to over 80% of gastric cancer cases.

What are the next steps for Biomerica after the 510(k) submission?

Biomerica is preparing for a CE Mark filing to enable sales in Europe.

What are the potential financial implications of hp+detect™?

The efficient manufacturing process could lead to high gross margins, positively impacting Biomerica's financial outlook.