Biomerica Received US FDA 510(k) Clearance for Their Hp Detect™ ELISA Test Product Designed to Detect the Presence of the H. pylori Bacteria That infects Approximately 35% of the U.S. Population

Rhea-AI Summary

Biomerica, Inc. (BMRA) has received FDA 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test to detect H. pylori bacteria, which infects 35% of the U.S. population. The test can diagnose H. pylori presence, crucial for assessing status after treatment, especially in the context of increasing antibiotic resistance. Over 80% of gastric cancers are attributed to H. pylori infection, making this FDA clearance a milestone in providing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S.

Positive

• FDA 510(k) clearance for Hp Detect™ Stool Antigen ELISA test is a significant achievement
• Test can diagnose H. pylori presence crucial for assessing status after treatment
• Over 80% of gastric cancers are attributed to H. pylori infection
• Clearance provides a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S.

Negative

• None.

• Over 80% of gastric cancers are attributed to H. pylori bacterial infection

• Gastric cancer is the third most common cause of cancer related death in the world

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

IRVINE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic products, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test (K232892), a new product that is designed to detect the presence of the H. pylori bacteria, which infects approximately 35% of the U.S. population. H. pylori infection is a disease which affects half the population of the world.

The Biomerica Hp Detect™ test 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. Physicians and medical centers will be able use the results from the Hp Detect™ Stool Antigen test to diagnose the presence of H. pylori and assess H. pylori infection status after treatment.

Dr. William Chey, an expert in the management of H. pylori infection and Chief, Division of GI and Hepatology, Michigan Medicine, stated, “Testing for H. pylori eradication to assess status after treatment is crucial, especially in the context of increasing antibiotic resistance.”​

Biomerica’s Chief Executive Officer Zack Irani stated, “This FDA clearance is a milestone in our commitment to bringing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S. We are particularly excited about this product as it has been shown to be highly accurate and has several key advantages for laboratories, physicians and patients. We have also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”

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, 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, Hp Detect™ test and other products and tests; actual efficacy 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, 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 InFoods^® products, Hp Detect™ test and other products and tests; regulatory approvals necessary prior to commercialization of the Company’s 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:

Zack Irani, CEO
zirani@biomerica.com
949-645-2111

FAQ

What is the significance of Biomerica, Inc. (BMRA) receiving FDA 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test?

The FDA clearance is a significant achievement for the company as it marks a milestone in providing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S.

Why is diagnosing H. pylori presence crucial for assessing status after treatment?

Diagnosing H. pylori presence is crucial, especially in the context of increasing antibiotic resistance, as it helps in assessing the status after treatment.

What percentage of the U.S. population is infected with H. pylori bacteria?

Approximately 35% of the U.S. population is infected with H. pylori bacteria.

How common is gastric cancer and what is its relation to H. pylori infection?

Gastric cancer is the third most common cause of cancer-related death worldwide, with over 80% of cases being attributed to H. pylori infection.