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IRVINE, Calif., Feb. 05, 2019 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA) announced today regulatory and clinical advancements in its development program for its H. pylori diagnostic product.
Based on recent discussions between Biomerica and the United States Food and Drug Administration (FDA) regarding the regulatory pathway for final FDA clearance of the Company’s H. pylori product, the Company needs less than 40 clinical trial patient samples in addition to the 210 samples already collected. These final clinical patient samples are expected to be collected over the next few months, after which the Company will complete the remaining analytical and clinical agreement studies and prepare a submission to the FDA for 510(k) FDA clearance.
Helicobacter pylori (H. pylori) infection is one of the most common, chronic, bacterial infections affecting humans. Complications associated with H. pylori infections include ulcers, inflammation of the stomach lining and stomach cancer. The diagnosis of H. pylori is important given that specific antibiotic treatment is highly effective in improving outcomes.
Zackary Irani, Chief Executive Officer of Biomerica, commented: “We look forward to completing the necessary studies to submit for FDA clearance and upon clearance, launching our H. pylori product into the market. This represents a significant revenue opportunity for Biomerica.”
About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company's products are designed to enhance the health and well-being, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.
The Company is also in clinical studies for a new Irritable Bowel Syndrome (IBS) therapy called InFoods™. The Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. eggs, broccoli, wheat, potatoes, corn, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve IBS outcomes. A clinical lab version of the product will be the first for which the company is seeking regulatory approval. The Company is also developing a follow-on point-of-care product that allows physicians to perform the test in-office using a finger stick blood sample. A billable CPT code that can be used by both clinical labs and physicians' office tests is already available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking; such as statements relating to intended launch dates, sales potential, significant benefits or opportunities, expected clinical sample collection, market size, prospects, new products, favorable outlook, new distributors, expansion, increases in productivity and margins, expected orders, leading market positions, anticipated future sales or production volume of the Company, the launch or success of product and new product offerings. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, new tariffs and restrictions on foreign trade, 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.