IRVINE, CA / ACCESSWIRE / November 20, 2017 / Biomerica Inc. (NASDAQ: BMRA) today announced the enrollment of its first patient at the University of Southern California for the Company's Helicobacter pylori (H. Pylori) clinical studies. The clinical trials are also being conducted at Vanderbilt University and a European University. The studies are expected to take 6 to 12 months to complete, after which the Company will pursue a 510(k) pathway clearance.
Helicobacter pylori (H. pylori) infection is one of the most common chronic bacterial infections affecting humans and an important cause of peptic ulcer disease and gastric. The exact means of H. pylori acquisition is not always clear.
William D. Chey, MD, FACG, Professor of Medicine and Nutrition, Michigan Medicine, stated, "The incidence and prevalence of H. pylori infection are generally higher among people born outside North America than among people born here. Within North America, the prevalence of the infection is higher in certain racial and ethnic groups, as well as people who have immigrated to North America. H. pylori infection is completely curable if detected accurately and early."
James Buxbaum, M.D., associate professor of clinical medicine at Keck School of Medicine of USC and study investigator, said, "The rate of gastric cancer within these certain ethnic groups, particularly North Americans from Asia and Latin America, in Southern California is alarming. However, this problem can be alleviated by treatment of the H. pylori infection after it is detected. One key to this problem is having an accurate and cost effective test."
Zackary Irani, Chief Executive Officer of Biomerica, commented, "We are pleased to announce the enrollment of our first patient for Biomerica's Helicobacter pylori (H. Pylori) clinical studies at USC. This is an important milestone to eventually move our H. Pylori test into the commercial stage and address a serious issue for so many individuals worldwide. This is also a significant opportunity for Biomerica to dramatically improve outcomes for so many patients."
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 of people while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes, and esoteric testing.
The Biomerica InFoods® IBS product identifies patient-specific foods that when removed may alleviate an individual's IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient-specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product will be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is 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, 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, 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.
SOURCE: Biomerica Inc.