IRVINE, CA -- September 12, 2017 -- Biomerica Inc. (NASDAQ: BMRA) today announced that the Company has commenced clinical studies to evaluate the performance of its new and proprietary Helicobacter pylori (H. pylori) test.
The clinical studies are being conducted at the University of Southern California (USC), Vanderbilt University, and a European University. The patient clinical studies are expected to take 6 to 12 months to complete. The Company will then need to complete the analytical studies and prepare for submission to the FDA and plans to utilize a 510(k) pathway clearance of the test. Biomerica's test is designed to increase the sensitivity and specificity of H. pylori testing and monitoring of treatment.
Zackary Irani, Chief Executive Officer of Biomerica, commented: "H. pylori is a type of bacteria that causes chronic inflammation in the lining of your stomach or upper part of your small intestine. The bacterium is a common cause of stomach ulcers and for certain individuals, stomach cancer. In Northern Europe and the United States, approximately one-third of adults are infected with H. pylori, while in Southern and Eastern Europe, South America and Asia, the prevalence is often greater than 50%. Our discussions with U.S. based laboratories and gastroenterologists have all pointed to a need for an accurate and cost effective test for this problem."
"This is a large addressable market for Biomerica, and we are excited about the prospects for bringing a test which may improve the diagnosis and treatment of this disease, thereby improving patient outcomes, while providing the opportunity to generate substantial revenue growth for our company." concluded Mr. Irani.
James Buxbaum, M.D., associate professor of clinical medicine at Keck School of Medicine of USC said, "We are concerned by alarming rates of gastric cancer among our diverse population in Southern California. This problem is driven by undetected and untreated H. pylori infection, particularly among those who have come to America from Asia and Latin America. More accurate and reasonably priced diagnostic tests are needed to identify and direct H. Pylori therapy before it causes injury and cancer."
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.
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