IRVINE, CA --(February 4, 2019) -- 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 of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Diabetes, Gastrointestinal Disease and esoteric testing.
The Biomerica InFoods IBS product identifies specific foods that when removed from the patient's diet can alleviate the patient's IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, physician 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. The Company is initially seeking regulatory (FDA) clearance for a clinical laboratory version of the product. A billable CPT code that can be used by both clinical labs and physicians' offices 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.