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Final patients to compete this double blinded trial by end of October.
Top-Line trial results expected by year end.
The InFoods® IBS Diagnostic-Guided Therapy is the first therapy of its kind for treating all forms of IBS.
InFoods® IBS product addresses the over $30 billion IBS market in the U.S.
Approximately 40 million Americans suffer from IBS¹.
IRVINE, Calif., Aug. 30, 2021 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA) today announced it expects final patient enrollment in its endpoint clinical trial for its InFoods® diagnostic-guided therapy (DGT), designed to alleviate Irritable Bowel Syndrome (IBS) symptoms. The clinical trial is being conducted by Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist hospital and the University of Michigan as primary enrollment centers for this study.
Biomerica expects the final patients enrolled in the endpoint trial to complete treatment by the end of October, after which the study data locked and final statistical analysis will be performed. Top-line trial results showing the efficacy of the InFoods® IBS product are expected by year end.
It is estimated that over 40 million Americans suffer from IBS and the symptoms are often triggered by consumption of specific foods (which are unique in each sufferer). The total cost (direct + indirect) of IBS has been estimated at $30 billion annually in just the United States. IBS is a common condition that can substantially impair a patients physical and mental well-being, and their ability to function both at home and in the workplace.
This endpoint trial is a double-blinded, randomized, controlled clinical trial using the InFoods® IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. The trial evaluates improvements in nine different endpoints (IBS symptoms) in patients using of the InFoods® diagnostic guided therapy. It also stratifies enrollment by the three main IBS subclasses (IBS-Constipation, IBS-Diarrhea and IBS-Mixed). There is currently no FDA cleared therapy for IBS-Mixed. InFoods® IBS utilizes an antibody guided blood test to identify patient-specific foods that may alleviate IBS symptoms when eliminated from the diet.
Pending a positive outcome from this endpoint trial, Biomerica will meet with FDA prior to initiating a final pivotal trial focused on the endpoint(s) that show the greatest improvement in the current trial. This pivotal trial would form the basis apply for FDA clearance for the product. The InFoods® IBS study design has already received a non-significant risk determination from FDA, which should expedite the final approval process.
A clinical lab version of the product is being used in the endpoint clinical trial. However, the Company is also developing InFoods® IBS DGT as a 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' offices is already available for the InFoods® IBS products. Research, conducted by a leading independent pharmaceutical marketing research firm, determined that up to 95% of physicians surveyed would utilize the InFoods® DGT depending on the IBS subclass.
Importantly, the InFoods® DGT can be used without or in conjunction with current pharmaceuticals to potentially improve patient outcomes. Since the InFoods® product is a diagnostic-guided therapy and not a drug, it has no drug-type side effects.
Zackary Irani, Chief Executive Officer of Biomerica, commented: “This ground-breaking new therapy that combines science, technology and diet could revolutionize how IBS patients are treated. By focusing on eliminating the cause of patient’s suffering rather than simply treating their symptoms I believe we can improve the lives of tens of millions of IBS sufferers around the world. Further, we are excited to expand our patented InFoods Technology Platform into treating patients suffering from other diseases, whose symptoms appear to be caused or exacerbated by specific foods in their diets.”
Mr. Irani concluded, “With this pending trial completion, we are now beginning the licensing/partnering discussions process with global health sciences, pharmaceutical and medical device companies, that can expedite the final pivotal trial, FDA clearance and global commercialization of the InFoods® IBS therapy.”
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 primarily focus is on Gastrointestinal and inflammatory Diseases where the Company has multiple diagnostic and therapeutic products in development.
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 the efficacy of the Company’s Covid product, hp-detect Product and other tests, FDA clearance of the Company’s products including the InFoods and hp-detect product, expected completion of clinical trials, first of a kind therapy, FDA and CE Mark clearance of these products, the rapidity of testing results, uniqueness of the Company’s products, test result accuracy of products, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s test kits, patent protection and freedom to operate on any of the Company’s products or 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. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: impacts on earnings and other financial results; results of studies testing the efficacy of the Company’s InFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; the Company’s ability to license its products or partner with others for the commercialization of its products; availability of the Company’s test kits and other products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; 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 make it difficult or impossible for the company to maintain current operations; regulations and the Company’s ability to obtain patent protection on any aspects of its rapid test technologies. 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.
John Nesbett /Jennifer Belodeau
IMS Investor Relations
1 Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245