BMRA Biomerica Inc

Biomerica Inc. (NASDAQ: BMRA) announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for Biomerica’s second U.S. patent pertaining to the Company’s InFoods® technology platform that offers a revolutionary new way to treat patients suffering from Irritable Bowel Syndrome (IBS) and other gastrointestinal diseases. Specifically, this allowed application #16/385,322 contains numerous claims that broadly cover the method that enables physicians to identify patient specific foods (e.g. pork, milk, shrimp, broccoli, chickpeas, etc.), that when removed may alleviate or improve an individual's IBS symptoms, such as constipation, diarrhea, bloating, severe cramping, pain and indigestion.

The InFoods® diagnostic guided IBS therapy is in clinical studies at Mayo Clinic, University of Texas Health Science Center at Houston, Houston Methodist (part of Texas Medical Center, the largest medical complex in the world), Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and at the University of Michigan.  Since the InFoods® IBS product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. Several members of the ROME Foundation have been working with the company to design and set up these trials.  Further the company expects the clinical trial sites will be active users of the product upon clearance by the FDA.

It is estimated that over 45 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 the United States. IBS is a common condition that can substantially impair patient well-being and a person’s ability to function both at home and in the workplace. A billable CPT code already exists that can be used by both clinical labs and physicians' offices upon clearance by the FDA. 

Biomerica has several additional U.S. and international patent applications in prosecution that cover other claims pertaining to the InFoods® IBS product. Further, Biomerica has filed patents, and is developing diagnostic guided therapies for other diseases utilizing the InFoods® technology platform, which include:  functional dyspepsia, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease (GERD), migraine headaches, and others.

“This is the second allowed patent in a series of applications to provide broad protection for a test panel and method to determine patient specific foods that may trigger IBS symptoms, and allows for a diagnostic guided therapy for IBS patients,” said Zack Irani, Chairman and Chief Executive Officer of Biomerica. “The allowance of these claims in the InFoods® patent estate clearly validates our strategy and strengthens our efforts to enable physicians to offer new and better therapies to patients.” 

“This patent is part of our ongoing strategy to protect the intellectual property for our unique IBS diet guided therapy, as well as similar products for use in other disorders such as GERD, functional dyspepsia, IBD, migraine headaches, and osteoarthritis,” said Elisabeth Laderman, Ph.D., VP of Development and Quality at Biomerica. “There is a growing body of evidence that food can exacerbate inflammation in the body, and we believe the InFoods® technology can identify patient-specific foods that may trigger inflammation and resulting symptoms.”

Issued patents for the InFoods® technology include:  newly allowed US patent application #16/385,322, US patent #10,309,970, Japanese patent #6681907, and Korean patent #10-1887545 covering compositions, devices and methods of IBS sensitivity testing.

The Company also provided an update on the company's COVID-19 antibody tests as the COVID-19 pandemic has substantially impacted the global healthcare delivery system.

COVID-19 Antibodies Rapid 10-minute Point of Care tests:  A newly published study in Canada reported that Biomerica’s rapid test showed 100% sensitivity and 100% specificity (https://www.studyfinds.org/not-all-covid-19-antibody-tests-are-created-equal-but-which-ones-are-best/) published in Diagnostics 2020, 10, 453; July 2020. The Company’s high-volume production version of its COVID-19 IgG/IgM and its standard version (both of which are finger stick blood tests with results in 10 minutes that can be performed by trained professionals anywhere) continue to be marketed in countries outside the US. 

Unique high-volume COVID-19 IgG ELISA laboratory test:  The Company is waiting for the FDA response to its submitted EUA.  The data that was submitted to the FDA under the EUA application for this test showed 100% specificity and zero percent cross reactivity with many common viruses or diseases. 

The Company also plans to issue its year-end results and SEC Form 10-K on August 31, 2020 for the fiscal year ended May 31, 2020, and will provide further updates on it progress with COVID tests, InFoods® and other clinical programs. 

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.

About 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 patented, 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 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. An estimated 45 million people in America currently suffer from IBS making it a leading cause for patient doctor visits.

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 tests (with included but are not limited to COVID-19 and InFoods® products), FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, use and commercial adoption of tests, pricing of the Company’s test kits, demand for international orders, availability of the Company’s test kits, and patent protection on the test technology. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s tests; regulatory approvals necessary prior to commercialization of the Company’s tests; availability of the Company’s test kits; 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 tests; 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 test technology. 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.

CONTACT INFORMATION

Company Spokesperson 949-645-2111 www.biomerica.com