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BMRA: InFoods 2nd Patent & COVID-19 Evaluation Support Optimistic Outlook

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By M. Marin

NASDAQ:BMRA

READ THE FULL BMRA RESEARCH REPORT

The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Biomerica’s (NASDAQ:BMRA) second U.S. patent on the InFoods® technology platform for the treatment of patients suffering from Irritable Bowel Syndrome (IBS) and other gastrointestinal diseases. These diseases impact an estimated more than 45 million Americans. IBS symptoms frequently are triggered when people eat specific foods. Trigger foods vary from one person to another. For instance, one person might be able to consume broccoli with no problem but milk triggers discomfort and symptoms, while another person might be fine with milk but cannot tolerate broccoli.

We believe the USPTO action will expand the potential applications and use of inFoods. It covers the method allowing doctors to identify specific foods (pork, milk, shrimp, broccoli, chickpeas, and others). When patients eliminate the foods that test positive for triggering IBS and/or other gastrointestinal distress, generally their symptoms such as constipation, diarrhea, bloating, severe cramping, pain and indigestion ease or are eliminated entirely.

This is the second allowed patent BMRA has received as it applies for broad patent protection for a test panel and method to determine patient specific foods that might trigger IBS symptoms. BMRA has several additional U.S. and international patent applications pending that cover other claims pertaining to the InFoods platform to increase its coverage and scope. Separately, the company also recently announced that it had received its first patent for inFoods in Japan.

BMRA’s InFoods diagnostic platform is in clinical studies at several prominent medical centers and research universities and the number of sites participating in the study continues to expand. Specifically, in June, the Mayo Clinic and the University of Texas Health Science Center joined the InFoods clinical trial.

Separately, in response to the current global health crisis, BMRA has developed a high-volume rapid 10-minute point-of-care test for exposure to the COVID-19 virus. The test is easy to use and portable, which means that it can be used at point-of-contact locations at airports, schools, businesses and other high-traffic venues. Medical personnel and other trained individuals can use the test by obtaining blood from the patient through a finger prick. BMRA recently announced that.

BMRA has begun shipping in the EU following receipt of the required CE mark. We expect the company to leverage its existing distribution network to supply end-users. The speed with which the company came to market in the EU reflects the expertise it has developed through its core operations that enables BMRA to leverage the technology, in our view.

BMRA also seeks EUA-FDA approval for commercial sales in the U.S. pursuant to the FDA’s EUA (Emergency Use Authorization) process that is designed to accelerate the commercial launch of a test during an emergency such as the COVID-19 pandemic.

The high-volume production version of the COVID-19 test is intended for large customers that are performing a significant number of screenings on an ongoing basis. A new Canadian study released last month indicates that BMRA’s RDT test showed 100% sensitivity and 100% specificity and was included in the rankings of top-performing COVID-19 serological tests based on independent evaluations of sensitivity/specificity.

Given the unmet demand for COVID-19 testing, we believe the new test could be highly additive to BMRA’s top-line and to the bottom line, depending on margins once the company has ramped production, and could augment the sum-of-the-parts valuation of BMRA shares.

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