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Google-The University of Texas Health Science Center at Houston joins Biomerica's InFoods® Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy (“DGT”) clinical trial - GlobeNewswire

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The University of Texas Health Science Center at Houston joins Biomerica's InFoods® Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy (“DGT”) clinical trial  GlobeNewswire

IRVINE, Calif., June 29, 2020 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA) today announced it has signed a definitive agreement with the University of Texas Health Science Center at Houston (“UTH”) to join the clinical trial for Biomerica’s new InFoods® diagnostic-guided therapy, designed to alleviate Irritable Bowel Syndrome (IBS) symptoms. The University of Texas Health Science Center at Houston is the fifth large medical center to be part of the InFoods® clinical trial which includes:  Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist and the University of Michigan as primary enrollment centers. UTH can now begin enrollment of patients in this trial.

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 physical and mental well-being of a patient and a person’s ability to function both at home and in the workplace.

A clinical lab version of the InFoods® IBS DGT product is being used in this clinical trial. However, the Company is also working to develop a point-of-care version of the InFoods® IBS DGT product that would potentially allow physicians to perform the test in-office using a finger stick blood sample. The point of care version would allow physicians to be reimbursed for administering the test.  A billable CPT code that can be used by both clinical labs and physicians' offices is already available for the InFoods® IBS products. Market research conducted by a leading, independent, pharmaceutical, marketing research firm, determined that over 70% of physicians surveyed would utilize the InFoods® DGT to treat their IBS patients without reimbursement and over 90% would utilize it with reimbursement. 

Importantly, the InFoods® DGT can be used without or in conjunction with current IBS 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.    

The current endpoint clinical trial is expected to be completed in approximately 6 months. However, due to the novel coronavirus’ impact on the U.S.’s healthcare system, it may take longer. If all goes as expected, Biomerica plans to commence the final pivotal trial several months thereafter, which is needed for submission to the FDA for final clearance.  The endpoint trial stratifies enrollment by the three main IBS subclasses (IBS-Constipation, IBS-Diarrhea and IBS-Mixed). The clinical study design has already received a non-significant risk determination from the FDA.

Dr. Brooks D. Cash, Chief of Gastroenterology, Hepatology, and Nutrition at the University of Texas Health Science Center at the Texas Medical Center, stated, “We are excited about the potential impact this can make for IBS patients and excited to be part of the clinical trial group for InFoods® IBS. The product is novel in that it is addressing a root cause of IBS with a non-pharmaceutical therapy, yet can be combined with current pharmaceutical therapies to improve outcomes.”

Zackary Irani, Chief Executive Officer of Biomerica, commented: “IBS remains a major burden for up to 45 million people in the United States who desperately seek some form of medical advancement providing relief.  We believe our approach, supported by a Scientific Advisory Board comprised of the leading minds in the IBS medical community, is differentiated by focusing on one possible root cause of IBS compared to simply treating symptoms.” 

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