Biomerica's InFoods Irritable Bowel Syndrome Diagnostic-Guided Therapy Clinical Trial Nears Completion of Enrollment

• Patient enrollment completion anticipated by the end of April 2021
  
• InFoods Diagnostic-Guided Therapy is designed to address the $30 billion market for IBS treatment
• Therapy seeks to identify patient-specific foods that trigger IBS symptoms and suffering
• Approximately 45 million Americans suffer from IBS¹

IRVINE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it is nearing completion of patient enrollment in the endpoint clinical trial for its InFoods Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”). This double-blinded, randomized, controlled clinical trial is validating the Biomerica InFoods IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. Utilizing an antibody guided blood test, the InFoods IBS product identifies patient-specific foods that may alleviate IBS symptoms when eliminated from the diet.

"I am pleased our clinical endpoint trial for InFoods IBS remains on track to complete enrollment despite the challenges imposed by this pandemic," stated Zack Irani, CEO of Biomerica. "There is clearly a large unmet need in IBS patients who seek relief but are limited to trial-and-error for foods or drugs that treat symptoms but not the cause. Importantly, the InFoods IBS therapy can be used in isolation or as part of the pharmacological drug therapy a patient would often receive, but without adding to the side-effect burden."

Mr. Irani concluded, "The endpoint trial results should open potential partnering opportunities with global health sciences, pharmaceutical and medical device companies, and is expected to pave the way to a final pivotal trial and ultimately lead to FDA clearance. InFoods IBS, provides a novel therapy for patients suffering from IBS without the drug side-effects. We look forward to providing updates on our continued progress in the coming months as we move closer to completing this endpoint trial."

As previously indicated, Mayo Clinic joined Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School Teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston and the University of Michigan as enrollment centers for this study. Biomerica expects to complete patient enrollment at these centers by the end of April 2021.

The clinical endpoint trial's objective is to validate key elements and provide the selection of a proper endpoint of a proposed larger and final FDA pivotal trial. The design of the InFoods IBS product clinical endpoint study has already received a non-significant risk determination from the FDA. The Company will not be required to submit an investigational device exemption (“IDE”) for the InFoods IBS product study.