Mayo Clinic joins Biomerica’s InFoods Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy clinical trial - Seite 2

A clinical lab version of the product is being used in this 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. Market research conducted by a leading, independent pharmaceutical marketing research firm, determined that seventy percent (70%) of physicians surveyed would utilize the InFoods DGT without reimbursement and over 90% would utilize it with reimbursement. 

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.  

The clinical trials are randomized, double-blinded, and placebo-controlled. Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, has completed its enrollment of patients for this endpoint study but will continue to participate in the final pivotal trial once that commences.

This clinical endpoint 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).   There is currently no FDA cleared therapy for IBS-Mixed.  The study design has already received a non-significant risk determination from FDA.

Zackary Irani, Chief Executive Officer of Biomerica, commented: “We are excited to have Mayo Clinic join the InFoods IBS trial.  IBS patients who desperately seek symptom relief will be the beneficiaries of this revolutionary disruptive technology.  Also, we are pleased to have additional countries issue patents with broad claims that acknowledge the novel and innovative attributes of this technology platform that can be used to help patients that suffer from IBS and many other diseases.”