Houston Methodist (part of Texas Medical Center, the largest medical complex in the world), will initiate enrollment for a clinical trial sponsored by Bioamerica, Inc. (NASDAQ: BMRA) and its InFoods Diagnostic Guided Therapy (DGT)—designed to identify patient specific foods, that when removed from the diet, alleviate an individual’s irritable bowel syndrome (IBS) symptoms. It is suspected that the study sponsor is scrambling to find patients to keep the study on track concerning timeline.
The IBS Challenge
It has been reported that approximately 45 million Americans suffer from IBS. It represents a group of symptoms—including abdominal pain and changes in the pattern of bowel movements without any evidence of underlying damage. The symptoms occur over a long time and even often years. There are four main types depending on whether diarrhea is common, constipation is common, both are common or neither occurs very often (IBS-D, IBS-C, IBS-M or IBS-U respectively), according to the NIDDK. The causes of IBS are not clear but theories include combinations of gut-brain axis problems, gut motility disorders, genetic factors, food sensitivity and others.
It is estimated that the many millions of Americans that 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 patient well-being and a person’s ability to function both at home and in the workplace.
Houston Methodist will join Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan as primary enrollment centers for the study according to the recent press release sponsored by Biomerica.
What is the InFoods® diagnostic-guided therapy (DGT)?
The patented Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. pork, milk, shrimp, broccoli, chickpeas, etc.), that when removed from the diet, may alleviate or improve an individual’s IBS symptoms including constipation, diarrhea, bloating, abdominal cramps, pain and indigestion. The InFoods® IBS point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample. A clinical lab version of the product is being used in this clinical trial. A billable CPT code that can be used by both clinical labs and physicians’ offices is already available for InFoods® IBS products. Market research conducted by a leading independent pharmaceutical marketing research firm determined that seventy percent (70 %) of physicians surveyed would use the InFoods® DGT without reimbursement and 90% would use it with reimbursement.
Importantly, the InFoods® DGT can be used without or in conjunction with current pharmacotherapy 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.
Challenges with Finding Enough Patients?
The InFoods® endpoint trial is expected to be completed before 2020. Biomerica is now in the process of adding several new large medical groups (including Houston Methodist) to assist with accelerating the endpoint trial and participate in the subsequent pivotal trial needed for final FDA clearance. Further, by adding large world-renowned centers to its trials, Biomerica continues to grow the number of leading gastrointestinal (GI) physicians using the InFoods® IBS product during the trials and once FDA clearance is received. For more on the study details see the link to Clinicaltrials.gov.
TrialSite News suspects the study could be behind because according to ClinicalTrials.gov it was commenced on June 21, 2018, and sought 180 participants. The research sites identified at that time included not only University of Michigan and Beth Israel Deaconess but also Family Medicine Specialists in Illinois and Gastroenterology Research of San Antonio.
Given the study sponsor is adding such a major health system it is reasonable assumption that the study is behind on its patient recruitment—which is a frequent and recurring problem for most sponsors.
Who is the Sponsor?
Bioamerica (BMRA) is a public traded company developing, manufacturing and marketing advanced diagnostic products used at the point-of-care (in home and physicians’ offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The company’s products are designed to enhance health and well-being, while reducing total healthcare costs.
The company primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing. Their InFoods® IBS product identifies specific foods that when removed may alleviate an individual’s IBS symptoms.
Business & Financials
Currently priced at $2.95 per share and a $30 million market capitalization, this microcap stock-based venture was founded in 1971 according to their website. Their stock has been stuck in microcap territory for many years. According to their 10K, they were originally called Nuclear Medical Systems, Inc. They have subsidiaries including Biomerica de Mexico (established for use as a maquiladora) and BioEurope GmbH, which serves as a distributor in Europe for certain products.
Their 2019 fiscal year resulted in net sales of $5.2 million which was a decline as compared to the $5.5 million in 2018 while their losses are growing ($2.3 million loss for fiscal 2019 as compared to net loss of $1.4 million in 2018). They do report some momentum with key milestones achieved over the past year—see the link.
William D. Chey, MD, University of Michigan
Anthony J. Lembo, MD Beth Israel Deaconess Medical Center