Biomerica Announces First Patient Enrollment in Clinical Study for New Irritable Bowel Syndrome (IBS) Diagnostic Guided Therapy
- Diagnostic Guided Therapy (DGT) is designed to identify patient specific foods, that when removed, may alleviate an individual's IBS symptoms
- Approximately 45 million Americans suffer from IBS1
- Studies being conducted at Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan.
IRVINE, Calif., June 25, 2018 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ:BMRA) today announced that the first patient has been enrolled in the randomized, double-blind, placebo-controlled, clinical trial of its new InFoods® diagnostic-guided therapy (DGT) to alleviate Irritable Bowel Syndrome (IBS) symptoms.
It is estimated that over 45 million Americans are affected by IBS. 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 patient well-being and a person’s ability to function both at home and in the workplace.
The Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. eggs, milk, wheat, sugar, corn, etc.), that when removed, may alleviate or improve an individual's IBS symptoms including but not limited to constipation, diarrhea, bloating, 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 while a clinical lab version of the product will be 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.
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.
The clinical studies are being conducted at Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan. This initial clinical study will include approximately 180 patients and is expected to take between 9 and 14 months to complete. The study will also stratify enrollment by the three main IBS subclasses (IBS-Constipation, IBS-Diarrhea and IBS-Mixed). There is no FDA cleared therapy for IBS-Mixed at the present time. The study design has already received a non-significant risk determination from FDA.
The results of this clinical study will be used to identify the primary endpoint(s) to be used in the pivotal study that will be required prior to submitting a 510(k) application to the FDA. The pivotal trial is expected to start after the completion and analysis of the initial trial.
Dr. William Chey, Primary Investigator at Michigan Medicine stated, “Many of our patients have been waiting for this trial to start. We are excited to be part of a trial for a product that offers the possibility to change the way we approach and treat IBS sufferers in the US”.
Dr. Anthony Lembo, Beth Israel Deaconess Medical Center, stated: “This product has the potential to provide patients with a non-pharmaceutical therapy for IBS, yet can be combined with current pharmaceutical therapies to improve outcomes. Our patients are excited about potential to have additional treatment options to address their IBS symptoms.”
Zackary Irani, Chief Executive Officer of Biomerica, commented: “We are thrilled to commence patient enrollment for the InFoods® DGT. Up to 45 million people in the United States with IBS desperately seek some form of symptom relief. We are also very pleased to be working with Dr. Chey and Dr. Lembo both of which are leading experts in functional GI disorders and have been the primary investigators in clinical studies for many of the leading drug therapies for IBS. This milestone demonstrates Biomerica’s commitment to introduce unique products and aligns with our strategy to focus in the area of Gastroenterology.”
About Biomerica (NASDAQ:BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking; such as statements relating to intended launch dates, sales potential, significant benefits, market size, prospects, new products, favorable outlook, new distributors, expansion, increases in productivity and margins, expected orders, leading market positions, anticipated future sales or production volume of the Company, the launch or success of product and new product offerings. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.
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