- DGT Designed to identify patient specific foods, that when removed, may alleviate an individual's IBS symptoms
- DGT can be used alongside current IBS drug treatments to potentially improve outcomes
- Market research determined that 70 % of physicians surveyed would use DGT
- Approximately 45 million Americans suffer from IBS1
IRVINE, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ:BMRA) today announced that the Company has signed definitive agreements with two of America’s leading research institutes to perform the clinical trials needed to validate the performance of its diagnostic-guided therapy (DGT) to alleviate Irritable Bowel Syndrome (IBS) symptoms. 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. 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.
It is estimated that over 45 million Americans are affected by IBS. The Biomerica InFoods® IBS product identifies foods specific to each patient that, when removed from the diet, may alleviate an individual's IBS symptoms. While a clinical lab version of the product will be used in this clinical trial, the Biomerica InFoods® IBS point-of-care product is also being developed to allow 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 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.
The clinical studies will be conducted at Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan. The initial clinical study will include approximately 180 patients and is expected to take between 9 and 14 months to complete. The results of this initial 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 study design has already received a non-significant risk determination from FDA.
The Company has strategically decided to conduct the InFoods® clinical program in two parts. This initial clinical study will be used to predominantly determine the primary end point(s) for the second part which will be the pivotal study. 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 pivotal trial is expected to start after the completion and analysis of the initial trial.
Dr. William Chey, Primary Investigator at Michigan Medicine stated, “We have been working with Biomerica for several years on developing the protocol for the Company’s IBS trials. We are pleased to be involved with the clinical trials of a therapy that offers the possibility of changing the lives of millions of patients and provides physicians’ a much-needed therapy for this very common problem.”
Dr. Anthony Lembo, Beth Israel Deaconess Medical Center, stated: “We are very excited about the impact this can make for IBS patients and we are thrilled 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 symptom relief. We believe our approach, supported by a Scientific Advisory Board and Strategic 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.”
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 Biomerica InFoods® IBS product identifies patient specific foods that when removed may alleviate an individual's IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The 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 the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects.
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.
Contact Information
Carolyn Shoup
949-645-2111
www.biomerica.com
[1] The epidemiology of irritable bowel syndrome
Clin Epidemiol. 2014; 6: 71–80. . doi: 10.2147/CLEP.S40245
Caroline Canavan, Joe West, and Timothy Card