IRVINE, CA--(Marketwired - October 04, 2016) - Biomerica, Inc. (BMRA), a global provider of advanced diagnostic products, today emphasized the market opportunity created by global market failure to effectively treat irritable bowel syndrome (IBS), further establishing the Company's unique approach to identifying patient specific foods that, when removed from an individual's diet, can alleviate IBS symptoms.
According to a recent study and poster published by Fabiane B. Klem, M.D., of the Universidade Federal do Parana, approximately one in nine people develop irritable bowel syndrome within a year of an intestinal infection, representing a risk that is four times higher than in those who don't experience such an infection. This, coupled with a recently updated report from the International Foundation for Functional Gastrointestinal Disorders which states that there are up to 45 million IBS sufferers in the United States, further entrenches the disease's reputation as a costly and challenging affliction that often goes undiagnosed and untreated.
Biomerica believes its personalized, dietary management approach, in stark contrast to many of the available treatments on the market which fail to produce long-term solutions for patients, represents significant market potential as it continues to progress through regulatory review. Many of the existing treatments on the market only address one form of IBS (IBS-C: constipation or IBS-D: diarrhea), and also produce side effects that are equally as challenging for patients to manage as IBS itself.
Biomerica's product (InFoods® IBS), is a simple blood test that identifies the body's reactions to specific foods, as opposed to food groups, allowing medical staff to provide therapeutic guidance on which foods should be removed from a patient's diet to alleviate symptoms. This approach is intended to address all three forms of IBS and focuses on food, one possible underlying cause for symptoms. The FDA has recently determined that the proposed study design for the validation of the product is a non-significant risk device study, thus the Company will not be required to submit an investigational device exemption (IDE) for the InFoods® IBS product clinical study.
"IBS remains a largely untreatable burden for up to 45 million people in the United States who desperately seek some form of medical advancement providing symptom relief," says Zackary Irani, CEO of Biomerica, Inc. "We believe our approach, led by a Scientific Advisory Board and Strategic Advisory Board comprised of the leading minds in the IBS medical industry, is the key differentiator between our InFoods® IBS diagnostic guided therapy and the treatment-based products currently available to patients. We continue to work with the FDA and leading research groups to further enhance the technology and its results, and hope to bring a more effective, non-drug solution to IBS patients everywhere."
About Biomerica (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 health and well-being, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.
This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity.
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.