IRVINE, CA--(Marketwired - July 11, 2016) - Biomerica, Inc. (BMRA) announced today that the U.S. Food and Drug Administration (FDA) has determined that the proposed clinical study to validate performance of its InFoods® IBS product is a nonsignificant risk (NSR) device study. The Company will not be required to submit an investigational device exemption (IDE) for the InFoods® IBS product clinical study.
The InFoods® IBS product is intended to identify patient specific foods that may alleviate IBS symptoms. Biomerica is pursuing a de novo 510(k) rather than a PMA (Premarket Approval Application). De novo clearance is faster and less expensive than the PMA route, which is the most stringent type of device marketing application required by FDA.
The InFoods® IBS product is a patent pending, diagnostic guided therapy that is designed to allow for a personalized dietary treatment to improve Irritable Bowel Syndrome (IBS) patient outcomes. A billable CPT code that can be used by both clinical labs and physicians' offices is available for InFoods® diagnostic products. The InFoods® IBS product is unique in that it has no drug type side effects. It is estimated that 10-15% of the world's population and over 45 million Americans suffer from IBS.
The Company has already filed numerous patents for the new technology and it is now patent pending. Biomerica's international patent application for the InFoods® IBS product was reviewed by the International Search Authority and all claims have been deemed novel and non-obvious.
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 the health and well being of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Diabetes, Gastrointestinal Disease 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, expected improvements in performance, new distribution, expected new product introductions, belief that new strategies will yield higher sales and margins, sales potential, market size, growth of business, possible regulatory clearances, positive outlook, expansion, expected regulatory path, leading market positions, anticipated future revenues or production volume of the Company, 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.