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Biomerica working with FDA on submission
9/29/2015
 

Biomerica working with FDA on submission for its IBS product

Irvine, California – September 29, 2015 -- Biomerica, Inc. (OTC BB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, announced today that following a meeting with the FDA on September 17, 2015, Biomerica is now moving forward with guidance from the FDA to develop the optimal clinical and regulatory path to begin clinical studies for its new IBS diagnostic product.   The product is intended to aid in identifying patient specific foods that may exacerbate IBS symptoms.  The regulatory path Biomerica is pursuing is a De Novo 510(k) which,  if accepted by FDA, would allow Biomerica to attain clearance of its product without filing a PMA (Premarket Approval Application).  De Novo approval is generally faster and much less expensive than the PMA route, which is the most stringent type of device marketing application required by FDA. 

Biomerica has already filed numerous patents for the new technology and it is now patent pending.  It is estimated that up to 58 million Americans suffer from IBS in one form or another, and Biomerica feels that many could be helped by this new technology.

“FDA has been very helpful and cooperative in providing us the guidance to develop the clinical trial to validate the accuracy of our new product,” stated Zackary Irani, Biomerica’s CEO.  “We are looking forward to working with them to finalize the path for submission.  In addition, Biomerica is also exploring regulatory approval in other countries.”
 

About Biomerica (OTCBB: 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 is 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.