Biomerica Receives Notice of Allowance for Irritable Bowel Syndrome (IBS) Test Panel and Methods in Korea
Published: Aug 02, 2018 By GLOBE NEWSWIRE
IRVINE, Calif., Aug. 02, 2018 (GLOBE NEWSWIRE) -- Biomerica Inc. (Nasdaq:BMRA) announced today that the Korean Intellectual Property Office (KIPO) has issued a Notice of Allowance for a patent application covering Biomerica’s compositions, devices and methods of IBS sensitivity testing. The patent is expected to issue before September 2018.
The patent application specifically applies to Biomerica’s InFoods® IBS product, which is currently in a clinical study in the U.S. This patent would be the first for the InFoods® patent portfolio, providing patent protection for InFoods® IBS in Korea until 2035.
It is estimated that over 45 million Americans are affected by Irritable Bowel Syndrome (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 InFoods® IBS diagnostic guided therapy (DGT) is designed to allow physicians to identify patient specific foods (e.g. pork, milk, onions, sugar, chickpeas, 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 is being used in the current clinical study. 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 for IBS.
Importantly, the InFoods® DGT can be used either without or in conjunction with current pharmacotherapy to potentially improve patient outcomes. Since the InFoods® IBS product is a diagnostic guided therapy and not a drug, it has no drug type side effects.
The current InFoods® IBS clinical study is being conducted at Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and at the University of Michigan. The study will 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, creating the possibility for the InFoods® DGT to penetrate a significantly unaddressed segment of the IBS market.
“We are excited about allowance of our first patent for our InFoods® technology” stated Zackary Irani, CEO of Biomerica. “The data from the current InFoods® IBS clinical study is expected to be forthcoming prior to August 2019 and we are excited about the response thus far.”
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, expected dates, 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.
Zack Irani | CEO