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Biomerica’s Diagnostic Product Guides Exclusionary Diet Treatment to Successfully Alleviate Symptoms of Ulcerative Colitis (UC) in Prospective Clinical Stud
- Eliminating positive foods identified by Biomerica’s diagnostic product showed statistically significant improvements (p<0.05) in both Quality of Life (FDA Instrument) and disease activity (Mayo Score) in UC patients.
- The study highlights that Biomerica’s platform technology can assist physicians in determining patient specific foods to eliminate in order to alleviate symptoms associated with GI inflammatory conditions such as UC.
IRVINE, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) is pleased to announce that its first generation food intolerance product has been shown to alleviate symptoms of Ulcerative Colitis and improve quality of life in an independent prospective study published in the Journal of Inflammatory Bowel Disease1.
This study validates that Biomerica’s technology can assist in guiding the treatment regimen to alleviate symptoms and improve quality of life in patients with UC. The study used the Company’s first-generation product with UC patients and found both significant symptom (Mayo Score) and Quality of Life improvement (QoL - a validated instrument used in FDA drug studies). After intervention, the Mayo score was significantly lower in the intervention group than in the control group (2.41 ± 0.89 vs 3.52 ± 1.15, P < 0.05). QoL also improved after guided food exclusion (P < 0.05).
UC patient samples were analyzed for the presence of antibodies specific to 14 different food antigens (egg, wheat, milk, corn, tomato, crab, rice, soybean, cod, shrimp, mushrooms, beef, chicken, and pork) using Biomerica’s enzyme-linked immunosorbent assay (ELISA). The diet intervention was designed to last for 6 months and was managed by doctors, nurses, and nutritionists. Individual diets were guided based on the foods that tested positive in utilizing the Biomerica product. Colonoscopy examinations were performed within two weeks of study initiation and at the end of the diet intervention. The examinations were blinded to the groups.
“Diet has been shown, in well-designed studies, to reduce key markers of inflammation and the risk of heart disease,” stated Zack Irani, CEO of Biomerica. “We believe that the optimum diet is person specific. For example, corn may be inflammatory to one person with a GI condition but not inflammatory to another person with the same condition. We continue to improve our technology and have developed a second generation diagnostic guided therapy (InFoods®). The InFoods technology is exponentially more targeted than the first generation and can be used in many GI diseases with an inflammatory component such as UC, Irritable Bowel Syndrome and Functional Dyspepsia. We believe that the outcome of this prospective clinical study further validates that InFoods® is a platform technology that can address multiple GI disease states.”
Importantly, Biomerica is currently in clinical studies at Harvard and the University of Michigan for its second-generation InFoods® product for the treatment of Irritable Bowel Syndrome (IBS), a condition affecting 45 million2 people in the US. Similar to UC, it has been identified that symptoms of IBS can be alleviated by excluding certain patient-specific foods (e.g. pork, milk, onions, sugar, chickpeas, etc.) from the diet. InFoods® is a diagnostic guided therapy (DGT) that is being developed to be performed in physicians’ offices and if desired can be combined with pharmacotherapy. This makes it a seamless solution for patients while providing physicians with an incremental revenue stream for their practices. In a recent survey3, the average primary care physician estimated they would use InFoods® therapy on over 90% of their IBS patients.
1Crohn’s and Colitis Foundation – Inflamm Bowel Dis • Volume 24, Number 9, September 2018
2Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact, A. P. S. Hungin, June 2005, Alimentary Pharma & Thera
3Market Vision marketing research survey
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. 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.
Zack Irani | CEO