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IRVINE, Calif., Nov. 02, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) announced that data derived from a clinical study of InFoods® IBS was presented at the 2022 American College of Gastroenterology (ACG) Annual Scientific Meeting in a poster titled “IgG-based Elimination Diets for Patients with IBS: Results From a Prospective, Multi-Center, Double-Blind, Placebo-Controlled Trial.” The poster was selected by ACG as a “Presidential Poster.” Fewer than 5% of accepted ACG abstracts each year receive this distinction, which is awarded for high quality, novel and potentially industry disruptive research.
The outcomes of this prospective, multi-center, double-blinded, placebo-controlled clinical trial presented at ACG showed that IBS patients who used the InFoods® IBS test to guide the elimination of specific foods from their diets for eight weeks (“treatment diet arm”) led to a material improvement of symptoms over placebo in several IBS measures including: abdominal pain intensity, bloating, Subject Global Assessment of Relief (SGA) and the Global Improvement Scale (GIS). People with IBS-Constipation and IBS-Mixed who participated in the study showed the greatest decrease in symptoms. No significant adverse events were reported.
In the data presented at the ACG annual meeting, for the Abdominal Pain Intensity (API) responder endpoint of >30% improvement in pain, patients with IBS Constipation and IBS Mixed in the treatment diet arm had a statistically significant improvement over patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment versus the placebo is considered clinically significant and is similar and, in some cases, better than the current drugs in the market.
Anthony Lembo, MD, FACG, Beth Israel Deaconess Medical Center and Harvard Medical School said, “The standard self-directed IBS elimination diets can be challenging to adhere to, require a significant time commitment and ultimately do not necessarily provide positive outcomes. These data show that this novel, proprietary IgG based test may help guide the elimination of specific foods resulting in benefit to some patients with IBS.”
These clinical study results presented at the ACG meeting were also featured in an article published by Medscape titled “ IgG-Based Elimination Diet Beneficial for IBS Symptoms: Study ” and in an additional article published by Gastroenterology Advisor titled “ IgG-Based Elimination Diets Reduce IBS Abdominal Pain, Bloating.”
Zack Irani, Chief Executive Officer of Biomerica, said, “We are highly encouraged by the data validations and this award-winning medical research that reinforces the potential efficacy of our revolutionary InFoods® IBS diagnostic-guided therapy. We believe that InFoods IBS can play an important role in the treatment of people who have IBS.”
About InFoods®
The Biomerica InFoods® IBS product is designed to allow physicians to identify patient-specific foods (e.g., eggs, broccoli, wheat, potatoes, pork, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, cramping, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient-specific, guided dietary regimen to improve IBS outcomes. A point-of-care version of the 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 expected to be the first for which the Company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is already available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 40 million people in America currently suffer from IBS making it a leading cause for patient doctor visits1.
About Biomerica (NASDAQ: BMRA )
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point of care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment 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’s primary focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.
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 the efficacy of the Company’s InFoods IBS test and other tests, breadth and accuracy of results derived from clinical trials on the InFoods IBS test and other tests, future FDA clearance of the Company’s products and tests, possible international regulatory clearance of the companies tests and products, the rapidity and/or accuracy of the InFoods IBS test results and the Company’s other products and tests, uniqueness of the Company’s products, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s InFoods IBS test and other test kits, and patent protection on any of the Company’s products or technologies. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s tests and other products; regulatory approvals necessary prior to commercialization any of the Company’s products; availability of the Company’s test kits and other products; capacity, resource and other constraints on our suppliers; dependence on our third party component manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection on any aspects of its rapid test technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, 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.
Corporate Contact:
Zack Irani
949-645-2111
zirani@biomerica.com
Source: Biomerica
1. Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245