- InFoods® IBS LDT validation testing at the CLIA Lab is completed and the product is now being offered commercially
- Clinical trial data shows InFoods® IBS treatment diet significantly improved several key IBS symptoms including Abdominal Pain Intensity (API)
- The improvement in API for patients in the treatment arm versus the placebo arm was similar to, and in some cases better than, the current IBS drugs in the market.
IRVINE, Calif., March 08, 2023 (GLOBE NEWSWIRE) — Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced the launch of its InFoods® IBS test. The test is being performed in a CLIA-certified, and CAP accredited high-complexity laboratory facility and offered as a laboratory developed test (LDT). The Company further announced all validation testing necessary for the InFoods IBS product to be offered as an LDT has been completed. The first patient samples have been processed.
Following the successful completion and positive results from the Company’s InFoods IBS clinical trial (run at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. – a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan), Biomerica has received significant interest from Gastroenterology (GI) physicians who would like to order the InFoods IBS test for their patients immediately. 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 arm versus the placebo arm is considered clinically significant and is similar and, in some cases, better than the current drugs in the market.
Rather than simply treating the symptoms of IBS, the InFoods® IBS platform is designed to identify the unique foods that trigger or worsen IBS symptoms in individual patients, paving the way for more effective treatment. It is estimated that over 40 million Americans suffer from IBS, with symptoms often triggered by consumption of specific foods (which are unique in each sufferer). The total direct and indirect cost of IBS has been estimated at $30 billion annually in the United States alone.
Mr. Robert Carlson is managing the InFoods IBS LDT launch as well as the future phases of the commercialization strategy including national reimbursement and FDA marketing authorization. Mr. Carlson has extensive specialized experience commercializing LDTs, diagnostics, and pharmaceutical products for the Life Sciences and Healthcare industries. He is the former Chief Commercial Officer, Vice President and head of sales, marketing, and corporate development at Prometheus Laboratories, Inc., which at the time was a Nestlé Health Science Company.
Zack Irani, Chief Executive Officer of Biomerica, commented, “After several years of extensive development we are excited about this significate milestone. In addition, we have seen very positive responses from GI physicians about using InFoods IBS as a tool to help patients manage the multiple and challenging symptoms of IBS.”
The InFoods IBS test involves a simple blood collection procedure and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the InFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented InFoods® Technology Platform can be found at: https://biomerica.com/infoods/our-technology/
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 primarily 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 Company’s InFoods® IBS test and other tests, FDA clearance or possible future clearance of the Company’s InFoods® IBS test and other products, timing of the commercial launch of the InFoods® IBS test, possible future revenues from the sale of the InFoods® IBS test, growth in future revenues from the sale of the InFoods® IBS test, acceptance of the InFoods® IBS test by physicians and their patients, international regulatory approval and sales of the InFoods® IBS test, accuracy, efficacy and clinical trial results of the InFoods® IBS test, the rapidity of testing results, negotiations with clinical labs who would offer the InFoods® IBS test, the ability of a CLIA-certified, high-complexity lab to offer the InFoods® IBS test as a laboratory developed test (LDT), discussions with physicians and physician groups who could or would offer the InFoods Test to their patients, efficacy of the InFoods IBS test to improve IBS symptoms in patients, the company’s ability to manufacture the InFoods® IBS test as a commercial product and to increase manufacturing capacity to meet future product demands, any future FDA marketing authorization, the uniqueness of the Company’s InFoods® IBS test and other products, pricing of the Company’s InFoods® IBS test, future possible insurer reimbursement for the InFoods® IBS test, patent protection on the InFoods® IBS and the underlying technology of the test, or on any of the Company’s other products or technologies, and current or future competition for the InFoods® IBS test from other medical manufacturers or distributors. 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 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 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.
Source: Biomerica, Inc.