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Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn's Disease and Ulcerative Colitis
Globe Newswire 26-Feb-2025 8:19 AM
Significant Milestone: Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union standards and allowing sales of the products in the EU
Focus on Precision Medicine: Certification covers Biomerica's food intolerance products developed to support patients with Crohn's Disease and Ulcerative Colitis (UC), both of which are chronic and debilitating inflammatory bowel diseases (IBD).
Global Reach: Positions Biomerica to expand its presence in the European market while adhering to the highest standards of safety, quality, and performance.
IRVINE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ:BMRA), a global leader in advanced medical diagnostic solutions, is proud to announce that its food intolerance products for Crohn's Disease and Ulcerative Colitis have achieved CE-marking under the European Union's new In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746).
This certification marks a significant milestone for Biomerica, underscoring the company's commitment to expanding its products in international markets. The newly approved food intolerance products are designed to address the growing need for non-invasive and personalized therapies to manage Crohn's Disease and Ulcerative Colitis, conditions affecting millions worldwide.
The IVDR framework, implemented to enhance the safety, quality, and performance of in-vitro diagnostics across Europe, introduces rigorous new requirements. Biomerica's food intolerance products successfully met these General Safety and Performance Requirements (Annex I of IVDR 2017/746), demonstrating the company's ability to deliver innovative solutions that improve patient outcomes. IVDR certification can also be the basis for easier market access in other international markets outside of Europe with stringent regulatory approval processes, as many countries recognize the EU IVDR certification.
Improving Care for Crohn's Disease and Ulcerative Colitis Patients Biomerica's food intolerance products use proprietary technology to identify specific foods that may trigger inflammation in Crohn's Disease and Ulcerative Colitis patients. By addressing dietary triggers, these products offer a novel, personalized approach to managing symptoms and improving quality of life.
"Achieving IVDR certification is a testament to our dedication to creating diagnostic products that achieve the highest technical standards," said Zack Irani, CEO of Biomerica. "This certification not only validates the safety and effectiveness of our products but also positions Biomerica to expand sales of these products in the European market. We are committed to providing innovative, non-invasive solutions that enhance patient care and address unmet medical needs. Our teams are now finalizing the materials for product launch in the near future."
Expanding Biomerica's Global Presence With this certification, Biomerica is positioned to expand its presence in the European In Vitro diagnostic market. The company continues to leverage its expertise in developing products that target one of the root causes of inflammation in chronic diseases, aligning with its global growth strategy to serve both patients and healthcare providers.
About Crohn's Disease and Ulcerative Colitis Crohn's Disease and Ulcerative Colitis are chronic inflammatory bowel diseases affecting millions of people worldwide. Symptoms include abdominal pain, diarrhea, and rectal bleeding, significantly impacting patients' quality of life. Current treatment options often involve medications with potential side effects, underscoring the need for alternative approaches like Biomerica's food intolerance products.
The market for Crohn's Disease and Ulcerative Colitis treatments is substantial and growing. The global UC market is expected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, with a CAGR of 5.7%. Globally, the Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023. These figures highlight the increasing demand for effective, non-invasive solutions to help manage the disease and improve patient outcomes.
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 primarily focuses 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 diagnostic tests, international regulatory clearance, FDA clearance or possible future clearance of the Company's diagnostic tests and other products, timing of the commercial launch of any of the company's tests and products, possible future revenues from the sale of the company's tests and products, growth in future revenues from the sale of the company's tests and products, acceptance of the company's tests and products by physicians and their patients, international regulatory approval and sales of the company's tests and products, accuracy, efficacy and clinical trial results of the company's tests and products, the rapidity of testing results, , discussions with physicians and physician groups who could or would offer the company's tests and products to their patients, efficacy of the company's tests and products to improve GI disease symptoms in patients, the company's ability to manufacture their tests and products, and to increase manufacturing capacity to meet future product demands, the uniqueness of the Company's tests and products, pricing of the Company's tests and products, future possible insurer reimbursement for the company's tests and products, patent protection on the underlying technology of the tests and product, and current or future competition for the company's tests and products 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.
