Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn's Disease and Ulcerative Colitis

Core Points - Biomerica, Inc. has achieved CE-marking for its food intolerance products aimed at Crohn's Disease and Ulcerative Colitis under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR) [1][3][10] - This certification signifies Biomerica's commitment to expanding its international market presence and addresses the need for non-invasive therapies for chronic inflammatory bowel diseases [2][6][10] - The IVDR framework enhances the safety and performance of in-vitro diagnostics, and Biomerica's products have met the stringent requirements, facilitating easier market access in other regions [3][10] Product Details - Biomerica's food intolerance products utilize proprietary technology to identify dietary triggers that may cause inflammation in patients with Crohn's Disease and Ulcerative Colitis, offering a personalized management approach [4][5] - The products aim to improve patient quality of life by addressing specific food intolerances [4][5] Market Opportunity - The global market for treatments of Ulcerative Colitis is projected to grow from $7.72 billion in 2024 to$12.03 billion by 2032, with a compound annual growth rate (CAGR) of 5.7% [8] - The Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023, indicating a significant demand for effective, non-invasive solutions [8] Company Strategy - With the IVDR certification, Biomerica is positioned to enhance its presence in the European in-vitro diagnostic market, aligning with its global growth strategy [6][10] - The company is focused on developing innovative diagnostic products that meet high technical standards and address unmet medical needs [5][10]