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

Core Insights - 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][9] - This certification enhances Biomerica's commitment to expanding its international market presence and addresses the need for non-invasive therapies for chronic inflammatory bowel diseases [2][6] Product and Market Overview - The newly approved food intolerance products utilize proprietary technology to identify dietary triggers that may exacerbate symptoms in patients with Crohn's Disease and Ulcerative Colitis [4][7] - The global market for treatments of Crohn's Disease and Ulcerative Colitis is substantial, with the UC market projected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, reflecting a CAGR of 5.7% [8] - The Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023, indicating a rising demand for effective, non-invasive management solutions [8] Regulatory and Strategic Implications - The IVDR framework introduces stringent requirements for in-vitro diagnostics, and Biomerica's successful compliance demonstrates its capability to deliver innovative solutions that enhance patient outcomes [3][5] - The certification not only validates the safety and effectiveness of Biomerica's products but also facilitates easier market access in other international markets that recognize EU IVDR certification [3][6] - Biomerica's strategy aligns with its goal to address unmet medical needs and improve patient care through innovative, non-invasive solutions [5][6]