Biomerica gains EU certification for IBD food intolerance products

IRVINE, Calif. - Biomerica, Inc. (NASDAQ:BMRA), a developer of medical diagnostic solutions, has achieved a significant regulatory milestone with the CE marking of its food intolerance products for Crohn’s Disease and Ulcerative Colitis under the European Union’s In Vitro Diagnostic Medical (EPA:ALDMS) Devices Regulation (IVDR). This certification enables the company to market these products within the EU, signaling a major step in Biomerica’s strategy to expand its global presence.

The IVDR certification ensures that Biomerica’s diagnostic products adhere to the EU’s rigorous safety, quality, and performance standards. The company’s proprietary technology identifies specific dietary triggers for individuals with Crohn’s Disease and Ulcerative Colitis, aiming to offer personalized management of these chronic inflammatory bowel diseases (IBD).

Zack Irani, CEO of Biomerica, stated that the certification is a testament to the company’s dedication to high technical standards and its commitment to enhancing patient care with innovative, non-invasive solutions. The products are expected to be launched in the European market in the near future.

The certification is also anticipated to facilitate easier access to other international markets that recognize the EU IVDR certification. Biomerica’s food intolerance products align with the company’s focus on addressing the root causes of inflammation in chronic diseases.

Crohn’s Disease and Ulcerative Colitis affect millions worldwide, with symptoms that significantly impact the quality of life. Current treatments often involve medications that can have side effects, highlighting the need for alternative approaches like the ones Biomerica offers.

The global market for Ulcerative Colitis treatments is projected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, while the Crohn’s Disease therapeutics market was estimated at $13.2 billion in 2023. These figures underscore the potential demand for Biomerica’s food intolerance products.

Biomerica is known for developing, patenting, manufacturing, and marketing advanced diagnostic and therapeutic products. The company focuses primarily on gastrointestinal and inflammatory diseases, with multiple diagnostic and therapeutic products in development.

This news is based on a press release statement from Biomerica, Inc.

In other recent news, Biomerica, Inc. announced significant findings from a clinical trial involving its inFoods® IBS test, which showed promise in reducing symptoms of Irritable Bowel Syndrome. The study reported that 59.6% of participants who followed a personalized diet based on the test’s results met the FDA-standard target for reducing abdominal pain. This development suggests a potential shift towards precision nutrition in managing IBS symptoms. Additionally, Biomerica received approval from the United Arab Emirates Ministry of Health and Prevention for its Fortel® Prostate Specific Antigen (PSA) Screening Test. This approval marks a strategic expansion into the Middle East, where prostate cancer cases are rising. In corporate governance, Biomerica’s recent Annual Meeting of Stockholders resulted in the election of five board members and the approval of executive compensation. The shareholders also ratified the continuation of Haskell & White LLP as the company’s independent accounting firm and approved a 2024 Stock Incentive Plan. These developments reflect the company’s ongoing efforts to enhance its diagnostic offerings and corporate strategies.

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