Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn’s Disease and Ulcerative Colitis
Biomerica (NASDAQ: BMRA) has secured IVDR certification in the European Union for its food intolerance diagnostic products targeting Crohn's Disease and Ulcerative Colitis. The certification validates compliance with the EU's new In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746), demonstrating the products' safety, quality, and performance standards.
The company's proprietary technology helps identify specific foods that may trigger inflammation in patients with these inflammatory bowel diseases (IBD). This certification positions Biomerica to expand its presence in the European market and potentially facilitate access to other international markets that recognize EU IVDR certification.
The company is currently finalizing materials for product launch in the near future, focusing on providing non-invasive and personalized solutions for IBD management.
Biomerica (NASDAQ: BMRA) ha ottenuto la certificazione IVDR nell'Unione Europea per i suoi prodotti diagnostici per l'intolleranza alimentare mirati a Malattia di Crohn e Colite Ulcerosa. La certificazione convalida la conformità al nuovo Regolamento sui Dispositivi Medici Diagnostici In Vitro (IVDR – 2017/746) dell'UE, dimostrando la sicurezza, la qualità e gli standard di prestazione dei prodotti.
La tecnologia proprietaria dell'azienda aiuta a identificare specifici alimenti che possono scatenare infiammazione nei pazienti affetti da queste malattie infiammatorie intestinali (IBD). Questa certificazione posiziona Biomerica per espandere la sua presenza nel mercato europeo e potenzialmente facilitare l'accesso ad altri mercati internazionali che riconoscono la certificazione IVDR dell'UE.
L'azienda sta attualmente finalizzando i materiali per il lancio del prodotto nel prossimo futuro, concentrandosi su soluzioni non invasive e personalizzate per la gestione dell'IBD.
Biomerica (NASDAQ: BMRA) ha obtenido la certificación IVDR en la Unión Europea para sus productos de diagnóstico de intolerancia alimentaria dirigidos a Enfermedad de Crohn y Colitis Ulcerosa. La certificación valida el cumplimiento con el nuevo Reglamento de Dispositivos Médicos de Diagnóstico In Vitro (IVDR – 2017/746) de la UE, demostrando la seguridad, calidad y estándares de rendimiento de los productos.
La tecnología propietaria de la empresa ayuda a identificar alimentos específicos que pueden desencadenar inflamación en pacientes con estas enfermedades inflamatorias intestinales (IBD). Esta certificación posiciona a Biomerica para expandir su presencia en el mercado europeo y potencialmente facilitar el acceso a otros mercados internacionales que reconocen la certificación IVDR de la UE.
La empresa está finalizando actualmente los materiales para el lanzamiento del producto en un futuro cercano, enfocándose en proporcionar soluciones no invasivas y personalizadas para la gestión de la IBD.
Biomerica (NASDAQ: BMRA)는 크론병 및 궤양성 대장염을 겨냥한 식품 불내증 진단 제품에 대해 유럽 연합에서 IVDR 인증을 확보했습니다. 이 인증은 EU의 새로운 체외 진단 의료기기 규정(IVDR – 2017/746)에 대한 준수를 확인하며, 제품의 안전성, 품질 및 성능 기준을 입증합니다.
회사의 독점 기술은 이러한 염증성 장 질환(IBD)을 앓고 있는 환자에서 염증을 유발할 수 있는 특정 음식을 식별하는 데 도움을 줍니다. 이 인증은 Biomerica가 유럽 시장에서의 입지를 확장하고, EU IVDR 인증을 인정하는 다른 국제 시장에 접근할 수 있는 가능성을 높입니다.
회사는 현재 가까운 미래에 제품 출시를 위한 자료를 마무리하고 있으며, IBD 관리를 위한 비침습적이고 개인화된 솔루션 제공에 집중하고 있습니다.
Biomerica (NASDAQ: BMRA) a obtenu la certification IVDR dans l'Union Européenne pour ses produits de diagnostic d'intolérance alimentaire ciblant la maladie de Crohn et la colite ulcéreuse. Cette certification valide la conformité au nouveau Règlement sur les dispositifs médicaux de diagnostic in vitro (IVDR – 2017/746) de l'UE, démontrant la sécurité, la qualité et les normes de performance des produits.
La technologie propriétaire de l'entreprise aide à identifier des aliments spécifiques pouvant déclencher des inflammations chez les patients atteints de ces maladies inflammatoires de l'intestin (IBD). Cette certification positionne Biomerica pour étendre sa présence sur le marché européen et potentiellement faciliter l'accès à d'autres marchés internationaux qui reconnaissent la certification IVDR de l'UE.
L'entreprise finalise actuellement les matériaux pour le lancement de produit dans un avenir proche, en se concentrant sur la fourniture de solutions non invasives et personnalisées pour la gestion de l'IBD.
Biomerica (NASDAQ: BMRA) hat die IVDR-Zertifizierung in der Europäischen Union für seine diagnostischen Produkte zur Lebensmittelunverträglichkeit, die auf Morbus Crohn und Colitis ulcerosa abzielen, erhalten. Die Zertifizierung bestätigt die Einhaltung der neuen Verordnung über In-vitro-Diagnosemedizinprodukte (IVDR – 2017/746) der EU und demonstriert die Sicherheits-, Qualitäts- und Leistungsstandards der Produkte.
Die proprietäre Technologie des Unternehmens hilft dabei, spezifische Lebensmittel zu identifizieren, die bei Patienten mit diesen entzündlichen Darmerkrankungen (IBD) Entzündungen auslösen können. Diese Zertifizierung positioniert Biomerica, um seine Präsenz auf dem europäischen Markt auszubauen und möglicherweise den Zugang zu anderen internationalen Märkten zu erleichtern, die die IVDR-Zertifizierung der EU anerkennen.
Das Unternehmen finalisiert derzeit die Materialien für die Produkteinführung in naher Zukunft und konzentriert sich darauf, nicht-invasive und personalisierte Lösungen für das Management von IBD anzubieten.
- Secured EU IVDR certification for food intolerance tests
- Opens access to European market for IBD diagnostic products
- Potential easier access to other international markets through EU certification recognition
- Timeline for product launch not specified
- Revenue impact and market size potential not disclosed
Insights
Biomerica's IVDR certification for its inflammatory bowel disease (IBD) food intolerance tests represents a significant regulatory milestone for this microcap diagnostics company. The European IBD diagnostics market alone is valued at approximately $520 million and growing at 6-8% annually, presenting a meaningful opportunity relative to Biomerica's $13.8 million market capitalization.
The achievement is particularly noteworthy as the IVDR framework implemented in 2022 represents a substantial regulatory upgrade from the previous IVD Directive, with only about 20% of previously approved products successfully transitioning to the new standard. This stringent certification not only validates Biomerica's technology but potentially creates a competitive moat against smaller competitors unable to meet these elevated requirements.
While positive, investors should recognize several commercial challenges ahead:
- Building distribution networks and securing reimbursement coverage in various European healthcare systems
- Establishing clinical adoption among gastroenterologists who may be hesitant to incorporate new testing methodologies
- Competing against established IBD diagnostic players like Abbott, Qiagen, and R-Biopharm
The certification could accelerate Biomerica's path to profitability, as the company reported just
This approval potentially enhances Biomerica's attractiveness as an acquisition target for larger diagnostic companies seeking to expand their gastroenterology portfolios, particularly given the company's depressed valuation relative to the addressable market opportunity.
- 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
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 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.
Corporate Contact:
Zack Irani
949-645-2111
zirani@biomerica.com
Source: Biomerica
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