Latest news with #ZackIrani
Associated Press
22-05-2025
- Health
- Associated Press
Biomerica Reports Real-World Data Showing 49% Reduction in IBS Symptoms with inFoods® IBS using a First of Its Kind Real-Time IBS Patient Feedback System
IRVINE, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc . (NASDAQ: BMRA), an innovator in diagnostic-guided therapy, today announced compelling real-world results demonstrating the effectiveness of its inFoods® IBS product, along with the launch of a proprietary real-time patient feedback system to enhance symptom tracking and improve patient outcomes. The initial analysis from more than 360 patients who enrolled in the real world inFoods® IBS study revealed an average: This ongoing study tracks symptom reduction from a two-week baseline through an eight-week intervention, during which patients eliminate specific trigger foods identified using the InFoods® IBS diagnostic system. These real-world outcomes align with—and in some cases exceed—results from prior randomized clinical trials conducted at leading U.S. medical centers. 'We're proud to share this real-world data that confirms the significant benefit inFoods® IBS delivers to patients suffering from IBS,' said Zack Irani, CEO of Biomerica. 'Our real-time symptom tracking platform gives physicians clinical insight throughout treatment, creating a personalized and dynamic approach to care.' New Real-Time Feedback System Enhances Clinical Decision-Making Biomerica's HIPAA-compliant platform provides physicians with visibility into patient-reported outcomes—such as abdominal discomfort, bloating, and overall well-being—throughout the course of inFoods® therapy. This allows clinicians to make data-informed decisions and adjust treatment plans with greater speed and accuracy, ultimately leading to improved patient outcomes. Addressing a Major Market Need IBS affects an estimated 10% to 15% of adults in the U.S., leading to decreased quality of life, loss of productivity, and reliance on medications with adverse side effects. Patients often suffer from chronic symptoms, such as abdominal pain and bloating, triggered by specific foods. inFoods® IBS offers a novel diagnostic-guided solution that identifies individual food triggers and enables patients and providers to target dietary changes that reduce symptoms—without the need for pharmaceuticals. Biomerica's inFoods® IBS diagnostic-guided therapy offers an innovative, affordable, and personalized solution to address these challenges, improving IBS management for both patients and healthcare providers. For more information visit: About Biomerica (NASDAQ: BMRA ) Biomerica, Inc. ( ) 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. About inFoods® The inFoods IBS test is designed to assess a patient's above normal immunoreactivity to specific foods utilizing a simple finger-stick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about trigger foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30% reduction in pain, for IBS patients in the treatment diet arm was greater than patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and for certain endpoints is similar and, in some cases, better than the current drugs in the market. Further information about Biomerica's patented inFoods® Technology Platform can be found at: 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 current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company's products and tests, FDA and/or international regulatory authorization for the Company's products to be marketed and sold, including the inFoods IBS product, and the Company's other current and future products, the possible expansion in to other markets, uniqueness of the Company's products, accuracy of the Company's tests and products, expected completion of clinical studies, new feedback system, pricing of the Company's test kits, domestic and/or international market adoption and acceptance and demand for the Company's products, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company's inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company's products; availability of the Company's test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company's ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 [email protected] Source: Biomerica, Inc.
Yahoo
22-05-2025
- Health
- Yahoo
Biomerica Reports Real-World Data Showing 49% Reduction in IBS Symptoms with inFoods® IBS using a First of Its Kind Real-Time IBS Patient Feedback System
Real-World Impact: Initial data from over 360 patients shows inFoods® IBS delivered an average 48.5% reduction in gastrointestinal pain and a 49.8% reduction in bloating over an 8-week period First-of-Its-Kind inFoods® IBS Feedback Platform: New real-time feedback system empowers physicians to adjust patient treatment based on actionable, patient-reported outcomes Precision Medicine: inFoods® IBS identifies specific individual food triggers that can cause IBS symptoms (bloating, pain, diarrhea, and constipation) offering a personalized, non-drug solution IRVINE, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), an innovator in diagnostic-guided therapy, today announced compelling real-world results demonstrating the effectiveness of its inFoods® IBS product, along with the launch of a proprietary real-time patient feedback system to enhance symptom tracking and improve patient outcomes. The initial analysis from more than 360 patients who enrolled in the real world inFoods® IBS study revealed an average: 48.5% reduction in gastrointestinal (GI) pain 49.8% reduction in bloating This ongoing study tracks symptom reduction from a two-week baseline through an eight-week intervention, during which patients eliminate specific trigger foods identified using the InFoods® IBS diagnostic system. These real-world outcomes align with—and in some cases exceed—results from prior randomized clinical trials conducted at leading U.S. medical centers. "We're proud to share this real-world data that confirms the significant benefit inFoods® IBS delivers to patients suffering from IBS," said Zack Irani, CEO of Biomerica. "Our real-time symptom tracking platform gives physicians clinical insight throughout treatment, creating a personalized and dynamic approach to care." New Real-Time Feedback System Enhances Clinical Decision-MakingBiomerica's HIPAA-compliant platform provides physicians with visibility into patient-reported outcomes—such as abdominal discomfort, bloating, and overall well-being—throughout the course of inFoods® therapy. This allows clinicians to make data-informed decisions and adjust treatment plans with greater speed and accuracy, ultimately leading to improved patient outcomes. Peer-Reviewed Results Published in The real-world findings build on results from a peer-reviewed study published in Gastroenterology and led by Cleveland Clinic and the University of Michigan. That study demonstrated that patients on an InFoods® IBS -guided diet experienced significantly more abdominal pain relief compared to those on a placebo diet (59.6% vs. 42.1%, p- value=0.02 using the FDA's responder endpoint for pain). Addressing a Major Market NeedIBS affects an estimated 10% to 15% of adults in the U.S., leading to decreased quality of life, loss of productivity, and reliance on medications with adverse side effects. Patients often suffer from chronic symptoms, such as abdominal pain and bloating, triggered by specific foods. inFoods® IBS offers a novel diagnostic-guided solution that identifies individual food triggers and enables patients and providers to target dietary changes that reduce symptoms—without the need for pharmaceuticals. Biomerica's inFoods® IBS diagnostic-guided therapy offers an innovative, affordable, and personalized solution to address these challenges, improving IBS management for both patients and healthcare providers. For more information visit: About Biomerica (NASDAQ: BMRA) Biomerica, Inc. ( 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. About inFoods® The inFoods IBS test is designed to assess a patient's above normal immunoreactivity to specific foods utilizing a simple finger-stick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about trigger foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30% reduction in pain, for IBS patients in the treatment diet arm was greater than patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and for certain endpoints is similar and, in some cases, better than the current drugs in the market. Further information about Biomerica's patented inFoods® Technology Platform can be found at: 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 current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company's products and tests, FDA and/or international regulatory authorization for the Company's products to be marketed and sold, including the inFoods IBS product, and the Company's other current and future products, the possible expansion in to other markets, uniqueness of the Company's products, accuracy of the Company's tests and products, expected completion of clinical studies, new feedback system, pricing of the Company's test kits, domestic and/or international market adoption and acceptance and demand for the Company's products, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company's inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company's products; availability of the Company's test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company's ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 Irani949-645-2111investors@ Source: Biomerica, Inc.
Associated Press
07-05-2025
- Health
- Associated Press
PLA Code Application Filed for inFoods IBS Test — A Key Step Toward Reimbursement
- Application represents milestone toward broadening patient access to inFoods IBS - inFoods® IBS pinpoints patient-specific foods that can trigger IBS symptoms like bloating, abdominal pain, diarrhea, and constipation IRVINE, Calif. , May 07, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical company dedicated to the development of advanced diagnostic products, announced that the Company and its CLIA laboratory partner have submitted an application to the American Medical Association (AMA) CPT Editorial Panel requesting the assignment of a Proprietary Laboratory Analysis (PLA) code for the inFoods® IBS diagnostic test. If granted, the PLA code will provide a test-specific code to submit claims to Medicare and other insurers. The PLA code would represent a next step on the pathway to expand patient access to the inFoods IBS product, a personalized test and therapy for treating Irritable Bowel Syndrome (IBS). Strategic Milestone to Expand Patient Access The PLA code application supports Biomerica's commercialization strategy to facilitate access to the inFoods® IBS test. The establishment of a PLA code for inFoods® IBS will allow for transparency in claims submission and adjudication for inFoods® IBS, and is a step towards enabling substantially more patients to benefit from the test. 'Submitting the PLA code application is indicative of our growth strategy,' said Zack Irani, CEO of Biomerica. 'Insurance reimbursement is essential to accelerating physician adoption, expanding patient access, and ultimately unlocking the full commercial value of our inFoods® technology platform, and a test-specific code will enable insurers to adjudicate claims for inFoods® IBS.' Addressing an Unmet Need in IBS Care The inFoods® IBS test is a novel, non-invasive diagnostic that identifies patient-specific IBS trigger foods that may be contributing to IBS symptoms such as bloating, abdominal pain, diarrhea, and constipation. By measuring immune responses to common foods, the test enables healthcare providers to make targeted dietary recommendations that reduce IBS symptoms and improve quality of life. This differentiated approach positions inFoods® as a clinically actionable alternative to the current trial-and-error diets and symptom-suppressing medications. IBS affects an estimated 10% to 15% of adults in the U.S. and contributes to billions of dollars in healthcare costs annually. The inFoods® platform addresses a significant unmet need for effective, personalized management strategies in this underserved market. Clinical Validation and Commercial Momentum A published, randomized clinical trial in Gastroenterology—the leading medical journal in gastrointestinal science—demonstrated that patients who followed a personalized diet based on inFoods® test results experienced significantly greater symptom relief compared to those on a placebo diet. These results underscore the clinical potential of the platform to meaningfully improve quality of life for IBS patients. Biomerica is actively working with leading gastroenterology groups and healthcare systems to drive adoption of inFoods® IBS. Additionally, the test is now available for direct-to-consumer ordering via expanding access to the growing self-pay and wellness markets. Positioned for Long-Term Value Creation The Company believes that insurance reimbursement, supported by growing clinical validation, positions inFoods® IBS as a category-defining diagnostic. This application marks one of several steps Biomerica is taking to advance its vision of delivering personalized, non-pharmaceutical diagnostics and therapies that address widespread, high-cost health conditions. Biomerica's inFoods® platform has the potential to transform how IBS—and potentially other GI-related disorders—are diagnosed and managed, creating value for patients, providers, and shareholders. About Biomerica (NASDAQ: BMRA ) Biomerica, Inc. ( or ) 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. For more information, visit and About inFoods® The inFoods IBS test is designed to assess a patient's above normal immunoreactivity to specific foods utilizing a simple finger-stick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about trigger foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30% reduction in pain, for IBS patients in the treatment diet arm was greater than patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and for certain endpoints is similar and, in some cases, better than the current drugs in the market. Further information about Biomerica's patented inFoods® Technology Platform can be found at: Forward Looking Statements 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 applying for a PLA code for the inFoods IBS product, and the future possibility of inFoods IBS receiving insurance reimbursement from Medicare or other insurers, the Company's current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company's products and tests, FDA and/or international regulatory authorization for the Company's products to be marketed and sold, including the inFoods IBS product, and the Company's other current and future products, the possible expansion in to other markets, uniqueness of the Company's products, accuracy of the Company's tests and products, expected completion of clinical studies, pricing of the Company's test kits, domestic and/or international market adoption and acceptance and demand for the Company's products, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company's inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company's products; availability of the Company's test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company's ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 [email protected] Source: Biomerica, Inc.
Associated Press
17-04-2025
- Health
- Associated Press
United Arab Emirates Ministry of Health and Prevention Approves Biomerica's Fortel® Kidney Disease Test for Early Detection of Kidney Damage
IRVINE, Calif., April 17, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced that its Fortel® Kidney Disease (Microalbumin) Test has been approved for sale by the United Arab Emirates (UAE) Ministry of Health and Prevention. This key regulatory milestone enables Biomerica to offer its innovative test across the UAE, a region facing a high burden of chronic kidney disease (CKD). The Fortel® Kidney Disease Test is a rapid, easy-to-use diagnostic tool that provides accurate results in 10 minutes using a urine sample. By detecting low levels of microalbumin in urine (a critical early marker), the test can enable the early detection of kidney disease. Individuals with diabetes, hypertension, obesity and those over the age of 65 are at significantly increased risk for developing chronic kidney disease (CKD) and should be tested frequently. CKD is a worldwide public health problem that is highly underrecognized and more than 80% of at-risk patients are not diagnosed. Kidney disease enhances the risk of major non-communicable diseases including ischemic heart disease, stroke, cancer, etc. By 2040, CKD is projected to be the 5th highest cause of years of life lost globally. Early detection of CKD allows for timely intervention that can slow or prevent progression to end-stage renal disease, requiring dialysis or kidney transplantation. In addition to reducing morbidity and mortality, early diagnosis can also lower the substantial economic burden associated with disease progression. Diabetes and Hypertension: Two Major Risk Factors in the UAE In the UAE, diabetes and hypertension are two of the most significant risk factors for chronic kidney disease (CKD). According to the International Diabetes Federation, over 12% of adults in the UAE live with diabetes, while regional studies estimate that 29% to 35% of the population have hypertension. Both conditions are leading contributors to CKD and often go undiagnosed until significant kidney damage has occurred. CKD is often referred to as a 'silent disease' because it typically shows few or no symptoms until it reaches an advanced and potentially irreversible stage. This makes early detection especially important. 'The Fortel® Kidney Disease Test addresses a critical need in preventative healthcare by allowing the possible detection of kidney disease before symptoms appear,' said Zack Irani, CEO of Biomerica. 'With the high prevalence of diabetes and hypertension in the UAE, this approval supports our mission to bring life-saving diagnostic tools to communities where they are most needed.' Supporting Healthcare Access in the Middle East This approval builds on Biomerica's growing presence in the Middle East, following the regional success of its EZ Detect™ Colon Disease Test and other innovative diagnostic products. The Company has established partnerships with leading distributors and healthcare providers in the UAE to allow the Fortel® Kidney Disease Test to be available across the country. A Commitment to Early Detection and Better Outcomes Biomerica remains dedicated to expanding access to cost-effective, high-quality diagnostics that empower patients and healthcare professionals. The Fortel® Kidney Disease Test is part of a broader portfolio of solutions designed to improve patient outcomes through early detection and personalized care. About Biomerica (NASDAQ: BMRA ) Biomerica, Inc. ( 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 current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company's products and tests including the Fortel® Kidney Disease Test, FDA and/or international regulatory authorization for the Company's products to be marketed and sold, including the Fortel® Kidney Disease Test, and the Company's other current and future products, the possible expansion in to other markets, uniqueness of the Company's products, accuracy of the Company's tests and products, pricing of the Company's test kits, domestic and/or international market adoption and acceptance and demand for the Company's products including the Fortel® Kidney Disease Test, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company's inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company's products; availability of the Company's test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company's ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 | CEO p. 949.645.2111 Source: Biomerica
Associated Press
26-02-2025
- Health
- Associated Press
Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn's Disease and Ulcerative Colitis
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. About Biomerica (NASDAQ: BMRA) Biomerica, Inc. ( 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
