United Arab Emirates Ministry of Health and Prevention Approves Biomerica's Fortel® Kidney Disease Test for Early Detection of Kidney Damage
- Regulatory milestone enables commercial expansion into high-need international market
- 10-minute test detects early signs of kidney damage using a simple urine sample
- Addresses global public health burden of Chronic Kidney Disease (CKD), with high relevance in the UAE
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. (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 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
www.biomerica.com
Source: Biomerica
