Biomerica, Inc. Receives Approval for Fortel® Kidney Test to Detect Early Kidney Damage in High-Risk UAE Patients

Biomerica's Fortel® Kidney Test gains UAE approval for home use, detecting early kidney damage in high-risk diabetes and hypertension patients.

Quiver AI Summary

Biomerica, Inc. has received approval from the UAE Ministry of Health and Prevention for its Fortel® Kidney Test, a rapid 10-minute home test designed to detect early kidney damage by identifying low levels of albumin in urine. This test is especially important for individuals with diabetes or hypertension, conditions that affect a significant portion of the UAE population—approximately one in four UAE nationals have diabetes and around one-third of adults are hypertensive. By facilitating early detection of chronic kidney disease (CKD), the Fortel® test seeks to enable timely medical intervention, potentially preventing the progression to kidney failure. With plans for distribution in pharmacies, clinics, and hospitals across the UAE, this initiative aligns with Biomerica's broader goal of enhancing preventive healthcare in high-need regions while addressing the global rise of CKD, which affects over 840 million people worldwide.

Potential Positives

The Fortel® Kidney Test has received approval for home use from the UAE Ministry of Health and Prevention, significantly expanding access to early detection of kidney damage.
This test targets high-risk populations, particularly those with diabetes and hypertension, allowing for timely medical intervention that can prevent progression to kidney failure.
The approval enhances Biomerica's presence and reputation in the Middle East's healthcare market, building on the success of other products like the EZ Detect™ Colon Disease Test.
The initiative aligns with global health concerns over chronic kidney disease, positioning Biomerica as a leader in preventive diagnostics in a region with high prevalence of risk factors.

Potential Negatives

Compliance and regulatory risks may hinder product availability and market expansion, as stressed in the forward-looking statements regarding the need for further regulatory approvals.
The competitive environment is highlighted as a significant concern, with reference to competitors having more resources, which could impact market share and sales of the Fortel® Kidney Test.
Potential dependence on third-party manufacturers and suppliers raises concerns about production and logistics, which could disrupt availability and timely product distribution.

FAQ

What is the Fortel® Kidney Test?

The Fortel® Kidney Test is a 10-minute home diagnostic tool that detects early kidney damage by measuring albumin levels in urine.

Who can benefit from the Fortel® Kidney Test?

This test is particularly beneficial for individuals with diabetes and hypertension, who are at higher risk for chronic kidney disease.

How does early detection help with kidney disease?

Early detection allows for timely medical intervention, which can slow down or prevent the progression to kidney failure.

Where will the Fortel® Kidney Test be available?

The test will be available in pharmacies, clinics, and hospitals throughout the UAE, enhancing healthcare access.

What makes this test significant in the UAE?

With high rates of diabetes and hypertension in the UAE, the Fortel® test addresses a critical need for preventive healthcare in the region.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

Full Release

10-minute home test detects early kidney damage in diabetic and hypertensive patients
Hypertension affects roughly one-third of adults in the UAE
Diabetes impacts approximately one in four UAE nationals

IRVINE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc . (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced today announced that the United Arab Emirates (UAE) Ministry of Health and Prevention has approved its Fortel ^® Kidney Test for home use. This important regulatory milestone expands access to accurate, easy-to-use diagnostic tools supporting early identification of kidney damage in high-risk populations.

The Fortel ^® Kidney Test is a rapid, 10-minute easy to use diagnostic test that detects low levels of albumin in urine, a critical early marker of kidney disease. The test is particularly valuable for people living with diabetes and hypertension, two of the leading risk factors for chronic kidney disease (CKD). Early detection provides an opportunity for timely medical intervention that can slow or prevent progression to kidney failure.

Diabetes and Hypertension: Major Risk Factors in the UAE

Diabetes affects approximately one in four UAE nationals, while a published meta-analysis found overall hypertension prevalence to be about 31%, with higher rates in men (43.9%) than women (34.5%). Both conditions are major contributors to CKD and often remain undiagnosed until significant kidney damage has occurred.

“The Fortel ^® Kidney Test addresses a gap in preventative healthcare by allowing patients and physicians to detect 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 strengthens Biomerica’s growing presence in the Middle East, following the regional success of its EZ Detect™ Colon Disease Test and other innovative diagnostic products. Through partnerships with leading distributors and healthcare providers, the Fortel ^® Kidney (Microalbumin) Test is planned available in pharmacies, clinics, and hospitals throughout the UAE.

Global and Local Significance

By aligning local initiative with global urgency, the Fortel ^® test addresses a window for intervention, at a time when CKD globally affects over 840 million people, is rising in prevalence, and continues to drive morbidity and mortality.

In the UAE, where diabetes and hypertension are widespread, Fortel ^® enables accessible, patient-centered monitoring, positioning Biomerica to become a leader of preventive diagnostics in a high-need region while echoing the broader imperative to curtail the CKD burden worldwide.

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 Test, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel ^® Kidney 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 Test, the availability of product in pharmacies, clinics, and hospitals, 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