United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® Kidney Disease Test for Early Detection of Kidney Damage
Biomerica (NASDAQ: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Kidney Disease Test, enabling commercial expansion in the UAE market. The 10-minute urine test detects early signs of kidney damage by measuring microalbumin levels.
The approval addresses a significant healthcare need in the UAE, where over 12% of adults have diabetes and 29-35% have hypertension - major risk factors for chronic kidney disease (CKD). The test targets high-risk individuals, including those with diabetes, hypertension, obesity, and people over 65.
CKD is globally underrecognized, with more than 80% of at-risk patients undiagnosed. By 2040, it's projected to be the 5th highest cause of years of life lost globally. Early detection enables timely intervention to prevent progression to end-stage renal disease, potentially reducing healthcare costs and improving patient outcomes.
Biomerica (NASDAQ: BMRA) ha ottenuto l'approvazione dal Ministero della Salute e della Prevenzione degli Emirati Arabi Uniti per il suo test Fortel® per le malattie renali, permettendo l'espansione commerciale nel mercato degli Emirati. Il test delle urine, della durata di 10 minuti, rileva i primi segni di danno renale misurando i livelli di microalbumina.
L'approvazione risponde a un'esigenza sanitaria importante negli Emirati, dove oltre il 12% degli adulti soffre di diabete e tra il 29% e il 35% ha ipertensione, fattori di rischio principali per la malattia renale cronica (MRC). Il test è rivolto a individui ad alto rischio, inclusi diabetici, ipertesi, persone obese e over 65.
La MRC è sottostimata a livello globale, con più del 80% dei pazienti a rischio non diagnosticati. Entro il 2040, si prevede che sarà la quinta causa principale di anni di vita persi nel mondo. La diagnosi precoce consente interventi tempestivi per prevenire la progressione verso l'insufficienza renale terminale, riducendo potenzialmente i costi sanitari e migliorando i risultati per i pazienti.
Biomerica (NASDAQ: BMRA) ha recibido la aprobación del Ministerio de Salud y Prevención de los Emiratos Árabes Unidos para su Prueba Fortel® de Enfermedad Renal, lo que permite la expansión comercial en el mercado de los EAU. La prueba de orina de 10 minutos detecta signos tempranos de daño renal midiendo los niveles de microalbúmina.
La aprobación responde a una necesidad sanitaria importante en los EAU, donde más del 12% de los adultos tienen diabetes y entre el 29% y 35% padecen hipertensión, factores de riesgo principales para la enfermedad renal crónica (ERC). La prueba está dirigida a personas en alto riesgo, incluyendo diabéticos, hipertensos, obesos y mayores de 65 años.
La ERC está subdiagnosticada a nivel mundial, con más del 80% de los pacientes en riesgo sin diagnosticar. Para 2040, se proyecta que será la quinta causa principal de años de vida perdidos a nivel global. La detección temprana permite intervenciones oportunas para prevenir la progresión a enfermedad renal terminal, reduciendo potencialmente los costos de salud y mejorando los resultados en los pacientes.
Biomerica (NASDAQ: BMRA)는 아랍에미리트 보건예방부로부터 Fortel® 신장 질환 검사 승인을 받아 UAE 시장에서 상업적 확장이 가능해졌습니다. 10분 소요되는 이 소변 검사는 미세알부민 수치를 측정하여 신장 손상의 초기 징후를 감지합니다.
이번 승인은 UAE에서 중요한 보건 수요를 충족합니다. UAE 성인의 12% 이상이 당뇨병을 앓고 있으며, 29~35%가 고혈압을 가지고 있어 만성 신장 질환(CKD)의 주요 위험 요인입니다. 이 검사는 당뇨병, 고혈압, 비만 환자 및 65세 이상 고위험군을 대상으로 합니다.
CKD는 전 세계적으로 인지도가 낮아 위험군 환자의 80% 이상이 진단받지 못하고 있습니다. 2040년까지 전 세계 잃어버린 수명의 5번째 주요 원인이 될 것으로 예상됩니다. 조기 발견은 말기 신장 질환으로의 진행을 예방하는 적시 개입을 가능하게 하여 의료비 절감과 환자 치료 결과 개선에 기여할 수 있습니다.
Biomerica (NASDAQ : BMRA) a obtenu l'approbation du Ministère de la Santé et de la Prévention des Émirats arabes unis pour son test Fortel® de détection des maladies rénales, permettant ainsi une expansion commerciale sur le marché des Émirats. Ce test urinaire de 10 minutes détecte les premiers signes de lésions rénales en mesurant les niveaux de microalbumine.
Cette approbation répond à un besoin sanitaire important aux Émirats, où plus de 12 % des adultes sont diabétiques et entre 29 et 35 % souffrent d’hypertension, principaux facteurs de risque de maladie rénale chronique (MRC). Le test cible les personnes à haut risque, notamment celles atteintes de diabète, d’hypertension, d’obésité et les plus de 65 ans.
La MRC est largement sous-diagnostiquée dans le monde, avec plus de 80 % des patients à risque non diagnostiqués. D’ici 2040, elle devrait devenir la 5e cause principale d’années de vie perdues à l’échelle mondiale. Une détection précoce permet une intervention rapide pour prévenir la progression vers l’insuffisance rénale terminale, réduisant potentiellement les coûts de santé et améliorant les résultats pour les patients.
Biomerica (NASDAQ: BMRA) hat die Zulassung des Gesundheitsministeriums der Vereinigten Arabischen Emirate für den Fortel® Nierenerkrankungstest erhalten, was eine kommerzielle Expansion auf dem UAE-Markt ermöglicht. Der 10-minütige Urintest erkennt frühe Anzeichen von Nierenschäden durch Messung des Mikroalbuminspiegels.
Die Zulassung deckt einen bedeutenden Gesundheitsbedarf in den VAE ab, wo über 12% der Erwachsenen Diabetes und 29-35% Bluthochdruck haben – Haupt-Risikofaktoren für chronische Nierenerkrankungen (CKD). Der Test richtet sich an Hochrisikopersonen, darunter Diabetiker, Bluthochdruckpatienten, Adipöse und Menschen über 65 Jahre.
CKD wird weltweit stark unterschätzt, da mehr als 80% der Risikopatienten nicht diagnostiziert sind. Bis 2040 wird erwartet, dass sie die fünftwichtigste Ursache für verlorene Lebensjahre weltweit sein wird. Früherkennung ermöglicht rechtzeitige Interventionen, um die Progression zur terminalen Nierenerkrankung zu verhindern, was potenziell Gesundheitskosten senkt und Patientenergebnisse verbessert.
- Secured regulatory approval in UAE, enabling market expansion
- Addresses underserved market with high diabetes (12%) and hypertension (29-35%) rates
- Quick 10-minute test results support efficient diagnosis
- Builds on existing Middle East presence and distribution partnerships
- None.
Insights
UAE approval of Biomerica's kidney test unlocks high-potential market with significant diabetes and hypertension prevalence, expanding revenue opportunities.
The UAE approval for Biomerica's Fortel® Kidney Disease Test represents a strategic market expansion into a region with compelling demographics. With 12% diabetes prevalence and 29-35% hypertension rates in the UAE population, the addressable market for kidney disease screening is substantial and underserved.
This regulatory milestone is particularly significant for a microcap company like Biomerica (market cap ~$7.5M). The approval provides immediate commercial access to a healthcare system with strong spending capacity and a growing focus on preventative care. The test's 10-minute turnaround time and non-invasive urine sample collection create meaningful differentiation from traditional laboratory testing methods.
From a regulatory perspective, this approval may establish a pathway for broader Middle East market access, potentially creating a domino effect for approvals in neighboring countries with similar regulatory frameworks. Biomerica's mention of existing regional partnerships suggests an established distribution infrastructure that could accelerate commercialization.
The approval also demonstrates Biomerica's regulatory execution capabilities and product validation in international markets. For investors, this represents tangible progress in geographic expansion with minimal additional R&D investment required, optimizing resource allocation for a small-cap healthcare company.
Biomerica's microalbumin test addresses critical early detection gap in high-risk UAE population where CKD is significantly underdiagnosed.
The clinical significance of Biomerica's Fortel® Kidney Disease Test approval in the UAE cannot be overstated from a public health perspective. Microalbuminuria detection represents the gold standard for early kidney damage identification, particularly in high-risk populations with diabetes and hypertension.
The UAE's demographic profile presents a perfect storm of CKD risk factors. Beyond the 12% diabetes prevalence, the region's high rates of obesity and metabolic syndrome create an urgent need for accessible screening tools. Most concerning is that over 80% of at-risk patients remain undiagnosed until significant kidney damage has occurred - a statistic that directly impacts mortality rates and healthcare economics.
The test's point-of-care format enables implementation across various healthcare settings, from primary care to specialty clinics, potentially transforming the CKD detection paradigm. Early kidney disease identification creates a critical intervention window where disease progression can be significantly slowed through medication adjustments, blood pressure control, and lifestyle modifications.
From a health economics standpoint, this test addresses a substantial cost burden. Late-stage kidney disease treatment through dialysis or transplantation represents one of healthcare's most expensive long-term interventions. A simple, 10-minute test that shifts detection earlier in the disease process provides compelling value by potentially reducing the progression to end-stage renal disease requiring these costly interventions.
- 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
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
“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
FAQ
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