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United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® Kidney Test for Home Use

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Biomerica (NASDAQ:BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Kidney Test for home use. The 10-minute diagnostic test detects early kidney damage by identifying low albumin levels in urine, particularly targeting patients with diabetes and hypertension.

The approval addresses a significant market, as approximately 25% of UAE nationals have diabetes, while hypertension affects 31% of adults in the region. The test will be distributed through pharmacies, clinics, and hospitals throughout the UAE, expanding Biomerica's presence in the Middle East following the success of its EZ Detect™ Colon Disease Test.

Biomerica (NASDAQ:BMRA) ha ottenuto l'approvazione dal Ministero della Salute e della Prevenzione degli Emirati Arabi Uniti per l'uso domestico del suo Fortel® Kidney Test. Questo test diagnostico, della durata di 10 minuti, individua i primi segni di danno renale rilevando bassi livelli di albumina nelle urine, rivolgendosi in particolare a pazienti con diabete e ipertensione.

L'approvazione riguarda un mercato rilevante: circa il 25% dei cittadini degli Emirati ha il diabete, mentre l'ipertensione colpisce il 31% degli adulti nella regione. Il test sarà distribuito tramite farmacie, cliniche e ospedali in tutto il paese, ampliando la presenza di Biomerica in Medio Oriente dopo il successo dell'EZ Detect™ Colon Disease Test.

Biomerica (NASDAQ:BMRA) ha recibido la aprobación del Ministerio de Salud y Prevención de los Emiratos Árabes Unidos para el uso doméstico de su Fortel® Kidney Test. Esta prueba diagnóstica de 10 minutos detecta el daño renal temprano al identificar niveles bajos de albúmina en la orina, dirigida especialmente a pacientes con diabetes e hipertensión.

La aprobación cubre un mercado significativo: aproximadamente el 25% de los ciudadanos de los EAU tiene diabetes, mientras que la hipertensión afecta al 31% de los adultos en la región. La prueba se distribuirá a través de farmacias, clínicas y hospitales en todo el país, ampliando la presencia de Biomerica en Oriente Medio tras el éxito de su EZ Detect™ Colon Disease Test.

Biomerica (NASDAQ:BMRA)가 아랍에미리트 보건예방부로부터 가정용 Fortel® Kidney Test 승인을 받았습니다. 이 10분 검사로 소변 내 낮은 알부민 수치를 확인해 초기 신장 손상을 감지하며, 특히 당뇨병 및 고혈압 환자를 대상으로 합니다.

이번 승인은 중요한 시장을 겨냥합니다. 아랍에미리트 국민의 약 25%가 당뇨병을 앓고, 성인의 31%는 고혈압에 시달리고 있습니다. 이 검사 제품은 약국, 클리닉 및 병원을 통해 UAE 전역에 유통되어, EZ Detect™ Colon Disease Test의 성공에 이어 Biomerica의 중동 시장 입지를 확대할 것입니다.

Biomerica (NASDAQ:BMRA) a obtenu l'approbation du ministère de la Santé et de la Prévention des Émirats arabes unis pour l'utilisation à domicile de son Fortel® Kidney Test. Ce test diagnostique de 10 minutes détecte les lésions rénales précoces en identifiant de faibles taux d'albumine dans les urines, ciblant particulièrement les patients diabétiques et hypertendus.

L'approbation concerne un marché important : environ 25 % des ressortissants des Émirats sont atteints de diabète, tandis que l'hypertension touche 31 % des adultes dans la région. Le test sera distribué via les pharmacies, cliniques et hôpitaux à travers les Émirats, étendant la présence de Biomerica au Moyen-Orient après le succès de son EZ Detect™ Colon Disease Test.

Biomerica (NASDAQ:BMRA) hat vom Ministerium für Gesundheit und Prävention der Vereinigten Arabischen Emirate die Zulassung für den Heimgebrauch seines Fortel® Kidney Test erhalten. Der zehnminütige diagnostische Test erkennt frühe Nierenschäden, indem er niedrige Albuminwerte im Urin nachweist und richtet sich insbesondere an Patienten mit Diabetes und Bluthochdruck.

Die Zulassung betrifft einen bedeutenden Markt: etwa 25 % der Einwohner der VAE leiden an Diabetes, während Bluthochdruck 31 % der Erwachsenen in der Region betrifft. Der Test wird über Apotheken, Kliniken und Krankenhäuser in den gesamten VAE vertrieben und stärkt Biomericas Präsenz im Nahen Osten nach dem Erfolg des EZ Detect™ Colon Disease Test.

Positive
  • None.
Negative
  • Faces potential competition in diagnostic market
  • Success dependent on distribution network development
  • Market penetration and adoption rates uncertain

Insights

UAE approval of Biomerica's kidney test expands market reach in region with high diabetes/hypertension rates, potentially boosting revenue.

The UAE Ministry of Health and Prevention's approval of Biomerica's Fortel® Kidney Test represents a significant regulatory milestone that opens a promising new market. The test addresses a critical healthcare need in the UAE, where approximately 25% of nationals have diabetes and 31% suffer from hypertension—both primary risk factors for chronic kidney disease (CKD).

This 10-minute home diagnostic detects microalbuminuria (low levels of albumin in urine), which serves as an early warning sign of kidney damage before symptoms appear. Early detection is crucial as it enables intervention before irreversible kidney damage occurs, potentially reducing the progression to more costly treatments like dialysis or transplantation.

The approval strengthens Biomerica's Middle East presence, building on their existing footprint with products like the EZ Detect™ Colon Disease Test. The UAE market is particularly valuable given its high prevalence of CKD risk factors and well-developed healthcare system. The company's distribution strategy through pharmacies, clinics, and hospitals should facilitate rapid market penetration.

From a competitive standpoint, Biomerica is positioning itself as a leader in preventative diagnostics in a region with high unmet medical needs. The Fortel® test aligns with global healthcare trends toward early detection, home-based testing, and patient empowerment—factors that have gained significance following the pandemic. With CKD affecting over 840 million people globally, this approval represents not just a regional opportunity but participation in addressing a worldwide health challenge.

  • 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


FAQ

What is the significance of UAE approval for Biomerica's (BMRA) Fortel® Kidney Test?

The approval allows Biomerica to market its 10-minute home kidney test in the UAE, where approximately 25% of nationals have diabetes and 31% have hypertension, representing a significant market opportunity for early kidney disease detection.

How does Biomerica's (BMRA) Fortel® Kidney Test work?

The Fortel® Kidney Test is a 10-minute diagnostic test that detects low levels of albumin in urine, which is an early marker of kidney disease, particularly important for patients with diabetes and hypertension.

What is the market size for Biomerica's (BMRA) kidney test in the UAE?

The test targets a substantial market in the UAE, where 1 in 4 nationals have diabetes and approximately 31% of adults have hypertension, both being major risk factors for chronic kidney disease.

Where will Biomerica's (BMRA) Fortel® Kidney Test be available in the UAE?

The test will be available through pharmacies, clinics, and hospitals throughout the UAE, distributed through partnerships with leading distributors and healthcare providers.

How does this approval impact Biomerica's (BMRA) Middle East presence?

This approval strengthens Biomerica's growing presence in the Middle East, building upon the regional success of its EZ Detect™ Colon Disease Test and other diagnostic products.
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