Biomerica Receives KFDA and Ministry of Health Approval for Colorectal Screening and Breast Screening Tests in Saudi Arabia and UAE

Rhea-AI Summary

Biomerica, Inc. (NASDAQ: BMRA) received regulatory clearances from the Kingdom of Saudi Arabia and UAE for two health products: the EZ Detect™ Colon Disease Test and the Aware® Breast Self Exam. These products will be launched through distribution partners in the Middle East and North Africa, targeting areas with high unmet needs. The EZ Detect test allows at-home screening for colorectal cancer, while the Aware device enhances breast cancer detection through self-exams. The company emphasizes the importance of accessible screening in improving health outcomes.

Positive

• Regulatory clearance for EZ Detect and Aware products enhances market expansion.
• Products address critical health needs in the MENA region.
• EZ Detect provides a convenient method for early colorectal cancer detection.
• Increases potential for partnerships and revenue in under-served markets.

Negative

• None.

Expands Commercialization Efforts in Areas with High Unmet Needs

IRVINE, Calif., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) received clearance from the Kingdom of Saudi Arabia Food and Drug Administration (KFDA), and the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) for the EZ Detect™ Colon Disease test and the Aware® Breast Self Exam device. The Company is working with distribution partners to launch the products in these countries and throughout the Middle East and North Africa (MENA) regions.

The EZ Detect™ Colon Disease Test is a simple two-minute at-home test for detecting hidden blood in the stool, a primary early warning sign of colorectal cancer. It’s the only test with no stool handling and suitable for national screening campaigns due to its convenience and cost-effectiveness. According to research published in the World Journal of Gastrointestinal Oncology, colorectal cancer represents the third most common cause of cancer globally with “a considerable prevalence in Egypt, Saudi Arabia, Qatar and the United Arab Emirates.” It has also been projected that there will be a 1.8-fold increase in cancer incidence by 2030 among those countries. (https://link.springer.com/chapter/10.1007/978-981-16-7945-2_23, Accessed 07 Dec 2022).

The Aware® Breast Self Exam is a revolutionary way for women to enhance the tactile sensitivity to feel abnormalities in breast tissue. About 80% of breast cancer cases are detected because women themselves notice changes in their breast (Cancer 2014; 120:20-5). As of 2019, there were 94.7 thousand incidence cases of female breast cancer in the MENA region, according to research published in Archives of Public Health, an approximate 90% increase since 1990. Performing breast self-exams in conjunction with other screening methods (clinical exams and periodic mammograms, etc.) increases the chance to detect breast cancer early.

“Access to simple, at-home screening tests is an important tool in saving lives around the world. Government agencies and Ministries of Health can save lives, enhance the health and well-being of people, and reduce total healthcare costs by facilitating at-home screening programs, particularly in areas of high unmet need and with limited laboratory resources,” said Zack Irani, Chairman and Chief Executive Officer of Biomerica. “Approval in the MENA region means there are now easy and affordable options to detect what may be early warning signs of colon and breast cancer.”

For more information on these products:

• EZ Detect Colon Disease Test: https://ezdetect.com/
• Aware Breast Self Exam: https://awarebse.com/

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’s primary focus is 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 efficacy of the Company’s EZ Detect and Aware products, future FDA clearance of the Company’s products and tests, possible international regulatory clearance of the companies tests and products, the rapidity and/or accuracy of the EZ Detect or Aware test results and the Company’s other products and tests, uniqueness of the Company’s products, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s EZ Detect and Aware products and other test kits, and patent protection on any of the Company’s products or technologies. 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 other 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 component 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
zirani@biomerica.com

Source: Biomerica

FAQ

What products did Biomerica receive clearance for in the MENA region?

Biomerica received clearance for the EZ Detect™ Colon Disease Test and the Aware® Breast Self Exam.

How does the EZ Detect test work?

The EZ Detect test is a simple at-home test that detects hidden blood in the stool, a key early warning sign of colorectal cancer.

Why is the Aware device important for breast cancer detection?

The Aware device increases women’s ability to notice changes in breast tissue, which is crucial for early detection of breast cancer.

What is the significance of the regulatory approvals for Biomerica?

The approvals allow Biomerica to market its products in regions with high unmet health needs, potentially increasing sales.

What markets is Biomerica targeting with these products?

Biomerica is targeting the Middle East and North Africa (MENA) regions for the launch of these products.