Ain Shams University

- 10-Minute PSA Test for Early Detection of Prostate Specific Antigen (PSA), an Early Warning Sign of Prostate Cancer - Prostate Cancer: The Second Most Common Cancer in Men Globally IRVINE, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of innovative diagnostic solutions, is proud to announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP). The Fortel® PSA Screening Test is a user-friendly diagnostic tool that provides accurate results in just 10 minutes using a simple finger-prick blood sample. By measuring elevated PSA levels, a recognized early marker of prostate disease, the test can enable early detection of prostate cancer and other prostate-related conditions. This rapid and accessible approach aims to enhance proactive health management, reduce the burden on healthcare systems, and improve patient outcomes. Strategic Expansion in the Middle East This milestone approval is part of Biomerica’s strategic initiative to expand its footprint in the Middle East, where prostate cancer is increasingly recognized as a critical public health concern. Building on its success in the region with the EZ Detect Colon Disease At-Home Screening Test, which received government insurance reimbursement in Dubai, Biomerica is working to replicating this achievement with the Fortel® PSA test. The Company has established partnerships with leading distributors and secured key regulatory approvals to make early cancer detection more accessible to patients in the region. Proven Performance The Fortel® PSA test has demonstrated outstanding performance in rigorous evaluations: A study reported 100% sensitivity, 95% specificity, and 97.5% accuracy, aligning with laboratory reference methods.Research conducted at the Faculty of Medicine, Ain Shams University in Egypt, further validated the test’s effectiveness, achieving 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy. These results highlight the Fortel® PSA test as a reliable and efficient tool for early detection. The Growing Global and Regional Impact of Prostate Cancer Prostate cancer is the second most common cancer among men worldwide, with 1.4 million new cases diagnosed and 375,000 deaths reported globally in 20201. Alarmingly, one new case is diagnosed every two minutes2. While extensive research and advancements in early detection have been made in Europe and North America, prostate cancer has become increasingly recognized as a significant public health challenge in the Middle East. The disease varies in prevalence and severity across different regions, age groups, ethnicities, and races and there remains a gap in comprehensive studies within the Middle East3. Looking Ahead: Expanding Access to Life-Saving Diagnostics Biomerica is reinforcing its commitment to expanding access to innovative diagnostic solutions in the Middle East. The company’s vision remains focused on providing affordable, accurate, and accessible tools to aid in the early detection and treatment of critical diseases like prostate cancer. https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%80%8Bhttps://zerocancer.org/about-prostate-cancer/facts-statisticsMutlay Sayan et al. Prostate Cancer Awareness in the Middle East: A Cross-Sectional International Study. JCO Glob Oncol 10, e2400171(2024). 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, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel PSA product, 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, 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 | CEOp. 949.645.2111www.biomerica.com Source: Biomerica

- 10-Minute At-Home PSA Test for Early Detection of Prostate Cancer - First order already shipped to Saudi Arabia - Prostate Cancer is the Second Most Common Cancer in Men Globally IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) is pleased to announce that the Saudi Food and Drug Authority (SFDA) has approved the Company's Fortel® Prostate (PSA) Screening Test to be sold and used in the country. This at-home test is designed to empower men with the ability to detect early warning signs of prostate cancer from the comfort of their own homes. The Fortel® Prostate (PSA) At-Home Screening Test is a user-friendly, rapid diagnostic tool that measures elevated PSA, an early indicator of prostate disease, including cancer. Utilizing a simple finger-prick blood sample, the test delivers highly accurate results within just 10 minutes, making it an accessible and essential tool in the fight against prostate cancer. Strategic Expansion in the Middle East This approval marks a milestone in Biomerica’s strategic expansion into the Middle East, a region where prostate cancer is increasingly recognized as a public health concern. Biomerica is dedicated to making early detection more accessible and has established partnerships with leading distributors, secured key regulatory approvals, and achieved insurance reimbursement from the Dubai government for its EZ Detect Colon Disease at-home Screening Test. The company is now working to replicate this success with the Fortel® PSA test across the region. Proven Performance The Fortel® PSA test has demonstrated exceptional performance. A study reported 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory reference methods. Additionally, a study conducted at the Faculty of Medicine in Ain Shams University, Egypt, confirmed the test’s robust performance with 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy. Global and Regional Impact Globally, approximately 1.4 million new cases of prostate cancer were diagnosed in 2020, resulting in 375,000 deaths1. Prostate cancer is the second most common cancer among men worldwide, with one new case every two minutes2. Over the past decade, prostate cancer has become increasingly recognized as a significant public health challenge in the Middle East. The disease varies in prevalence and severity across different regions, age groups, ethnicities, and races. While extensive research on prostate cancer has been conducted in Europe and North America, there remains a gap in comprehensive studies within the Middle East.3 Looking Ahead Biomerica has shipped the first order of the Fortel® PSA Screening Tests to its distributors in Saudi Arabia. The company remains committed to expanding its footprint in the region, offering innovative, accessible diagnostic solutions that address the urgent need for early cancer detection. https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%80%8B (accessed 05 Aug 2024)https://zerocancer.org/about-prostate-cancer/facts-statistics (accessed 05 Aug 2024)Mutlay Sayan et al. Prostate Cancer Awareness in the Middle East: A Cross-Sectional International Study. JCO Glob Oncol 10, e2400171(2024). 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, efficacy of the Company’s products and tests, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel PSA product, 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, future use of the Company's products by individuals or by physicians to treat their patients. 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 as needed, 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 | CEOp. 949.645.2111www.biomerica.com Source: Biomerica

Thought leaders and experts in healthcare digitisation from the Middle East and North Africa (MENA) region and beyond gathered during the 2022 HIMSS Middle East Health Conference & Exhibition for three days of world-class education and programming. Held in Riyadh, Saudi Arabia from 19 to 21 November, the event concluded with a promising proposed roadmap to reimagine the future of healthcare. In her closing remarks relating to conference recommendations, Dr. Taghreed Justinia, Regional Director for IT Services, Technology and Health Informatics at the King Saud bin Abdulaziz University for Health Sciences, as well as a HIMSS Future 50 Healthcare IT Leader and HIMSS Blockchain Taskforce Member, outlined to the audience a series of recommendations under five themes. TEN CONFERENCE RECOMMENDATIONS Under the first theme “Digital Health: Transformation in Action”, Dr. Justinia reiterated the importance of long-term strategy and investment, stating: “Under the first theme, [HIMSS22 Midde East’s] first recommendation [is to] design digital transformation strategies in which governance is seen as a continuous and iterative process [that is] built into services and workflows from the start and throughout. “Next, we [also] recommend enhancing the capabilities and abilities necessary for data privacy, security, and resilience through long-term investment and infrastructure, [as well as] software, technology, and human capital.” With the second theme covering “Integration Through Data and Technology”, Dr. Justinia explained that HIMSS22 Middle East’s recommendation roadmap was to “develop national and regional policies to govern the use of health data, assuring privacy and protection, with the focus on safer care when integrating health services.” She continued: “We [also] recommend building robust IT systems that can provide accountable and sustainable care by integrating data between multiple stakeholders across regional and national platforms.” DATA-DRIVEN APPROACH TO SERVICE DELIVERY Under the third theme of “Digital Health: Impacts and Benefits,” Dr. Justinia stated that HIMSS22 Middle East recommended the region create “country-wide registries with coded, structured data and data standards, to identify patients and to manage disease. “We also recommend leveraging artificial intelligence and predictive analytics to enable [a] more preventative data-driven approach to service delivery, supporting citizens to stay well for longer,” she said. For the fourth theme, “Innovating Person-centred Care”, the first recommendation shared was to “apply a holistic socio-technical approach to precision and personalised medicine, driven by artificial intelligence and drug discovery.” Dr. Justinia added: “We also recommend introducing legislative frameworks using appropriate national mechanisms to regulate data usage and to protect creative patient privacy.” “Global Health Issues: The Big Picture” formed the fifth and final theme of HIMSS22 in Riyadh, with the first recommendation being the development of a “standard framework to collect social determinants of health for the Middle East population, to support health equity, clinical care, population health, and research.” Dr. Justinia concluded by saying: “We also recommend recruiting, training, and sustaining a digital health workforce and leadership through continuous, professional development, and rewarding career paths. We truly hope that all of these recommendations come to fruition in the Middle East.” CLOSING REMARKS In his closing remarks, Prof. Amr Jamal, consultant, family physician and clinical informatician, plus chairman of the Family and Community Medicine Department at King Saud University, paid tribute to the HIMSS22 Middle East scientific and organising committees that helped shape the conference and exhibition. Comprising the scientific committee are: Dr. Justinia, Dr. Ahmed Mohammed Balkhair of the Saudi Ministry of Health, Dr. Tamara Sunbul of John Hopkins Aramco Healthcare, Dr. Dari Alhuwail from the College of Life Sciences at Kuwait University, Dr. Osama El Hassan of the Dubai Health Authority, Eng Fahad Al-Hussein at Megamind IT Solutions, Mohammed Alhajjy at King Saud University Medical City, Dr. Rania Mohell at Ain Shams University, Dr. Mohammed Aldhoayan at King Saud bin Abdulaziz University for Health Sciences, Prof. Mowafa Househ of Hamad Bin Khalifa University, Lisa Thomlinson at HIMSS in the United Kingdom, Dr. Nasser Aljehani at the Council of Health Insurance, Sara Mohammed Aloudah of the Saudi Health Council, Dr. Hassan Ghazal at the National Center for Scientific and Technological Research, Dr. Najeeb Al-Shorbaji of the Middle East and North Africa Association of Health Informatics, and of course, Prof. Jamal. Making up the organising committee are: Waleed Albahli, Faiz AlRasheedi, Ahood Alshahrani, and Areej Al-Shehri of the National Health Information Center, plus the Saudi Health Council’s Aloudah, Prof. Jamal, and Dr. Balkhair. The 2022 HIMSS Middle East Health Conference & Exhibition was held under the patronage of His Excellency Eng. Fahad Al-Jalajel, Minister of Health of the Kingdom of Saudi Arabia, and in joint collaboration with the Ministry of Health, the Saudi Health Council, the Saudi Commission for Health Specialties, and the National Health Information Center.