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Biomerica Inc. (NASDAQ: BMRA) is a global biomedical technology company that specializes in developing, manufacturing, and marketing advanced diagnostic and therapeutic products for early detection and monitoring of chronic diseases. These products are used at the point-of-care, such as in homes and physicians’ offices, as well as in hospital and clinical laboratories.
The company's primary focus is on gastrointestinal diseases, food intolerances, diabetes, and esoteric testing. Biomerica’s flagship product, the inFoods® IBS, helps identify specific foods that, when eliminated, can relieve symptoms of irritable bowel syndrome (IBS). This diagnostic-guided therapy aims to provide a personalized dietary regimen for improved IBS management.
Another significant product is the Hp Detect™ Stool Antigen ELISA test, which recently received FDA 510(k) clearance. This test detects the presence of the H. pylori bacteria, a pathogen that infects approximately 35% of the U.S. population and is linked to gastric cancer, the third most common cause of cancer-related deaths worldwide. The test offers a reliable solution for diagnosing and assessing H. pylori infection status post-treatment.
Biomerica operates mainly in one segment: the development, marketing, and sales of diagnostic kits. The company has made notable achievements, such as receiving FDA clearances and forming partnerships with esteemed institutions like the University of Michigan. Their latest developments and news include presenting data on inFoods IBS technology at the 2024 Digestive Disease Week (DDW) Conference and appointing Jack Kenny, a seasoned healthcare executive, as the Chairman of the Board of Directors.
In terms of financial health, Biomerica generates the majority of its revenue from the European market. The company is committed to reducing healthcare costs while ensuring that their products enhance health and well-being. Their innovative approaches and strategic leadership aim to make significant advancements in the medical diagnostic industry.
Biomerica (NASDAQ: BMRA) announced that the Canadian Patent Office has issued a notice of allowance for its InFoods® IBS diagnostic-guided therapy patent. This technology aims to identify specific foods that aggravate Irritable Bowel Syndrome (IBS) symptoms. IBS affects 30% of Canadians, with current treatment options being limited. Biomerica's InFoods® approach promises to revolutionize IBS management by tailoring dietary regimens. The company holds 11 patents worldwide, with most related to IBS set to expire in 2036 or later, supporting its growth in the diagnostic field.
Biomerica, Inc. (Nasdaq: BMRA) has launched a new website for its Aware® at-home breast self-exam pad, coinciding with Breast Cancer Awareness Month. This FDA-cleared device enhances sensitivity in self-exams, allowing patients to obtain results within minutes. In 2021, an estimated 281,550 new invasive breast cancer cases will be diagnosed in the US, highlighting the importance of early detection. CEO Zack Irani emphasizes the product's role in facilitating quick self-exams, which can lead to early detection of abnormalities.
Biomerica, Inc. (BMRA) has announced the in-store rollout of its EZ Detect™ colorectal disease screening test in over 4,600 Walmart locations across the U.S. The product, designed for at-home use, detects hidden blood in stool, a key early warning sign for colorectal cancer. Walmart began online sales earlier this month. The company aims to boost its market presence and is negotiating international distribution deals. With colorectal cancer being a leading cause of cancer death in the U.S., the EZ Detect™ is positioned as a simple, effective screening option.
Biomerica, Inc. (NASDAQ: BMRA) reported a 10% revenue increase for Q1 fiscal 2022, totaling $1.2 million, compared to $1.1 million in the same period the previous year. Sequentially, revenues grew 20% from the last quarter. The net loss narrowed to $1.5 million, down from $1.9 million year-over-year. A strong customer backlog exceeding $1.5 million and the recent launch of its EZ Detect™ Colorectal Screening Test at Walmart are noteworthy highlights. The company expects to file for FDA clearance for its hp+detect™ product by year-end, further enhancing its portfolio.
Biomerica, Inc. (BMRA) has partnered with Walmart to sell its EZ Detect™ colorectal disease screening test online, marking a significant retail expansion. The EZ Detect™ test allows for at-home screening without stool handling, detecting occult blood within two minutes. With colorectal cancer as a leading cause of cancer death in the U.S., the product aims to increase screening rates. Biomerica is also negotiating international distribution agreements. The CEO highlighted the growing trend of at-home testing as a potential driver for sales.
Biomerica (NASDAQ: BMRA) anticipates final patient enrollment in its InFoods® IBS Diagnostic-Guided Therapy trial to conclude by the end of October, with top-line results expected by year-end. This innovative therapy targets the $30 billion IBS market, addressing symptoms triggered by specific foods affecting approximately 40 million Americans. The study involves major institutions like Mayo Clinic and aims to gain FDA approval pending positive outcomes. Additionally, a point-of-care version is in development for easier testing, indicating significant market potential.
Biomerica (BMRA) reported fiscal 2021 revenues of $7.2 million, a 7.6% increase from $6.7 million in 2020, but also a net loss of $6.5 million compared to $2.3 million in the prior year. The company is rapidly advancing its InFoods® IBS Endpoint Trial, with full enrollment expected shortly. Additionally, Biomerica has received multiple patent allowances for its InFoods® Technology Platform, providing protection through 2036. The FDA filing for the H. Pylori product is anticipated in October 2021. The company is also negotiating sales agreements for its EZ Detect™ colorectal disease test.
Biomerica (NASDAQ: BMRA) received a notice of allowance for its first patent in Japan, relating to a novel treatment for depression. This patent enables the identification of specific foods that may worsen depressive symptoms. Recent studies indicate a strong connection between Irritable Bowel Syndrome (IBS) and depression, with 44% to 84% co-occurrence in patients. Biomerica’s InFoods® technology can determine adverse immune responses to certain foods, allowing for dietary adjustments to help alleviate depression. The company has obtained eight patents globally for its IBS technology and continues to seek additional patent protections.
Biomerica announces the launch of its new EZ Detect™ Colon Disease Test website alongside a digital health advertising campaign. The website provides critical information on colorectal disease detection and treatment, aimed at increasing product sales. The company is in discussions with major retailers to enhance distribution of the EZ Detect™ test, which is a simple, at-home diagnostic tool for detecting hidden blood in stool, a key indicator of colorectal disease. Colorectal cancer is a leading cause of cancer deaths in the U.S., emphasizing the importance of early detection.
Biomerica (NASDAQ: BMRA) has signed a five-year exclusive distribution agreement with a Canadian partner for its new Helicobacter pylori test, hp+detect™. This product aims to identify and monitor H. pylori infection, linked to gastric ulcers and cancer, addressing the 35%-40% infection rate in the U.S. The partner will seek Health Canada clearance while Biomerica also targets CE Mark and FDA clearance. The hp+detect™ test is designed for higher sensitivity and specificity compared to existing market products, fulfilling a critical need in early disease detection and treatment monitoring.
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