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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, Inc. (NASDAQ: BMRA) announced the pricing of its underwritten public offering, consisting of 3,333,333 shares of common stock at $2.40 each, expected to generate approximately $8 million in gross proceeds. The offering, managed by Craig-Hallum Capital Group LLC, is set to close on March 7, 2023, pending customary conditions. Proceeds will fund various corporate activities, including clinical studies, marketing expansion, R&D, and general working capital. The shares are offered under an SEC shelf registration statement filed previously. Full details will be available in the final prospectus supplement.
Biomerica, Inc. (NASDAQ: BMRA) has announced an underwritten public offering of its common stock, with all shares being offered by the company subject to market conditions. Craig-Hallum Capital Group LLC is the sole managing underwriter. The net proceeds from this offering are intended for various corporate purposes, including conducting clinical studies, expanding marketing activities, developing new products, and general working capital needs. The offering will be made under a previously filed shelf registration statement with the SEC.
Biomerica, Inc. (NASDAQ: BMRA) reported a decline in net sales to $1.5 million for Q2 fiscal 2023, down from $4.6 million in Q2 fiscal 2022, mainly due to decreased demand for Covid-19 tests. However, excluding Covid-19 products, revenue rose by 8%. The company experienced a net loss of $1.6 million, compared to $1.1 million the previous year. The launch of the InFoods® IBS test is expected in Q3, promising personalized dietary solutions for IBS sufferers. The company’s gross margin improved to 24%. Key developments included the recognition of InFoods® IBS data by ACG and sales fulfillment through Amazon for other products.
Biomerica, Inc. (Nasdaq: BMRA) has appointed Dr. Brian E. Lacy, a prominent gastroenterologist from Mayo Clinic, to its Scientific Advisory Board. Dr. Lacy will advise on the commercialization of the InFoods® IBS product, a diagnostic-guided therapy designed to identify and eliminate specific foods that trigger Irritable Bowel Syndrome (IBS) symptoms. This therapy aims to provide personalized treatment without drug side effects. With IBS affecting 10-15% of American adults, Biomerica plans a nationwide launch of this innovative product.
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.
Biomerica (NASDAQ: BMRA) announced that its InFoods® IBS clinical study data received the prestigious ACG Presidential Award at the 2022 Annual Scientific Meeting.
The study highlighted significant improvements in IBS symptoms, such as abdominal pain intensity, outperforming some existing drugs.
With no reported adverse effects, the findings were published in respected medical outlets, enhancing the visibility of InFoods® IBS as a revolutionary approach to managing IBS symptoms, potentially impacting treatment protocols.
Biomerica, Inc. (NASDAQ: BMRA) announces a partnership with Walmart for the Aware® Breast Self Exam device, now available in over 2400 stores. This FDA-cleared device enhances sensitivity for self-exams, crucial for early breast cancer detection, which significantly improves survival rates. The product, retailing at $19.95, is expected to boost visibility and accessibility for women. CEO Zack Irani emphasized the importance of early detection and the role of their product in cancer survival. Discussions for further distribution partnerships are ongoing.
Biomerica, Inc. (BMRA) reported a 30% increase in net sales for Q3 2022, totaling $1.67 million compared to $1.26 million in the previous year. However, the company experienced a net loss of $2 million, or $0.16 per share, up from a $1.5 million loss the prior year. This loss is attributed to increased expenses, including higher salaries and legal fees. The company received patent allowances in Australia and Japan for its InFoods® Technology, which treats ADD/ADHD and depression, respectively. Biomerica aims to launch multiple products by year-end 2022, including an IBS test and an H. Pylori product.
Biomerica (NASDAQ: BMRA) recently announced that its Aware® Breast Self Exam device and EZ Detect™ Colon Disease test are now available on Amazon. The Aware® device enhances tactile sensitivity for breast self-exams, crucial for early detection of breast cancer, the most common cancer among women. Meanwhile, EZ Detect™ is a two-minute test for hidden blood in stool, an early sign of colorectal cancer. Increased availability on Amazon may enhance sales potential, addressing critical health issues with innovative home testing solutions.
Biomerica, Inc. (Nasdaq: BMRA) announced the upcoming launch of its InFoods® IBS test, expected before the end of 2022. This test will be offered through a CLIA-certified laboratory as a laboratory developed test (LDT). Following successful clinical trials at notable centers like Mayo Clinic, there is significant interest from gastroenterologists. Robert Carlson has been appointed Chief Commercial Officer to oversee the launch and commercialization strategy, aiming for national reimbursement and FDA authorization. Revenues from the InFoods IBS test are anticipated before year-end 2022.
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