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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 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.
Biomerica (NASDAQ: BMRA) has announced a significant milestone with the Mexican Patent Office granting a notice of allowance for a patent on its InFoods® technology, addressing Irritable Bowel Syndrome (IBS). This technology helps identify specific foods that may trigger IBS symptoms for patients, thus offering a personalized dietary solution. The recent patent joins similar protections in Japan and Korea, enhancing Biomerica's global presence. CEO Zack Irani stated that this development validates their unique approach to IBS treatment and is part of their strategy to expand intellectual property internationally.
Biomerica, Inc. (Nasdaq: BMRA) announced its participation in the upcoming Truist Life Sciences Series and LD Micro Invitational XI investor conferences. CEO Zack Irani will present virtually at the LD Micro event on June 8 at 2:30 PM ET. Additionally, Biomerica will conduct one-on-one investor meetings on June 10 as part of the Truist series. Biomerica focuses on developing advanced diagnostic and therapeutic products, particularly for gastrointestinal and inflammatory diseases, aiming to improve health outcomes and reduce healthcare costs.
Biomerica, Inc. (Nasdaq: BMRA) announced the launch of its new COVID-19 Antigen Rapid Test, utilizing a less invasive nasal swab method that enhances patient comfort. The test can be administered by various healthcare providers without specialized equipment, delivering results in just 15 minutes. Clinical trials outside the U.S. demonstrated a 92.5% sensitivity and 100% specificity, positioning this test as a reliable option for rapid screening. The company continues to prioritize its InFoods® diagnostic platform, aimed at treating gastrointestinal diseases.
Biomerica (BMRA) reported a significant 208% increase in fiscal Q3 2021 sales, reaching $3.62 million, driven by the launch of its COVID-19 Antigen Rapid Test in Europe post-CE Mark approval. The company also secured two new patents for its InFoods® diagnostic technology. Despite the revenue growth, Biomerica incurred a net loss of $1.84 million due to higher costs, including a large inventory reserve of $1.43 million. The company expects significant developments in its InFoods clinical trial by Q3 2021.
Biomerica, Inc. (BMRA) reported second quarter fiscal 2021 revenues of $1.373 million, down from $1.596 million YoY, attributed to declining sales in Asia. The net loss increased to $1.485 million, primarily due to rising R&D and administrative costs. The company is under FDA review for its COVID-19 IgG ELISA Test and has received CE marking for its 15-minute Antigen Rapid Test, with significant initial European orders. Patient enrollment for the InFoods® IBS clinical trial is nearing completion, with results expected by July 2021.
Biomerica (NASDAQ: BMRA) has received CE Mark approval for its COVID-19 Rapid Antigen Test, boasting a 94.7% sensitivity and 99.7% specificity compared to PCR tests. The company has secured initial orders from Europe and plans to commence shipping soon. The test is designed for ease of use by healthcare providers, providing results within 15 minutes, which enhances testing efficiency. Biomerica aims to expand its market presence while continuing to develop its InFoods® products aimed at treating Irritable Bowel Syndrome (IBS).
Biomerica (NASDAQ: BMRA) is nearing completion of patient enrollment for its InFoods® IBS diagnostic-guided therapy clinical trial, aimed at alleviating symptoms for the 45 million Americans with IBS. The double-blind trial seeks to identify specific foods that trigger IBS symptoms, potentially revolutionizing treatment. CEO Zack Irani expressed optimism about the trial's progress despite pandemic challenges, emphasizing the need for effective IBS solutions. Completion of enrollment is expected by April 2021, followed by a pivotal trial aimed at FDA clearance.
Biomerica, Inc. (BMRA) reported a net loss of $1.6 million for Q3 2020, up from a $0.5 million loss in Q3 2019. Net sales fell to $1.14 million, down from $1.19 million in the same quarter last year. R&D expenses surged over 80% to $0.7 million due to COVID-19 test development, while SG&A expenses doubled to $1.2 million due to increased reserves and hiring. Cash and cash equivalents stood at $7 million as of August 31, 2020. CEO Zackary Irani indicated a decrease in international demand for their point-of-care antibody tests, although he anticipates a rise in demand for tests as new COVID-19 cases increase.
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