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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) reported a remarkable 162% increase in revenues for fiscal 2022, totaling $18.9 million, compared to $7.2 million in fiscal 2021. The net loss also improved to $4.6 million from $7.5 million year-over-year. Significant sales growth was driven by COVID-19 antigen tests and OTC products. Important milestones include positive clinical trial results for its InFoods® IBS product, six new patents granted, and successful completion of clinical studies for its H. pylori diagnostic test, with FDA clearance anticipated.
Biomerica, Inc. (BMRA) announced that its Aware® Breast Self Exam device will be available in Walmart stores and online, enhancing early breast cancer detection. The Aware® device, FDA-cleared, helps women increase sensitivity during self-exams, crucial since 80% of breast cancers are detected by women themselves. Walmart's extensive distribution network will boost visibility. Studies indicate the device is effective in detecting early breast changes. The product rollout aims to empower women with health management tools and facilitate monthly self-examinations.
Biomerica Inc. (NASDAQ: BMRA) announced participation in the 2022 BTIG Biotechnology Conference on August 8-9 in New York City. The CEO will engage in one-on-one meetings at the event. Biomerica specializes in biomedical technologies, developing diagnostic and therapeutic products for gastrointestinal and inflammatory diseases. Their offerings aim to improve health outcomes while reducing healthcare costs.
Biomerica, Inc. (BMRA) announced that its hp+detect™ diagnostic test for Helicobacter pylori has received the CE Mark, allowing commercialization in the European Union and other international markets. This test identifies H. pylori, a significant cause of gastric cancer, affecting 45% of the population in Europe's largest countries. CEO Zack Irani confirmed plans to market the product while awaiting FDA clearance for U.S. sales. The CE Mark represents a critical step in expanding Biomerica's reach in the diagnostics market.
Biomerica, Inc. (Nasdaq: BMRA) announced the submission of a 510(k) premarket notification to the FDA for its new product, hp+detect™, which detects H. pylori infection, a major contributor to gastric cancer and peptic ulcers affecting about 35% of the U.S. population. The FDA aims to provide a decision within 90 days. Biomerica is also preparing a CE Mark filing for European sales. CEO Zack Irani highlighted the product's accuracy and low-cost manufacturing process, indicating potential for high gross margins.
Biomerica (BMRA) reported its Q3 fiscal 2022 results, showing a revenue of $7.6 million, up over 111% from $3.6 million in Q3 fiscal 2021. The net loss improved to $0.01 per share, compared to $0.18 per share in the same period last year. For the nine months, revenue rose 120% to $13.6 million, with a net loss of $0.22 per share. The company has a backlog of over $4 million in unfilled customer orders and is advancing its InFoods® IBS product, which aims to provide targeted dietary solutions for IBS patients, towards FDA clearance.
Biomerica (BMRA) announced positive topline results from its InFoods® IBS diagnostic-guided therapy clinical trial, showing statistically significant symptom improvements across various IBS subtypes. The trial, conducted at prestigious medical institutions, demonstrated p-values of 0.007 for overall symptom relief and significant reductions in pain and bloating for IBS-Mixed and IBS-Constipation patients. With around 40 million Americans suffering from IBS, the company plans to meet with the FDA for a pivotal trial aimed at securing FDA clearance. This therapy targets a potential $30 billion market.
Biomerica, Inc. (BMRA) reported a remarkable 239% increase in revenues for Q2 fiscal 2022, reaching $4.6 million compared to $1.4 million in the previous year. The company's net loss decreased to $1.1 million, down from $1.7 million a year earlier, while cash reserves rose to $7.2 million. A significant customer orders backlog of over $4.0 million was noted. Key developments include Walmart's launch of the EZ Detect™ Colon Disease Test and the completion of the InFoods® IBS trial, with topline results expected by the end of January 2022.
Biomerica, Inc. (BMRA) announced preliminary financial results for Q2 of fiscal 2022, projecting revenues of approximately $4.6 million, marking a 238% increase from $1.4 million in Q2 of fiscal 2021, primarily driven by rising demand for COVID tests. The company faces an operating loss between $0.9 million and $1.3 million due to increased shipping costs and logistics constraints, impacting profit margins. Despite these challenges, Biomerica holds over $7 million in cash and anticipates top-line results from its InFoods IBS clinical trial to be released in January 2022.
Biomerica (NASDAQ: BMRA) announces the formation of a Colorectal Cancer Scientific Advisory Board, chaired by Dr. Brooks Cash, a notable gastroenterology expert. The board aims to enhance the use of Biomerica's EZ Detect product, an at-home test for detecting hidden blood in stool, which is critical for early colorectal cancer screening. This test is now available at major retailers like Walmart. With colorectal cancer being a leading cause of cancer deaths in the U.S., this initiative seeks to improve screening access, particularly in underserved populations.
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