Welcome to our dedicated page for Biomerica news (Ticker: BMRA), a resource for investors and traders seeking the latest updates and insights on Biomerica stock.
Stay informed about the latest developments from Biomerica, Inc. (NASDAQ: BMRA), a biomedical technology company specializing in medical diagnostic products for gastrointestinal diseases, food intolerances, and various screening applications. This news feed aggregates press releases, regulatory announcements, clinical study publications, and market updates related to Biomerica's diagnostic product portfolio and contract manufacturing services.
Biomerica's news coverage frequently includes updates on its flagship inFoods® IBS test for irritable bowel syndrome, which uses blood-based analysis to identify food triggers causing inflammation and IBS symptoms. The company regularly announces clinical trial results, regulatory approvals, reimbursement decisions, and commercial availability expansions for this and other diagnostic products. News may also cover the company's EZ Detect™ colorectal screening test, H. pylori diagnostic products, kidney disease screening tests, and food intolerance tests for inflammatory bowel disease patients.
As a Contract Development and Manufacturing Organization (CDMO), Biomerica also releases news related to its manufacturing services business, including facility expansions, new service offerings, and partnerships with biotechnology and diagnostic companies. The company maintains ISO 13485 certification and operates FDA-registered cGMP manufacturing facilities.
Regulatory news represents a significant category of Biomerica updates, including FDA 510(k) clearances, CE Mark certifications, IVDR approvals in the European Union, and regulatory authorizations in international markets. The company's news stream also includes Medicare reimbursement decisions, CPT code assignments, and other coverage determinations that affect product commercialization.
This news feed may also feature distribution partnership announcements with retail pharmacy chains and healthcare providers, clinical study publications in peer-reviewed medical journals, new product launches, expansion into new geographic markets, and quarterly or annual financial results. Investors and industry observers can use this feed to track Biomerica's product development pipeline, regulatory milestones, commercial progress, and strategic initiatives in the medical diagnostics sector.
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.
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.
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