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.
Biomerica, Inc. (NASDAQ: BMRA) is a global biomedical technology company focused on advanced diagnostic and therapeutic products, with an emphasis on gastrointestinal and inflammatory diseases. The Biomerica news feed on Stock Titan highlights company announcements that explain how its diagnostic-guided therapies, rapid screening tests, and contract development and manufacturing (CDMO) services are evolving over time.
Readers can follow updates on the inFoods® IBS diagnostic-guided therapy, including clinical evidence, commercialization partnerships, and reimbursement milestones. Recent news has covered the American Medical Associations approval of a PLA code for inFoods IBS and the Centers for Medicare & Medicaid Services (CMS) decision to set a national Medicare payment rate for the test. Articles also describe the launch of the AI-backed inFoods IBS Trigger Food Navigator, a digital companion tool designed to support personalized IBS dietary therapy.
Biomerica news also covers regulatory authorizations and international expansion for its rapid screening portfolio. Examples include authorization by the Egyptian Drug Authority for the companys complete screening test portfolio and approvals by the United Arab Emirates Ministry of Health and Prevention for the Fortel® Ulcer and Fortel® Kidney tests for home use. These items provide insight into how Biomericas products are being introduced into new markets and care settings.
Investors and healthcare observers can also track updates on Biomericas expanding CDMO services, board and governance changes, and periodic financial results that discuss revenue mix, cost discipline, and the shift toward higher-margin diagnostic-guided therapy products and services. Bookmark this page to monitor BMRA news related to product launches, clinical publications, regulatory developments, commercial partnerships, and strategic initiatives as disclosed by the company.
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.
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.