Biomerica Inc Stock Price, News & Analysis

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.

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.