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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 (NASDAQ: BMRA) has received approval from the United Arab Emirates Ministry of Health and Prevention for its Fortel® PSA Screening Test, a 10-minute diagnostic tool for detecting prostate cancer markers through finger-prick blood samples. The test has demonstrated impressive clinical performance with 100% sensitivity, 95% specificity, and 97.5% accuracy in studies.
This approval marks a strategic expansion in the Middle East market, where Biomerica already has success with its EZ Detect Colon Disease Test. The Fortel® PSA test aims to address the growing concern of prostate cancer, which is the second most common cancer in men globally with 1.4 million new cases and 375,000 deaths reported in 2020.
The company is working with regional distributors to make early cancer detection more accessible, building on their previous achievement of securing government insurance reimbursement in Dubai for their colon screening test.
Biomerica (NASDAQ: BMRA) reported Q2 fiscal 2025 results showing a 5% year-over-year revenue growth to $1.64 million. The company achieved significant improvements in financial metrics, including gross margin expansion from 21% to 27% and a 26% reduction in operating expenses to $1.43 million.
Key developments include the direct-to-consumer launch of inFoods® IBS Test and securing three patents for inFoods® technology covering GERD, Crohn's Disease, and Ulcerative Colitis in multiple European countries. The company's cost-saving initiatives delivered approximately $670,000 in savings, targeting annual reductions of $1.0-1.4 million.
Operating losses decreased by 39% to $990,000, while net losses reduced by 37% to $950,000. Cash position stood at $2.37 million at quarter-end, down from $2.82 million in Q1.
Biomerica (NASDAQ: BMRA) has secured three key patent allowances in European markets for its inFoods® Technology, targeting GERD, Crohn's Disease, and Ulcerative Colitis. The patents cover major European markets including Germany, UK, France, Italy, Spain, and over 30 other EPO nations. These markets represent significant opportunities: GERD ($4B+ annually), Crohn's Disease ($2.5B+ annually), and Ulcerative Colitis (projected $1.9B by 2028). The inFoods® Technology platform identifies specific foods triggering symptoms in patients, enabling personalized dietary plans as alternatives to traditional medications, particularly addressing concerns over PPI side effects in GERD treatment.
Biomerica (BMRA) has received a 180-day extension from Nasdaq to meet the minimum $1.00 per share bid price requirement for continued listing. The company now has until May 5, 2025, to regain compliance by maintaining a closing bid price of $1.00 or higher for at least ten consecutive business days. The extension was granted as Biomerica meets all other Nasdaq Capital Market listing requirements, including minimum market value of publicly held shares. The company has expressed its commitment to maintaining its Nasdaq listing and is actively working to meet the bid price requirement.
Biomerica (NASDAQ: BMRA) announces direct-to-consumer availability of its inFoods® IBS test through infoodsibs.com. The test, which requires only a finger-prick blood sample, helps identify foods triggering IBS symptoms like bloating and gastrointestinal pain. A licensed physician remotely authorizes the test, eliminating the need for office visits.
The technology's effectiveness was validated in a double-blinded, placebo-controlled multicenter clinical study at institutions including Mayo Clinic and Beth Israel Deaconess Medical Center, showing significant improvement in symptoms without medication side effects. The solution targets a considerable market, as IBS affects 1 in 20 Americans and contributes to $10 billion in annual direct medical costs.
Biomerica, Inc. (Nasdaq: BMRA) reported financial results for Q1 fiscal 2025 ended August 31, 2024. Key highlights include:
1. Saudi FDA approval for Fortel® Prostate (PSA) Screening Test
2. Completion of inFoods® IBS pilot with 1,100 physician group
3. Ongoing discussions for potential distribution partnerships for inFoods® IBS
4. Progress on H. pylori product distribution
Financial results:
- Revenue increased 6% YoY to $1.8 million
- Gross margin at 16%, down from 24% in Q1 fiscal 2024
- Operating expenses rose to $1.7 million from $1.6 million
- Operating loss increased to $1.4 million from $1.2 million
- Net loss rose to $1.3 million from $1.1 million
The company implemented a cost-savings plan expected to reduce annual expenses by 16% to 23% ($1.0 to $1.4 million).
Biomerica (Nasdaq: BMRA) has received approval from the Saudi Food and Drug Authority (SFDA) for its Fortel® Prostate (PSA) Screening Test. This at-home test allows men to detect early signs of prostate cancer in just 10 minutes using a finger-prick blood sample. The test has shown impressive performance, with studies reporting up to 100% sensitivity and 97.5% accuracy compared to laboratory methods.
This approval marks Biomerica's strategic expansion into the Middle East, where prostate cancer is a growing concern. The company has already shipped its first order to Saudi Arabia and aims to replicate the success of its EZ Detect Colon Disease test, which has secured insurance reimbursement in Dubai.
Prostate cancer is the second most common cancer in men globally, with 1.4 million new cases diagnosed in 2020. Biomerica's Fortel® PSA test aims to address the need for early detection in the region, where comprehensive studies on prostate cancer are still lacking.
Biomerica reported fiscal 2024 year-end results with a 1% increase in total revenue to $5.4 million. Core revenue, excluding COVID tests, grew by 5%. The company improved its gross margin to 11% from 8% and reduced its net loss by 15% to $6.0 million. Biomerica implemented a cost-savings plan expected to reduce expenses by $1.0 to $1.4 million in the coming year.
Key achievements include FDA 510(k) clearance for the Hp Detect™ Stool Antigen ELISA test, advancement of the inFoods® IBS diagnostic test with a new patient self-collection system, and an exclusive distribution agreement in the UAE for EZ Detect™ and Aware® products. The company is focusing on three strategic growth areas: expanding at-home tests in the MENA region, capitalizing on H. pylori antigen sales in the U.S., and expanding inFoods® IBS opportunities.
Biomerica (Nasdaq: BMRA) has launched an at-home sample collection system for its inFoods® IBS diagnostic test, enhancing patient convenience and expanding access to millions of IBS sufferers. Using a simple finger-stick method, patients can now self-collect blood samples at home, eliminating the need for healthcare facility visits. This innovation allows the inFoods® IBS product to be offered nationwide through telehealth and online medical providers, potentially increasing product revenues. With IBS affecting one in twenty Americans and contributing to $10 billion in medical costs annually, Biomerica's new system aims to provide cost-effective, non-pharmaceutical solutions by identifying dietary triggers for IBS symptoms.
Biomerica, Inc. (Nasdaq: BMRA) has announced the pilot launch of its inFoods® IBS product with a 1,100-member physician group starting in June 2024. This innovative technology aims to identify dietary triggers for IBS symptoms, providing relief for the majority of patients. IBS affects 10-15% of the global population, with associated direct medical costs of $21 billion annually. The positive clinical data of inFoods IBS will be presented at the 2024 Digestive Disease Week Conference.
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