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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. (BMRA) reported second quarter fiscal 2021 revenues of $1.373 million, down from $1.596 million YoY, attributed to declining sales in Asia. The net loss increased to $1.485 million, primarily due to rising R&D and administrative costs. The company is under FDA review for its COVID-19 IgG ELISA Test and has received CE marking for its 15-minute Antigen Rapid Test, with significant initial European orders. Patient enrollment for the InFoods® IBS clinical trial is nearing completion, with results expected by July 2021.
Biomerica (NASDAQ: BMRA) has received CE Mark approval for its COVID-19 Rapid Antigen Test, boasting a 94.7% sensitivity and 99.7% specificity compared to PCR tests. The company has secured initial orders from Europe and plans to commence shipping soon. The test is designed for ease of use by healthcare providers, providing results within 15 minutes, which enhances testing efficiency. Biomerica aims to expand its market presence while continuing to develop its InFoods® products aimed at treating Irritable Bowel Syndrome (IBS).
Biomerica (NASDAQ: BMRA) is nearing completion of patient enrollment for its InFoods® IBS diagnostic-guided therapy clinical trial, aimed at alleviating symptoms for the 45 million Americans with IBS. The double-blind trial seeks to identify specific foods that trigger IBS symptoms, potentially revolutionizing treatment. CEO Zack Irani expressed optimism about the trial's progress despite pandemic challenges, emphasizing the need for effective IBS solutions. Completion of enrollment is expected by April 2021, followed by a pivotal trial aimed at FDA clearance.
Biomerica, Inc. (BMRA) reported a net loss of $1.6 million for Q3 2020, up from a $0.5 million loss in Q3 2019. Net sales fell to $1.14 million, down from $1.19 million in the same quarter last year. R&D expenses surged over 80% to $0.7 million due to COVID-19 test development, while SG&A expenses doubled to $1.2 million due to increased reserves and hiring. Cash and cash equivalents stood at $7 million as of August 31, 2020. CEO Zackary Irani indicated a decrease in international demand for their point-of-care antibody tests, although he anticipates a rise in demand for tests as new COVID-19 cases increase.
Biomerica (NASDAQ: BMRA) reported significant financial growth, with fiscal fourth quarter revenues increasing by 133.7% year-over-year. For the fiscal year ending May 31, 2020, net sales reached $6.7 million, up 28.7% from $5.2 million in 2019. The company reported a net loss of $2.3 million, a slight decrease from $2.4 million in the previous year. The company also received a new patent for its InFoods® product in Singapore and expanded clinical trials involving major health institutions.
Biomerica (NASDAQ: BMRA) announced the retirement of CFO Janet Moore, effective September 3, 2020, after years of dedicated service. She will remain with the company during the transition and remain on the Board until the Annual Meeting on December 10, 2020. Steve Sloan has been appointed as the new CFO, bringing 13 years of experience from General Electric and 10 years from Medtronic. Additionally, Cathy Coste has been elected as a new independent board member and Audit Committee Chair, bringing extensive expertise from Deloitte.
Biomerica (NASDAQ: BMRA) announced a Notice of Allowance from the U.S. Patent and Trademark Office for its second patent related to the InFoods® technology platform, aimed at treating Irritable Bowel Syndrome (IBS). This patent covers methods to identify specific foods that may alleviate IBS symptoms. The InFoods® approach is undergoing clinical studies at major medical institutions, and Biomerica anticipates that these sites will adopt the product post-FDA clearance. The company also has several patents pending for other diseases utilizing this technology.
Biomerica Inc. (NASDAQ: BMRA) announced the filing of a new three-year shelf registration statement on Form S-3 with the SEC, replacing the previous registration effective since July 2017. This move offers the company flexibility for future capital market access. Additionally, 571,429 shares of common stock are being registered on behalf of Palm Global Master Small Cap Master Fund LP, related to their previous purchase of convertible preferred stock. Biomerica has no immediate plans to offer any securities under this new registration.
Biomerica (NASDAQ: BMRA) has partnered with the University of Texas Health Science Center at Houston to advance its InFoods® diagnostic-guided therapy aimed at alleviating symptoms of Irritable Bowel Syndrome (IBS). With over 45 million Americans affected by IBS, the trial focuses on identifying specific foods that trigger symptoms. The clinical trial is set to complete within 6 months, with the potential for a pivotal trial afterward for FDA submission. The InFoods® therapy is non-pharmaceutical, addressing the root causes of IBS while being compatible with existing treatments.
Biomerica (NASDAQ: BMRA) has submitted an EUA application to the FDA for an ELISA lab-based serology blood test to detect COVID-19 antibodies. This test aims to identify prior infections, supporting the reopening of economies. It boasts 100% specificity and no cross-reactivity. Biomerica plans to manufacture this test at its Irvine facility, which simplifies blood collection using a proprietary device. This is the third COVID-19 antibody test from Biomerica, adding to existing finger-prick tests sold internationally.
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