- Revenues up 239% over prior year fiscal second quarter
- Customer orders backlog of over
$4.0 million atNovember 30, 2021
- Walmart began in-store and online sales of Biomerica’s EZ Detect™ Colon Disease Test during fiscal second quarter
- InFoods® IBS endpoint trial is complete, topline trial results expected by the end of January
Net sales for the three months ended
Sales, general and administrative expenses for the three months ended
Key Developments:
- InFoods® Endpoint Study Completion: The final patients were enrolled in the InFoods® IBS endpoint trial and
Biomerica is on track to have topline results by end of January, 2022. Rather than simply treating the symptoms of IBS, the InFoods® IBS platform is designed to identify the unique foods that trigger or worsen IBS symptoms in individual patients, paving the way for more effective treatment. It is estimated that over 40 million Americans suffer from IBS. IBS symptoms are often triggered by consumption of specific foods (which are unique in each sufferer). The total direct and indirect cost of IBS has been estimated at$30 billion annually inthe United States alone. - Walmart/EZ Detect: During fiscal second quarter 2022 Walmart began online and instore sales of the Company’s EZ Detect™ Colon Disease Test. In addition,
Biomerica is in negotiations with other large partners for distribution of the EZ Detect™ product inAsia and theMiddle East . Colorectal cancer is the second most common cause of cancer deaths inthe United States in men and women combined. It's expected to cause approximately 52,980 deaths during 2021. - H. pylori: The Company expects to file for FDA 510(k) clearance before the end of February, 2022. The
Biomerica hp+detect™ product detects the presence of the H. pylori bacteria which infects approximately 35% of theU.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers can use hp+detect™ to diagnose the presence of H. pylori and monitor the efficacy of treatment. - Customer order backlog: At
November 30, 2021 , outstanding unfilled customer orders (backlog) were over$4.0 million . The Company expects to ship most of these orders in the fiscal third quarter endedFebruary 28, 2022 , along with other orders that are placed during the quarter.
“We continued to see strong momentum during the second quarter of 2022, both in terms of finalizing the data analysis of our InFoods® endpoint trial and sales of our specialty diagnostic products,” statedZackary Irani , CEO ofBiomerica . “We are looking forward to releasing the results of our InFoods® IBS clinical trial along with our Principal Investigators atMayo Clinic ,Beth Israel Medical Center Inc. , aHarvard Medical School Hospital , theUniversity of Michigan University Hospital , theTexas Health Science Center atHouston , and Houston Methodist (part ofTexas Medical Center , the largest medical complex in the world). Additionally, we are in the process of completing the studies necessary for us to file for FDA clearance for our H. Pylori diagnostic test. What’s more, the pandemic has accelerated consumer demand for in-home and point-of-care testing alternatives, which has resulted in increased sales for our COVID-19 testing products and our other in-home testing products. Overall, this was a successful quarter for our Company. As we look to the future, we’re excited about our possibilities of enhancing people's lives with science, diet and technology.”
About
About InFoods®
The Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. eggs, broccoli, wheat, potatoes, corn, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve IBS outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product is expected to be the first for which the Company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is already available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 40 million people in America currently suffer from IBS, making it a leading cause for patient doctor visits.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s estimated future financial results, demand for the Company's products, the Company's ability to fulfill orders, and possible success of our clinical trials. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; actual efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; expected completion of clinical studies and trials; the rapidity of testing results; uniqueness of the Company’s products; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® test and other products and tests, including FDA clearance, approval by
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