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Biomerica Plans Launch of InFoods® IBS Test; Names Robert Carlson as Chief Commercial Officer

BMRA | August 30, 2022

InFoods® IBS commercial launch and revenues expected before the close of calendar year 2022
Mr. Carlson is an accomplished and performance-driven Commercial and Corporate Strategy and Development Executive

IRVINE, Calif., Aug. 30, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced plans to launch its InFoods® IBS test before calendar year end. The test will be performed in a CLIA-certified, high-complexity laboratory facility and offered as a laboratory developed test (LDT). The Company further announced it has hired Robert Carlson to serve as the Company’s Chief Commercial Officer in preparation for the launch of InFoods IBS.

Following the successful completion and positive results from the Company’s InFoods IBS clinical trial (run at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. – a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan), Biomerica has received significant interest from Gastroenterology (GI) physicians who would like to order the InFoods IBS test for their patients immediately. Therefore, in parallel with the Company’s existing strategy to seek FDA marketing authorization, it is now also preparing to launch InFoods IBS as an LDT through a CLIA-certified, high-complexity laboratory, to provide patient test results to assist GI physicians in treating their IBS patients. The commercial launch of the InFoods IBS test is expected before calendar year-end 2022.

Mr. Carlson will manage the immediate logistics of the LDT launch, and drive the mid-term InFoods IBS commercialization strategy including national reimbursement and FDA marketing authorization. Mr. Carlson has extensive specialized experience commercializing LDTs, diagnostics, and pharmaceutical products for the Life Sciences and Healthcare industries. He is the former Chief Commercial Officer, Vice President and head of sales, marketing, and corporate development at Prometheus Laboratories, Inc., which at the time was a Nestlé Health Science Company. While at Prometheus, Mr. Carlson led the commercial operations for the CLIA diagnostic and pharmaceutical business units directing a team of 160 employees and generating more than $100M in annual revenue.

Zack Irani, Chief Executive Officer of Biomerica, commented, “We have seen very positive responses from GI physicians about using InFoods IBS as a tool to help patients manage the multiple and challenging symptoms of IBS. After several years of extensive development, testing, validation and clinical trials of our patented InFoods technology platform, we’re excited to now be launching the InFoods IBS test. We expect to begin generating revenues before the end of calendar year 2022. We are also very pleased to expand our executive team with the experience, knowledge and relationships Rob brings, along with his extensive understanding of the gastroenterology LDT market.”

The InFoods IBS test is expected to initially be offered to large physician groups comprising hundreds of GI medical professionals, who collectively see hundreds of thousands of IBS patients per year. To ensure a positive experience for patients and physicians, Biomerica anticipates offering the InFoods IBS LDT through an initial sub-set of GI offices within these large physician groups, then expand the number of participating offices over time. In addition to large GI physician groups, the Company intends to also initially offer InFoods IBS through GI doctors at the medical centers where the recent clinical trial was conducted, including: Mayo Clinic, Beth Israel Deaconess Medical Center Inc. – a Harvard Medical School teaching hospital, and Michigan Medicine.

Robert Carlson, Biomerica Chief Commercial Officer said, “The InFoods platform technology has the potential to greatly improve how IBS and other diseases are managed, as it enables physicians to provide personalized medicine for their patients. I’m excited to bring to market the clinically validated InFoods IBS test as an important new tool for physicians to help improve the lives of their patients with this debilitating disease.”

The InFoods IBS test involves a simple blood collection procedure, and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the InFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented InFoods® Technology Platform can be found at: https://biomerica.com/infoods/our-technology/

About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point of care (in home and in physicians’ offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company’s products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica’s primarily focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s InFoods® IBS test and other tests, FDA clearance or possible future clearance of the Company’s InFoods® IBS test and other products, timing of the commercial launch of the InFoods® IBS test, possible future revenues from the sale of the InFoods® IBS test, growth in future revenues from the sale of the InFoods® IBS test, acceptance of the InFoods® IBS test by physicians and their patients, international regulatory approval and sales of the InFoods® IBS test, accuracy, efficacy and clinical trial results of the InFoods® IBS test, the rapidity of testing results, negotiations with clinical labs who would offer the InFoods® IBS test, the ability of a CLIA-certified, high-complexity lab to offer the InFoods® IBS test as a laboratory developed test (LDT), discussions with physicians and physician groups who could or would offer the InFoods Test to their patients, efficacy of the InFoods IBS test to improve IBS symptoms in patients, the company’s ability to manufacture the InFoods® IBS test as a commercial product and to increase manufacturing capacity to meet future product demands, the uniqueness of the Company’s InFoods® IBS test and other products, pricing of the Company’s InFoods® IBS test, future possible insurer reimbursement for the InFoods® IBS test, patent protection on the InFoods® IBS and the underlying technology of the test, or on any of the Company’s other products or technologies, and current or future competition for the InFoods® IBS test from other medical manufacturers or distributors. 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 tests and products; regulatory approvals necessary prior to commercialization any of the Company’s products; availability of the Company’s test kits and other products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection on any aspects of its rapid test technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.