BMRA Biomerica Inc

Biomerica Inc. (NASDAQ: BMRA) announced today that the Japanese Patent Office has issued a notice of allowance for Biomerica’s first patent pertaining to a revolutionary new treatment option for patients suffering from depression. Specifically, this allowed patent contains broad claims that enables physicians to identify patient specific foods (e.g. salmon, milk, shrimp, broccoli, chickpeas, etc.), that when removed from the patient’s diet, may alleviate or improve an individual's depression symptoms.

There is considerable recent clinical research which shows strong correlation between Irritable Bowel Syndrome (IBS) and depression. This field of study, linking depression and IBS, has gained momentum with research around the gut-brain axis and alterations in gut microbes that affect mental health.¹ Further, anxiety/depression and irritable bowel syndrome (IBS) are highly prevalent and burdensome conditions, and their co-occurrence prevalence is an estimated 44% to 84% of patients.² Research performed at Biomerica that formed the basis for claims in this allowed depression-related patent, indicates that certain foods are linked to an elevated adverse immune response in patients with depression. While there is still additional research and development to be done, this technology could potentially improve the lives of the hundreds of million people worldwide that live with depression.

Depression represents the number one cause of disability worldwide and is often fatal. Inflammatory processes have been linked to the pathophysiology of depression. It is now well established that dysregulation of the immune systems occurs in depressed patients. In addition, these changes affect prognosis and response to antidepressant therapy. Studies suggest the immune system regulates mood and is the potential cause of a dysfunctional inflammatory response in depressed patients.ᶾ

Biomerica’s InFoods® technology utilizes a simple blood test to determine if a patient is suffering an elevated adverse immune response to one or more specific foods (e.g. milk, salmon, barley, etc.), that have been identified as potentially problematic for patients with depression. Once identified, eliminating the problematic food(s) may result in an improvement in the patient’s depression symptoms.

Biomerica has now been granted or allowed 8 patents in the US and globally on its IBS related technology, while this Japanese patent is the first to be allowed for a disease other than IBS. Further, the Company has dozens of additional patents filed that are in active prosecution (under review by patent offices) in the US and many other countries for these and other diseases. For example, Biomerica also recently received notice of allowance from the Mexican Patent Office for its initial InFoods® IBS patent filed in that country.

Biomerica is in the process of finalizing its first clinical study utilizing the InFoods® diagnostic guided therapy technology on patients suffering from IBS. The InFoods® diagnostic-guided IBS therapy is in clinical studies at the Mayo Clinic, Beth Israel Medical Center Inc., a Harvard Medical School Hospital, the University of Michigan University Hospital, the Texas Health Science Center at Houston, and Houston Methodist (part of Texas Medical Center, the largest medical complex in the world). Since the InFoods® IBS product is a diagnostic-guided therapy, and not a drug, it has no drug-type side effects.

Biomerica is working to provide diagnostic guided therapies to alleviate disease symptoms and dramatically improve quality of life and general health. The Company has performed research with findings of an elevated immune response to differing groups of foods in patients suffering from diseases which include: Irritable Bowel Syndrome (IBS), functional dyspepsia, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease (GERD), migraine headaches, depression, and attention deficit/hyperactivity disorder. The Company’s longer term strategy is to also move forward with clinical studies for addressing these other diseases with the InFoods technology.

“We are very close to the completion of the first InFoods® diagnostic guided therapy study for IBS patients performed by leading medical institutions in the US. With the growing body of evidence that specific foods can cause inflammation in the body and lead to or intensify physical and mental illnesses, we believe the InFoods® Technology platform has the ability to revolutionize how patients are diagnosed and treated. Our InFoods® Technology has the potential to offer a dramatic reduction in suffering and improve people’s ability to live happy productive lives,” said Zack Irani, Chairman and Chief Executive Officer of Biomerica.

1. Mudyanadzo, T.A., et al., Irritable Bowel Syndrome and Depression: A Shared Pathogenesis. Cureus, 2018. 10(8): p. e3178.
2. Simpson, C.A., et al., Feeling down? A systematic review of the gut microbiota in anxiety/depression and irritable bowel syndrome. J Affect Disord, 2020. 266: p. 429-446.
3. Beurel, E., M. Toups, and C.B. Nemeroff, The Bidirectional Relationship of Depression and Inflammation: Double Trouble. Neuron, 2020. 107(2): p. 234-256.

About InFoods® IBSThe Biomerica InFoods® IBS product is designed to allow physicians to identify patient-specific foods (e.g., eggs, broccoli, wheat, potatoes, pork, 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. A point-of-care version of the 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® 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.

(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 efficacy of the Company’s tests, the breadth and quality of the claims in the Company’s patents, and the effectiveness of the Company’s patents to impede competition from competitors, future clinical trials, or FDA clearance of, the Company’s products, the results of current and future clinical trials, the rapidity of testing results, uniqueness of the Company’s products and performance of these products as compared to competitors’ products, test result accuracy of products, ability of the Company’s products to diagnose or treat various diseases, pricing of the Company’s test kits, demand for domestic or international orders, retailer and distributor interest in the Products, potential revenues from the sale of current or future products, availability of the Company’s test kits, and patent protection on any of the Company’s products or technologies. 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, including its COVID-19 tests, InFoods® tests and other products; regulatory approvals necessary prior to commercialization 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; regulations and regulatory clearance for the company’s manufacturing facilities and other clearances needed to manufacture and sell a medical related product, and the Company’s ability to obtain patent protection on any aspects of its rapid test technologies or other products. 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 revenue fluctuations, drop in demand for the Company’s products, changes in 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.Corporate Contact:

John Nesbett /Jennifer BelodeauIMS Investor Relations203.972.9200jnesbett@institutionalms.com

Source: Biomerica, Inc.