New patents position Biomerica to address multi-billion-dollar markets in Europe, including GERD ($4 billion+), Crohn’s Disease ($2.5 billion+), and Ulcerative Colitis ($1.9 billion+)
The company received three notices of allowance in countries within the European Patent Organization (EPO), including Germany, UK, France, Italy, Spain, and over 30 additional nations within the European Patent Treaty
IRVINE, Calif., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical technology company, announces they have recently received three patent notices of allowance covering technology and methods for treating Gastroesophageal Reflux Disease (“GERD”), Crohn’s Disease, and Ulcerative Colitis using its proprietary inFoods® Technology. These patents apply to countries under the European Patent Organization (“EPO”), including major markets such as Germany, UK, France, Italy, and Spain, as well as over 30 other nations within the EPO.
Prevalence and Market Potential in Europe
GERD, Crohn’s Disease and Ulcerative Colitis represent significant worldwide healthcare challenges across Europe.
GERD: The GERD treatment market in Europe exceeds $4 billion annually. Studies indicate that 8.8% to 25.9% of Europeans experience GERD symptoms weekly (gut.bmj.com), with lifetime risk ranging between 20% and 30%. Recent research has linked long-term use of proton pump inhibitors (“PPIs”)—a common GERD treatment—to serious health risks, including Alzheimer’s disease and kidney damage, underscoring the need for safer, innovative solutions like inFoods®.
Crohn’s Disease: The market for Crohn’s Disease treatments in Europe is estimated at $2.5 billion annually (gminsights.com). This chronic inflammatory condition requires new approaches to improve patient outcomes and reduce healthcare costs.
Ulcerative Colitis: The European market size of $1.5 billion in 2023 is projected to surpass $1.9 billion by 2028 according to Market Data Forecasts.
These recent notices of allowance and issuance of patents are a significant milestone in Biomerica's mission to enhance patient care through personalized medical solutions. The Company is currently marketing an inFoods® Technology test to treat IBS sufferers, which is already covered by 15 different patents globally. The issuance of patents in these additional disease states opens the door for Biomerica to complete development of inFoods therapeutic products to treat patients within this broader spectrum of gastrointestinal diseases.
inFoods®: A Personalized and Safer Approach to GI Care
Biomerica’s inFoods® Technology is a diagnostic-guided platform that identifies specific foods in each patient that trigger worsening symptoms in GERD, Crohn’s Disease, and Ulcerative Colitis. This allows healthcare providers to create personalized dietary plans, addressing the root cause of symptoms and reducing reliance on medications with severe side effects.
For GERD: inFoods® offers an alternative to proton pump inhibitors (“PPIs”), which are widely prescribed despite their links to dementia, Alzheimer’s, and kidney disease. This non-drug, dietary-based solution is a safer option for millions of patients.
For Crohn’s and Ulcerative Colitis: inFoods® supports tailored dietary interventions that work alongside traditional pharmaceutical therapies, potentially reducing symptom severity, healthcare costs, and improving overall quality of life.
“With these European patents, Biomerica can expand its GI offerings to address GERD, Crohn’s, and Ulcerative Colitis,” said Zack Irani, CEO of Biomerica. “inFoods® represents a paradigm shift in gastrointestinal care, offering safer, non-drug solutions that align with the growing demand for personalized medicine. This achievement underscores our dedication to enhancing patient outcomes and creating value for our investors.”
The issuance of each patent in individual countries, following approval by the respective national patent authorities, depends on the Company completing required steps, such as payment of the necessary patent issuance fees. In some cases, the Company may strategically prioritize certain countries within the EPO or other regions and may not proceed with issuance in every eligible country. For more information about Biomerica and the inFoods® platform, please visit www.biomerica.com and www.infoods.com.
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 primary focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.
About inFoods® The 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 45 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 (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 current and future issuance of patents, the Company proceeding with issuance of every patent in every approved country, including issuance in every member nation within the EPO, freedom to operate in specific diseases and/or regions, efficacy of the Company’s patents at limiting competition, breadth of coverage these patents provide, the efficacy of the Company’s inFoods products in treating patients suffering from various gastrointestinal diseases, and the efficacy of the Company’s other tests, future FDA clearance of the Company’s products, the rapidity of testing results, negotiations with international distribution partners, uniqueness of the Company’s products, accuracy of inFoods test result, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s test kits, and timing of the commercial launch of various inFoods tests. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: the Company’s ability or willingness to pay, or continue to pay the patent issuance fees, and/or pay the patent’s annual maintenance fees, results of studies testing the efficacy of the Company’s inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; domestic or international 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; 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 additional 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.
