Biomerica's InFoods® Irritable Bowel Syndrome Diagnostic-Guided Therapy Clinical Trial Nears Completion of Enrollment

Rhea-AI Summary

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.

Positive

• Nearing completion of patient enrollment in IBS clinical trial.
• Potential to address a $30 billion market with InFoods® therapy.
• No investigational device exemption required, streamlining FDA approval process.

Negative

• None.

• Patient enrollment completion anticipated by the end of April 2021
  
• InFoods® Diagnostic-Guided Therapy is designed to address the $30 billion market for IBS treatment
• Therapy seeks to identify patient-specific foods that trigger IBS symptoms and suffering
• Approximately 45 million Americans suffer from IBS¹

IRVINE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it is nearing completion of patient enrollment in the endpoint clinical trial for its InFoods® Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”). This double-blinded, randomized, controlled clinical trial is validating the Biomerica InFoods® IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. Utilizing an antibody guided blood test, the InFoods® IBS product identifies patient-specific foods that may alleviate IBS symptoms when eliminated from the diet.

"I am pleased our clinical endpoint trial for InFoods® IBS remains on track to complete enrollment despite the challenges imposed by this pandemic," stated Zack Irani, CEO of Biomerica. "There is clearly a large unmet need in IBS patients who seek relief but are limited to trial-and-error for foods or drugs that treat symptoms but not the cause. Importantly, the InFoods® IBS therapy can be used in isolation or as part of the pharmacological drug therapy a patient would often receive, but without adding to the side-effect burden."

Mr. Irani concluded, "The endpoint trial results should open potential partnering opportunities with global health sciences, pharmaceutical and medical device companies, and is expected to pave the way to a final pivotal trial and ultimately lead to FDA clearance. InFoods® IBS, provides a novel therapy for patients suffering from IBS without the drug side-effects. We look forward to providing updates on our continued progress in the coming months as we move closer to completing this endpoint trial."

As previously indicated, Mayo Clinic joined Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School Teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston and the University of Michigan as enrollment centers for this study. Biomerica expects to complete patient enrollment at these centers by the end of April 2021.

The clinical endpoint trial's objective is to validate key elements and provide the selection of a proper endpoint of a proposed larger and final FDA pivotal trial. The design of the InFoods® IBS product clinical endpoint study has already received a non-significant risk determination from the FDA. The Company will not be required to submit an investigational device exemption (“IDE”) for the InFoods® IBS product study.

Biomerica will commence the final pivotal trial following the completion of the clinical endpoint trial.

About IBS
It is estimated that over 45 million Americans suffer from IBS.¹ IBS is a common condition that can significantly impair the physical and mental well-being and a person's ability to function at home and in the workplace. The symptoms of IBS are often triggered by the consumption of specific foods, which differ for every individual. The total cost of IBS has been estimated at $30 billion annually in just the United States.

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 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 primarily focuses 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, 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, severe 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 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 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, written statements and other press release issued, made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the timing of the completion of clinical studies and clinical trials, the final clinical results from clinical trials, potential partnering opportunities, the efficacy of the Company's COVID-19 test and other tests and products developed by the Company, FDA clearance, EUA clearance, receipt of CE Mark, the rapidity of testing results, uniqueness of a product, pricing of the Company's various test kits, demand for domestic and international orders for the Company's COVID-19 tests and other Company products, availability of the Company's COVID-19 tests, and patent protection on the Company's products and 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 COVID-19 tests, InFoods tests and other Company products; regulatory approvals necessary prior to commercialization of the Company's COVID-19 tests and other Company products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; competition from products similar to those developed or sold by the Company and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that could make it difficult or impossible for the Company to maintain current operations; regulations and the Company's ability to obtain patent protection on any aspects of its tests and 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 competes, 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.

¹Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245

Corporate Contact:
Company Spokesperson
949-645-2111

FAQ

What is the objective of Biomerica's InFoods® clinical trial for IBS?

The objective is to validate the InFoods® IBS test to identify specific foods that trigger symptoms and manage IBS effectively.

When is patient enrollment for the InFoods® trial expected to be completed?

Patient enrollment is anticipated to be completed by the end of April 2021.

How many people in the U.S. suffer from IBS?

Approximately 45 million Americans suffer from IBS.

What market does the InFoods® IBS therapy target?

The therapy targets the $30 billion IBS treatment market.

What are the next steps after the clinical endpoint trial?

After the endpoint trial, a final pivotal trial will commence to seek FDA clearance for the InFoods® product.