BMRA Biomerica Inc

Biomerica, Inc. (Nasdaq: BMRA), a global leader in advanced medical diagnostic solutions, is proud to announce that patients with Irritable Bowel Syndrome (IBS) may experience significant relief from abdominal pain when following a dietary therapy created and guided by the inFoods® IBS blood test. The findings from a clinical trial published in Gastroenterology, demonstrate that participants who adhered to a personalized diet therapy based on the test results experienced greater symptom improvement compared to those following a sham (placebo) elimination diet.

The inFoods® IBS test was designed specifically for IBS patients. It identifies individual foods that trigger an elevated (above normal) Immunoglobulin G (IgG) antibody responses—which is a marker of inflammation associated with IBS symptoms. Every food in the inFoods IBS panel is set with a 95% confidence interval cutoff to provide accurate results. No other IBS product has this technology.

Irritable bowel syndrome (IBS) affects an estimated 10% to 15% of adults in the United States and is known to significantly reduce quality of life and work productivity. The condition presents a range of symptoms, including abdominal pain and cramps, which can be exacerbated by consuming certain foods.

“We have patients all the time who say, ‘I know food is a problem for me. Is there any way to figure out which foods I'm sensitive to?’” said Prashant Singh, MBBS, Michigan Medicine gastroenterologist and lead author on the paper.

Study Design and Key Findings

The randomized, multicenter, double-blind, placebo-controlled trial enrolled 238 IBS patients across eight leading academic centers in the U.S. Each participant was tested for IgG antibody responses to 18 common IBS trigger foods using the inFoods IBS® product. Patients were then randomly assigned to one of two groups:

• The treatment group eliminated actual foods identified by the inFoods test as triggering an abnormally high IgG antibody immune response in that patient.
• The control group (placebo) followed a sham diet that removed foods for which the patient tested negative with the inFoods IBS test and consumed in a similar amount, (e.g., if a patient tested positive for walnuts, they were instructed to eliminate almonds from their diet).

The study found that 59.6% of patients in the treatment group of the study, and who eliminated their identified trigger foods, met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group. Notably, the benefits were most pronounced in patients with IBS-C (constipation-predominant IBS) and IBS-M (mixed constipation and diarrhea). 67.1% of IBS-C patients in the treatment group met the FDA target for reduction in pain, versus 35.8% in the control group. 66% of IBS-M patients in the treatment group experienced a reduction in pain that met the FDA target, compared to 29.5% in the control group.

“Patients had done all sorts of IgG antibody testing before, and it wasn’t very reliable. This latest test is supported by science. I can refer patients to this IBS-specific antibody testing, after explaining the science and the limitations of the study,” said Dr. Prashant Singh, MBBS.

A Personalized, Targeted Approach to IBS Management

While prior research suggested a potential link between IgG antibody responses and IBS symptoms, previous studies faced limitations such as small sample sizes, IgG tests not adequately designed for patients with IBS, single-center trials, and a lack of well-designed control diets. The inFoods® IBS study was specifically designed to overcome these shortcomings.

“One of the key challenges in past studies was distinguishing normal IgG responses from those that may contribute to IBS symptoms,” Singh explained. “This research takes a targeted approach by using an IBS-specific IgG test to personalize dietary recommendations.”

Compared to pharmaceuticals, personalized elimination diets offer a proactive approach to managing IBS by avoiding symptom triggers rather than treating inflammation after symptoms arise. Many existing IBS dietary interventions, such as the low-FODMAP diet, can be restrictive, difficult to follow, and costly. In contrast, the inFoods® IBS test enables patients to eliminate only a select number of trigger foods (2 to 4 foods on average) rather than broadly restricting their diet.

“Our diets are complex and identifying dietary triggers can be difficult. This IBS-specific IgG test can help patients who suffer from IBS identify specific dietary triggers,” said Anthony Lembo, M.D., vice chair of Research at Cleveland Clinic’s Digestive Disease Institute.

Advancing Toward Precision Therapy in IBS Treatment

The positive results observed in IBS-M patients are particularly significant, as no FDA-approved medications currently exist for treating this IBS subtype. The study underscores the potential for a precision nutrition approach, allowing healthcare providers to tailor dietary recommendations to each patient’s unique needs.

William Chey, M.D., chief of Gastroenterology & Hepatology at the University of Michigan and a principal investigator in the study, said: “This IBS-specific, IgG antibody test requires additional validation but could move us one step closer to a ‘precision nutrition’ approach, in which providers can offer personalized dietary recommendations to each patient with IBS.”

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 primarily focuses 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, 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 of 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.

Corporate Contact:

Zack Irani

949-645-2111

zirani@biomerica.com

Source: Biomerica