Biomerica’s inFoods® IBS Product Featured in Biotherapeutics Quarterly, a Henry Schein Publication, Highlighting a New Precision Approach for Treating IBS

Rhea-AI Summary

Biomerica (NASDAQ: BMRA) announced that its inFoods® IBS diagnostic-guided dietary therapy is featured in the Fall 2025 issue of Biotherapeutics Quarterly, highlighting results from a randomized, multicenter, double-blind, placebo-controlled trial.

The study enrolled 223 IBS patients across 8 U.S. academic centers and found 59.6% of treated patients met the FDA abdominal pain reduction target versus 42.1% for control. Subgroup results: IBS-C 67.1% vs 35.8%; IBS-M 66.0% vs 29.5%. The assay tests IgG responses to 18 IBS-specific foods and typically identifies elimination of 2–4 foods per patient, positioned as a more targeted alternative to broad diets like low-FODMAP.

Positive

• 59.6% abdominal pain reduction response in treatment group
• 67.1% response in IBS-C subgroup
• 66.0% response in IBS-M subgroup
• Study enrolled 223 patients across 8 major U.S. centers
• Assay typically limits elimination to 2–4 foods per patient

Negative

• No regulatory approval or commercialization timeline disclosed
• Study size of 223 patients may limit broader generalization

Insights

Clinical Evidence Analyst

Large, randomized multicenter trial shows a targeted dietary test produced higher abdominal pain response versus a sham diet.

Biomerica’s inFoods® IBS assay guided an elimination diet in a randomized, double-blind, placebo-controlled study of 223 patients across eight U.S. academic centers, producing a 59.6% responder rate for the FDA-defined abdominal pain target versus 42.1% for the control arm. Subgroup outcomes were stronger in IBS-C (67.1% vs 35.8%) and IBS-M (66.0% vs 29.5%), which are explicit, measurable trial results that support a clinically meaningful effect on pain reduction.

The study design elements reported—randomization, multicenter enrollment including named academic centers, double blinding, a sham diet control matched for type and quantity, and an IBS-specific food panel with a stated proprietary statistical method—directly address common trial limitations. Key dependencies and risks remain: durability of benefit over time is not stated, safety or adverse-event reporting is not included here, and the proprietary discriminatory p-value method is described but not detailed, which limits independent reproducibility assessment.

Practical implications follow clearly from the disclosed facts: the protocol typically eliminates only 2–4 foods per patient on average, which the text frames as less restrictive than broad diets. Monitorable items to watch in the near term include peer-reviewed publication details and full trial data release that report adverse events, statistical methods, and longer-term follow-up; expect those items to appear following the Fall 2025 feature in Biotherapeutics Quarterly.

• Publication details large multicenter clinical trial demonstrating significant reductions in IBS symptoms through inFoods IBS guided dietary therapy
  
  

IRVINE, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic solutions, is proud to announce that its inFoods® IBS diagnostic-guided therapy product is being featured in the Fall 2025 issue of Biotherapeutics Quarterly, a Henry Schein publication. The article, titled “Precision Medicine for IBS: A Novel, IBS-Specific Immune Response Guided Dietary Therapy”, presents comprehensive clinical and scientific insights into the company’s innovative approach to managing Irritable Bowel Syndrome (IBS).

The publication details results from a randomized, multicenter, double-blind, placebo-controlled clinical trial evaluating the effectiveness of the inFoods® IBS test in identifying patient-specific dietary IBS triggers and guiding targeted food elimination to reduce IBS symptoms.

Large Multicenter Study Demonstrates Clinically Meaningful Pain Reduction

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. Symptoms such as often severe abdominal pain, bloating, diarrhea, and constipation are frequently exacerbated by specific foods, yet identifying individual dietary triggers has historically relied on trial-and-error approaches.

The inFoods IBS clinical trial analyzed 223 IBS patients across eight major U.S. academic medical centers including Mayo Clinic, Harvard Beth Israel Deaconess Medical Center, and Cleveland Clinic. Participants were tested for abnormal antibody responses to 18 IBS-specific foods using the inFoods® IBS assay and then randomized into two study arms:

• Treatment Group: Eliminated foods identified by the inFoods® IBS test as producing an abnormally elevated IgG immune response.
• Control Group: Followed a placebo (sham) diet eliminating foods for which the patient tested negative in the inFoods IBS test, matched in type and quantity to ensure blinding.

Key Findings:

• 59.6% of patients in the inFoods IBS-guided diet (treatment group) achieved the FDA-defined target for abdominal pain reduction, compared to 42.1% in the control group for all IBS subclasses.
• Particularly strong results were observed in difficult-to-treat IBS subtypes:
  • IBS-C: 67.1% response vs. 35.8% in controls
  • IBS-M: 66.0% response vs. 29.5% in controls

These findings demonstrate that patients following the inFoods® IBS-guided elimination diet experienced a significantly greater symptom relief than those following the placebo (sham) diet.

A Personalized, Targeted Approach to IBS Management

Unlike prior studies that were often limited by small sample sizes, non-IBS-specific assays, single-center designs, or inadequate control diets, the inFoods® IBS study was specifically designed to overcome these limitations using an IBS-specific food panel and robust statistical methodology.

The inFoods® IBS assay employs a proprietary discriminatory p-value method that identifies foods producing abnormal IgG responses unique to IBS patients, minimizing unnecessary dietary restrictions and focusing only on foods with statistical and clinical relevance.

Compared to broad dietary strategies such as the low-FODMAP diet — commonly described as restrictive, difficult to follow long-term, and costly — the inFoods® IBS protocol typically results in the elimination of only 2 to 4 foods per IBS patient on average, offering a more practical and sustainable option for patients.

“This publication reinforces the growing role of precision in gastrointestinal care,” said Dr. Astrid Starke, Marketing Director at Biomerica. “By combining rigorous clinical validation with an IBS-specific assay, inFoods IBS provides a targeted, science-based solution that empowers patients and healthcare providers to identify meaningful dietary triggers that may be causing or intensifying IBS symptoms. This allows for more informed, personalized nutrition decisions – reducing unnecessary dietary restriction and supporting sustainable, long-term relief for those living with IBS.”

Advancing Precision Nutrition for an Unmet Clinical Need

The study’s strong outcomes, particularly in IBS-M patients — a subgroup for which no FDA-approved medications currently exist — underscore the potential of a diagnostic-guided dietary strategy to address an important unmet clinical need.

The findings support the evolving shift toward precision medicine in gastrointestinal care, where individualized biological markers guide tailored treatment decisions rather than generalized dietary or pharmaceutical approaches.   More information at www.infoodsibs.com.

Recognition Through Henry Schein’s Clinical Platform

The inclusion of inFoods® IBS in Biotherapeutics Quarterly reflects growing recognition of Biomerica’s innovation among healthcare professionals and aligns with advancing evidence-based clinical solutions that improve patient outcomes.

The article offers an in-depth analysis of the assay’s development, clinical validation, and real-world implications for IBS management, reinforcing the role of diagnostic-guided dietary therapy as a meaningful advancement in the standard of care.

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 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

FAQ

What did Biomerica announce about inFoods IBS on November 25, 2025 (BMRA)?

Biomerica said inFoods IBS was featured in Biotherapeutics Quarterly, reporting trial results from a randomized, multicenter study of 223 patients.

How effective was the inFoods IBS-guided diet in the BMRA study for abdominal pain?

The study reported 59.6% of treated patients reached the FDA abdominal pain reduction target versus 42.1% in controls.

What were the inFoods IBS results for IBS-C and IBS-M subgroups in the BMRA trial?

Results showed IBS-C 67.1% vs 35.8% and IBS-M 66.0% vs 29.5% treatment vs control response rates.

How many foods does the inFoods IBS assay typically recommend eliminating per patient (BMRA)?

The inFoods IBS protocol typically results in elimination of about 2 to 4 foods per patient, on average.

How large and where was the inFoods IBS clinical trial mentioned by BMRA?

The trial included 223 patients across 8 U.S. academic centers, including Mayo Clinic, Harvard Beth Israel Deaconess, and Cleveland Clinic.

Does the BMRA announcement state that inFoods IBS has FDA approval?

No; the announcement reports clinical trial results but does not state any FDA approval or a regulatory timeline.