Biomerica’s inFoods® IBS Clinical Study Results Published in June Issue of Gastroenterology

Rhea-AI Summary

Biomerica announced the publication of its pivotal clinical trial results for the inFoods® IBS test in Gastroenterology journal. The randomized, multicenter, double-blind study involving 238 patients across eight U.S. academic centers demonstrated significant symptom improvement in IBS patients following a personalized elimination diet. The treatment group showed 59.6% of patients achieving FDA-defined abdominal pain reduction versus 42.2% in the control group. Notably, IBS-M patients showed remarkable improvement with 66% meeting treatment targets compared to 29.5% in controls. The test, which identifies specific foods triggering immune responses in IBS patients, showed particular promise for IBS-M patients, who represent 33% of the IBS market and currently lack FDA-approved drug treatments.

Positive

• Clinical trial demonstrated statistically significant improvement in IBS symptoms using inFoods IBS test
• 59.6% of treatment group achieved FDA responder definition for pain reduction vs 42.2% in control group
• Strong efficacy for IBS-M patients (66% success rate), addressing an untapped market segment with no current FDA-approved treatments
• Publication in prestigious Gastroenterology journal validates scientific credibility
• Test provides data-driven, non-drug treatment approach for IBS management

Negative

• None.

Insights

Gastroenterology Specialist

Biomerica's inFoods IBS test shows strong clinical validation with significant symptom improvement, especially for underserved IBS-M patients.

This peer-reviewed clinical validation of Biomerica's inFoods IBS test in Gastroenterology represents a significant advancement in IBS management. The multicenter, double-blind trial involving 238 patients across eight prestigious academic centers demonstrated compelling efficacy, particularly for symptom reduction. Most notable is the 59.6% responder rate for abdominal pain reduction in the treatment group versus 42.2% in controls.

The results for IBS-M patients are particularly groundbreaking, with 66.0% meeting FDA responder criteria compared to just 29.5% in controls. This is clinically meaningful as IBS-M affects approximately 33% of IBS sufferers and currently lacks FDA-approved pharmacological options. The test's mechanism—identifying foods triggering abnormal immune responses rather than using traditional IgG markers—represents a more sophisticated and targeted approach to dietary management.

Publication in Gastroenterology, with its rigorous peer-review process and premier status in the field, significantly enhances the credibility of these findings. This validation could position inFoods IBS as a first-line intervention for IBS management, particularly given its non-pharmacological nature and personalized approach. The test addresses a fundamental challenge in IBS therapy—identifying patient-specific dietary triggers without extensive elimination trials—potentially improving treatment adherence and clinical outcomes.

• Landmark Peer-Reviewed Study Demonstrates Effectiveness of Personalized Dietary Therapy for IBS Patients Using inFoods^® IBS Test.
• Gastroenterology, the premier journal in gastrointestinal science, features data supporting inFoods IBS as an effective personalized, non-drug approach for managing IBS.
• Study results suggest inFoods IBS could be particularly beneficial for IBS-M patients, a population with no current FDA-approved drug treatments.
  

IRVINE, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global leader in advanced diagnostic-guided therapies, today announced that data from its pivotal clinical trial evaluating the inFoods^® IBS test in treating IBS sufferers has been published in the June 2025 issue of Gastroenterology, the official journal of the American Gastroenterological Association and the highest-impact publication in the GI field.

The randomized, multicenter, double-blind, placebo-controlled trial demonstrated that patients with Irritable Bowel Syndrome (IBS) experienced statistically significant improvement in symptoms—particularly abdominal pain and bloating—when following a personalized elimination diet guided by the inFoods IBS test. The test identifies specific foods that provoke an abnormal immune response, believed to be a key trigger of IBS symptoms.

“This publication in Gastroenterology reinforces the scientific rigor, statistical significance and clinical impact of the inFoods IBS approach for treating patients,” said Zack Irani-Cohen, CEO of Biomerica. “It marks a major milestone in precision nutrition as a non-drug treatment pathway for IBS.”

Key Findings Highlighted in Gastroenterology

The trial included 238 patients across eight U.S. academic centers (including Mayo Clinic, Clevland Clinic and Univ. of Michigan), comparing outcomes between a treatment group who eliminated foods identified by the inFoods IBS test versus a control group following a placebo “sham” diet.

• 59.6% of patients in the treatment group achieved the FDA responder definition for abdominal pain reduction, compared to 42.2% in the control group
• Among patients with IBS-C, 67.1% in the treatment arm reached this benchmark vs. 35.8% in controls
• Among those with IBS-M, 66.0% in the treatment group met the target vs. 29.5% in controls
  
  

These results suggest inFoods IBS could be particularly beneficial for IBS-M patients, an underserved group, for whom there are currently no FDA-approved drug treatments. IBS-M patients are estimated to represent approximately 33% of the IBS market.

A New Standard in IBS Management

The inFoods IBS test utilizes a proprietary assay that measures each patient’s immune response to a panel of foods, using IBS-specific p-value associations and 95% confidence thresholds. Unlike traditional IgG food tests, inFoods IBS is clinically validated and designed specifically to identify dietary triggers in IBS patients.

“Our diets are complex, and identifying individual food triggers can be extremely challenging,” said Anthony Lembo, M.D., Vice Chair of Research at Cleveland Clinic’s Digestive Disease Institute. “This test offers a data-driven path to help IBS patients reduce symptoms by identifying specific problematic foods.”

The full study is available in the June 2025 issue of Gastroenterology and can be accessed at www.gastrojournal.org.

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com or www.inFoodsIBS.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. For more information, visit www.inFoodsIBS.com and www.biomerica.com.

About inFoods^®

The inFoods IBS test is designed to assess a patient’s above normal immunoreactivity to specific foods utilizing a simple finger-stick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about trigger foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30% reduction in pain, for IBS patients in the treatment diet arm was greater than patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and for certain endpoints is similar and, in some cases, better than the current drugs in the market. Further information about Biomerica’s patented inFoods^® Technology Platform can be found at: www.inFoodsIBS.com.

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 current and future sales, revenues, operations and earnings, performance and efficacy of the Company’s products and tests, patient results and benefits from use of the Company’s products and tests, uniqueness of the Company’s products, accuracy of the Company’s tests and products, domestic and/or international market adoption and acceptance and demand for the Company’s products, future use of the Company's products by physicians to treat their patients, and potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; 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; availability of the Company’s test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 | CEO
p. 949.645.2111
www.biomerica.com

Source: Biomerica

FAQ

What are the key findings of Biomerica's (BMRA) inFoods IBS clinical trial?

The trial showed 59.6% of treated patients achieved FDA-defined pain reduction versus 42.2% in controls, with particularly strong results in IBS-M patients where 66% met treatment targets compared to 29.5% in controls.

How does Biomerica's (BMRA) inFoods IBS test work?

The test uses a proprietary assay to measure patients' immune responses to various foods, using IBS-specific p-value associations and 95% confidence thresholds to identify dietary triggers specific to IBS patients.

What percentage of IBS patients could benefit from Biomerica's (BMRA) treatment for IBS-M?

IBS-M patients, who could particularly benefit from this treatment, represent approximately 33% of the total IBS market.

Which major medical centers participated in Biomerica's (BMRA) inFoods IBS clinical trial?

The trial was conducted across eight U.S. academic centers, including Mayo Clinic, Cleveland Clinic, and University of Michigan.

What makes Biomerica's (BMRA) inFoods IBS test different from traditional food sensitivity tests?

Unlike traditional IgG food tests, inFoods IBS is clinically validated and specifically designed to identify dietary triggers in IBS patients using IBS-specific measurements.