Biomerica Reports Real-World Data: Nearly 60% of IBS Patients Achieved Clinically Meaningful Pain Reduction and 68% Achieved Bloating Reduction with the inFoods IBS Therapy

Physician Interview Now Available

Key Highlights

• Responder Analysis: 59.4% of patients achieved ≥30% reduction in abdominal pain; 68.1% achieved ≥30% reduction in bloating—using the FDA-recognized responder endpoint consistent with the Company’s peer-reviewed randomized controlled trial.
• CMS Payment Rate: $300 national Medicare payment rate established, effective January 1, 2026.
• Physician Perspective: New interview with Gastroenterologist Dr. Dak Patel about inFoods IBS in clinical use now available.
  

IRVINE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), an innovator in diagnostic-guided therapy, today announced responder analysis results from its ongoing real-world study of inFoods® IBS. The data demonstrates that a majority of patients achieved clinically meaningful reductions in both abdominal pain and bloating—the two most debilitating symptoms of Irritable Bowel Syndrome (IBS).

Responder Analysis

The analysis was conducted on 69 patients who completed the full 8-week study protocol with both baseline and endpoint assessments. The FDA-recognized responder definition of ≥30% improvement in weekly average symptom scores was applied—the same endpoint used in the Company’s peer-reviewed randomized controlled trial (RCT) published in Gastroenterology:

• Abdominal Pain: 59.4% of patients (41 of 69) met the responder threshold.
• Bloating: 68.1% of patients (47 of 69) met the responder threshold.

Among the 69 patients, 62 patients tested positive for one or more food sensitivities on the IBS-specific IgG assay:

• Mean abdominal pain scores decreased 34.6%, from 3.24 at baseline to 2.12 at 8 weeks (P = 0.0002).
• Mean bloating scores declined 41.7%, from 4.35 to 2.54 at 8 weeks (P < 0.0001).

These results validate the inFoods® IBS test in a real-world clinical setting using the same rigorous endpoints the FDA applies to clinical trials for IBS drug therapies, demonstrating clinical utility beyond controlled trial conditions.

Consistency with Peer-Reviewed Controlled Trial

These real-world findings build on a peer-reviewed, randomized controlled clinical trial of inFoods® IBS which is published in Gastroenterology. That study was conducted across five major academic centers, including Mayo Clinic, Cleveland Clinic, Beth Israel Deaconess Medical Center (Harvard Medical School), the University of Michigan, and Houston Methodist Hospital. That pivotal study demonstrated significantly greater abdominal pain relief in the treatment arm versus the sham diet arm (59.6% vs. 42.1%, p = 0.02 using the FDA responder endpoint).

The 59.4% real-world pain responder rate from the use of inFoods® IBS closely mirrors the 59.6% result from the controlled trial—offering an unusual degree of consistency between controlled and real-world settings that strengthens confidence in the product’s clinical utility.

Commercial Milestones

• CMS Medicare Payment Rate: In December 2025, CMS established a national Medicare payment rate of $300 for the inFoods® IBS test under the Clinical Laboratory Fee Schedule, effective January 1, 2026. The Company is working with Medicare Administrative Contractors to begin coverage and will also use the CMS pricing as a benchmark for negotiations with private commercial insurers.
• Henry Schein Marketing Agreement: In late 2025, the Company entered into a marketing services agreement with Henry Schein, Inc. (Nasdaq: HSIC), providing access to more than 400 medical field sales and tele-sales representatives targeting primary care and gastroenterology practices nationwide.
• Dedicated CPT® Code: The American Medical Association approved a unique CPT® PLA code for inFoods® IBS, effective October 1, 2025, simplifying billing for physicians and laboratories.
  

Physician Interview

A new interview with Dr. Dak Patel—discussing his first-hand clinical experience prescribing inFoods® IBS—is now available on the Company’s investor relations website. The interview offers investors, prospective physician partners, and other stakeholders insight into how the product is being integrated into clinical practice and the patient outcomes observed in a real-world setting.

“This responder analysis represents another significant data set for inFoods® IBS,” said Zack Irani, CEO of Biomerica. “Nearly 60% of patients saw clinically meaningful pain relief and more than two-thirds experienced significant improvement in bloating—using the FDA’s own standard for clinical response. These outcomes, combined with the $300 CMS Medicare rate, and our Henry Schein partnership, are building an increasingly compelling case for physicians, patients, payers, and potential partners.”

Market Opportunity

IBS affects an estimated 30 to 45 million adults in the United States, representing 10%–15% of the adult population. The condition leads to decreased quality of life, lost productivity, and reliance on medications with adverse side effects. Current IBS drugs address symptoms without targeting the underlying dietary triggers specific to each patient.

inFoods® IBS takes a fundamentally different approach—a precision diagnostic that identifies individual food triggers via a simple finger-stick blood test, enabling targeted, patient-specific dietary recommendations. This non-pharmacologic, personalized solution addresses a significant unmet clinical need within an estimated $30 billion total addressable market.

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.

About inFoods® IBS

inFoods® IBS is a diagnostic-guided therapy that identifies patient-specific food triggers responsible for symptoms such as abdominal pain, bloating, diarrhea, and constipation. Using a simple finger-stick blood sample, the test enables physicians to recommend targeted dietary changes tailored to the patient’s immune response—offering a non-pharmaceutical, precision-based approach to symptom relief.

A multicenter, double-blinded clinical study on the inFoods® IBS test was published in the June issue of Gastroenterology, the top peer-reviewed GI journal. As the largest study of its kind, it demonstrated statistically significant outcomes:

• 59.6% of patients in the treatment group (who eliminated identified trigger foods) achieved the FDA’s endpoint for abdominal pain reduction, compared to 42.2% in the control group.
• Among IBS-C patients, 67.1% of patients in the treatment group vs. 35.8% in the control group.
• Among IBS-M patients, 66% of patients in the treatment group vs. 29.5% in the control group.
  

These results highlight inFoods® IBS as the only targeted therapy to demonstrate efficacy specifically in IBS-M patients, a subgroup historically underserved by existing treatments. The study was conducted at leading U.S. institutions including Cleveland Clinic, Mayo Clinic, University of Michigan, and Beth Israel Deaconess Medical Center.

inFoods® IBS is Laboratory Developed Test (LDT) used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

Forward-Looking Statements