Biomerica Announces Responder Analysis Results From Ongoing Real-World Study Of inFoods IBS

• 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 at https://investors.biomerica.com/events-and-presentations/default.aspx

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.