Biomerica inFoods IBS Study Shows 59.4% Pain Relief Rate
Biomerica 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. 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 greater than or equal to30% improvement in weekly average symptom scores was applied-the same endpoint used in the Company's peer-reviewed randomized controlled trial published in Gastroenterology: Abdominal Pain: 59.4% of patients met the responder threshold. Bloating: 68.1% of patients 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 Mean bloating scores declined 41.7%, from 4.35 to 2.54 at 8 weeks. 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. 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, 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. 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.
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- Widening Losses: Biomerica reported a net loss of $1.32 million in Q2, a 39.5% increase from last year's loss of $0.95 million, indicating greater pressure on the company's profitability.
- Revenue Decline: The company's revenue fell to $1.21 million, down 26.2% from $1.64 million last year, reflecting weak market demand and sales challenges that could impact future liquidity.
- Performance Comparison: The loss per share widened from $0.09 to $0.12 compared to the same period last year, suggesting that efforts to control costs and boost revenue have not yielded expected results.
- Market Outlook: With both revenue and profitability declining, Biomerica may need to reassess its market strategy to navigate the current economic environment and competitive pressures in the industry.
- Financial Performance Decline: Biomerica reported a Q2 net loss of $1.32 million, which is a 39% increase from a $0.95 million loss in the same quarter last year, indicating greater pressure on the company's profitability.
- Significant Revenue Drop: The company's revenue fell to $1.21 million, down 26.2% year-over-year, reflecting weak market demand and insufficient sales strategies, which could impact future liquidity.
- Investor Attention: As financial performance worsens, investor interest in Biomerica is likely to increase, potentially leading to heightened stock price volatility and affecting the company's ability to raise capital in the market.
- Uncertain Future Outlook: Given the current financial situation, Biomerica needs to reassess its business strategy to address market challenges and restore growth potential.
- Collaborative Promotion: Biomerica entered a marketing services agreement with Henry Schein to support the commercialization of its inFoods®IBS test in the U.S., aiming to enhance awareness among healthcare providers and drive broader adoption in clinical practice.
- AI Tool Launch: The introduction of the inFoods®IBS Trigger Food Navigator, an AI-driven digital companion tool designed to improve patient dietary compliance and treatment success, helps patients identify 2 to 4 specific foods that trigger IBS symptoms, providing a personalized dietary plan.
- Medicare Payment Rate Established: The CMS set a national Medicare payment rate of $300 for the inFoods®IBS test, effective January 1, 2026, which will expand patient access to the product through the Medicare system, enhancing market penetration.
- International Expansion Authorization: The Egyptian Drug Authority authorized Biomerica's complete screening test portfolio, further expanding access to the company's rapid diagnostic solutions in Egypt and supporting the ongoing international expansion of Biomerica's diagnostic products.
- Medicare Payment Established: CMS has set a national Medicare payment rate of $300 for Biomerica's inFoods IBS test, effective January 1, 2026, which is expected to significantly enhance patient access and lay a foundation for the company's future commercial growth.
- Substantial Market Potential: With approximately 30 million IBS patients in the U.S., the inFoods IBS test addresses this unmet medical need through a personalized diagnostic approach, likely driving the company's market share in the rapidly growing gastrointestinal disease sector.
- Strong Clinical Validation: In a multicenter randomized controlled trial, 59.6% of patients who eliminated trigger foods identified by the inFoods IBS test achieved abdominal pain reduction, significantly higher than the 42.2% in the control group, providing robust clinical support for product marketing.
- Optimized Commercial Strategy: Biomerica plans to use the CMS payment rate as a benchmark for negotiations with private insurers while expanding collaborations with gastroenterology practices to further enhance market penetration.
- Market Access Breakthrough: Biomerica has received authorization from the Egyptian Drug Authority to promote its rapid screening tests, which is expected to significantly enhance early detection rates for cancers and chronic diseases in Egypt, addressing the growing health needs of the population.
- Diverse Product Portfolio: The authorization covers multiple products including the EZ Detect™ Colon Disease Test, Aware® Breast Self Exam, and Fortel Prostate PSA Test, designed to support early disease identification through convenient home testing, thereby reducing healthcare costs.
- Addressing Public Health Challenges: With colorectal cancer incidence in Egypt at approximately 5-10 cases per 100,000 people annually, Biomerica's testing tools will aid in identifying high-risk populations, facilitating a shift in national public health policies towards early detection and improving patient outcomes.
- Strategic Expansion Plans: This authorization not only strengthens Biomerica's market position in the Middle East and North Africa but also provides opportunities for large-scale screening initiatives in underserved areas, further advancing global preventive healthcare trends.
- Comprehensive Screening Authorization: Biomerica's rapid testing portfolio has received authorization from the Egyptian Drug Authority, covering cancers and chronic diseases, marking a significant breakthrough in the Egyptian market and expected to significantly enhance early detection rates.
- Convenient Testing Tools: The EZ Detect™ Colon Disease Test provides results within two minutes without stool handling, greatly facilitating user convenience and supporting early detection of colorectal diseases, thereby reducing late-stage diagnosis risks.
- Addressing Market Needs: With colorectal cancer incidence at 5-10 cases per 100,000 people annually in Egypt and breast cancer being the most common among women, Biomerica's products will help improve early screening, reduce mortality rates, and enhance public health outcomes.
- Strategic Expansion Plans: This authorization not only strengthens Biomerica's market position in the Middle East and North Africa but also provides opportunities for large-scale screening initiatives in resource-limited areas, aligning with global preventive healthcare trends.









