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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- Medicare Coverage Confirmation: Biomerica's inFoods® IBS test has received confirmation from the Medicare Administrative Contractor that claims will be reviewed on an individual basis, with eligible claims potentially receiving a $300 payment, marking a crucial step towards revenue growth for the company.
- Streamlined Claims Process: Claims for the test will be processed through Biomerica's CLIA-certified laboratory, ensuring centralized handling and review of claims, thereby enhancing the company's competitiveness in the healthcare market.
- Clinical Evidence Support: The inFoods® IBS test demonstrated significant clinical efficacy in a multicenter randomized controlled trial, with 59.6% of patients in the treatment group achieving FDA endpoints for abdominal pain reduction, strengthening the rationale for Medicare claims.
- Significant Market Potential: IBS affects 10-15% of U.S. adults, particularly over 20% of the elderly population, providing a strong demand foundation that is expected to generate substantial revenue opportunities for Biomerica.
- Financial Decline: Biomerica's net sales for Q3 FY2026 fell to $0.98 million from $1.12 million year-over-year, reflecting a 12.5% decrease that highlights the challenges faced during the company's transition, potentially impacting future market confidence.
- Widening Net Loss: The net loss for the third quarter widened to $1.31 million from $1.16 million in the prior year, although the per-share loss narrowed by 37% to $0.92, indicating efforts in cost control that may lay the groundwork for future profitability.
- Strategic Restructuring: CEO Zack Irani stated that the company is restructuring around higher-margin, diagnostically-driven products and a growing Contract Development and Manufacturing Organization (CDMO) services business, suggesting that while short-term revenues are affected, the long-term strategy may enhance market competitiveness.
- Stock Price Volatility: BMRA's stock has traded between $1.87 and $4.88 over the past year, closing at $2.01 on Monday, down 2.80%, but rising 1.44% to $2.11 in after-hours trading, indicating market interest in the company's future transformation.
- Financial Performance Decline: Biomerica reported a net loss of $1.31 million for Q3 of fiscal 2026, an increase from $1.16 million in the same quarter last year, indicating pressure on the company's profitability.
- Revenue Drop: The revenue for the third quarter was $0.99 million, reflecting an 11.6% year-over-year decline, which suggests challenges in market competitiveness that could impact future liquidity and investor confidence.
- Market Reaction: Due to the disappointing financial results, investors may adopt a cautious stance regarding Biomerica's growth prospects, potentially leading to negative impacts on the stock price and increasing market uncertainty.
- Need for Strategic Adjustment: In light of ongoing losses and declining revenues, the company may need to reassess its market strategies and operational efficiencies to restore profitability and attract investment in a highly competitive environment.
- Clinical Data Highlights: Among patients using inFoods®IBS, 59.4% achieved a ≥30% reduction in abdominal pain and 68.1% achieved a ≥30% reduction in bloating, based on FDA-recognized responder endpoints, indicating the product's effectiveness in alleviating IBS symptoms and potentially driving future sales growth.
- Medicare Payment Rate Established: CMS has set a national Medicare payment rate of $300 for the inFoods®IBS test, effective January 1, 2026, marking a significant milestone that will help expand patient access to the product and enhance market penetration.
- European Market Growth: Revenue from European customers grew 45% year-over-year in the third quarter, increasing from $198,000 to $287,000, reflecting Biomerica's strengthening commercial momentum in the region, while hp+detect™ received UK regulatory registration, laying the groundwork for future commercial sales.
- R&D Expenses Reduced: Year-to-date R&D expenses decreased by 24%, from $771,000 to $583,000, reflecting effective resource allocation as the company transitions towards commercialization, with expectations for further margin improvement.
- First Commercial Order: Biomerica announced it has secured its first commercial order for the Hp Detect H. pylori test from a major European lab chain, specifically targeting the UK market, marking a significant step in the company's expansion into European commercialization.
- Regulatory Approval Context: This order follows the MHRA clearance obtained in February 2026, demonstrating the company's capability to meet stringent regulatory requirements, thereby enhancing its competitive position in the European market.
- Market Expansion Potential: The order is expected to support further distribution partnerships in the U.S. and EU markets, driving the company's market penetration and sales growth on a global scale.
- Stock Price Reaction: Following this announcement, Biomerica's shares rose by 4.00%, reflecting investor optimism regarding the company's future growth potential.
- 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.








