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Earnings documents stored for BMRA.
Investor releaseQuarter not tagged2026-04-14Biomerica Reports Third Quarter Fiscal 2026 Financial Results
GlobeNewswire
Biomerica Reports Third Quarter Fiscal 2026 Financial Results
IRVINE, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (“Biomerica” or the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the third quarter of fiscal 2026 ended February 28, 2026. Key Highlights: 1. inFoods® IBS Real-World Data: Nearly 60% of Irritable Bowel Syndrome (“IBS”) Patients Achieved Clinically Meaningful Pain Reduction and 68% Achieved Bloating Reduction with inFoods® IBS During the third quarter, Biomerica reported real-world data showing: 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 Biomerica’s peer-reviewed randomized controlled trial These real-world findings build on a peer-reviewed, randomized controlled clinical trial published in Gastroenterology, conducted across five major academic centers including Mayo Clinic, Cleveland Clinic, and 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). 2. CMS Establishes National Medicare Payment Rate for inFoods® IBS Test The Centers for Medicare & Medicaid Services (CMS) established a national Medicare payment rate of $300 for inFoods® IBS, effective January 1, 2026. This milestone provides reimbursement clarity and represents an important step toward expanding patient access to inFoods® IBS through the Medicare system. Biomerica and its lab partner are working with the appropriate Medicare Administrative Contractor to attain Medicare coverage for inFoods® IBS. 3. European Revenue Up 45% in the Quarter; hp+detect™ Receives UK Regulatory Registration Revenue from European customers grew 45% year-over-year in the third quarter, increasing from $198,000 to $287,000. Biomerica believes this growth reflects building commercial momentum on the continent. Subsequent to quarter end, Biomerica further strengthened its European position on two fronts: UK MHRA Registration: hp+detect™ received registration from the UK Medicines and Healthcare products Regulatory Agency, providing the regulatory foundation for commercial sales in the United Kingdom. First Commercial European Lab Order: Biomerica received its first commercial order for hp+dete…Read full documentShow less
IRVINE, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (“Biomerica” or the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the third quarter of fiscal 2026 ended February 28, 2026. Key Highlights: 1. inFoods® IBS Real-World Data: Nearly 60% of Irritable Bowel Syndrome (“IBS”) Patients Achieved Clinically Meaningful Pain Reduction and 68% Achieved Bloating Reduction with inFoods® IBS During the third quarter, Biomerica reported real-world data showing: 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 Biomerica’s peer-reviewed randomized controlled trial These real-world findings build on a peer-reviewed, randomized controlled clinical trial published in Gastroenterology, conducted across five major academic centers including Mayo Clinic, Cleveland Clinic, and 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). 2. CMS Establishes National Medicare Payment Rate for inFoods® IBS Test The Centers for Medicare & Medicaid Services (CMS) established a national Medicare payment rate of $300 for inFoods® IBS, effective January 1, 2026. This milestone provides reimbursement clarity and represents an important step toward expanding patient access to inFoods® IBS through the Medicare system. Biomerica and its lab partner are working with the appropriate Medicare Administrative Contractor to attain Medicare coverage for inFoods® IBS. 3. European Revenue Up 45% in the Quarter; hp+detect™ Receives UK Regulatory Registration Revenue from European customers grew 45% year-over-year in the third quarter, increasing from $198,000 to $287,000. Biomerica believes this growth reflects building commercial momentum on the continent. Subsequent to quarter end, Biomerica further strengthened its European position on two fronts: UK MHRA Registration: hp+detect™ received registration from the UK Medicines and Healthcare products Regulatory Agency, providing the regulatory foundation for commercial sales in the United Kingdom. First Commercial European Lab Order: Biomerica received its first commercial order for hp+detect™ from one of the largest clinical laboratory chains operating across Europe. This strategic account’s scale and geographic reach positions it as a reference account and potential gateway to broader European Union laboratory channel adoption, with recurring orders expected as hp+detect™ is integrated into routine testing workflows. H. pylori affects an estimated 45% of the population across Europe’s five largest countries. The World Health Organization designates H. pylori as a Class 1 carcinogen and lists it among the 16 antibiotic-resistant bacteria posing the greatest threat to human health globally. 4. R&D Expenses Reduced 24% Year-to-Date — Reflecting Transition from Development to Commercialization Research and development (“R&D”) expenses decreased 24% year-to-date, from $771,000 to $583,000, as both the hp+detect™ development project and the inFoods® IBS clinical program have completed development phases. This reflects disciplined capital allocation as Biomerica directs resources toward commercial execution rather than further development spend. 5. Over-the-Counter Product Line Delivers 16% Revenue Growth Over-the-counter revenue grew 16% year-over-year in the third quarter reflecting consumer demand growth and continued diversification of Biomerica’s revenue mix. Management Commentary Zack Irani, CEO said, " This quarter reflects the cost of doing something harder than maintaining the status quo. We are restructuring Biomerica around higher-margin, diagnostically-driven products and a growing Contract Development and Manufacturing Organization (“CDMO”) services business — and near-term revenue reflects that transition. The underlying indicators are encouraging: post-quarter CDMO customer demand has improved and inFoods® IBS and hp+detect™ represent genuine commercial catalysts. The fixed cost base is established. We expect margin expansion to follow as these initiatives contribute revenue." Third Quarter and Year-to-Date Fiscal 2026 Financial Results Net Sales Net sales for the third quarter of fiscal 2026 were approximately $987,000, compared to $1.12 million in the prior year quarter. The decrease primarily reflects lower contract manufacturing revenue following the completion of prior customer projects, as well as normal variability in the timing of project-based activity. These impacts were partially offset by growth in inFoods® IBS sales and a 16% increase in over-the-counter product lines. For the nine months ended February 28, 2026, net sales were $3.58 million, compared to $4.56 million in the prior year period. The decrease primarily reflects lower contract manufacturing revenue following the completion of a prior R&D project, as well as the absence of large initial distributor stocking orders in the Middle East and North Africa (“MENA”) region recorded in the prior year. These impacts were partially offset by continued growth in inFoods® IBS sales. Gross Margin For the nine months ended February 28, 2026, gross margin was approximately 13%, compared to 15% in the prior year period. The decrease primarily reflects changes in product mix and lower overall sales volume during the current period. Management expects gross margins to improve over time as inFoods® IBS and hp+detect™ sales continue to scale, along with the development of additional Contract Development and Manufacturing Organization (“CDMO”) revenue opportunities. Operating Expenses Operating expenses for the third quarter of fiscal 2026 were $1.25 million, compared to $1.23 million in the same period last year. For the nine months ended February 28, 2026, operating expenses decreased approximately 2% to $4.22 million, compared to $4.32 million in the prior year period, reflecting Biomerica’s continued focus on cost discipline. Excluding certain professional service expenses related to ERTC filings, operating expenses decreased by approximately 5%. Net Loss Net loss for the third quarter of fiscal 2026 was $1.31 million, compared to $1.16 million in the prior year quarter. For the nine months ended February 28, 2026, net loss improved to $2.63 million, compared to $3.43 million in the prior year period, primarily due to sustained expense discipline and the recognition of a tax credit earlier in the fiscal year. Net loss per share for the nine months ended February 28, 2026, improved 37% to $(0.92), compared to $(1.47) in the prior year period, reflecting the Company’s progress in cost management and operating efficiency as it transitions toward a higher-margin revenue mix. 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 (“GI”) 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 uses a blood test 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 utilizing inFoods® IBS was published in the June 2025 issue of Gastroenterology, the top peer-reviewed GI journal. As the study 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 42.1% 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 a potentially effective targeted therapy 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, and University of Michigan. For more information about inFoods® IBS, visit 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 contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods® IBS product, hp+detect™ product, CDMO offerings and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. Such important risks and uncertainties, include, among others: 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; 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. Additional factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), and available on the SEC's website (www.sec.gov). In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The Company is under no obligation to update any forward-looking statements after the date of this release. Source: Biomerica, Inc. CONTACT: Corporate Contact: Zack Irani 949-645-2111 [email protected]
Investor releaseQuarter not tagged2026-01-15Biomerica Reports Second Quarter Fiscal 2026 Financial Results
GlobeNewswire
Biomerica Reports Second Quarter Fiscal 2026 Financial Results
Operating Expenses Decline 4% Year-to-Date Balance Sheet Strengthens and Working Capital Improves by 14.7% IRVINE, Calif., Jan. 14, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the second quarter of fiscal 2026 ended November 30, 2025. Key Highlights: Management Commentary Zack Irani, CEO said, "We are executing a deliberate strategic pivot from legacy, lower-margin products to higher-value, higher-margin diagnostic-guided therapy products. The current revenue softness reflects this transition, not fundamental business deterioration. With our fixed cost structure largely in place, we believe incremental revenue from inFoods® IBS and new partnerships such as Henry Schein as well as hp+detect™ opportunities should drive significant margin expansion. Additionally, our contract development and manufacturing organization (CDMO) expansion leverages existing infrastructure to generate higher-margin revenue while diversifying our revenue base." "While second quarter revenue reflected expected variability across our established product lines, Biomerica continued to strengthen its financial foundation through successful capital raising activities and disciplined cost management,” said Gary Lu, CFO of Biomerica. “Earlier in the fiscal year, the Company also received approximately $1.10 million in Employee Retention Credit (ERC) refunds, which, together with our financing initiatives, contributed to a $457,000 year-to-date improvement in working capital and an increase in our cash position to $2.5 million. As we advance key programs from development into commercialization, we are prudently reallocating resources, which resulted in a 27% reduction in research and development expenses, while continuing to invest in the commercial launch of high-value diagnostic programs, including inFoods® IBS and hp+detect™. We maintain access to additional capital through our existing shelf registration to support future growth initiatives.” Second Quarter and Year-to-Date Fiscal 2026 Financial Results Net sales for the second quarter of fiscal 2026 were $1.21 million, compared to $1.64 million in the prior year quarter. The decrease primarily reflects the absence of large initial distributor stocking orders in the Middle East and North Africa (“MENA…Read full documentShow less
Operating Expenses Decline 4% Year-to-Date Balance Sheet Strengthens and Working Capital Improves by 14.7% IRVINE, Calif., Jan. 14, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the second quarter of fiscal 2026 ended November 30, 2025. Key Highlights: Management Commentary Zack Irani, CEO said, "We are executing a deliberate strategic pivot from legacy, lower-margin products to higher-value, higher-margin diagnostic-guided therapy products. The current revenue softness reflects this transition, not fundamental business deterioration. With our fixed cost structure largely in place, we believe incremental revenue from inFoods® IBS and new partnerships such as Henry Schein as well as hp+detect™ opportunities should drive significant margin expansion. Additionally, our contract development and manufacturing organization (CDMO) expansion leverages existing infrastructure to generate higher-margin revenue while diversifying our revenue base." "While second quarter revenue reflected expected variability across our established product lines, Biomerica continued to strengthen its financial foundation through successful capital raising activities and disciplined cost management,” said Gary Lu, CFO of Biomerica. “Earlier in the fiscal year, the Company also received approximately $1.10 million in Employee Retention Credit (ERC) refunds, which, together with our financing initiatives, contributed to a $457,000 year-to-date improvement in working capital and an increase in our cash position to $2.5 million. As we advance key programs from development into commercialization, we are prudently reallocating resources, which resulted in a 27% reduction in research and development expenses, while continuing to invest in the commercial launch of high-value diagnostic programs, including inFoods® IBS and hp+detect™. We maintain access to additional capital through our existing shelf registration to support future growth initiatives.” Second Quarter and Year-to-Date Fiscal 2026 Financial Results Net sales for the second quarter of fiscal 2026 were $1.21 million, compared to $1.64 million in the prior year quarter. The decrease primarily reflects the absence of large initial distributor stocking orders in the Middle East and North Africa (“MENA”) region recorded in the prior year period, as the Company’s regional partner ramped up its initial market rollout. While Biomerica continues to generate recurring revenue from the region, the prior year quarter benefited from these upfront inventory purchases. The quarter also reflects normal timing variability in international shipments as well as lower contract manufacturing activity. These impacts were partially offset by continued growth in inFoods® IBS sales. For the six months ended November 30, 2025, net sales were $2.59 million, compared to $3.44 million in the prior year period. Gross margin for the six-month period was 18%, compared to 21% in the prior year, reflecting lower overall sales volume as the Company transitions from legacy products to higher-margin diagnostic-guided therapy offerings. Management expects gross margins to expand as inFoods® IBS and hp+detect™ sales scale and added CDMO services. Operating expenses for the second quarter of fiscal 2026 were $1.42 million, compared to $1.43 million in the same period last year. For the six months ended November 30, 2025, operating expenses decreased approximately 4% to $2.96 million, compared to $3.09 million in the prior year period. This performance reflects Biomerica’s continued focus on cost discipline and operational efficiency, including targeted reductions across administrative, research, and manufacturing. Notably, when excluding professional service fees related to Employee Retention Tax Credit (ERTC) filings, which contributed to the Company's increase in cash, normalized operating expenses for the six-month period decreased by approximately 7% compared to the prior year. With the Company's fixed cost structure now largely optimized, management expects incremental revenue from new product launches and strategic partnerships to drive meaningful operating leverage and margin expansion. Net loss for the second quarter of fiscal 2026 was $1.32 million, compared to $0.95 million in the prior year quarter, reflecting lower revenue and gross margin during the period. For the six months ended November 30, 2025, net loss improved to $1.31 million, compared to $2.27 million in the prior year period, primarily due to sustained expense discipline and the recognition of a non-recurring tax credit earlier in the fiscal year. Biomerica continues to prioritize operational efficiency and disciplined cost management while selectively investing in core diagnostic programs designed to drive long term value. The Company's strategic focus on transitioning its revenue mix toward higher-margin products, combined with its optimized cost structure, positions Biomerica to benefit from significant operating leverage as inFoods® IBS, hp+detect™, and CDMO services gain commercial traction. 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® The inFoods IBS test involves a simple blood collection procedure and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented inFoods® Technology Platform can be found at: https://biomerica.com/inFoods/our-technology/. The inFoods IBS clinical study was performed 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%, for IBS patients in the treatment diet arm had a statistically significant improvement over 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 is similar and, in some cases, better than the current drugs in the market. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods® IBS product, hp+detect™ product and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC's website (www.sec.gov). The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani 949-645-2111 [email protected] Source: Biomerica, Inc.
Investor releaseQuarter not tagged2025-11-25Biomerica’s inFoods® IBS Product Featured in Biotherapeutics Quarterly, a Henry Schein Publication, Highlighting a New Precision Approach for Treating IBS
GlobeNewswire
Biomerica’s inFoods® IBS Product Featured in Biotherapeutics Quarterly, a Henry Schein Publication, Highlighting a New Precision Approach for Treating IBS
Publication details large multicenter clinical trial demonstrating significant reductions in IBS symptoms through inFoods IBS guided dietary therapy IRVINE, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic solutions, is proud to announce that its inFoods® IBS diagnostic-guided therapy product is being featured in the Fall 2025 issue of Biotherapeutics Quarterly, a Henry Schein publication. The article, titled “Precision Medicine for IBS: A Novel, IBS-Specific Immune Response Guided Dietary Therapy”, presents comprehensive clinical and scientific insights into the company’s innovative approach to managing Irritable Bowel Syndrome (IBS). The publication details results from a randomized, multicenter, double-blind, placebo-controlled clinical trial evaluating the effectiveness of the inFoods® IBS test in identifying patient-specific dietary IBS triggers and guiding targeted food elimination to reduce IBS symptoms. Large Multicenter Study Demonstrates Clinically Meaningful Pain Reduction IBS affects an estimated 10% to 15% of adults in the United States and is known to significantly reduce quality of life and work productivity. Symptoms such as often severe abdominal pain, bloating, diarrhea, and constipation are frequently exacerbated by specific foods, yet identifying individual dietary triggers has historically relied on trial-and-error approaches. The inFoods IBS clinical trial analyzed 223 IBS patients across eight major U.S. academic medical centers including Mayo Clinic, Harvard Beth Israel Deaconess Medical Center, and Cleveland Clinic. Participants were tested for abnormal antibody responses to 18 IBS-specific foods using the inFoods® IBS assay and then randomized into two study arms: Treatment Group: Eliminated foods identified by the inFoods® IBS test as producing an abnormally elevated IgG immune response. Control Group: Followed a placebo (sham) diet eliminating foods for which the patient tested negative in the inFoods IBS test, matched in type and quantity to ensure blinding. Key Findings: 59.6% of patients in the inFoods IBS-guided diet (treatment group) achieved the FDA-defined target for abdominal pain reduction, compared to 42.1% in the control group for all IBS subclasses. Particularly strong results were observed in difficult-to-treat IBS subtypes: IBS-C: 67.1% respons…Read full documentShow less
Publication details large multicenter clinical trial demonstrating significant reductions in IBS symptoms through inFoods IBS guided dietary therapy IRVINE, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic solutions, is proud to announce that its inFoods® IBS diagnostic-guided therapy product is being featured in the Fall 2025 issue of Biotherapeutics Quarterly, a Henry Schein publication. The article, titled “Precision Medicine for IBS: A Novel, IBS-Specific Immune Response Guided Dietary Therapy”, presents comprehensive clinical and scientific insights into the company’s innovative approach to managing Irritable Bowel Syndrome (IBS). The publication details results from a randomized, multicenter, double-blind, placebo-controlled clinical trial evaluating the effectiveness of the inFoods® IBS test in identifying patient-specific dietary IBS triggers and guiding targeted food elimination to reduce IBS symptoms. Large Multicenter Study Demonstrates Clinically Meaningful Pain Reduction IBS affects an estimated 10% to 15% of adults in the United States and is known to significantly reduce quality of life and work productivity. Symptoms such as often severe abdominal pain, bloating, diarrhea, and constipation are frequently exacerbated by specific foods, yet identifying individual dietary triggers has historically relied on trial-and-error approaches. The inFoods IBS clinical trial analyzed 223 IBS patients across eight major U.S. academic medical centers including Mayo Clinic, Harvard Beth Israel Deaconess Medical Center, and Cleveland Clinic. Participants were tested for abnormal antibody responses to 18 IBS-specific foods using the inFoods® IBS assay and then randomized into two study arms: Treatment Group: Eliminated foods identified by the inFoods® IBS test as producing an abnormally elevated IgG immune response. Control Group: Followed a placebo (sham) diet eliminating foods for which the patient tested negative in the inFoods IBS test, matched in type and quantity to ensure blinding. Key Findings: 59.6% of patients in the inFoods IBS-guided diet (treatment group) achieved the FDA-defined target for abdominal pain reduction, compared to 42.1% in the control group for all IBS subclasses. Particularly strong results were observed in difficult-to-treat IBS subtypes: IBS-C: 67.1% response vs. 35.8% in controls IBS-M: 66.0% response vs. 29.5% in controls These findings demonstrate that patients following the inFoods® IBS-guided elimination diet experienced a significantly greater symptom relief than those following the placebo (sham) diet. A Personalized, Targeted Approach to IBS Management Unlike prior studies that were often limited by small sample sizes, non-IBS-specific assays, single-center designs, or inadequate control diets, the inFoods® IBS study was specifically designed to overcome these limitations using an IBS-specific food panel and robust statistical methodology. The inFoods® IBS assay employs a proprietary discriminatory p-value method that identifies foods producing abnormal IgG responses unique to IBS patients, minimizing unnecessary dietary restrictions and focusing only on foods with statistical and clinical relevance. Compared to broad dietary strategies such as the low-FODMAP diet — commonly described as restrictive, difficult to follow long-term, and costly — the inFoods® IBS protocol typically results in the elimination of only 2 to 4 foods per IBS patient on average, offering a more practical and sustainable option for patients. “This publication reinforces the growing role of precision in gastrointestinal care,” said Dr. Astrid Starke, Marketing Director at Biomerica. “By combining rigorous clinical validation with an IBS-specific assay, inFoods IBS provides a targeted, science-based solution that empowers patients and healthcare providers to identify meaningful dietary triggers that may be causing or intensifying IBS symptoms. This allows for more informed, personalized nutrition decisions – reducing unnecessary dietary restriction and supporting sustainable, long-term relief for those living with IBS.” Advancing Precision Nutrition for an Unmet Clinical Need The study’s strong outcomes, particularly in IBS-M patients — a subgroup for which no FDA-approved medications currently exist — underscore the potential of a diagnostic-guided dietary strategy to address an important unmet clinical need. The findings support the evolving shift toward precision medicine in gastrointestinal care, where individualized biological markers guide tailored treatment decisions rather than generalized dietary or pharmaceutical approaches. More information at www.infoodsibs.com. Recognition Through Henry Schein’s Clinical Platform The inclusion of inFoods® IBS in Biotherapeutics Quarterly reflects growing recognition of Biomerica’s innovation among healthcare professionals and aligns with advancing evidence-based clinical solutions that improve patient outcomes. The article offers an in-depth analysis of the assay’s development, clinical validation, and real-world implications for IBS management, reinforcing the role of diagnostic-guided dietary therapy as a meaningful advancement in the standard of care. 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. 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 inFoods® IBS test and other tests, FDA clearance or possible future clearance of the Company’s inFoods® IBS test and other products, timing of the commercial launch of the inFoods® IBS test, possible future revenues from the sale of the inFoods® IBS test, growth in future revenues from the sale of the inFoods® IBS test, acceptance of the inFoods® IBS test by physicians and their patients, international regulatory approval and sales of the inFoods® IBS test, accuracy, efficacy and clinical trial results of the inFoods® IBS test, the rapidity of testing results, discussions with physicians and physician groups who could or would offer the inFoods test to their patients, efficacy of the inFoods IBS test to improve IBS symptoms in patients, the company’s ability to manufacture the inFoods® IBS test as a commercial product and to increase manufacturing capacity to meet future product demands, the uniqueness of the Company’s inFoods® IBS test and other products, pricing of the Company’s inFoods® IBS test, future possible insurer reimbursement for the inFoods® IBS test, patent protection on the inFoods® IBS and the underlying technology of the test, or on any of the Company’s other products or technologies, and current or future competition for the inFoods® IBS test from other medical manufacturers or distributors. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s tests and products; regulatory approvals necessary prior to commercialization any of the Company’s products; availability of the Company’s test kits and other products; capacity, 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; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection on any aspects of its rapid test 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 949-645-2111 [email protected] Source: Biomerica
Investor releaseQuarter not tagged2025-10-15Biomerica Reports First Quarter Fiscal 2026 Financial Results
GlobeNewswire
Biomerica Reports First Quarter Fiscal 2026 Financial Results
Reported Improved Gross Margin from Contribution from Higher-Margin Product Mix Operating Expenses Continued to Decline Compared to the First Quarter of the Prior Fiscal Year, Reflecting the Company’s Ongoing Focus on Cost Reduction and Operational Efficiency Earnings per Share $0.00, Compared to a Net Loss of $0.08 per Share in the First Quarter of the Prior Fiscal Year. IRVINE, Calif., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), ("Biomerica" or the "Company") a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the first quarter ended August 31, 2025. Key Highlights: First Quarter Fiscal 2026 Financial Results Net sales for the first quarter of fiscal 2026 were $1.4 million, compared to $1.8 million in the first quarter of fiscal year 2025. The decrease primarily reflects reduced retail market activity, the timing of international orders impacted by global tariff tensions, and decreased demand under certain contract manufacturing agreements and was partially offset by rising inFoods® IBS product sales. Despite the lower sales, gross profit increased, driven by a more favorable product mix and greater contribution from higher-margin contract manufacturing services. Operating expenses for the first quarter of fiscal 2026 decreased to $1.5 million, compared to $1.7 million in the first quarter of fiscal year 2025, highlighting Biomerica’s continued emphasis on cost discipline and streamlining operations. The reduction was primarily achieved through targeted savings across research, administrative, and manufacturing support functions. As a result, operating loss for the first quarter of fiscal 2026 improved to $1.1 million, compared to $1.4 million in the first quarter of fiscal year 2025. Other income for the quarter included a non-recurring tax credit, which contributed to a net profit of approximately $2,000 for the first quarter of fiscal 2026, compared to a net loss of $1.3 million in the first quarter of fiscal year 2025. Biomerica continues to prioritize operational efficiency, strengthen its balance sheet, and invest selectively in core diagnostic programs that support long-term profitability. 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…Read full documentShow less
Reported Improved Gross Margin from Contribution from Higher-Margin Product Mix Operating Expenses Continued to Decline Compared to the First Quarter of the Prior Fiscal Year, Reflecting the Company’s Ongoing Focus on Cost Reduction and Operational Efficiency Earnings per Share $0.00, Compared to a Net Loss of $0.08 per Share in the First Quarter of the Prior Fiscal Year. IRVINE, Calif., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), ("Biomerica" or the "Company") a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the first quarter ended August 31, 2025. Key Highlights: First Quarter Fiscal 2026 Financial Results Net sales for the first quarter of fiscal 2026 were $1.4 million, compared to $1.8 million in the first quarter of fiscal year 2025. The decrease primarily reflects reduced retail market activity, the timing of international orders impacted by global tariff tensions, and decreased demand under certain contract manufacturing agreements and was partially offset by rising inFoods® IBS product sales. Despite the lower sales, gross profit increased, driven by a more favorable product mix and greater contribution from higher-margin contract manufacturing services. Operating expenses for the first quarter of fiscal 2026 decreased to $1.5 million, compared to $1.7 million in the first quarter of fiscal year 2025, highlighting Biomerica’s continued emphasis on cost discipline and streamlining operations. The reduction was primarily achieved through targeted savings across research, administrative, and manufacturing support functions. As a result, operating loss for the first quarter of fiscal 2026 improved to $1.1 million, compared to $1.4 million in the first quarter of fiscal year 2025. Other income for the quarter included a non-recurring tax credit, which contributed to a net profit of approximately $2,000 for the first quarter of fiscal 2026, compared to a net loss of $1.3 million in the first quarter of fiscal year 2025. Biomerica continues to prioritize operational efficiency, strengthen its balance sheet, and invest selectively in core diagnostic programs that support long-term profitability. 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 sham-controlled trial on the inFoods® IBS test was published in the June 2025 issue of Gastroenterology, a peer-reviewed GI journal. As the study 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 42.1% 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 the potential effectiveness of a personal elimination diet based on using inFoods® IBS 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. For more information about inFoods® IBS, visit www.inFoodsibs.com. inFoods IBS is Laboratory Developed Test used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments to perform high-complexity testing. 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. The Company primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods IBS product, Hp Detect product and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of the Company. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC's website (www.sec.gov). The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani 949-645-2111 [email protected] Source: Biomerica, Inc.
Investor releaseQuarter not tagged2025-08-30Biomerica Reports Fiscal 2025 Year End Results
GlobeNewswire
Biomerica Reports Fiscal 2025 Year End Results
$1.3 Million in Operating Expense Reductions Achieved– Operating Loss Improves 19% Year-Over-Year Resilient Portfolio Performance with International Sales Despite Global Economic Uncertainties Cash Used in Operating Activities Reduced to $3.8 Million vs. $5.3 Million in the Prior Year, Reflecting Stronger Operating Discipline IRVINE, Calif., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA) today reported its financial results for the fiscal year ended May 31, 2025 (Fiscal 2025). The Company reported net sales of $5.3 million, compared to $5.4 million in the prior year. Revenue was modestly lower due to global tariff-related uncertainties, which caused certain international customers to delay orders, and a shift in product mix with fewer over-the-counter (OTC) retail sales during the fourth quarter. These headwinds were partially offset with increased sales from inFoods® IBS. Gross profit for the year was $498,000, versus $611,000 in the prior year, reflecting the impact of the macro-economic events on revenue and product mix. Cash used in operating activities improved significantly to $3.8 million, compared to $5.3 million in the prior year, a $1.5 million improvement driven by operating efficiencies and disciplined expense management. Through disciplined cost management, Biomerica reduced selling, general and administrative expenses to $4.6 million, compared to $5.5 million in the prior year and reduced research and development expenses to $1.0 million, compared to $1.5 million in the prior year. In total, operating expenses declined by more than $1.3 million, delivering on the cost-reduction goals announced at the beginning of the fiscal year. As a result, operating loss improved to $5.1 million, compared to $6.4 million in the prior year – a 19% year-over-year improvement, despite revenue headwinds. Strategic Growth Areas: Biomerica is actively working in three key areas to drive revenue growth: inFoods® IBS Opportunities – Insurance Reimbursement: The American Medical Association CPT Editorial Panel has issued a Proprietary Laboratory Analyses (PLA) code for Biomerica’s inFoods® IBS test, advancing the pathway for reimbursement and broader access. EZ Detect™ and Other At-Home Tests in the MENA Region: Continued regulatory clearances and expanded distribution partnerships across the Middle East and North Africa; Biomerica is also pursuing…Read full documentShow less
$1.3 Million in Operating Expense Reductions Achieved– Operating Loss Improves 19% Year-Over-Year Resilient Portfolio Performance with International Sales Despite Global Economic Uncertainties Cash Used in Operating Activities Reduced to $3.8 Million vs. $5.3 Million in the Prior Year, Reflecting Stronger Operating Discipline IRVINE, Calif., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA) today reported its financial results for the fiscal year ended May 31, 2025 (Fiscal 2025). The Company reported net sales of $5.3 million, compared to $5.4 million in the prior year. Revenue was modestly lower due to global tariff-related uncertainties, which caused certain international customers to delay orders, and a shift in product mix with fewer over-the-counter (OTC) retail sales during the fourth quarter. These headwinds were partially offset with increased sales from inFoods® IBS. Gross profit for the year was $498,000, versus $611,000 in the prior year, reflecting the impact of the macro-economic events on revenue and product mix. Cash used in operating activities improved significantly to $3.8 million, compared to $5.3 million in the prior year, a $1.5 million improvement driven by operating efficiencies and disciplined expense management. Through disciplined cost management, Biomerica reduced selling, general and administrative expenses to $4.6 million, compared to $5.5 million in the prior year and reduced research and development expenses to $1.0 million, compared to $1.5 million in the prior year. In total, operating expenses declined by more than $1.3 million, delivering on the cost-reduction goals announced at the beginning of the fiscal year. As a result, operating loss improved to $5.1 million, compared to $6.4 million in the prior year – a 19% year-over-year improvement, despite revenue headwinds. Strategic Growth Areas: Biomerica is actively working in three key areas to drive revenue growth: inFoods® IBS Opportunities – Insurance Reimbursement: The American Medical Association CPT Editorial Panel has issued a Proprietary Laboratory Analyses (PLA) code for Biomerica’s inFoods® IBS test, advancing the pathway for reimbursement and broader access. EZ Detect™ and Other At-Home Tests in the MENA Region: Continued regulatory clearances and expanded distribution partnerships across the Middle East and North Africa; Biomerica is also pursuing insurance reimbursement for newly cleared products. H. pylori Antigen Sales in the U.S. and Europe: The Company is in discussion for the evaluations of the Hp Detect™ Stool Antigen ELISA test. Key Milestones Achieved in Fiscal Year 2025: PLA Code Submission: Biomerica submitted a Proprietary Laboratory Analyses (PLA) code application for its inFoods® IBS diagnostic product. Further, following year-end, the Company received a PLA code advancing the pathway for Medicare and Medicaid reimbursement and broader patient access. Peer-Reviewed Validation: Clinical study results for inFoods® IBS were published in June 2025 Gastroenterology, confirming statistically significant improvements in abdominal pain and bloating with patient-specific dietary guidance. IVDR Certification: The Company achieved EU IVDR certification for its food-intolerance diagnostic tests targeting Crohn’s disease and ulcerative colitis, supporting future European commercialization. MENA Expansion: Following the year-end, the United Arab Emirates Ministry of Health and Prevention approved Biomerica’s Fortel® PSA rapid screening test, expanding the Company’s footprint in the Middle East. Direct-to-Consumer Launch: Biomerica introduced direct-to-consumer availability of inFoods® IBS, significantly broadening patient reach through telehealth and digital distribution channels. Intellectual Property Growth: Three new international patents were issued covering applications of the inFoods® technology platform in gastroesophageal reflux disease (GERD), Crohn’s disease, and ulcerative colitis. Advancement of inFoods® IBS: The inFoods® IBS diagnostic test has progressed significantly with the introduction of a new patient self-collection system. This system allows patients to collect their own blood samples at home using a simple finger-stick device, enabling nationwide access through telehealth and online medical providers. This innovation greatly expands the reach of inFoods® IBS to millions of IBS sufferers. Biomerica remains committed to advancing its financial position and driving long-term growth through innovative medical products and strategic partnerships. 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® The inFoods® IBS test involves a simple blood collection procedure and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods® IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented inFoods® Technology Platform can be found at: https://biomerica.com/inFoods/our-technology/. The inFoods® IBS clinical study was performed 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%, for IBS patients in the treatment diet arm had a statistically significant improvement over 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 is similar and, in some cases, better than the current drugs in the market. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods® IBS product, Hp Detect product and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC's website (www.sec.gov). The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani 949-645-2111 [email protected] Source: Biomerica, Inc.
Investor releaseQuarter not tagged2025-06-05Biomerica’s inFoods® IBS Clinical Study Results Published in June Issue of Gastroenterology
GlobeNewswire
Biomerica’s inFoods® IBS Clinical Study Results Published in June Issue of Gastroenterology
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 under…Read full documentShow less
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 | CEOp. 949.645.2111www.biomerica.com Source: Biomerica
Investor releaseQuarter not tagged2025-04-18Biomerica Third Quarter 2025 Earnings: US$0.061 loss per share (vs US$0.11 loss in 3Q 2024)
Simply Wall St.
Biomerica Third Quarter 2025 Earnings: US$0.061 loss per share (vs US$0.11 loss in 3Q 2024)
Revenue: US$1.12m (up 10.0% from 3Q 2024). Net loss: US$1.16m (loss narrowed by 39% from 3Q 2024). US$0.061 loss per share (improved from US$0.11 loss in 3Q 2024). We've discovered 5 warning signs about Biomerica. View them for free. All figures shown in the chart above are for the trailing 12 month (TTM) period Biomerica shares are down 6.5% from a week ago. It is worth noting though that we have found 5 warning signs for Biomerica (4 are potentially serious!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-04-15Biomerica Reports Third Quarter Fiscal 2025 Financial Results
GlobeNewswire
Biomerica Reports Third Quarter Fiscal 2025 Financial Results
Total Revenue Increases 10% Year-Over-Year Delivers Improved Gross Margins, Achieves Annual Cost Savings Target Early, and Reduces Cash Burn Over 55% IRVINE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the third quarter of fiscal 2025 ended February 28, 2025. Key Highlights: 1. Fortel® PSA Screening Test Approved by UAE Ministry of Health & Prevention:Biomerica’s Fortel® Prostate Specific Antigen (PSA) Screening Test has received regulatory approval from the United Arab Emirates Ministry of Health & Prevention (MOHAP). The Fortel® test offers fast, accurate PSA results in just 10 minutes using a simple finger-prick blood sample. By enabling earlier detection of prostate cancer and other prostate conditions, this easy-to-use diagnostic tool aims to enhance preventative care, reduce pressure on healthcare systems, and support improved patient outcomes. 2. inFoods® IBS Clinical Trial Results Published in Gastroenterology:New clinical data published in Gastroenterology, the leading peer-reviewed journal for gastrointestinal medicine, demonstrated that patients with Irritable Bowel Syndrome (IBS) experienced statistically significant reductions in abdominal pain and bloating when following a personalized diet therapy plan guided by Biomerica’s inFoods® IBS test. Unlike other IBS products, inFoods® IBS uniquely identifies specific foods that trigger elevated Immunoglobulin G (IgG) responses—a marker of inflammation linked to IBS symptoms—using a 95% confidence interval for each food in the panel. IBS affects an estimated 10%–15% of adults in the U.S. and contributes to reduced quality of life and productivity. The findings support the role of personalized food-guided therapy as a meaningful intervention for IBS management. 3. CE-IVDR Certification Achieved for Food Intolerance Products Targeting Ulcerative Colitis:Biomerica’s new food intolerance products targeting Ulcerative Colitis have been awarded CE-marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), a stringent regulatory framework designed to enhance diagnostic safety and performance across Europe. This IVDR certification highlights Biomerica’s continued leadership in developing non-invasive, personalized diagno…Read full documentShow less
Total Revenue Increases 10% Year-Over-Year Delivers Improved Gross Margins, Achieves Annual Cost Savings Target Early, and Reduces Cash Burn Over 55% IRVINE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the third quarter of fiscal 2025 ended February 28, 2025. Key Highlights: 1. Fortel® PSA Screening Test Approved by UAE Ministry of Health & Prevention:Biomerica’s Fortel® Prostate Specific Antigen (PSA) Screening Test has received regulatory approval from the United Arab Emirates Ministry of Health & Prevention (MOHAP). The Fortel® test offers fast, accurate PSA results in just 10 minutes using a simple finger-prick blood sample. By enabling earlier detection of prostate cancer and other prostate conditions, this easy-to-use diagnostic tool aims to enhance preventative care, reduce pressure on healthcare systems, and support improved patient outcomes. 2. inFoods® IBS Clinical Trial Results Published in Gastroenterology:New clinical data published in Gastroenterology, the leading peer-reviewed journal for gastrointestinal medicine, demonstrated that patients with Irritable Bowel Syndrome (IBS) experienced statistically significant reductions in abdominal pain and bloating when following a personalized diet therapy plan guided by Biomerica’s inFoods® IBS test. Unlike other IBS products, inFoods® IBS uniquely identifies specific foods that trigger elevated Immunoglobulin G (IgG) responses—a marker of inflammation linked to IBS symptoms—using a 95% confidence interval for each food in the panel. IBS affects an estimated 10%–15% of adults in the U.S. and contributes to reduced quality of life and productivity. The findings support the role of personalized food-guided therapy as a meaningful intervention for IBS management. 3. CE-IVDR Certification Achieved for Food Intolerance Products Targeting Ulcerative Colitis:Biomerica’s new food intolerance products targeting Ulcerative Colitis have been awarded CE-marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR), a stringent regulatory framework designed to enhance diagnostic safety and performance across Europe. This IVDR certification highlights Biomerica’s continued leadership in developing non-invasive, personalized diagnostic tools for chronic gastrointestinal conditions. The newly approved tests will help meet the increasing demand for individualized approaches to managing diseases such as Ulcerative Colitis, which affects millions globally. 4. Achieved Full-Year Cost Savings Target Nine Months Into Fiscal 2025:Biomerica reached its annual cost savings target ahead of schedule, delivering approximately $1.1 million in savings — representing 16% of annual operating expenses within the first nine months of fiscal 2025. Financial Highlights for the Third Quarter of Fiscal 2025Biomerica’s third quarter results reflect continued execution against its strategic priorities, delivering year-over-year revenue growth, expanded gross margins, and substantial reductions in both operating expenses and cash burn. Revenue and Sales Performance: For the fiscal third quarter of 2025, Biomerica reported net sales of $1.10 million, a 10% increase from $1.00 million recorded in the same quarter of the previous year. This growth reflects continued demand for Biomerica’s product offerings and reinforces the appeal of our diverse product portfolio. Cost Management and Margin Enhancement: Gross margin improved from negative 15% in the third quarter of fiscal 2024 to positive 2% in the current quarter, reflecting a favorable product mix and lower direct labor and overhead costs, achieved through strategic workforce reductions and operational efficiency initiatives. Operating expenses decreased 37% year-over-year to $1.20 million in the third quarter of fiscal 2025, down from $1.90 million in the same period last year, driven by the Company’s continued focus on operational efficiencies and disciplined cost management. Biomerica continued to make significant progress with its cost-saving initiatives, targeting an annual expense reduction of 16% to 23%. Impressively, the Company has already achieved approximately $1.1 million in savings within the first nine months of fiscal 2025, representing 16% of annual operating expenses and reaching the lower end of its full-year target range ahead of schedule. Reduced Net Losses & Improved Cash Burn: Operating loss improved to ($1.20) million in the third quarter of fiscal 2025, compared to ($2.00) million in the prior year. Net loss also narrowed to ($1.20) million from ($1.90) million in the same period last year, both representing a 37% year-over-year improvement. Liquidity and Capital Resources: As of February 28, 2025, Biomerica’s cash and cash equivalents totaled $3.06 million, an increase from $2.37 million at the end of the second quarter of fiscal 2025. This increase was primarily driven by proceeds from the Company’s successful utilization of its At-The-Market (ATM) equity program. Importantly, excluding ATM proceeds, the Company’s underlying quarterly cash burn improved to approximately $800,000, compared to $1.8 million in the same period of the prior year representing a reduction of more than 55% and highlighting the tangible impact of the Company’s cost-saving initiatives. “Our third quarter results reflect the meaningful progress we’ve made in strengthening our financial foundation while continuing to serve customers and grow our business,” said Zack Irani, CEO of Biomerica. “We are particularly pleased with the significant reduction in our cash burn and operating expenses, which positions us well as we continue to focus on driving revenue growth and moving closer to achieving cash flow break-even.” 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® The inFoods IBS test involves a simple blood collection procedure and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented inFoods® Technology Platform can be found at: https://biomerica.com/inFoods/our-technology/. The inFoods IBS clinical study was performed 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%, for IBS patients in the treatment diet arm had a statistically significant improvement over 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 is similar and, in some cases, better than the current drugs in the market. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods IBS product, Hp Detect product and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC's website (www.sec.gov). The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani 949-645-2111 [email protected] Source: Biomerica, Inc.

