Core Insights - Biomerica, Inc. has received approval from the UAE Ministry of Health and Prevention for its Fortel Kidney Disease (Microalbumin) Test, enabling its sale in a region with a high prevalence of chronic kidney disease (CKD) [1][8] - The Fortel Kidney Disease Test is a rapid diagnostic tool that provides results in 10 minutes using a urine sample, allowing for early detection of kidney disease [2][8] - CKD is a significant global public health issue, with over 80% of at-risk patients undiagnosed, and is projected to be the 5th leading cause of years of life lost by 2040 [2][8] Company Overview - Biomerica is a global biomedical technology company focused on developing advanced diagnostic and therapeutic products for point-of-care and clinical laboratory use [7] - The company aims to enhance health and well-being while reducing healthcare costs, with a particular focus on gastrointestinal and inflammatory diseases [7] Market Context - In the UAE, diabetes and hypertension are major risk factors for CKD, with over 12% of adults living with diabetes and 29% to 35% estimated to have hypertension [4] - CKD is often asymptomatic until advanced stages, making early detection crucial for effective intervention [4][5] Strategic Initiatives - The approval of the Fortel Kidney Disease Test supports Biomerica's mission to provide life-saving diagnostic tools in high-need areas, particularly in the Middle East [5][6] - The company has established partnerships with leading distributors and healthcare providers in the UAE to ensure the test's availability across the country [5]

Core Viewpoint - Biomerica, Inc. will implement a 1-for-8 reverse stock split to increase the bid price of its common stock and regain compliance with Nasdaq's minimum bid price requirement [2][3]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 12:01 a.m. Eastern time on April 21, 2025, with trading on a split-adjusted basis starting the same day [1]. - The number of shares outstanding will decrease from approximately 20,366,095 shares to about 2,545,762 shares, while the number of authorized shares will remain unchanged [3]. - Stockholders will automatically have fractional shares rounded up to the next whole share, and adjustments will be made to equity awards and option exercise prices accordingly [3][4]. Group 2: Compliance and Authorization - The reverse stock split was authorized by Biomerica's stockholders during the 2024 Annual Meeting held on December 13, 2024, with the final ratio determined by the Board of Directors [2]. - The company aims to enhance its stock price to meet Nasdaq's listing requirements, which is critical for its continued presence on the exchange [2]. Group 3: Company Overview - Biomerica, Inc. is a global biomedical technology company focused on developing advanced diagnostic and therapeutic products for medical conditions, particularly gastrointestinal and inflammatory diseases [6]. - The company markets products designed to improve health outcomes while reducing healthcare costs, with a strong emphasis on point-of-care testing [6].

Core Insights - Biomerica, Inc. reported financial results for the third quarter of fiscal 2025, highlighting revenue growth, improved gross margins, and significant reductions in operating expenses and cash burn [1][6][10]. Regulatory Approvals and Product Developments - The Fortel Prostate Specific Antigen (PSA) Screening Test received regulatory approval from the UAE Ministry of Health & Prevention, enabling faster and more accurate prostate cancer detection [2]. - Clinical trial results for the inFoods IBS test were published in Gastroenterology, showing significant reductions in abdominal pain and bloating for IBS patients using personalized diet therapy [3]. - Biomerica's food intolerance products targeting Ulcerative Colitis achieved CE-IVDR certification, enhancing the company's position in the European market for chronic gastrointestinal conditions [4]. Financial Performance - For the third quarter of fiscal 2025, Biomerica reported net sales of $1.10 million, a 10% increase from $1.00 million in the same quarter of the previous year, reflecting strong demand for its products [7]. - Gross margin improved from negative 15% in Q3 fiscal 2024 to positive 2% in Q3 fiscal 2025, attributed to a favorable product mix and reduced labor and overhead costs [8]. - Operating expenses decreased by 37% year-over-year to $1.20 million, down from $1.90 million, due to operational efficiencies and disciplined cost management [9]. Cost Management and Cash Flow - Biomerica achieved its annual cost savings target of approximately $1.1 million, representing 16% of annual operating expenses, ahead of schedule [5][11]. - The operating loss improved to ($1.20) million in Q3 fiscal 2025, compared to ($2.00) million in the prior year, indicating a 37% year-over-year improvement in net loss [12]. - As of February 28, 2025, cash and cash equivalents totaled $3.06 million, an increase from $2.37 million, primarily due to the successful utilization of the At-The-Market equity program [13].

Financial Performance - Consolidated net sales for the three months ended February 28, 2025, were approximately $1,119,000, a 10% increase from $1,017,000 for the same period in 2024[45] - For the nine months ended February 28, 2025, consolidated net sales were approximately $4,562,000, compared to $4,299,000 for the same period in 2024, reflecting a 6% increase[45] - Total revenue for the three months ended February 28, 2025, was $1,119,000, an increase from $1,017,000 for the same period in 2024, representing a growth of approximately 10%[87] - North America generated $404,000 in revenue for the three months ended February 28, 2025, compared to $393,000 in 2024, reflecting a growth of about 2.8%[87] - Asia's revenue increased significantly to $365,000 in the three months ended February 28, 2025, from $210,000 in 2024, marking a growth of approximately 73.8%[87] Financial Position - As of February 28, 2025, the company had cash and cash equivalents of approximately $3,058,000 and an accumulated deficit of approximately $52 million[29] - As of February 28, 2025, total gross receivables were approximately $1,293,000, with key customers accounting for 76% of gross accounts receivable[46] - The Company had approximately $55,000 in advances from domestic customers as of February 28, 2025, representing prepayments on future shipments[70] - The Company has total minimum future lease payments of $569,000 as of February 28, 2025, with an imputed interest of $26,000[93] Operating Results - The company incurred net losses and negative cash flows from operations, indicating ongoing financial challenges[29] - Research and development costs were approximately $217,000 for the three months ended February 28, 2025, down from $343,000 for the same period in 2024[73] - Share-based compensation expenses related to stock options were approximately $91,000 for the three months ended February 28, 2025, compared to $340,000 for the same period in 2024[65] - Advertising costs were approximately $4,000 for the three months ended February 28, 2025, compared to $25,000 for the same period in 2024[76] Stock Transactions - The company sold 3,333,333 shares of common stock at a gross sales price of $2.40 per share, resulting in net proceeds of approximately $7,300,000 after deducting issuance fees[34] - During the nine months ended February 28, 2025, the company sold 3,525,359 shares at prices ranging from $0.36 to $1.04, generating net proceeds of approximately $2,015,000[37] - The Company sold 3,525,359 shares of common stock during the nine months ended February 28, 2025, resulting in gross proceeds of approximately $2,143,000[86] Asset Management - The Company invested approximately $165,000 into a privately held Polish distributor, owning about 6% of the investee[61] - The Company has established a reserve of approximately $25,000 for credit losses as of February 28, 2025[52] - Inventory reserves were approximately $422,000 as of February 28, 2025, down from $467,000 as of May 31, 2024[55] - As of February 28, 2025, the Company had approximately $475,000 of gross inventory located in Mexicali, Mexico[87] Lease Obligations - The total lease cost for the nine months ended February 28, 2025, was $280,000, slightly down from $283,000 in the same period of 2024[92] - Cash paid for operating lease liabilities was $274,000 for the nine months ended February 28, 2025, compared to $267,000 for the same period in 2024[93] - The weighted-average remaining lease term decreased to 1.06 years as of February 28, 2025, from 2.77 years in the previous year[93] - The Company operates a facility in Irvine, California, with a lease expiring in August 2026, and has the option to extend for an additional five years[89] Legal Matters - There were no material legal proceedings pending as of February 28, 2025, indicating a stable legal environment for the Company[95] Intangible Assets - The Company did not identify any indicators of impairment for intangible assets during the nine months ended February 28, 2025[60] - Amortization expense for intangible assets was approximately $5,000 for the three months ended February 28, 2025, compared to $4,000 for the same period in 2024[59] - The Company recognized a net operating loss that generated deferred tax assets for NOL carryforwards, establishing a full valuation allowance against these deferred tax assets as of February 28, 2025[74]

Core Insights - Biomerica, Inc. has achieved CE-marking for its food intolerance products aimed at Crohn's Disease and Ulcerative Colitis under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR) [1][3][9] - This certification enhances Biomerica's commitment to expanding its international market presence and addresses the need for non-invasive therapies for chronic inflammatory bowel diseases [2][6] Product and Market Overview - The newly approved food intolerance products utilize proprietary technology to identify dietary triggers that may exacerbate symptoms in patients with Crohn's Disease and Ulcerative Colitis [4][7] - The global market for treatments of Crohn's Disease and Ulcerative Colitis is substantial, with the UC market projected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, reflecting a CAGR of 5.7% [8] - The Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023, indicating a rising demand for effective, non-invasive management solutions [8] Regulatory and Strategic Implications - The IVDR framework introduces stringent requirements for in-vitro diagnostics, and Biomerica's successful compliance demonstrates its capability to deliver innovative solutions that enhance patient outcomes [3][5] - The certification not only validates the safety and effectiveness of Biomerica's products but also facilitates easier market access in other international markets that recognize EU IVDR certification [3][6] - Biomerica's strategy aligns with its goal to address unmet medical needs and improve patient care through innovative, non-invasive solutions [5][6]

Core Points - Biomerica, Inc. has achieved CE-marking for its food intolerance products aimed at Crohn's Disease and Ulcerative Colitis under the EU's In Vitro Diagnostic Medical Devices Regulation (IVDR) [1][3][10] - This certification signifies Biomerica's commitment to expanding its international market presence and addresses the need for non-invasive therapies for chronic inflammatory bowel diseases [2][6][10] - The IVDR framework enhances the safety and performance of in-vitro diagnostics, and Biomerica's products have met the stringent requirements, facilitating easier market access in other regions [3][10] Product Details - Biomerica's food intolerance products utilize proprietary technology to identify dietary triggers that may cause inflammation in patients with Crohn's Disease and Ulcerative Colitis, offering a personalized management approach [4][5] - The products aim to improve patient quality of life by addressing specific food intolerances [4][5] Market Opportunity - The global market for treatments of Ulcerative Colitis is projected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, with a compound annual growth rate (CAGR) of 5.7% [8] - The Crohn's Disease therapeutics market was estimated at $13.2 billion in 2023, indicating a significant demand for effective, non-invasive solutions [8] Company Strategy - With the IVDR certification, Biomerica is positioned to enhance its presence in the European in-vitro diagnostic market, aligning with its global growth strategy [6][10] - The company is focused on developing innovative diagnostic products that meet high technical standards and address unmet medical needs [5][10]

Core Insights - Biomerica, Inc. has announced that its inFoods® IBS blood test can significantly alleviate abdominal pain in patients with Irritable Bowel Syndrome (IBS) through a personalized dietary therapy [1][5][10] Company Overview - Biomerica, Inc. is a global biomedical technology company focused on developing advanced diagnostic and therapeutic products, particularly for gastrointestinal and inflammatory diseases [13] Product Details - The inFoods® IBS test identifies specific foods that trigger elevated Immunoglobulin G (IgG) antibody responses, which are linked to IBS symptoms, with a 95% confidence interval for accuracy [2][5] - The test is unique in its technology, specifically designed for IBS patients, and aims to provide personalized dietary recommendations [2][7] Clinical Trial Findings - A randomized, double-blind, placebo-controlled trial involving 238 IBS patients showed that 59.6% of those following a personalized elimination diet based on the inFoods test met FDA standards for abdominal pain reduction, compared to 42.2% in the control group [5] - The benefits were particularly notable in patients with constipation-predominant IBS (IBS-C) and mixed IBS (IBS-M), with 67.1% and 66% respectively meeting the FDA target for pain reduction [5][12] Market Context - IBS affects approximately 10% to 15% of adults in the U.S., significantly impacting quality of life and work productivity [3] - Current IBS treatments often involve restrictive diets or pharmaceuticals, whereas the inFoods® IBS test allows for a more targeted approach by identifying only a few specific trigger foods [10][11]

Core Insights - Biomerica, Inc. has announced that patients with Irritable Bowel Syndrome (IBS) can achieve significant relief from abdominal pain through a dietary therapy guided by the inFoods IBS blood test, as demonstrated in a clinical trial published in Gastroenterology [1][5]. Group 1: Product Overview - The inFoods IBS test identifies individual foods that trigger elevated Immunoglobulin G (IgG) antibody responses, which are markers of inflammation associated with IBS symptoms [2]. - The test is unique in its design, providing results with a 95% confidence interval cutoff, making it more reliable than previous IgG testing methods [2][6]. Group 2: Clinical Trial Findings - A randomized, multicenter, double-blind, placebo-controlled trial involved 238 IBS patients, showing that 59.6% of those in the treatment group met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group [5]. - The benefits were particularly notable in patients with constipation-predominant IBS (IBS-C) and mixed IBS (IBS-M), with 67.1% and 66% of patients in the treatment group meeting the FDA target for pain reduction, respectively [5]. Group 3: Implications for IBS Management - The inFoods IBS test allows for a personalized dietary approach, enabling patients to eliminate only a few specific trigger foods rather than following restrictive diets like the low-FODMAP diet [10]. - This precision nutrition approach is significant, especially for IBS-M patients, as there are currently no FDA-approved medications for this subtype [12]. Group 4: Expert Commentary - Experts emphasize the importance of identifying dietary triggers for IBS patients, noting that the inFoods IBS test can help in this regard [11]. - The study's design addresses limitations of previous research, such as small sample sizes and inadequate IgG tests for IBS patients, paving the way for more effective dietary recommendations [7][8].

Core Insights - Biomerica, Inc. has received approval for its Fortel Prostate Specific Antigen (PSA) Screening Test from the United Arab Emirates Ministry of Health and Prevention, marking a significant step in early prostate cancer detection [1][3] Group 1: Product Overview - The Fortel PSA Screening Test is a rapid diagnostic tool that provides results in just 10 minutes using a finger-prick blood sample, enabling early detection of prostate cancer and related conditions [2] - The test measures elevated PSA levels, which are recognized as an early marker of prostate disease, aiming to enhance proactive health management and improve patient outcomes [2] Group 2: Strategic Expansion - The approval of the Fortel PSA test is part of Biomerica's strategy to expand its presence in the Middle East, where prostate cancer is increasingly recognized as a public health concern [3] - Biomerica aims to replicate its success with the EZ Detect Colon Disease At-Home Screening Test in the region, having established partnerships with leading distributors and secured key regulatory approvals [3] Group 3: Performance Validation - The Fortel PSA test has shown impressive performance metrics, with a study reporting 100% sensitivity, 95% specificity, and 97.5% accuracy, aligning with laboratory reference methods [8] - Additional research from Ain Shams University in Egypt validated the test's effectiveness, achieving 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy [8] Group 4: Industry Context - Prostate cancer is the second most common cancer among men globally, with 1.4 million new cases and 375,000 deaths reported in 2020, highlighting the urgency for effective early detection methods [5] - The disease's prevalence and severity vary across different regions, age groups, and ethnicities, indicating a significant public health challenge, particularly in the Middle East [5] Group 5: Future Commitment - Biomerica is committed to expanding access to innovative diagnostic solutions in the Middle East, focusing on providing affordable and accurate tools for early detection and treatment of critical diseases like prostate cancer [6]

Core Insights - Biomerica, Inc. has received approval for its Fortel® Prostate Specific Antigen (PSA) Screening Test from the United Arab Emirates Ministry of Health and Prevention, marking a significant step in early prostate cancer detection [1][3]. Product Overview - The Fortel® PSA Screening Test is a rapid diagnostic tool that delivers results in just 10 minutes using a finger-prick blood sample, allowing for early detection of prostate cancer and related conditions [2][4]. - The test has shown high performance metrics, including 100% sensitivity, 95% specificity, and 97.5% accuracy in studies, validating its effectiveness [7]. Market Context - Prostate cancer is the second most common cancer among men globally, with 1.4 million new cases and 375,000 deaths reported in 2020, highlighting the urgent need for effective screening solutions [5]. - The disease is increasingly recognized as a public health concern in the Middle East, where there is a gap in comprehensive studies and awareness [5]. Strategic Initiatives - Biomerica aims to expand its presence in the Middle East, building on previous successes with other diagnostic tests, and has established partnerships with distributors to enhance accessibility to early cancer detection [3][6]. - The company is committed to providing affordable and accurate diagnostic tools to improve health outcomes in the region [6].