Core Viewpoint - Biomerica, Inc. has received regulatory approval for its Fortel Ulcer Test in the UAE, enabling the introduction of a rapid diagnostic tool for Helicobacter pylori infection, addressing a significant public health concern in the region [1][5]. Group 1: Product Overview - The Fortel Ulcer Test is a quick and user-friendly diagnostic tool that detects antibodies to H. pylori, providing accurate results in just 10 minutes [2][8]. - H. pylori infection is linked to various gastrointestinal diseases, including peptic ulcers, dyspepsia, and gastric cancer, with approximately 80% of gastric cancer cases attributed to this bacterium [4][8]. Group 2: Market Context - H. pylori infects about 35% of the U.S. population and 45% in the five largest European countries, with local studies in the UAE estimating infection rates exceeding 50% [3]. - The World Health Organization has classified H. pylori as a Class 1 carcinogen and identified it as one of the top 16 antibiotic-resistant bacteria posing a significant health threat [4]. Group 3: Strategic Impact - The approval of the Fortel Ulcer Test enhances Biomerica's presence in the Middle East, following the successful launch of other diagnostic products [5]. - The company is collaborating with local distributors and healthcare providers to ensure the availability of the Fortel Ulcer Test throughout the UAE [5][6]. Group 4: Company Mission - Biomerica is focused on delivering affordable and innovative diagnostic tools aimed at improving patient outcomes through early disease detection [6][7]. - The Fortel Ulcer Test aligns with the company's mission to enhance global health by providing fast and accessible diagnostics [6].

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 across the UAE, 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, particularly in high-risk populations [2][4] - 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 globally by 2040 [2][4] Company Overview - Biomerica is a global biomedical technology company focused on developing advanced diagnostic and therapeutic products, particularly for gastrointestinal and inflammatory diseases [7] - The company aims to enhance health outcomes while reducing healthcare costs through its innovative diagnostic solutions [7][6] - Biomerica has established partnerships with distributors and healthcare providers in the UAE to ensure the availability of the Fortel® Kidney Disease Test across the country [5] Market Context - In the UAE, diabetes and hypertension are major risk factors for CKD, with over 12% of adults living with diabetes and an estimated 29% to 35% of the population having hypertension [4] - The approval of the Fortel® Kidney Disease Test addresses a critical need for preventative healthcare in a region where these conditions are prevalent [5][8] - Early detection through the Fortel® test can lead to timely interventions, potentially reducing the economic burden associated with CKD progression [3]

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].