Core Insights - Biomerica, Inc. announced the publication of pivotal clinical trial data for its inFoods IBS test in the June 2025 issue of Gastroenterology, highlighting its significance in treating Irritable Bowel Syndrome (IBS) [1][7] Group 1: Clinical Trial Results - The randomized, multicenter, double-blind, placebo-controlled trial involved 238 patients and showed statistically significant improvement in IBS symptoms, particularly abdominal pain and bloating, when following a personalized elimination diet guided by the inFoods IBS test [2][3] - 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 [8] - Among patients with IBS-C, 67.1% in the treatment arm reached this benchmark versus 35.8% in controls, and for IBS-M patients, 66.0% in the treatment group met the target compared to 29.5% in controls [8] Group 2: Test Methodology and Validation - The inFoods IBS test utilizes a proprietary assay to measure each patient's immune response to specific foods, designed specifically for IBS patients, and is clinically validated [5][10] - The test identifies dietary triggers that may alleviate IBS symptoms, offering a data-driven approach to managing complex dietary restrictions [6][10] Group 3: Market Implications - The inFoods IBS test could be particularly beneficial for IBS-M patients, who represent approximately 33% of the IBS market and currently have no FDA-approved drug treatments available [4][7] - The publication in a high-impact journal reinforces the scientific rigor and clinical impact of the inFoods IBS approach, marking a significant milestone in precision nutrition as a non-drug treatment pathway for IBS [3][7]

Core Insights - Biomerica, Inc. announced real-world results demonstrating the effectiveness of its inFoods IBS product, which includes a new real-time patient feedback system to enhance symptom tracking and improve patient outcomes [1][2] Group 1: Product Effectiveness - The initial analysis from over 360 patients showed an average reduction of 48.5% in gastrointestinal pain and 49.8% in bloating over an 8-week period [6][7] - The real-world outcomes align with and in some cases exceed results from prior randomized clinical trials conducted at leading U.S. medical centers [1] Group 2: Real-Time Feedback System - Biomerica's HIPAA-compliant platform provides physicians with visibility into patient-reported outcomes, allowing for data-informed decisions and adjustments to treatment plans [2] - The real-time feedback system empowers physicians to adjust patient treatment based on actionable, patient-reported outcomes [6] Group 3: Market Need and Impact - IBS affects an estimated 10% to 15% of adults in the U.S., leading to decreased quality of life and reliance on medications with adverse side effects [4] - The inFoods IBS product offers a novel diagnostic-guided solution that identifies individual food triggers, enabling targeted dietary changes without pharmaceuticals [4][5] Group 4: Clinical Validation - Peer-reviewed results published in Gastroenterology indicated that patients on an inFoods IBS-guided diet experienced significantly more abdominal pain relief compared to those on a placebo diet (59.6% vs. 42.1%, p-value=0.02) [3]

Core Insights - Biomerica, Inc. has submitted an application for a Proprietary Laboratory Analysis (PLA) code for its inFoods IBS diagnostic test, aiming to enhance patient access and insurance reimbursement for the test [1][2][3] Group 1: Product and Market Overview - The inFoods IBS test identifies patient-specific foods that trigger IBS symptoms such as bloating, abdominal pain, diarrhea, and constipation, providing a personalized approach to treatment [1][3] - IBS affects approximately 10% to 15% of adults in the U.S., leading to significant healthcare costs, indicating a substantial market opportunity for effective management solutions [4] - The inFoods platform addresses an unmet need for personalized management strategies in the IBS market, differentiating itself from traditional trial-and-error diets and symptom-suppressing medications [3][4] Group 2: Clinical Validation and Adoption - A randomized clinical trial published in a leading medical journal demonstrated that patients following a personalized diet based on inFoods test results experienced significantly greater symptom relief compared to those on a placebo diet, highlighting the clinical potential of the platform [5] - Biomerica is collaborating with leading gastroenterology groups and healthcare systems to promote the adoption of the inFoods IBS test, which is also available for direct-to-consumer ordering [6] Group 3: Strategic Goals and Long-Term Vision - The application for the PLA code is part of Biomerica's broader commercialization strategy to facilitate access to the inFoods IBS test and enhance transparency in claims submission [2][3] - The company believes that insurance reimbursement, supported by clinical validation, positions inFoods IBS as a category-defining diagnostic, contributing to long-term value creation [7][8]

Core Insights - Biomerica, Inc. has received regulatory approval from the UAE Ministry of Health and Prevention for its Fortel® Ulcer Test, enabling the introduction of this rapid diagnostic tool for H. pylori infection in the UAE [1][5] - The Fortel® Ulcer Test is designed to detect antibodies to H. pylori, providing accurate results in just 10 minutes, which is crucial for timely medical intervention [2][8] - H. pylori infection rates are notably high in the UAE, with local studies estimating rates exceeding 50%, leading to significant health concerns including peptic ulcers and gastric cancer [3][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 improve patient outcomes through early disease detection and affordable diagnostic tools, exemplified by the Fortel® Ulcer Test [6][7] - Biomerica is expanding its presence in the Middle East, collaborating with local distributors and healthcare providers to enhance access to its diagnostic products [5][6]

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]