10-minute home test enables detection of Helicobacter pylori, a leading cause of peptic ulcers, dyspepsia, and gastric cancerH. pylori linked to approximately 80% of gastric cancer cases; classified as a Class 1 carcinogen by the World Health OrganizationGastric cancer ranks as the fifth most common cancer globally and the fourth leading cause of cancer-related deaths IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, today a ...

Core Viewpoint - Biomerica, Inc. has received a Current Procedural Terminology (CPT) code for its inFoods IBS test, which will facilitate insurance reimbursement and expand patient access starting October 1, 2025 [1][2][10]. Group 1: Commercialization and Patient Access - The issuance of the PLA code is a significant milestone in Biomerica's strategy to commercialize the inFoods IBS test, enhancing transparency in claims submission and adjudication [3][4]. - The PLA code will streamline the claims process, supporting the goal of increasing adoption of the inFoods technology among patients and physicians [4][9]. - The inFoods IBS test is designed to identify food triggers for IBS symptoms, providing a personalized dietary therapy alternative to traditional medications [5][13]. Group 2: Market Need and Financial Implications - IBS affects approximately 10% to 15% of adults in the U.S., leading to up to $10 billion in direct annual medical costs, highlighting a substantial unmet need in the market [6]. - The inFoods IBS test offers a scientifically validated, non-invasive solution aimed at improving symptom control and quality of life for patients [6][9]. Group 3: Clinical Validation and Effectiveness - Results from a randomized, controlled clinical trial published in June 2025 demonstrated that patients following a diet based on inFoods test results experienced significantly greater symptom reduction compared to those on a placebo diet [7][14]. - The study showed that 59.6% of patients in the treatment group achieved the FDA's endpoint for abdominal pain reduction, compared to 42.2% in the control group [17]. Group 4: Long-Term Value Creation - The PLA code issuance enhances reimbursement transparency for the inFoods IBS test, aligning with the company's mission to provide personalized, non-drug solutions for chronic conditions [9][11]. - As insurance coverage expands and clinical evidence accumulates, the inFoods IBS test is positioned to become a key tool in managing IBS and related gastrointestinal disorders [9].

Core Viewpoint - Biomerica Inc. has appointed Scott Madel as Chief Commercial Officer to enhance commercialization and revenue growth for its inFoods IBS product, which aims to improve the quality of life for patients with chronic gastrointestinal conditions [1][5][6]. Company Overview - Biomerica Inc. is a global biomedical technology company focused on developing, patenting, manufacturing, and marketing advanced diagnostic and therapeutic products, particularly for gastrointestinal and inflammatory diseases [12]. Leadership Appointment - Scott Madel brings over 20 years of experience in healthcare and diagnostics, having previously served as President of Boston Heart Diagnostics, where he led a successful turnaround and revenue growth [2][3]. - His past roles include CEO positions at BioHealth Diagnostics and Genova Diagnostics Europe, where he contributed to significant revenue growth and strategic partnerships [3][4]. Product Focus: inFoods IBS - inFoods IBS is a diagnostic-guided therapy that identifies food triggers causing symptoms in patients with IBS, using a simple finger-stick blood sample [7]. - The product offers a non-pharmaceutical, precision-based approach to symptom relief, targeting dietary changes based on individual immune responses [7]. Clinical Study Results - A multicenter clinical study published in Gastroenterology showed that 59.6% of patients in the treatment group achieved significant abdominal pain reduction compared to 42.2% in the control group [9]. - Among IBS-C patients, 67.1% in the treatment group achieved the endpoint versus 35.8% in the control group, indicating strong efficacy [9]. - The study highlighted inFoods IBS as the only targeted therapy demonstrating efficacy specifically in IBS-M patients, a historically underserved subgroup [10]. Strategic Goals - In his new role, Scott Madel will focus on expanding strategic partnerships, developing a robust payer strategy, and enhancing brand recognition for inFoods IBS [5][6]. - The company aims to achieve third-party payer reimbursement and scale provider engagement both domestically and internationally [5].

Core Viewpoint - Biomerica, Inc. has appointed Eric B. Chin to its Board of Directors, enhancing its corporate governance and financial oversight as it scales commercialization efforts for its diagnostic and therapeutic products [1][7]. Group 1: Appointment Details - Eric B. Chin has been appointed as Chairperson of the Audit Committee and a member of the Nominating and Corporate Governance Committee and the Compensation Committee, effective June 4, 2025 [1]. - Chin replaces Cathy Coste, whose resignation was not due to any disagreement with the company [3]. Group 2: Eric B. Chin's Background - Chin is an accomplished financial executive with over 20 years of experience in public and private healthcare organizations [2][7]. - He currently serves as CFO of Akido Labs, where he successfully raised $60 million in recent financing [2][7]. - His previous roles include executive positions at Astrana Health, Public Storage, and Alexandria Real Estate Equities, and he began his career at Ernst & Young LLP [2]. Group 3: Company Overview - Biomerica, Inc. develops, patents, manufactures, and markets advanced diagnostic and therapeutic products aimed at enhancing health and reducing healthcare costs, primarily focusing on gastrointestinal and inflammatory diseases [4]. - The company's inFoods IBS test assesses patients' immunoreactivity to specific foods, providing targeted dietary recommendations to alleviate IBS symptoms [5].

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]