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 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]