Trinity Biotech Reports Landmark First-Day Accuracy Gains in CGM Pre-Pivotal Trial

Core Insights - Trinity Biotech's patented technology is set to revolutionize the continuous glucose monitoring (CGM) market, which is projected to exceed $20 billion by 2029 [1] - The company has reported significant improvements in the first-day performance of its next-generation CGM system, addressing a critical pain point for users [2][3] Performance Improvements - The latest pre-pivotal trial showed a 35% improvement in Mean Absolute Relative Difference (MARD) and over 50% improvement in Mean Absolute Difference (MAD) compared to the previous Waveform product [2] - The trial involved 30 diabetic participants, primarily with Type 1 diabetes, wearing multiple sensors over a 15-day period, confirming the effectiveness of the redesigned CGM sensor [3] Product Design and Accessibility - The redesigned CGM system focuses on affordability, accuracy, and sustainability, featuring reusable and rechargeable components to reduce costs and environmental impact [4] - This innovation aims to make continuous glucose monitoring more accessible to millions who previously could not afford it [4] Regulatory and Commercialization Plans - Trinity Biotech is on track for regulatory submissions in Europe in 2025 and plans to file with the U.S. FDA in 2026, targeting both diabetes patients and health-conscious consumers [5] - The company plans to initiate further pre-pivotal clinical trials in Q1 2025 to enhance the device [5] Technical Advancements - The new CGM system demonstrates superior signal quality and enhanced reliability post-insertion, significantly improving consistency and reducing variability for users [8] - The accuracy for low blood sugar readings now aligns with industry benchmarks, a critical achievement for hypoglycemia management [8] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors [10] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, with a recent entry into the wearable biosensor industry [10]