Trinity Biotech reports findings from latest pre-pivotal trial on CGM system

Trinity Biotech (TRIB) announced new findings from its latest pre-pivotal trial, highlighting significant improvements in first-day performance for its next-generation continuous glucose monitoring, CGM, system. The latest analysis confirms that first-day accuracy – a critical performance metric for CGM users – shows an approximately 35% improvement in Mean Absolute Relative Difference and a more than 50% improvement in Mean Absolute Difference with Trinity Biotech’s redesigned CGM sensor compared to the previously marketed Waveform product. The Company remains on track for regulatory submissions in Europe in 2025, followed by a U.S. FDA filing in 2026, with commercialization efforts targeting both diabetes patients and broader health-conscious consumers. Building on the success of its latest trial, Trinity now plans to begin further pre-pivotal clinical trials in Q1 2025 on additional device enhancements