Trinity Biotech plc announced on January 28, 2025, compelling results from its latest pre-pivotal clinical trial for its next-generation continuous glucose monitoring (CGM) system. The trial included 30 diabetic participants, primarily individuals with Type 1 diabetes, who wore multiple sensors over a 15-day period. This represents a significant milestone in Trinity's mission to deliver affordable, high-performance CGM technology.
The trial evaluated modifications made by Trinity's R&D team to technology acquired from Waveform Technologies, Inc., aimed at enhancing sensor design and performance. Trinity Biotech's redesigned ergonomic modular device features a reusable applicator and a rechargeable wearable transmitter, eliminating costly disposable components. This innovative approach is designed to deliver care at a significantly lower cost than current market leaders, potentially expanding access to millions of individuals.
The company expects to complete further clinical trials on additional device enhancements and remains on track to file for regulatory approval in the European Union in 2025, followed by filing for U.S. FDA approval in 2026. The global CGM market is projected to exceed $20 billion by 2029, and Trinity Biotech aims to disrupt this market by addressing the high cost of existing technologies.
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