Trinity Biotech Accelerates CGM+ Clinical Trials

John Gillard, CEO, commented: "These are some of the most important technical advancements to date in our CGM+ development program. The glucose measurement accuracy gains achieved by the incorporation of key components of our enhanced electronics architecture gives us strong conviction to accelerate into pivotal trials this year. The fact that these enhanced electronic components also underpin our innovative multi-modal sensing architecture gives us a valuable foundation from which we intend to deliver a truly differentiated device, CGM+, to key markets globally. Metabolic health problems sit at the center of the world's disease burden, with rising incidence of obesity, diabetes, hypertension, and related cardiometabolic disorders. In everyday life, metabolic health shapes how we perform, recover, and age. Key metabolic health factors include glucose levels, activity, sleep, and stress - metrics that are measurable and personalized. Using AI-native health monitoring, CGM+ is being designed to translate these metrics into powerful insights to support better metabolic health. Our innovation agenda is central to our growth ambitions at Trinity Biotech, and our latest results highlight our commitment to deliver industry-leading innovation, precision, and quality. We are excited with what we have achieved, and we are increasingly confident that CGM+ provides Trinity Biotech with the platform to deliver a significant step-change in the growth and scale of the company. We look forward to initiating a pivotal clinical trial and bringing this important solution to market." The Company has collected more than 650 days of clinical testing data across a number of trials on an updated glucose sensor architecture which has now been integrated with key next-generation electronic components. The updated system delivered a substantial improvement in glucose measurement accuracy across multi-day wear, achieving a material reduction in Mean Absolute Relative Difference compared to prior clinical studies of the upgraded glucose sensor. These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs. The new electronics also underpin CGM+'s multimodal data-capture capabilities, which are designed to support advanced, AI-driven analytical models. Utilizing this multimodal approach, the Company aims to position CGM+ not only as a glucose sensor, but as an important enabling platform for broader AI-enhanced digital health, with a particular focus on personalized metabolic health insights. The next-generation components are also critical to enabling the CGM+ device's user-friendly modular design which drives significant cost and sustainability benefits compared to current market leading CGMs. The cost of current CGM solutions remains one of the main barriers to broader adoption of this important technology. In addition, Trinity Biotech has conducted trials on an updated needle-free glucose sensor insertion process. This new insertion process is fundamental to the next-generation, user-friendly modular design and is yet another important milestone in confirming the technical viability of the updated device design. Based upon feedback from key stakeholders and given the strength of these recent clinical trial results, Trinity Biotech is now advancing the CGM+ program through the final design phase and anticipates initiating a pivotal clinical trial in 2026, targeting regulatory submissions in key global markets immediately thereafter.