TRIB News & Events

Trinity Biotech announced it has entered into a collaboration agreement with the University at Buffalo, New York, or UB. The partnership focuses on advancing and commercializing a suite of proprietary biomarkers for the earlier and more accurate detection of Sjogren's Syndrome, one of the most common but underdiagnosed autoimmune diseases. Sjogren's Syndrome is a chronic, systemic autoimmune disease that primarily affects moisture producing glands in the eyes and mouth, with potential progressive involvement of multiple organ systems. The disease may affect the nervous system, lungs, and kidneys as well as the function of most other exocrine glands in the human body. Chronic fatigue, joint pain, and neuropathic pain are significant sources of disability. It is widely underdiagnosed and often mistaken for other autoimmune or inflammatory conditions. Under the collaboration agreement Trinity Biotech will codevelop and commercialize proprietary biomarkers discovered by UB faculty researchers and licensed to Trinity Biotech subsidiary IMMCO through Business and Entrepreneur Partnership's Technology Transfer Office, which manages UB's intellectual property and facilitates collaborations between UB faculty researchers and industry partners. Trinity Biotech expects the collaboration to generate multiple downstream benefits, including expanded clinical partnerships, enhanced payer relevant data packages, and a strengthened platform for future biomarker commercialization.

Trinity Biotech has commenced the commercial rollout in Brazil of its updated laboratory blood glucose monitoring solution, the next-generation HbA1c column system for its Premier Hb9210 platform, following receipt of local regulatory approval. This approval enables the introduction of the Company's upgraded boronate affinity column system into one of the world's largest diabetes markets. The enhanced Premier Hb9210 platform recently became the only HbA1c system worldwide to receive the prestigious International Federation of Clinical Chemistry Gold" classification for 2026, a designation recognising the highest levels of clinical accuracy, precision and traceability.

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.

The company said, "The Company's key strategic objectives are to grow the existing business profitably and to advance its exciting innovation agenda, including the flagship development CGM+. As such, the Company continues to focus on, and make substantial progress in, its Comprehensive Transformation Plan, which is designed to substantially improve the long-term profitability of the Company's existing business lines. The Company has recently secured several key regulatory approvals, including in February 2026, local regulatory approval for outsourcing and offshoring the production of its Uni-Gold HIV rapid test. The receipt of this regulatory approval allows the Company to proceed with the final transition of Uni-Gold manufacturing and, as previously announced, this key aspect of its Comprehensive Transformation Plan is being prioritised during the first quarter of 2026. In addition to pursuing profitability focused operational transformation, such as the finalisation of outsourced manufacturing, the Company continues to focus on commercialisation of its rapid HIV test franchise and this is underpinned by renewed strength in global HIV testing demand. In particular, the Company is seeing strong demand for Uni-Gold HIV. As the Company gains continued commercial traction with TrinScreen and sees improved Uni-Gold HIV demand, it is expected that Rapid HIV will be a larger proportion of the Company's revenue base in 2026. Given the nature of global health HIV test procurement, where order timing and size can vary significantly, and in particular the typical scale of TrinScreen orders, the Company expects a higher degree of quarter-on-quarter revenue variability. The move to outsourced manufacturing for its Uni-Gold HIV and TrinScreen products is intended to mitigate the profitability impact of this increased revenue variability by transitioning a significant portion of the continuing cost base from fixed cost to variable costs, though the transition to outsourcing itself will also temporarily introduce a further degree of quarter-on-quarter revenue variability in the first half of 2026. As a result of these factors, the Company now anticipates that some HIV revenue will shift from Quarter 1 into Quarter 2 and also from Quarter 2 into Quarter 3, shifting the cadence of quarterly profitability and cashflows as the Company stays firmly focused on full-year and long-term performance, in line with its strategic objectives. The Company also continues to focus on the execution of its multi-facetted business improvement plan for its diabetes care Premier Hb9210 HbA1c laboratory blood glucose monitoring solution. Having secured the prestigious Gold Classification from the International Federation of Clinical Chemistry and Laboratory Medicine for 2026, and obtained regulatory clearances in multiple countries for the expanded rollout of its next-generation high-capacity HbA1c column system, the Company is now focusing on increasing commercial efforts for this upgraded HbA1c column system. These commercial efforts are focused on building new sales relationships in the US and Brazil where the Company has a direct sales presence. The Company is also now building new and expanded relationships with third party distributors in other territories, as this product line is positioned for renewed long-term growth. The upgraded column system builds upon broader improvement initiatives in the Company's haemoglobin business, including the transition of certain manufacturing processes to other group manufacturing sites to increase manufacturing capacity and to reduce costs as part of its profitability focused Comprehensive Transformation Plan. The Company is confident that these product development, commercial and operational developments, coupled with rising global diabetes prevalence, position this business for long-term profitable growth, again consistent with the Company's overall strategic objectives."