- Clinical trial results support progression of CGM+ toward regulatory submissions and scaled commercialization
- Anticipating initiation of pivotal clinical trial in 2026
- Updated electronics architecture delivers significant improvement in glucose measurement accuracy, with a material reduction in MARD across multi-day wear
- Multimodal sensing platform powered by advanced AI-native analytics to deliver personalized metabolic health insights
- CGM+ next-generation modular device architecture designed to reduce cost and improve sustainability versus current market-leading CGMs
- Company is positioning device to participate in fast-growing $15bn CGM market and adjacent sectors
DUBLIN and WILSONVILLE, Ore., March 10, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced a number of significant technical advancements in the development of its next-generation, finger-stick calibration-free Continuous Glucose Monitoring (CGM) system, CGM+, marking a major step toward bringing the technology to global markets.
John Gillard, Trinity Biotech President & Chief Executive Officer, 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 (MARD) 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 unique 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 successful 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.
The Company believes that these breakthrough results significantly strengthen the device's technical readiness, reduce system level risk, and support the progression of CGM+ toward regulatory submissions and scaled commercialization. CGM+ has the potential to make high quality metabolic intelligence more affordable, more intuitive, and more widely available than ever before.
Anticipating Initiation of Pivotal Clinical Trial In 2026
Since the unveiling of CGM+ in July 2025, Trinity Biotech has continued to innovate and refine this next-generation biosensor platform. Prior breakthrough results released in August 2025 on its redesigned proprietary needle-free glucose sensor, confirmed the elimination of the requirement for finger-stick calibration and de-risked the commercialization pathway for CGM+.
The Company is collaborating with clinicians, scientists, user groups, and digital health leaders to further optimize its innovative multi-sensor CGM+ architecture which is being designed to collect multiple selected physiological metrics alongside glucose in a single modular device.
Advanced AI-native analytics will transform this complex, multifactorial data into personalized and actionable insights, giving CGM+ users a seamless connected experience and clinicians a powerful treatment tool.
Based upon enthusiastic 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.
CGM+ is uniquely positioned at the confluence of advanced glucose monitoring technology, AI-native healthcare analytics, and increasing demand for AI wearables. Market dynamics indicate strong growth in these already sizeable markets and recent forecasts predict strong growth in the coming years:
- Global CGM Market: Projected to grow from $15.3B in 2026 to $31.4B by 2031 (CAGR: 15.4%)1
- AI in Healthcare: Forecast to reach approximately $250B by 2031, growing at a 35.7% CAGR2
- Wearable AI: Expected to reach $360B by 2034, growing at a 24.7% CAGR3
For more information on CGM+ please visit our dedicated website https://cgm.trinitybiotech.com/
1 https://www.mordorintelligence.com/industry-reports/continuous-glucose-monitoring-market
2 https://www.mordorintelligence.com/industry-reports/artificial-intelligence-in-healthcare-market
3 https://www.fortunebusinessinsights.com/wearable-ai-market-109561
Forward-Looking Statements
This release includes statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"), including but not limited to statements related to Trinity Biotech's cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms "may," "believes," "projects," "expects," "anticipates," or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company's distributors, losses or system failures with respect to Trinity Biotech's facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech's products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech's intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under "Risk Factors" in Trinity Biotech's annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech's other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.
About Trinity Biotech
Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.
| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
| Gary Keating, Ph.D | Dave Gentry, CEO | |
| (353)-1-2769800 | (1)-407-644-4256 | |
| (1)-800-RED-CHIP (733-2447) | ||
| TRIB@redchip.com |
