Trinity Biotech plc (Nasdaq: TRIB) has announced promising results from its latest pre-pivotal clinical trial for its next-generation continuous glucose monitoring (CGM) system. The trial, which included 30 participants primarily with Type 1 diabetes, showcased significant improvements in first-day accuracy and overall performance. These findings reinforce Trinity Biotech's confidence in delivering a high-performance, calibration-free CGM system that meets the FDA's iCGM standards. The company anticipates regulatory submissions in Europe in 2025, followed by a U.S. FDA filing in 2026.
Enhanced Accuracy and Reliability
The latest analysis of the pre-pivotal trial data confirms that first-day accuracy, a critical performance metric for CGM users, has improved significantly. The redesigned CGM sensor demonstrated an approximate 35% improvement in Mean Absolute Relative Difference (MARD) and a more than 50% improvement in Mean Absolute Difference (MAD) compared to the previously marketed Waveform product. This addresses a key challenge in the CGM industry, where sensor accuracy often fluctuates during the first 24 hours due to the body’s natural response to insertion.
Key Performance Metrics
The pre-pivotal trial evaluated modifications made by Trinity Biotech’s R&D team to technology acquired from Waveform Technologies, Inc. These enhancements to sensor design and performance yielded exceptional results, including:
- Superior Signal Quality: Significant improvements in signal clarity compared to previously released Waveform CGM sensors.
- Enhanced Reliability Post-Insertion: Sensor performance immediately after placement demonstrated markedly improved consistency, reducing variability for users.
- Breakthrough Accuracy: A 25-30% improvement in MARD over earlier Waveform CGM sensors.
- Industry-Standard Low-Glucose Precision: Accuracy for low blood sugar readings (measured by MAD) is now aligned with industry benchmarks, a critical achievement for hypoglycemia management.
Addressing Market Needs
John Gillard, CEO of Trinity Biotech, emphasized the potential of the new CGM system to expand access to this life-changing technology. "We believe that our patented technology—featuring a modular, eco-friendly design and cutting-edge sensor performance—represents a paradigm shift in the CGM market, which is projected to exceed $20 billion by 2029," Gillard stated. He noted that the current CGM market is constrained by high costs, with the two largest manufacturers serving less than 2% of the 800 million people living with diabetes worldwide. Trinity Biotech aims to deliver a solution that drastically reduces costs while maintaining top-tier performance.
Design and Sustainability
Trinity Biotech’s redesigned CGM system features a reusable applicator and a rechargeable wearable transmitter, eliminating costly disposable components. By using more durable, reusable components, enabled by Trinity’s proprietary self-inserting sensor technology, the Trinity CGM is designed to deliver care at a significantly lower cost. This innovative approach not only expands access but also redefines sustainability in the CGM space.
Path to Commercialization
Building on the success of the pre-pivotal trial, Trinity Biotech plans to begin further clinical trials in Q1 2025 on additional device enhancements. The company remains on track to file for regulatory approval in the European Union in 2025, followed by a U.S. FDA filing in 2026. These steps will pave the way for commercial rollouts targeting both diabetes patients and the broader market of individuals seeking real-time glucose insights.
