Trinity Biotech plc announced the successful completion of its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM) technology on October 7, 2024. The study assessed analytical performance enhancements implemented by Trinity Biotech since acquiring the technology from Waveform Technologies in January 2024. This marks a significant step in the development of a factory-calibrated CGM designed for accuracy, user experience, and reduced cost and waste.
Key design modifications, including a significant reduction in the biosensor wire length, were introduced and evaluated in this trial. The results demonstrated that the refined sensor achieved a mean absolute relative difference (MARD) that compares favorably to the previous Waveform device. This outcome confirms the effectiveness of the research and development plan executed by the company.
Trinity Biotech's Chief Technology Officer, Dr. Gary Keating, stated that the next phase of refinements, guided by these positive results, will be tested in a second European pre-pivotal trial scheduled for the fourth quarter of 2024. This will set the stage for a pivotal trial in 2025. The global CGM market is estimated to be over $11 billion and is expected to surpass $20 billion by 2029.
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