Trinity Biotech Reports Positive Pre-pivotal Study Data For Continuous Glucose Monitor Technology

(RTTNews) - Trinity Biotech plc (TRIB), a commercial-stage biotechnology company, Monday said it has successfully completed its first pre-pivotal study of its continuous glucose monitor (CGM) technology in Europe.

The study assessed the performance of CGM technology enhancements implemented by Trinity Biotech since acquiring the CE marked technology from Waveform Technologies in January 2024.

Key modifications in the design included significant reduction in the biosensor wire length aimed at enhancing in-body performance. Results from the study showed that the refined sensor achieved a mean absolute relative difference (MARD) that compares favorably to the previous Waveform device. According to the Clinical Laboratory Standards Institute (CLSI), the mean absolute relative difference (MARD) is the average distance between a blood glucose or CGM reading and reference values.

"Our next phase of refinements, guided by this study's positive results, will be tested in a second European pre-pivotal trial, which is scheduled to take place in the fourth quarter of this year and will set the stage for our pivotal trial in 2025," said Trinity Biotech's Chief Technology Officer, Gary Keating.