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Trinity Biotech Announces Positive Pre-Pivotal Trial Results for Its Next-Generation Continuous Glucose Monitor Technology
DUBLIN, Oct. 07, 2024 (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 the successful completion of its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM) technology. The study assessed the analytical performance of CGM technology enhancements implemented by Trinity Biotech since acquiring the technology from Waveform Technologies in January 2024.
"We have made significant progress in the development of our next generation factory-calibrated CGM, combining a high degree of accuracy with a unique modular design that simplifies and enhances user experience, while significantly reducing cost and waste," stated John Gillard, President and Chief Executive Officer of Trinity Biotech. "The outcome of this pre-pivotal study confirms the effectiveness of the R&D plan executed since the acquisition of the Waveform Technologies assets earlier this year and will be used to guide further sensor design optimisations."
Trinity Biotech implemented a research and development plan aimed at improving both the performance and usability of the CE-marked, 15-day wear CGM device. Key design modifications introduced in this study include a significant reduction in the biosensor wire length, a change aimed at enhancing in-body performance. The trial results demonstrated that the refined sensor achieved a mean absolute relative difference (MARD) that compares favourably to the previous Waveform device.
"We have made significant progress in the development of our next generation factory-calibrated CGM, combining a high degree of accuracy with a unique modular design that simplifies and enhances user experience, while significantly reducing cost and waste," stated John Gillard, President and Chief Executive Officer of Trinity Biotech. "The outcome of this pre-pivotal study confirms the effectiveness of the R&D plan executed since the acquisition of the Waveform Technologies assets earlier this year and will be used to guide further sensor design optimisations."
Trinity Biotech implemented a research and development plan aimed at improving both the performance and usability of the CE-marked, 15-day wear CGM device. Key design modifications introduced in this study include a significant reduction in the biosensor wire length, a change aimed at enhancing in-body performance. The trial results demonstrated that the refined sensor achieved a mean absolute relative difference (MARD) that compares favourably to the previous Waveform device.
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