Biotech Daily Dose

Trinity Biotech Reveals New Findings From Pre-Pivotal Trial Of Next-Gen CGM

Trinity Biotech plc (TRIB), a biotechnology company focused on diabetes management, on Thursday announced notable advances in its pre-pivotal trial for its next-generation continuous glucose monitoring or CGM system.

The findings show approximately 35 percent improvement in first-day accuracy or Mean Absolute Relative Difference or MARD and more than 50 percent improvement in Mean Absolute Difference or MAD compared to its previous Waveform product.

These advancements address a key issue in the CGM market—first-day sensor accuracy, which has historically fluctuated due to body responses.

The trial, involving 30 diabetic participants, also highlighted improvements in signal quality, sensor reliability, and low-glucose precision.

The new design of Trinity's CGM system aims to make continuous glucose monitoring more affordable, sustainable, and accessible, with a focus on reducing costs and environmental impact.

Trinity plans to submit regulatory filings in Europe in 2025, followed by a U.S. FDA filing in 2026, and further pre-pivotal trials are set to begin in Q1 2025.

TRIB closed Wednesday's (FEB.05 2025) trading at $0.86 down by 7.31%. In premarket trading Thursday the stock is down by 0.20% at $0.86.

by RTTNews Staff Writer

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