Trinity Biotech(TRIB) Newsfilter·2025-01-28 12:20Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [1] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry [7] - Trinity Biotech's products are used to detect infectious diseases and quantify Haemoglobin A1c and other chemistry parameters in serum, plasma, and whole blood [7] - The company sells directly in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide [7] Product Innovation - Trinity Biotech has announced compelling results from its latest pre-pivotal clinical trial for its next-generation continuous glucose monitoring (CGM) system [1] - The redesigned ergonomic modular device features a reusable applicator and a rechargeable wearable transmitter, eliminating costly disposable components [2] - The CGM system is designed to deliver care at a significantly lower cost than current market leaders, addressing affordability as a key barrier to adoption [2] - The company's patented technology features a modular, eco-friendly design and cutting-edge sensor performance, representing a paradigm shift in the CGM market [3] Market Potential - The CGM market is projected to exceed 11 billion in sales annually, serving just 10 million users combined, which is less than 2% of the 800 million people living with diabetes worldwide [3] - Trinity Biotech's innovative approach has the potential to bring CGM technology to millions of individuals who have been priced out of the market [2] Clinical Trial Results - The pre-pivotal clinical trial involved 30 diabetic participants, primarily individuals with Type 1 diabetes, each of whom wore multiple sensors over a 15-day period [4] - The trial evaluated modifications made by Trinity's R&D team to technology acquired from Waveform Technologies, Inc, yielding exceptional results [4] - Significant improvements in signal clarity, enhanced reliability post-insertion, and a 25-30% improvement in the key accuracy metric (mean absolute relative difference, or MARD) were observed [5] - Accuracy for low blood sugar readings is now aligned with industry benchmarks, a critical achievement for hypoglycemia management [5] Regulatory and Commercialization Plans - Trinity Biotech expects to complete further clinical trials on additional device enhancements and remains on track to file for regulatory approval in the European Union in 2025, followed by filing for U.S FDA approval in 2026 [4] - The company aims to deliver a calibration-free CGM system that meets FDA's iCGM standard, enabling seamless integration with insulin pumps [4] - Commercial rollouts are targeting both diabetes patients and the broader market of individuals seeking real-time glucose insights [4]