BioSensors

BioSensors: Biosensors' BioMatrix Flex has been chosen for the largest ever clinical trial involving a drug-eluting stent (DES). The trial, named GLOBAL LEADERS, is an investigator-driven trial and plans to enroll around 16,000 patients to compare the effectiveness of two different pharmaco-intervention strategies. All patients will receive the BioMatrix Flex and be randomised to 2 different follow-up drug treatments. Patients will be followed up for two yrs. Separately, Biosensors also announced plans for a new study involving its next generation BioFreedom drug-coated stent (DCS). The study would involve randomized trial between a DCS and a bare-metal stent (BMS) to assess the potential to deliver anti-restenotic benefit of a DS with a shorter course of dual anti-platelet therapy in patients with high risk of bleeding. The results would show if this new type of stent can be more effective than BMS in a subgroup of patients not previously studied, and yet be just as safe. The trial, term LEADERS FREE will enrol 2,500 patients from 60 sites across Europe, Asia and South America with follow-up for two years. The clinical trials would serve to build a body of clinical evidence around Biosensors' key BioMatrix product and its next generation BioFreedom product. We believe that this would serve to provide more published data to support the safety and efficacy of Biosensors' products.