SINGAPORE (Oct 15): Medical device developer and manufacturer Biosensors International Group ( Valuation: 0.90, Fundamental: 0.80) announced that its Leaders Free clinical trial demonstrated “superior safety and efficacy” for BioFreedom compared with a bare-metal stent.

The results were presented by Dr Philip Urban, principal investigator for Leaders Free at the 27^th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

Leaders Free is a double-blinded randomised study comparing BioFreedom – a polymer-free stent coated with Biolimus A9 – with an uncoated BMS (Gazelle) in patients at high risk of bleeding undergoing percutaneous coronary intervention (PCI) with only one month of dual anti-platelet therapy (DAPT). The trial assessed the shortest course of DAPT ever used with an active stent. The trial randomised a total of 2,466 patients at 68 sites across Europe, Asia, Australia and Canada, with a follow-up phase for two years.

The new results of Leaders Free showed a 50% reduction in the need for repeat revascularisation. The primary efficacy endpoint with 5.1% of patients receiving BioFreedom experienced clinically driven target lesion revascularisation (TLR) at 390 days versus 9.8% of patients receiving a bare-metal stent. Patients in the BioFreedom arm also had a 29% reduction in risk of cardiac death, myocardial infarction or stent thrombosis.

BioFreedom has received CE Mark approval and is currently available in select markets. Biosensors has also received conditional IDE approval to conduct a US-based clinical trial of BioFreedom, designed to collect additional safety and effectiveness data.

Biosensors shares closed at 66.5 cents on Wednesday.