Biosensors kicks off clinical trial for BioFreedom

One big step forward.

According to OCBC, Biosensors International Group (BIG) announced that it has enrolled its first patient in LEADERS FREE, a clinical trial involving its next generation BioFreedom polymer-free drug-coated stent (DCS), which is still awaiting CE Mark approval.

Here's more from OCBC:

This trial would be carried out on patients at high risk of bleeding and is aimed at comparing the safety and efficacy of BioFreedom™ to a bare-metal stent.

Patients would only be required to take a month-long course of dual anti-platelet therapy, versus 12 months for its current flagship BioMatrix™ drug-eluting stent.

The clinical trial will enrol c.2,500 patients across Europe, Asia and South America, with the enrolment process expected to be completed by early 2014; while primary endpoint data is likely to be presented during 2015.

We believe that this trial is significant to the continued growth of BIG, as clinical trial results are one of the most important factors impacting an interventional cardiologist’s decision to adopt a stent for use.

Hence any positive outcomes reported would enable BIG to further drive its penetration rates, in our view. Meanwhile, BIG’s share price has jumped 8.8% since we recommended it as our top healthcare pick for 2013 on 4 Dec 2012.