BIOSENSORS Launches BioMatrix® Drug-Eluting Stent in Europe

April 2, 2008 – Morges, Switzerland – Biosensors International announced today the full launch of its BioMatrix® drug-eluting stent system in all major European markets (excluding France and Belgium), as well as in key markets in the Middle East, Africa and Asia. Developed internally by Biosensors, BioMatrix is a unique drug-eluting stent (DES) system that combines a biodegradable PLA polymer and the company’s proprietary limus drug, Biolimus A9®. The company received CE Mark for BioMatrix in January 2008.

“We are delighted to be making BioMatrix widely available to physicians across Europe,” said Jeffrey B. Jump, Managing Director of Biosensors Europe. “The clinical data we have accumulated to date demonstrate excellent procedural performance and outcome characteristics, and we have received consistently positive feedback from practitioners. We believe BioMatrix provides a valuable alternative to the drug-eluting stents currently available.”

More than 3,000 patients have already been treated with the BioMatrix DES. Describing his own experience with the product, Prof. Bernhard Meier, Chief of Cardiology at the University Hospital of Bern, Switzerland, said, “We have treated about 200 patients with BioMatrix and our impression is excellent. The stent is very deliverable and we have had no stent-related adverse events. We will continue to use this new drug eluting stent in our daily practice.”

Together with the commercial launch, Biosensors has also begun enrollment in a comprehensive patient registry to collect five-year data on the safety and efficacy of BioMatrix in up to 5,000 patients. The unique design of the e-BioMatrix online registry involves two parallel studies using the same protocol: a post-marketing surveillance study with 100% monitoring of 1,000 patients across more than 10 study sites, and a post-marketing registry with 10% monitoring of 4,000 patients across 40 global sites.

“We are very pleased to be initiating such an important registry, unique in its scientific rigor and incorporating a high percentage of monitoring. I believe that this type of study is the right approach to confirm product performance in real-world clinical conditions, and I hope that the large number of targeted patients will confirm the safety profile of this exciting new technology,” commented Principal Investigator Dr. Philip Urban, Chief of Interventional Cardiology at the Hôpital de la Tour in Geneva, Switzerland.

For more information regarding BioMatrix, please visit http://www.biomatrix.com/
For more information about Biosensors, please visit http://www.biosensors.com/

About BioMatrix®

BioMatrix® offers the unique combination of an innovative anti-restenotic drug, Biolimus A9®, a biodegradable poly-lactic acid (PLA) polymer, and an advanced, highly flexible stent designed for enhanced deliverability.

Biolimus A9 was designed specifically for use in drug-eluting stent systems. In addition to effective immunosuppressive and anti-inflammatory properties, the drug has a higher lipophilic and hydrophobic profile than other limus analogs, enabling rapid absorption of the drug into the targeted tissue and reduced systemic exposure. Precision automated coating ensures the PLA and drug combination is applied only to the abluminal (outer) surface of the stent. The PLA fully degrades into water and carbon dioxide as the drug elutes, ultimately leaving in place a biocompatible stent surface.