"Our drug-eluting stent systems are combination devices, comprised of a stent with a drug coating, which require clinical trials and regulatory approval as medical devices before they can be marketed. We have completed treatment of patients in three clinical trials: AXXESS, AXXESS PLUS and AXXENT. The six-month data from the AXXESS PLUS trial, which studied the Axxess stent system in 139

patients, was presented at the Transcatheter Cardiovascular Therapeutics Conference, or TCT, in October 2005 and demonstrated favorable initial safety and effectiveness for the treatment of ECA bifurcation lesions.

In October 2006 at TCT, we presented the six-month data from the 33 patient AXXENT study, which we believe is the only clinical study of a stent specifically designed to treat LMCA bifurcation lesions. The data showed that the Axxess LM stent can successfully treat LMCA lesions and had an in-stent binary restenosis rate of 0% at six-month follow-up.

We believe that the results of these trials indicate that the Axxess technology platform may offer superior clinical results when compared with stenting techniques not indicated for use, or off-label.

We license our drug coating from a third party, an affiliate of Biosensors International Group, Ltd., or Biosensors, and our filings with regulatory authorities in the United States and the European Union reference Biosensors' drug master file, or DMF, and device master file, or MAF. The approval of our products by these regulatory authorities is dependent in part upon data contained within Biosensors' DMF and MAF as they relate to our products.

 We submitted an application for the CE Mark to gain European regulatory approval for our Axxess stent system and, in December 2006, we received questions from the Competent Authority regarding, among other things, Biosensors' DMF and MAF as they relate to our products.

We are prepared to respond to these questions following the resolution of the questions relating to Biosensors' European DMF

and MAF for Biolimus A9. We expect to receive CE Mark approval by late 2007.

Such approval will allow us to begin commercialization of the Axxess stent system in select countries within the European Union and countries outside of the European Union that recognize the CE Mark for regulatory purposes."

Devax DES Stent has been praised highly by Prof Eberhad Grube - Mentioned in the TCT 2007 audio conference call.

Not a call to buy/sell.

 

From 1994 to 2001, Mr. Sayer was the Chief Financial Officer of Minimed, Inc., a Nasdaq-listed medical device company focused on diabetes management. During his tenure at Minimed, Mr. Sayer managed multiple financing and strategic transactions and played a central role in the 2001 acquisition of Minimed, Inc., by NYSE-listed Medtronic, Inc. From 2001 to 2002, he co-led the integration team for the newly-combined entity within Medtronic and assumed executive responsibilities over operations as vice president and general manager of their External Pump and Disposable Products business unit.