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Endologix's CEO Discusses Q3 2011 Results - Earnings Call Transcript

Outside the U.S., we completed the transition of our European distribution agreement with LeMaitre Vascular and began working directly with European customers on September 1. We are actively recruiting, training, and building the team to support our current customers and prepare for the European launches of AFX, Nellix, and Ventana in 2012.

Turning to our new product pipeline, we continue to make good progress on all programs. First, we are still on track to complete enrollment in the PEVAR clinical trial by the end of this year. Second, we have 20 of the 30 patients enrolled in the Ventana international clinical trial. Third, we have a conditional IDE approval for Ventana. And last, we are still on track to submit our EU regulatory submission for Nellix by the end of this year.

Combined with the AFX, these new products will give Endologix a lineup of innovative market expanding devices that will enhance our ability to gain market share and be the leader in endovascular aneurysm repair. In Europe, we expect to launch AFX in the first quarter of 2012 and then pending CE Mark approval, we will start with a very limited market introduction of Nellix in mid 2012. We have planned to move very deliberately and limit the number of centers in order to focus on good outcomes and refining all aspects of the procedure. We’ll probably stay in a limited market release phase through the balance of 2012 and then look at opening it up in 2013.

For Ventana, we hope to gain CE approval in the fall and begin a limited rollout in selected centers again focusing on clinical outcomes and building one good customer at a time. In U.S., we expect to keep growing with a full year of AFX sales in 2012 and hope to receive the percutaneous indication by the end of next year, which would position Endologix is the only is our company that can promote and trained the percutaneous technique.

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