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Endologix's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Now, switching to the new product pipeline, we are pleased to announce the completion of our PVAR clinical trial and submission of a PMA supplement to the FDA. We remain hopeful that we’ll receive approval for a percutaneous indication in the United States by the end of this year. For Nellix, we continue to wait for feedback from the notified body and are still expecting to receive the CE Mark on the current version of the device in the near-term. Since submitting our original CE back in December of last year we have continued to do clinical cases and receive positive feedback from physicians.

Most recently, we received a reported case of a thrombosis which is a known complication in EVAR. Although our thrombosis rate with Nellix is still well within the rates reported in the literature for other devices, we have determined that the minor process and design enhancements will enable us to further optimize the device. So, we have adjusted our plans to implement these improvements prior to filing the IDE in initiating our European limited market introduction. We expect this change to pushback our estimated IDE filing from Q3, 2012 to Q1, 2013 and the limited market introduction in Europe from Q3, 2012 to Q2, 2013. Although it’s a difficult decision to impose a delay on the program, we think it’s the right thing to do for the long-term clinical and commercial success of the technology.

To further demonstrate our confidence in the Nellix platform, during the quarter, we entered into an exclusive worldwide license agreement for the polymer technology used in the Nellix system. This agreement includes 23 issued patents covering a wide range of polymers and hydrogels for the treatment of aortic and peripheral aneurysms. The agreement further strengthens our intellectual property position with Nellix and significantly increases competitive barriers to entry.

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