Endologix Inc. Wins CE Mark Nellix® EndoVascular Aneurysm Sealing System
Published: Jan 25, 2013
This approval of the Nellix System includes a few enhancements intended to further optimize the device compared to the previous version, which received CE Mark in October 2012. Endologix expects to begin a limited market introduction of the Nellix System in Europe during the second quarter 2013. The Company will also initiate a post-market clinical study of the Nellix System beginning in the third quarter of 2013 in selected European centers of excellence.
John McDermott, President and Chief Executive Officer, said, "We are very excited to receive CE Mark for the Nellix System, which will allow Endologix to introduce the world's first AAA endovascular aneurysm sealing system, or EVAS, to physicians and patients in Europe. We believe Nellix has the potential to simplify AAA procedures, treat a broad range of patients and improve clinical outcomes. The initial commercial activity for Nellix will begin in the second quarter 2013, with a focus on building the clinical experience in collaboration with thought-leading physicians. We will also begin a post-market clinical study, to gather additional data and patient follow-up to support gradual introductions in other markets. The physicians at the initial clinical sites will collect this data and also help us train other physicians as we gradually roll-out Nellix over the course of the year, with a broader launch anticipated in 2014."
Mr. McDermott added, "We are well positioned in Europe with our AFX(R) and Nellix systems and look forward to potential CE Mark for our Ventana(R) product in the near future. We have received strong interest in all of these products from the medical community and believe that Endologix offers physicians the most innovative range of products to treat their AAA patients. We look forward to providing training and clinical support for these and other new technologies in 2013 and the years ahead."
About Endologix, Inc.
Endologix, Inc. (the "Company") develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's Web site at www.endologix.com.
Except for historical information contained herein, this news release contains forward-looking statements relating to the commercial launch and clinical acceptance to the Nellix System, the approval of the Ventana product, and the introduction of other new technologies, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in, product research and development efforts, regulatory submissions and approvals and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
John McDermott, CEO
The Ruth Group
Nick Laudico (646) 536-7030
Zack Kubow (646) 536-7020