Endologix Receives CE Mark for Nellix(R) EndoVascular Aneurysm Sealing System
Remains on Track With Additional Device Enhancements and Expected Limited Market Introduction in Europe in Second Quarter 2013
IRVINE, Calif., Sept. 6, 2012 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today achievement of the CE (Conformite Europeenne) Mark of the current version of the Nellix® EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms ("AAA"). Nellix is an innovative new endovascular aneurysm sealing ("EVAS") system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale.
Endologix is currently implementing a few enhancements to the Nellix System intended to further optimize the device for commercialization. When complete, the Company will submit these enhancements to its Notified Body, with expectations of gaining CE Mark approval for the commercial version of the device and beginning a limited market introduction of the enhanced system in Europe by the end of the second quarter 2013.
John McDermott, President and Chief Executive Officer, said, "Nellix has the potential to treat more AAA patients and get better clinical outcomes than any other device for the endovascular repair of AAA. Receiving CE Mark for the current version of the system is an important regulatory milestone and we look forward to providing this ground-breaking technology to physicians and their patients in 2013."
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 enhancements to, further CE Mark receipt, and the commercial launch and clinical acceptance to the Nellix System, 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.
CONTACT: COMPANY CONTACT:
John McDermott, CEO
The Ruth Group
Nick Laudico (646) 536-7030
Zack Kubow (646) 536-7020
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