ENDOLOGIX UPDATE ON U.S. REGULATORY PROGRESS
Reaffirms expectations for FDA approval in the second half of 2004
IRVINE, Calif. (May 4, 2004) Endologix, Inc. (Nasdaq: ELGX) today provided an update on its recent communication with the FDA concerning its pending PMA Application for its Powerlink® System. The Company has received its anticipated letter from the FDA upon the agency's completion of its in-depth review of the PMA Application. As is normal for the in-depth review process, the letter requested supplemental information and clarification with regard to its submission. The Company plans to respond fully within the next week, to the majority of the letter's questions, which pertain to clarification of its R&D testing. The requested supplementary statistical analysis is scheduled to be submitted to the FDA within five weeks. The FDA has yet to make the determination of the requirement for a Panel Review of the Company's PMA Application. Within the past month, the FDA has conducted and completed a BIMO (Clinical) and QSIT (Quality) inspection during a visit to the Company's Irvine facility. There were no Form 483 Inspectional Observations issued as the result of this facility inspection.
"This is very good news," commented Paul McCormick, President and Chief Executive Officer. "This recent activity and communication clearly keeps the Company on track to obtain U.S. marketing approval for the Powerlink in the second half of this year. The completeness of our submission and clinical results speak volumes about the quality of work conducted by our investigators, their clinical coordinators, the Endologix personnel, and the Powerlink technology itself."
The Powerlink System is a unibody self-expandable device, with a durable frame made of stainless steel alloy covered with an ePTFE graft. The one-piece bifurcated design featuring a fully-supported stent cage was developed to overcome the many shortcomings associated with earlier-generation ELG devices. The Powerlink System is covered by 14 U.S. patents with 296 allowed claims. Upon receiving FDA marketing clearance the Company plans to initiate a focused U.S. product launch.
Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. AAA, a life threatening condition, 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 AAAs is approximately 75%, making it the 13th leading cause of death in the United States. Most patients with an AAA do not exhibit any symptoms and the first sign oftentimes is a rupture of the aneurysm. When an AAA ruptures, patients will experience pain in the abdomen and back, fainting and loss of consciousness frequently leading to shock and death. Once diagnosed, AAA patients will be managed by a combination of medical therapy and non-invasive monitoring, or by undergoing a major surgical procedure to repair the aneurysm. Additional information about Endologix and its products can be found at www.endologix.com.
Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to clinical trials and the regulatory approval process, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended Dec. 31, 2003 and the Company's other filings with the U.S. Securities Exchange Commission.