Company to Host an Investor Conference Call on May 18, 2017 at 7:30
IRVINE, Calif.--(BUSINESS WIRE)--
Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative
treatments for aortic disorders, today announced that the Company met
with the Food and Drug Administration (FDA) regarding its Nellix®
Endovascular Aneurysm Sealing System (the Nellix® EVAS System).
Based upon that meeting and further internal analysis, the Company has
determined that it will seek U.S. approval of the Nellix® EVAS System by
conducting a confirmatory clinical study with the previously updated
Instructions for Use (IFU) and the Gen2 device design, which is
currently sold in Europe and other international markets. The Company
will collaborate with the FDA over the coming months on the confirmatory
clinical study protocol and anticipates beginning patient enrollment in
the fourth quarter of this year with PMA approval estimated to occur in
John McDermott, Chief Executive Officer of Endologix, Inc., commented,
"While the timeline has shifted from our projections, we appreciate the
FDA's collaboration as Nellix® EVAS proceeds in the regulatory process.
We have evidence that our previously updated Nellix® IFU provides
excellent patient outcomes and look forward to starting the confirmatory
clinical study with our Gen2 device. We appreciate the support of our
physicians worldwide and their continued collaboration in developing new
technologies and conducting clinical studies to provide the best
outcomes for patients with abdominal aortic aneurysms."
Positive clinical outcomes with the Nellix® EVAS System will be reported
at upcoming medical meetings, including Critical Issues in Aortic
Endografting in Nuremburg, Germany on May 19 and May 20, 2017 and the
2017 Vascular Annual Meeting in San Diego, California on May 31 through
The Company will host a conference call at 7:30 a.m. ET on May 18, 2017
to discuss the information contained in this press release. To
participate in the conference call, dial 888-576-4382 (domestic) or
719-325-2190 (international). The conference call will also be webcast
and can be accessed from the "Investors" section of the Company's
website at www.endologix.com.
The webcast replay of the call will be available at the same site
approximately one hour after the end of the call.
Additionally, the Company will host a previously announced conference
call at 3:00 p.m. ET on June 3, 2017 to discuss Dr. Jeffrey Carpenter's
presentation of "Refinement of the IFU for the Nellix® System for
Endovascular Aneurysm Sealing Based Upon Outcomes From the EVAS FORWARD
IDE Trial" at the Society of Vascular Surgery ("SVS").
Supplemental slides will be available by 7:00 a.m. ET on May 18, 2017 on
the "Investors - Events & Presentations" section of the Company's
website at www.endologix.com.
About Endologix, Inc.
Endologix, Inc. 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 80%, making it a leading cause of death in the United
States. For more information, visit www.endologix.com.
This communication includes statements that may be "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including with respect to enrollment in clinical
trials, clinical outcomes with the new IFU and Nellix® Gen2 device, and
the timeline for regulatory actions, 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 unanticipated
clinical outcomes, the timing and results of clinical trials,
uncertainties in regulatory actions and timing, and additional
regulatory requirements. Undue reliance should not be placed on
forward-looking statements, which speak only as of the date they are
made. Endologix undertakes no obligation to update any forward-looking
statements to reflect new information, events or circumstances after the
date they are made, or to reflect the occurrence of unanticipated
events. Please refer to Endologix's Annual Report on Form 10-K for the
year ended December 31, 2016, and Endologix's subsequent 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.
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Vaseem Mahboob, CFO,
Source: Endologix, Inc.
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