Thursday, August 06, 2020
Transforming the treatment of aortic disorders, Endologix® Inc., today announced that it has received a CE Mark for the ALTO™ Abdominal Stent Graft System (ALTO).
“We are very excited to receive a CE Mark for the ALTO system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI ” commented Matt Thompson, Chief Medical Officer of Endologix. “ALTO will provide our physician partners and patients in the EU with a differentiated low profile endovascular treatment option designed to improve durability over traditional EVAR. In addition, with ALTO, we anticipate observing improved short-term outcomes relative to the Ovation iX Abdominal Stent Graft System (Ovation iX) as a result of the design and manufacturing changes incorporated into ALTO. Lastly, CE Mark of the ALTO system is yet another critical milestone for Endologix as we seek to introduce a portfolio of devices to address the current unmet needs of endovascular aneurysm repair (EVAR).”
“ALTO offers a highly differentiated endovascular treatment option to AAA patients and includes design features that we believe will enhance ease-of-use, improve acute outcomes and preserve the long-term durability associated with patient-specific anatomically adaptive sealing,” commented John Onopchenko, Chief Executive Officer of Endologix. “We believe ALTO, with its ultra-low profile and 7mm aortic neck length indication, will provide patients and physicians with an endograft capable of treating the highest proportion of patients within the indications for use of the device. As we continue with the global roll-out of the ALTO system, which has commenced in the U.S., Endologix is committed to investing in the highest levels of clinical evidence by initiating a head-to-head randomized controlled trial versus traditional undifferentiated EVAR grafts, with the intent of proving the superiority of ALTO. Finally, with our recent announcement regarding our proposed transition to a private company, we are poised to meet the needs of our customers and the patients we proudly serve and fulfill our company mission.”
About Endologix, Inc.
Endologix, Inc. develops, manufactures, markets and sells innovative medical devices for the treatment of aortic disorders. The Company's products are intended for the minimally invasive endovascular treatment of abdominal aortic aneurysms (“AAA”). AAA occurs when a portion of the abdominal aorta bulges into an aneurysm because of a weakening of the vessel wall, which may result in life threatening internal bleeding upon rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it among the leading causes of death in the United States. For more information, visit www.endologix.com.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” "continue," "outlook," “guidance,” "future,” other words of similar meaning and the use of future dates. Forward-looking statements used in this press release include, but are not limited to, statements regarding the improved outcomes expected from the Company’s ALTO product and the Company’s ability to successfully market its ALTO product, the accuracy of which are necessarily subject to risks and uncertainties that may cause Endologix’s actual results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ materially and adversely from anticipated results the Company’s ability to complete its Chapter 11 process and the transactions contemplated by the agreement to take the Company private and the Company’s ability to achieve the expected results of its ALTO product. Undue reliance should not be placed upon the forward-looking statements contained in this press release, which speak only as of the date of this press release. Endologix undertakes no obligation to update any forward-looking statements contained in this press release 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 filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Reports on Form 10-Q, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.
Contacts
INVESTOR CONTACT:
Endologix, Inc.
Cindy Pinto, Interim CFO
(949) 595-7200
