IRVINE, Calif.--(BUSINESS WIRE)--Transforming the treatment of aortic disorders, Endologix® Inc. (OTC: ELGXQ) (“Endologix” or the “Company”), today announced the first commercial implant and the U.S. commercial release of its recently FDA-approved ALTO® endograft for the treatment of abdominal aortic aneurysms (AAA).
“ALTO represents a differentiation from traditional endovascular aneurysm repair (EVAR) and, with its introduction, a significant landmark for Endologix. With its unique anatomically adaptive sealing technology, ALTO offers patients improved acute outcomes and the ability to preserve long-term durability. The ALTO launch, enabled by our world-class field team and supported by treating physicians committed to ensuring the best outcomes for each of their patients, will transform the treatment of aortic disorders,” commented John Onopchenko, Chief Executive Officer of Endologix. “We are steadfast in our belief that our products, pipeline and plan of clinical investigation will realize meaningful, life-long benefits for patients and establish a new, higher standard of aortic care. With our recent announcement of the agreement to take Endologix private, we anticipate having access to new financing and are poised to execute on our mission and reach our full potential.”
ALTO offers a workhorse endograft with broad indications to treat the widest range of patients. ALTO’s unique, anatomically adaptive sealing technology and 7 mm neck indication is designed to ensure a precise seal near the renal arteries for every case. In addition, the ALTO design enables a very low profile (15 Fr OD) for treating patients with small vessels and challenging access, and has an integrated balloon for convenience in optimizing the seal during the procedure. The core anatomically adaptive sealing technology, which has been studied in nearly 1,300 patients in the ENCORE database, demonstrates favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.
“This new endograft, as seen in the ELEVATE IDE trial, has allowed us to treat patients on label with short necks and challenging access without adjunctive devices or access routes,” said Sean Lyden, MD, Chairman of the Department of Vascular Surgery, Cleveland Clinic (U.S.), National Primary Investigator for the ELEVATE IDE trial, for which he was compensated by Endologix for that role. Lyden, who performed the first commercial implant of the ALTO endograft, also said, “A device with a polymer sealing ring at 7 mm has expanded the number of patients that can be offered minimally invasive endovascular repair that are not treatable with other commercial infrarenal fixation devices.”
The ALTO endograft builds and improves upon the anatomically adaptive sealing technology, which has been studied in over 1,300 patients in ENCORE and ELEVATE.
“ALTO is differentiated from traditional devices for EVAR through the use of a conformable liquid polymer. This technology offers many advantages, including its low-profile graft design with a durable, customized, anatomically adaptive aortic seal,” said Matt Thompson, MD, Chief Medical Officer at Endologix. “In addition to being a workhorse device, ALTO may offer incremental advantages, particularly in specific patient cohorts, such as women, patients with challenging access, patients needing fast-track EVAR and patients with poor predicted durability using traditional EVAR grafts.”
In speaking about Endologix’s portfolio and clinical pipeline, Thompson added, “Endologix offers the most differentiated portfolio of AAA endovascular technologies available. The introduction of ALTO is a critical landmark for Endologix and the next step in our journey to address the current unmet needs of EVAR, which also includes a randomized control trial for ALTO and pivotal trials (EVAS2 and ChEVAS ONE) for breakthrough therapies.”
The first commercial implant marks the official start of the U.S. release of the ALTO Abdominal Stent Graft System. The commercial release of ALTO will be supported by a world-class team of sales representatives and clinical specialists at Endologix, all focused on the collective objective of improving the health and lives of patients with aortic disorders through a steadfast commitment to delivering innovative and trusted EVAR solutions.
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 Company’s expectations regarding its agreement to take the Company private and secure additional financing, the improved outcomes expected from the Company’s ALTO product, the Company’s ability to operate its business as usual while under Chapter 11 protection, 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.