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Company Description

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2 Musick

Irvine, CA 92618

United States

Phone: 949-595-7200

Fax:

Endologix, Inc. develops, manufactures, markets, and sells 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). The AAA products are built on one of two platforms, such as traditional minimally-invasive endovascular repair (EVAR) or endovascular sealing (EVAS), the company’s solution for sealing the aneurysm sac while maintaining blood flow through two blood flow lumens. Products EVAR Platform The company’s EVAR products include the Endologix AFX Endovascular AAA System (AFX), the VELA Proximal Endograft (VELA), and the Endologix Powerlink with Intuitrak Delivery System (Intuitrak). The company’s EVAR products consist of a cobalt chromium alloy stent covered by expanded polytetrafluoroethylene graft material (Stent Graft) and an accompanying delivery system. Once fixed in its proper position within the abdominal aorta, the company’s EVAR device provides a conduit for blood flow, thereby relieving pressure within the weakened or ‘aneurysmal’ section of the vessel wall, which reduces the potential for the AAA to rupture. The company’s EVAR products consist of its EVAR Stent Graft and catheter delivery system, branded under the names, Powerlink, IntuiTrak, AFX and VELA. EVAS Platform The company’s EVAS product is the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System). The company’s EVAS product consists of bilateral covered stents with endobags, a biocompatible polymer injected into the endobags to seal the aneurysm, and a delivery system and polymer dispenser. The company’s EVAS product seals the entire aneurysm sac, effectively, excluding the aneurysm sac and reducing the likelihood of future aneurysm rupture. Additionally, it has the potential to reduce the need for post procedural re-interventions. EVAR and EVAS Extensions and Accessories Aortic Extensions and Limb Extensions: The company offers proximal aortic extensions and limb extensions, which attach to the ‘main body’ of its EVAR Device, allowing physicians to customize it to fit the patient's anatomy. In 2014, the company launched a new proximal extension in the U.S., VELA, designed primarily for the treatment of proximal aortic neck anatomies. VELA features a circumferential graft line marker and controlled delivery system that enable predictable deployment and final positional adjustments. The company began a commercial introduction of VELA in Europe in January 2015. Accessories: The company offers various accessories to facilitate the optimal delivery of its EVAR products, including compatible guidewires, snares, and catheter introducer sheaths. Marketing and Sales The company markets and sells its products in the U.S. and in 12 Western European countries (the United Kingdom, Ireland, France, Germany, Italy, Portugal, Switzerland, the Netherlands, Austria, Belgium, Luxembourg, and Monaco) through a direct sales force and network of agents. In eight other European countries, Japan, four Latin American countries, and five other Asian countries, the company sold its EVAR products through independent distributors or agents. In 2015, the company marketed its products in 30 countries outside the U.S. The company markets its EVAS products through direct sales, agents and distributor channels in Europe and its independent agent in New Zealand. The U.S.: The company markets and sells its products in the U.S. through a direct sales force. The primary customer and decision maker for its products is the vascular surgeon, and to a lesser extent, the cardiovascular surgeon, interventional radiologist and interventional cardiologist. Through its direct sales force, the company provides clinical support and service to many of the approximately 1,600 hospitals and approximately 4,000 physicians in the U.S. that perform EVAR. Strategy Key elements of the company’s strategy are to focus exclusively on the aorta for the commercialization of innovative products; design and manufacture EVAR and EVAS products that are easy to use and deliver excellent clinical outcomes; design EVAR and EVAS products

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