Endologix Reveals Positive Clinical Data From Nellix EVAS FORWARD-IDE Study

Endologix, Inc.

revealed positive clinical data from the Nellix investigational device exemption (IDE) clinical study, the EVAS FORWARD-IDE Study. According to the company, this multicenter, prospective, single arm clinical study is meant to assess the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms ("AAA"). Endologix said that the data from the EVAS FORWARD-IDE study illustrated that the Nellix EVAS System met the study primary endpoints for major adverse events at 30 days (safety) and Treatment Success at one year (effectiveness). The key highlights from the EVAS FORWARD-IDE study clinical data included 150 patients in the pivotal cohort getting treatment at 30 centers in the US and Europe between January and November 2014. The company's chairman of Surgery for Cooper Medical School, Jeffrey Carpenter, commented, "We are very pleased to report that the EVAS FORWARD-IDE Study met its primary safety and effectiveness endpoints. The 1-year results are highly encouraging and demonstrate that low overall endoleaks can reduce secondary interventions. This is an important milestone towards achieving FDA approval and making the Nellix aneurysm sealing technology available to AAA patients in the United States." Endologix disclosed that the results from the EVAS FORWARD-IDE Study were submitted to the FDA as part of its premarket approval (PMA) submission for Nellix EVAS System. The Company indicated that it remained on track to get potential FDA approval for the Nellix EVAS System at the end of the current year or early 2017. Shares of the company traded 3.55 percent higher on Thursday.