Endologix Falls On 2-Year Follow-Up Request

News Behind the Move

The FDA, the drug watchdog, isn't apparently happy with the clinical trial results of its EVAS FORWARD-IDE study for Nellix. The Nellix EVAS System is the company's investigational device to seal the entire abdominal aortic aneurysm sac developed to reduce all types of endoleaks and improve long-term patient outcomes.

Only in late May did the company announce that the study met both primary and secondary end points for major adverse events at 30 days and treatment success at one year. The company had said then the results from the study was submitted to the FDA for securing pre-market approval and that it expects potential FDA approval at the end of 2016 or early 2017.

FORWARD Study Issues Push Approval Backward

Through a Global Newswire release, the company revealed that the FDA has sought two-year patient follow-up data from the EVAS-FORWARD IDE Study. The company said it expects to make the data available to the FDA in the second quarter of 2017, with a possible FDA advisory panel meeting now scheduled for the end of 2017.

As against an end-of-2016 or early 2017 approval, the company now has to wait till the second quarter of 2018 for the PMA approval.

Separately, the company also announced positive five-year safety and effectiveness clinical data from the global Ovation Pivotal Trial at the 2016 VEITH symposium. Among the key highlights mentioned by the company were broad patient applicability, stable aortic neck diameters and no migration and conversion.

At last check, shares of Endologix were down 22.76 percent at $7.60.