The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021.
The forecast is based on current enrollment rates in the company’s EVAS2 clinical confirmatory study “and other factors,” according to an SEC filing.
Endologix won FDA investigational device exemption for a clinical trial of the Nellix last October, after the federal safety watchdog earlier that year asked for two-year follow-up data on the device.
Last May ELGX shares plunged more than 30% after Endologix revealed that meetings with the FDA and “further internal analysis” “led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed in November 2016 when the federal safety watchdog asked for two-year follow-up data from the EVAS-Forward investigational device exemption study.
Endologix won CE Mark approval in the European Union for Nellix back in 2012, less than 2 years after acquiring its namesake company in an all-stock transaction.