Irvine, Calif.-based Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when the federal safety watchdog asked for 2-year follow-up data from the EVAS-Forward investigational device exemption study.
Endologix said yesterday that the confirmatory study will aim to cover the existing instructions for use for Nellix and for the Gen2 device that’s already on the market in Europe. Pending consultations with the FDA, the company said it expects to begin enrolling patients during the 4th quarter with pre-market approval expected in 2020.
“While the timeline has shifted from our projections, we appreciate the FDA’s collaboration as Nellix EVAS proceeds in the regulatory process. We have evidence that our previously updated Nellix IFU provides excellent patient outcomes and look forward to starting the confirmatory clinical study with our Gen2 device. We appreciate the support of our physicians worldwide and their continued collaboration in developing new technologies and conducting clinical studies to provide the best outcomes for patients with abdominal aortic aneurysms,” CEO John McDermott said in prepared remarks.
ELGX shares closed down -1.0% at $6.73 apiece yesterday, plunging another -30.1% to $4.70 each in pre-market trading before dropping -34.3% to $4.42 per share in early trading.
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.