Irvine, Calif.-based Endologix said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of 2017, pushes potential pre-market approval from the FDA back to the 2nd quarter of 2018, Endologix said.
Investors reacted by pushing ELGX shares down -24.5% to $7.43 apiece today in mid-morning trading.
“We’re disappointed by these requirements and the resulting delay, but encouraged by the 2-year clinical outcomes we have seen so far with Nellix under our newly revised instructions for use. We remain committed to EVAS with Nellix and have demonstrated outstanding clinical results in selected patients with both traditional and complex AAA anatomies. We look forward to providing this important new technology to physicians and patients in the U.S. and other markets as soon as possible,” CEO John McDermott said in prepared remarks.
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.