Is There Hope for an Endologix Comeback?

A year ago, Endologix CEO John McDermott walked into the VEITHsymposium at the New York Hilton-Midtown, saw the look on the face of his head of regulatory and clinical affairs as he approached the Endologix booth, and knew something was wrong. Sure enough, FDA had just asked Endologix to provide two-year patient follow-up data from its EVAS-FORWARD study of the Nellix endovascular aneurysm sealing (EVAS) system. "So that night we worked through the night to get out our press release first thing the next morning to inform the world that there was going to be pushback in the timeline and the clinical requirements," McDermott said. "So that was a bit of a tough week." Shares tumbled nearly 24% on double normal volume after the delay was announced. Unfortunately, that rough week was the beginning of a rough month.    Endologix CEO John McDermott at Stifel Healthcare Conference, according to SeekingAlpha transcripts: Followed unfortunately, couple of weeks later, we had our CE Mark spend it for the AFX product and that was a result of legacy version of that device and some clinical complaints that were reported to the notified body. They didn't distinguish between the old version and the new version of the device, so they put the entire product line on hold. And then, to finish the year we ran into a manufacturing challenge in our Ervin manufacturing plant and had to temporarily suspend the manufacturing of AFX, so that all happened in about 30-day period of time that was a pre...
Source: MDDI - Category: Medical Devices Authors: Tags: Medical Device Business Source Type: news