Endologix Inc. (NASDAQ: ELGX) saw its shares hit a multiyear low following a meeting with the U.S. Food and Drug Administration (FDA). After this meeting, the company provided an update that its timeline for the Nellix Endovascular Aneurysm Sealing System (EVAS) may be longer than once thought.
Based on the FDA meeting and other internal analysis, the company has decided to seek U.S. approval of the Nellix EVAS by conducting a confirmatory clinical study with the previously updated Instructions for Use (IFU) and the Gen2 device design, which is currently sold in Europe and other international markets.
Going forward, Endologix will collaborate with the FDA over the coming months on the confirmatory clinical study protocol and anticipates beginning patient enrollment in the fourth quarter of this year with PMA approval estimated to occur in 2020.
John McDermott, CEO of Endologix, commented:
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.
After this, the company was sure to note that positive clinical outcomes with the Nellix EVAS will be reported at upcoming medical meetings, later this month and in early June.
Excluding this massive move, the stock was actually up year to date about 18%. Although, over the past 52 weeks the stock was down 43%.
Shares of Endologix were last seen down 37% at $4.25, with a consensus analyst price target of $7.94 and a 52-week trading range of $4.20 to $14.50.