For the first quarter of 2016, Endologix, Inc.’s revenue increased 16 percent to $42.4 million compared with the same period last year. The company also reported a net loss of $47.7 million for the quarter and a negative adjusted EBITDA of $14.1 million.
Endologix, which develops treatments for aortic disorders, completed its merger with TriVascular Technologies, Inc. on Feb. 3. The company also announced on Feb. 29 that a vascular surgeon at Maine Medical Center had implanted the first AFX2 bifurcated endograft system in the U.S.
In October 2015, the FDA approved the AFX2 bifurcated endograft system to treat abdominal aortic aneurysms.
Endologix CEO John McDermott said in a news release that the company plans on hearing from the FDA later this year or next year on the approval of the Nellix endovascular aneurysm sealing system. The Nellix received a CE Mark in April.
McDermott said in a conference call with analysts that Endologix will present the one-year results of the U.S. investigational device exemption trial involving the Nellix system on June 11 at the Society for Vascular Surgery annual meeting.
During the first quarter, U.S. revenue increased 19 percent to $29.9 million, while the company’s gross margin of 66.0 percent was down from 73.4 percent in the first quarter of 2015.
Endologix also provided guidance for the full year of 2015. The company expects revenue of $192 million to $202 million, a GAAP loss of $1.20 to $1.30 per share and an adjusted loss of $0.70 to $0.80 per share.
Endologix also has the FDA-approved Ovation abdominal stent graft platform to treat a wide range of anatomies for endovascular aortic repair.