Endologix (NSDQ:ELGX) is facing a lawsuit from stockholders alleging the company miscommunicated and failed to disclose issues related to its Nellix EVAS stent graft designed for treating abdominal aortic aneurysms. The shareholders filed the suit in the US District Court for the Central District of California, representing individuals who purchased shares between Aug. 2, 2016 and […]
Endologix
Endologix shares dip on Q4, FY2016 miss
Shares in Endologix (NSDQ:ELGX) fell today after the medical device maker missed expectations on Wall Street with its 4th quarter earnings result. The Irvine, Calif.-based company posted losses of $24.9 million, or 30¢ per share, on sales of $47.5 million for the 3 months ended Dec. 31. That equates to growth of losses on the bottom-line […]
Teva Pharma CEO Vigodman steps down | Personnel Moves | February 7, 2017
Teva Pharmaceuticals (NYSE:TEVA) said this week that CEO Erez Vigodman has stepped down from their position at the head of the world’s biggest generic drugmaker. Vigodman’s exit from the company will take effect immediately, with board chair Yitzhak Peterburg taking on the interim role of chief exec. Israel-based Teva has seen shares plummet after a series of […]
Endologix wins CE Mark reinstatement for AFX, AFX2, touts 3-year post market Ovation study
Endologix (NSDQ:ELGX) said today it received notice that the CE Mark approval for its AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately, after being put on hold in early December. The Irvine, Calif.-based company also released 3-year post-market registry data on its Ovation system, designed to treat abdominal aortic aneurysms, touting a […]
Smith & Nephew pulls the trigger on planned CFO succession | Personnel Moves | January 20, 2017
Smith & Nephew (NYSE:SNN) said last week that CFO Julie Brown left the orthopedics & wound care company, after announcing her succession last July. Brown was named finance chief in November 2012 and assumed the role in February the following year. She is moving on to work as chief operating & financial officer for British luxury brand […]
Endologix cuts outlook for 2017
Endologix is reportedly lowering its revenue growth outlook to flat- to low-single digits. The company has previously said it expects mid-single digit growth for 2017. The Irvine, Calif.-based company’s management commented on Endologix’s outlook at the 35th JP Morgan Healthcare Conference, according to a report from Leerink. The company has not made a formal statement regarding its […]
Endologix puts hold on AFX shipments over manufacturing issues
Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices. The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company. The hold came only weeks after Endologix […]
Endologix AFX CE Mark suspended over endoleak issues
Endologix (NSDQ:ELGX) said yesterday that the CE Mark approval of its AFX abdominal aortic aneurysm system will be suspended over reports of type III endoleaks with a previous-gen version of the device. The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company. The Irvine, Calif.-based company […]
Veith 2016 Roundup: Stent grafts take center stage
Medtronic touts Endurant stent graft data from Engage study Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease. First-time results from a review of […]
Endologix shares dive on FDA request for more Nellix data
Endologix (NSDQ:ELGX) shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms. 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 […]
Appeals court denies inventor in patent spat with Endologix pickup TriVascular
A federal appeals court yesterday upheld a lower court’s ruling on the claim construction in a patent infringement dispute between the inventor of a vascular stent patent and Endologix (NSDQ:ELGX) acquisition TriVascular Technologies. In February, the U.S. Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board ruling that the patent was not invalid due to obviousness. […]