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News Breaks
June 17, 2014
09:06 EDTELGXEndologix announces revenue milestone for Nellix EndoVascular System
Endologix announced that it has achieved $10M in trailing twelve month international sales of the Nellix EndoVascular Aneurysm Sealing System, triggering a milestone payment to the former Nellix stockholders, in the form of 2,666,555 shares of Endologix common stock. Based on the company's 2010 acquisition agreement for Nellix, the revenue milestone triggered a $20M payment in Endologix common stock to former Nellix stockholders. The stock price used to calculate the share payment is subject to a floor of $3.50 and a ceiling of $7.50. Accordingly, because Endologix's stock price is currently above the $7.50 ceiling, the company will issue 2,666,555 shares by the end of June. Nellix has obtained CE Mark and is currently undergoing a U.S. Investigational Device Exemption trial to establish clinical evidence for U.S. Food and Drug Administration approval. The U.S. study, EVAS FORWARD-IDE is approved to enroll 180 patients at up to 30 sites in the U.S., Canada and Europe. The EVAS FORWARD Global Registry is planned to include 300 patients enrolled in up to 30 international centers. Nellix has not been approved for marketing or commercial sale in the U.S.
News For ELGX From The Last 14 Days
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November 21, 2014
07:16 EDTELGXEndologix trial results 'highly encouraging,' says Stifel
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November 20, 2014
07:13 EDTELGXCanaccord to hold a forum
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November 18, 2014
11:00 EDTELGXEndologix to host investor meeting
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07:11 EDTELGXEndologix completes patient enrollment in Nellix EVAS FORWARD-IDE clinical trial
Endologix announced that it has completed patient enrollment in the EVAS FORWARD-IDE clinical trial, the company's U.S. pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms, or AAA. Primary endpoint analysis results at one-year and beyond will be used to support the company's premarket approval, or PMA, application to the FDA for the Nellix EVAS System. The EVAS FORWARD-IDE clinical trial enrolled 179 patients at 29 centers in the U.S. and Europe. Enrollment under an extended investigation phase is anticipated to begin shortly and will continue during the pivotal trial follow-up period and PMA preparation/review process. Based on current assumptions and timelines, the company anticipates FDA approval of the Nellix System in the U.S. before the end of 2016.

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