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ELGX

Endologix

$5.70

0.05 (0.88%)

08:01
10/06/17
10/06
08:01
10/06/17
08:01

Endologix receives IDE approval for EVAS2 study to evaluate Nellix system

Endologix announced that it has received Investigational Device Exemption approval from the FDA to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System, or EVAS, for the endovascular treatment of infrarenal abdominal aortic aneurysms. The EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study will prospectively evaluate the refined Indications for Use and the Nellix Gen2 EVAS System. The study is approved to enroll up to 90 primary patients, with one-year follow-up data required for the Pre-market Approval Application. The Nellix EVAS system is an endovascular abdominal aortic aneurysm therapy designed to seal the entire aneurysm. Nellix is the first and only EVAS product developed as an alternative treatment approach to traditional EVAR devices. John McDermott, CEO for Endologix, said, "We are pleased to receive IDE approval from the FDA to begin this confirmatory study and look forward to collaborating with the investigators to achieve the goal of commencing enrollment by the end of this year. Based on the anticipated enrollment timeline, one-year follow up period, and regulatory review process, we continue to estimate PMA approval in 2020."

ELGX Endologix
$5.70

0.05 (0.88%)

05/18/17
05/18/17
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Symantec (SYMC) downgraded to Neutral from Buy at UBS with analyst Fatima Boolani citing a more balanced risk/reward. 2. Jack in the Box (JACK) downgraded to Sector Weight from Overweight at KeyBanc and to Market Perform from Outperform at Telsey Advisory. 3. Grainger (GWW) downgraded to Sell from Hold at Deutsche Bank with analyst John Inch saying the company is "positioned to quickly lose share" as competitors respond with price cuts of their own. 4. Stratasys (SSYS) downgraded to Hold from Buy at Jefferies with analyst James Kisner citing the recent rally in the shares and uncertainty around the timing of new manufacturing opportunities. The analyst raised his price target for the stock to $30 from $24 following the company's first quarter results. 5. Endologix (ELGX) was downgraded to Equal Weight from Overweight at Stephens, to Neutral from Buy at BTIG, and to Hold from Buy at Stifel. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
05/18/17
SPHN
05/18/17
DOWNGRADE
Target $6
SPHN
Equal Weight
Endologix downgraded to Equal Weight from Overweight at Stephens
Stephens analyst Chris Cooley downgraded Endologix to Equal Weight from Overweight after the company announced that its Nellix plans are delayed again and it will now seek U.S. approval of the Nellix EVAS System by conducting a confirmatory clinical study with its Gen2 device design. Cooley cut his price target on Endologix shares to $6 from $10.
05/18/17
OPCO
05/18/17
DOWNGRADE
Target $5.5
OPCO
Perform
Endologix downgraded to Perform from Outperform at Oppenheimer
Oppenheimer analyst Steven Lichtman downgraded Endologix to Perform and lowered his price target for the shares to $5.50 from $10. The downgrade follows the company's announcement that it willseek U.S. approval of the Nellix EVAS System by conducting a confirmatory clinical study. BTIG and Stifel this morning also downgraded Endologix.
05/18/17
BTIG
05/18/17
DOWNGRADE
BTIG
Neutral
Endologix downgraded on new trial at BTIG
As noted earlier, BTIG downgraded Endologix to Neutral from Buy. Analyst Sean Lavin downgraded the stock after the company announced that following its meeting with the FDA it will not seek approval of its first generation Nelix device and will instead seek approval of its second generation Nelix device. Lavin notes that an additional clinical trial will have to be performed on the second generation device before it can be approved. He does not expect the device to reach the U.S. market until 2020. Target $7.

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