Endologix
ENDOLOGIX INC /DE/ (Form: 8-K, Received: 10/06/2017 08:31:18)


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 6, 2017
 

ENDOLOGIX, INC.
(Exact name of registrant as specified in its charter)
 

 
 
 
Delaware
(State or other jurisdiction of
incorporation)
000-28440
(Commission File Number)
68-0328265
(IRS Employer
Identification No.)
 
 
 
2 Musick
Irvine, California
(Address of principal executive offices)
 
92618
(Zip Code)
(949) 595-7200
Registrant’s telephone number, including area code


(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).                  Emerging growth company o                          
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o






Item 8.01 Other Events.
On October 6, 2017, Endologix, Inc. (the “Company”) issued a press release announcing that it received Investigational Device Exemption approval from the United States Food and Drug Administration to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix ® EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d)      Exhibits.
 
Exhibit
Number
 
Description
 
 
Press Release dated October 6, 2017.













SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ENDOLOGIX, INC.
Date: October 6, 2017                  /s/ Vaseem Mahboob             
Vaseem Mahboob
Chief Financial Officer



Exhibit 99.1             

LOGOA07.JPG     
                                        
    
INVESTOR CONTACT:
 
Endologix, Inc.

 
Vaseem Mahboob, CFO

 
(949) 595-7200

 
                
Endologix Receives IDE Approval for the EVAS2 Confirmatory Clinical Study to Evaluate the Nellix ® EndoVascular Aneurysm Sealing System


IRVINE, California, October 6, 2017. Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System ("EVAS") for the endovascular treatment of infrarenal abdominal aortic aneurysms. The EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study (“EVAS2”) will prospectively evaluate the refined Indications for Use (IFU) 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 (PMA).
The Nellix EVAS system is an endovascular abdominal aortic aneurysm ("AAA") 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, Chief Executive Officer 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."

About Endologix
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the U.S. For more information, visit  www.endologix.com

The Nellix ® EndoVascular Aneurysm Sealing System has obtained CE Mark in the EU and is only approved as an investigational device in the United States.
                                                                            
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” "continue," "outlook," “guidance,” "future,” other words of similar meaning and the use of future dates. Forward-looking statements used in this press release include, but are not limited to, statements regarding the anticipated enrollment, progress and results of Endologix’s EVAS2 confirmatory clinical study (including enrollment timeline), Endologix’s ability to obtain regulatory approval of the Nellix EVAS System within currently anticipated timeframes, and future commercial availability of the Nellix EVAS System, the accuracy of which are necessarily subject to risks and uncertainties that may cause Endologix’s actual results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ materially and adversely from anticipated results include Endologix’s ability to continue integrating the businesses and operations of, and to realize the expected benefits of its merger with, TriVascular, continued market acceptance, endorsement and use of Endologix's products (including market acceptance and adoption of the Nellix EVAS System with its refined IFU), risks associated with the manufacturing of Endologix’s products, the success of clinical trials relating to Endologix’s products (including the clinical results of the EVAS2 study), product research and development efforts, uncertainty in the process of obtaining and maintaining U.S. FDA and other regulatory approvals for Endologix's products, risks associated with international operations, including currency exchange rate fluctuations, Endologix’s ability to protect its intellectual property rights and proprietary technologies, and other economic, business, competitive and regulatory factors. Undue reliance should not be placed upon the forward-looking statements contained in this press release, which speak only as of the date of this press release. Endologix undertakes no obligation to update any forward-looking statements contained in this press release to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2016, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.