Form 8-K ENDOLOGIX INC /DE/ For: Aug 10

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): August 10, 2018

ENDOLOGIX, INC.

(Exact name of registrant as specified in its charter)

2 Musick, Irvine, CA 92618

(Address of principal executive offices, with zip code)

(949) 595-7200

(Registrant’s telephone number, including area code)

N/A

(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 (see General Instruction A.2. below):

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  ☐

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.  ☐

Item 8.01 Other Events.

Endologix, Inc. (the “Company”) has updated its currently estimated timeline for anticipated U.S. Food and Drug Administration (“FDA”) approval of the Company’s premarket approval (“PMA”) application for its Nellix 3.5 endovascular aneurysm sealing system. Based on current enrollment rates in the Company’s EVAS2 clinical confirmatory study and other factors, the Company estimates that FDA’s approval determination will occur in the first half of 2021.

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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.

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