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 29, 2014

 

InspireMD, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

  

001-35731

  

26-2123838

(State or other jurisdiction
of incorporation)		   (Commission File Number)   (IRS Employer
Identification No.)
     

 

321 Columbus Avenue

Boston, Massachusetts

  

02116

(Address of principal executive offices)   (Zip Code)

 

 

Registrant’s telephone number, including area code: (857) 453-6553 

(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))

 

 

 
 

Item 8.01 Other Events.

 

On October 29, 2014, InspireMD, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has approved the Company’s submitted investigational device exemption amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company’s April 30, 2014 voluntary field action.

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press release dated October 29, 2014

 

 

 
 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

  inspiremd, inc.
   
   
   
Date: October 29, 2014 By:  /s/ Craig Shore  
   

Name: Craig Shore

Title: Chief Financial Officer