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EX-99.1 - EXHIBIT 99.1 - Conformis Incex991.htm



 

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): June 20, 2017
 

ConforMIS, Inc.
(Exact Name of Company as Specified in Charter)
 

Delaware
 
001-37474
 
56-2463152
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

600 Technology Park Drive
Billerica, MA 01821
(Address of Principal Executive Offices) (Zip Code)

Company’s telephone number, including area code: (781) 345-9001

(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):

¨
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))
þ
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.
þ

 






Item 8.01
Other Events.


On June 14, 2017, ConforMIS, Inc. (the “Company”) received 510(k) clearance from the U.S. Food and Drug Administration to market the iTotal Hip, the Company’s primary total hip replacement implant system. On June 20, 2017, the Company issued a press release announcing the 510(k) clearance. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.


Item 9.01
Financial Statements and Exhibits.


(d)
Exhibits.


Exhibit No.
Description

99.1*
Press Release of ConforMIS, Inc., dated June 20, 2017


*Furnished herewith




 







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.
 
 
 
 
 
 
 
 
 
 
 
 
CONFORMIS, INC.
 
 
 
 
Date: June 20, 2017
 
 
 
By:
 
/s/Paul Weiner
 
 
 
 
 
 
Paul Weiner
 
 
 
 
 
 
Chief Financial Officer