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): September 14, 2016
GI DYNAMICS, INC.
(Exact name of registrant as specified in its charter)
| | | | |
| Delaware | | 000-55195 | | 84-1621425 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
355 Congress Street
Boston, MA 02210
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (781) 357-3300
25 Hartwell Avenue
Lexington, MA 02421
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)) |
On September 13, 2016, GI Dynamics, Inc. (the “Company”) issued a press release advising that the Company received email correspondence advising that the Medical Device Branch of the Australian Therapeutic Goods Administration (“TGA”) has recommended that the Company’s EndoBarrier device inclusion on the Australian Register of Therapeutic Goods (“ARTG”) be cancelled.
On September 14, 2016, GI Dynamics, Inc. (the “Company”) issued a press release indicating that the Company received formal notification from the TGA of the cancellation of EndoBarrier device’s inclusion on the ARTG taking effect on October 12, 2016.
The full text of the September 13, 2016 and September 14, 2016 press releases are attached as Exhibit 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
See Exhibit Index attached hereto, which is incorporated by reference herein.
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.
| | | | | | |
| | | | | | GI DYNAMICS, INC. |
| | | |
| Dated: September 14, 2016 | | | | | | /s/ James Murphy |
| | | | | | James Murphy |
| | | | | | Chief Financial Officer |
EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| |
| 99.1 | | Press release issued by the Company on September 13, 2016. |
| |
| 99.2 | | Press release issued by the Company on September 14, 2016. |
