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): July 17, 2017
SECOND SIGHT MEDICAL PRODUCTS, INC. | |||||
(Exact Name of Registrant as Specified in Its Charter) | |||||
California | |||||
(State or Other Jurisdiction of Incorporation) | |||||
333-198073 | 02-0692322 | ||||
(Commission File Number) | (IRS Employer Identification No.) | ||||
12744 San Fernando Road, Suite 400 | |||||
(Address of Principal Executive Offices) | |||||
(818) 833-5000 | |||||
(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 (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))
Item 8.01 Other Events
On July 17, 2017, Second Sight Medical Products, Inc. (the “Company”) submitted an application for an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) for approval to conduct an early feasibility study of its OrionTM Cortical Visual Prosthesis System in a clinical trial of up to five patients. It is typical for an IDE application to involve several rounds of question and answer interactions with the FDA. Timing of the review and FDA approval process is unpredictable and no assurance can be given as to when the Company will receive an IDE for the planned Orion feasibility study.
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.
Date: July 17, 2017
SECOND SIGHT MEDICAL PRODUCTS, INC.
/s/ Thomas B. Miller | |
By: Thomas B. Miller | |
Chief Financial Officer |