UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On June 13, 2024, Vivani Medical, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold and cleared the Company to initiate the LIBERATE-1TM Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the Company’s miniature, six-month GLP-1 implant in development for treatment of type 2 diabetes. A copy of the press release issued in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release issued by Vivani Medical, Inc. on June 13, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 thereunto duly authorized.
| VIVANI MEDICAL, INC. | ||
| Date: June 13, 2024 | By: | /s/ Brigid A. Makes |
| Name: | Brigid A. Makes | |
| Title: | Chief Financial Officer |