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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 26, 2024


 

 

Vivani Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

 

 

 

 

 

Delaware

 

001-36747

 

02-0692322

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

1350 S. Loop Road

Alameda, California 94502

(Address of principal executive offices, including zip code)

 

(415) 506-8462

(Telephone number, including area code, of agent for service)

 

(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))

 Securities registered pursuant to Section 12(b) of the Act:

 

 

 

 

 

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

VANI

 

Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934240.12b-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.




Item 8.01 Other Events.

 

On September 26, 2024, Vivani Medical, Inc. (the “Company”) announced it received regulatory approval to initiate a first in human clinical trial, known as the LIBERATE-1™, with the Company’s GLP-1 (exenatide) implant in obese and overweight individuals in Australia. 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 September 26, 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: September 26, 2024

By:

/s/ Donald Dwyer

 

Name:

Donald Dwyer

 

Title:

Chief Business Officer