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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): November 13, 2025
enVVeno
Medical Corporation
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-38325 |
|
33-0936180 |
| (State
or other jurisdiction |
|
(Commission
|
|
(I.R.S.
Employer |
| of
incorporation) |
|
File
Number) |
|
Identification
No.) |
70
Doppler
Irvine,
California 92618
(Address
of principal executive offices) (Zip Code)
(949)
261-2900
(Registrant’s
telephone number, including area code)
N/A
(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 $0.00001 per share |
|
NVNO |
|
The
NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in 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. ☐
Item
7.01 Regulation FD Disclosure.
On
November 13, 2025, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”)
issued a press release announcing the Company had received an unfavorable appeal decision from the U.S. Food & Drug Administration
in response to its Premarket Approval application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic
venous insufficiency. The press release is being furnished as Exhibit 99.1 to this report.
Statements
that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning
future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,”
“anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such
forward-looking statements, including those concerning our clinical trials, involve risks, uncertainties and other factors, some of which
are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different
from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties
and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections
of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake
no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented
in this Current Report.
Item
9.01 Financial Statements and Exhibits.
Set
forth below is a list of Exhibits included as part of this Current Report:
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
| |
ENVVENO
MEDICAL CORPORATION |
| |
|
| Dated:
November 13, 2025 |
/s/
Robert A. Berman |
| |
Robert
A. Berman |
| |
Chief
Executive Officer |
