Form 8-K

8-K — enVVeno Medical Corp

Accession: 0001493152-26-019485

Filed: 2026-04-29

Period: 2026-04-29

CIK: 0001661053

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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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): April 29, 2026

enVVeno

Medical Corporation

(Exact

name of registrant as specified in its charter)

Delaware

001-38325

33-0936180

(State

or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification No.)

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 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 ☐

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.

April 29, 2026, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) announced

that the Company received notification from the FDA that it had approved the Company’s IDE application, authorizing the Company

to commence a study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal

study will evaluate the Company’s minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency

(CVI). The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety

results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout

the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will

begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients

receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from

the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE

study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional

cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible

to file for FDA post-marketing approval.

Key

features of enVVe system include:

● Minimally

invasive procedure requiring no general anesthesia or overnight hospital stay;

● Self-expanding

frame made from a specially formulated biocompatible nickel and titanium alloy;

● Frame

geometry that accommodates the natural dilation and contraction of the vein;

● 3

enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;

● Unique,

mono-cusp leaflet design that is laser cut from porcine pericardium tissue;

● Delivery

profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement

valve currently in use for the cardiovascular system; and

● Delivery

via an over-the-wire, coaxial, single-stage pull system for ease of use.

Please

refer to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 for more information regarding the

enVVE System, including, without limitation, the section entitled “Risk Factors” therein.

Additionally,

on April 29, 2026, the Company announced that as of March 31, 2026, the Company had approximately $25 million cash and investments on

hand which is expected to fund operations into the third quarter of 2027.

Item

2.02 Results of Operations and Financial Condition.

The

statements concerning the Company’s cash position as of March 31, 2026 are incorporated by reference into this Item 2.01.

Item

7.01 Regulation FD Disclosure.

April 29, 2026, the Company issued a press release announcing the Company had received a favorable decision from the U.S. Food &

Drug Administration in connection with the Company’s Investigational Device Exemption application for the Transcatheter Venous

Valve Endoprosthesis (TAVVE®) pivotal study. The press release is being furnished as Exhibit 99.1 to this Current 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 the enVVe System and our TAAVE pivotal study, 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:

April 29, 2026

/s/

Robert A. Berman

Robert

A. Berman

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

enVVeno

Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous Valve

First-in-Class

enVVe system to be evaluated in TAVVE U.S. Pivotal Trial

Clinical

site activation and patient enrollment expected to commence later this year

Large

unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous Insufficiency

Potential

multi-billion-dollar untapped U.S. market

Company

has approximately $25 million in cash and investments to fund operations into Q3 2027

IRVINE,

Calif. – April 29, 2026 – enVVeno Medical Corporation (Nasdaq: NVNO) (“enVVeno” or the “Company”),

a company setting new standards of care for the treatment of deep venous disease, today announced that the U.S. Food and Drug Administration

(FDA) has awarded the Company the first-ever IDE approval to proceed with a U.S. pivotal study of a non-surgical replacement venous valve.

The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company’s minimally invasive

enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI).

This

IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million

U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

“We

have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to

see in evaluating the safety and efficacy of enVVe and that we are in complete alignment,” said Robert Berman, enVVeno Medical’s

Chief Executive Officer. “We have also been busy speaking with clinical sites that are interested in participating in the TAVVE

study. A transcatheter-based non-surgical replacement venous valve has always been considered the “holy-grail” for patients

with severe CVI and the interest and enthusiasm among physicians and their clinical teams has been extremely high. We are excited to

be able to officially start the process of selecting and activating clinical sites and look forward to the first implantation procedure

using the enVVe System.”

About

the TAVVE Study

The

first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results

will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study,

and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately

after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the

enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients

who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll

patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists.

One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA

post-marketing approval.

Key

features of enVVe system include:

● Minimally

invasive procedure requiring no general anesthesia or overnight hospital stay;

● Self-expanding

frame made from a specially formulated biocompatible nickel and titanium alloy;

● Frame

geometry that accommodates the natural dilation and contraction of the vein;

● 3

enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;

● Unique,

mono-cusp leaflet design that is laser cut from porcine pericardium tissue;

● Delivery

profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement

valve currently in use for the cardiovascular system; and

● Delivery

via an over-the-wire, coaxial, single-stage pull system for ease of use.

enVVeno

also announced that as of March 31, 2026, the Company had approximately $25 million cash and investments on hand which is expected to

fund operations into the third quarter of 2027.

About

CVI

Deep

venous CVI occurs when insufficient blood is returned to the heart and lungs from the lower leg. The disease is most often caused by

blood clots (deep vein thromboses or DVTs) resulting in permanently damaged valves in the deep veins of the leg. When valves inside the

deep veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg

to increase (venous hypertension).

Symptoms

of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease

can severely impact everyday functions such as sleeping, bathing, dressing and walking, and is known to result in high rates of depression

and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates

indicate that there are approximately 3 million patients in the U.S. with severe deep venous CVI, costing the U.S. healthcare system

in excess of $20 billion each year.

About

enVVeno Medical Corporation

enVVeno

Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative

bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently

developing enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe

deep Chronic Venous Insufficiency (CVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the

leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation

and should not require an over-night hospital stay.

Cautionary

Note on Forward-Looking Statements

This

press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the

“Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements”

within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks

and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,”

“will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,”

“estimates,” “intends,” “plans,” “potential” or similar expressions. These statements

are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties,

including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results and timing (may differ

significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and

uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company

undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations

or otherwise, except as required by applicable law.

INVESTOR

CONTACT:

JTC Team, LLC

Jenene

Thomas

NVNO@jtcir.com

(908)

824-0775

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