enVVeno Medical Corp
For the period ended Dec 10, 2026. Filed Oct 29, 2026.
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Dec 10, 2026 · Filed Oct 29, 2026
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to
Section 14(a) of the Securities Exchange Act of 1934
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Filed by a Party other than the Registrant ☐
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| ☐ | Preliminary Proxy Statement |
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| ☐ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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| ☒ | Definitive Proxy Statement |
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| ☐ | Definitive Additional Materials |
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| ☐ | Soliciting Material Pursuant to §240.14a-12 |
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enVVeno Medical Corporation
(Name of Registrant as Specified in Its Charter)
N/A
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| ☐ | Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11 |
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October 29, 2026
To Our Valued Shareholders:
This has been a year of strategic transition for enVVeno Medical. We redirected our principal development efforts from the VenoValve, our surgical replacement venous valve, to enVVe, our minimally invasive transcatheter replacement venous valve. Our long-term strategy has always been to advance from a surgical therapy to a less invasive option; following the FDA’s not-approvable decision for VenoValve, we accelerated that transition.
The FDA’s not-approvable decision identified three principal concerns: bleeding from the surgical pocket following open surgery, insufficient hemodynamic evidence of effectiveness, and the potential for a Hawthorne or placebo effect to account for observed improvements. The enVVe System and the randomized TAVVE pivotal study were designed to address each of those concerns. First, because enVVe is delivered without open surgery, it is designed to avoid the surgical-pocket bleeding associated with the VenoValve procedure. Second, enVVe’s nitinol frame is intended to allow imaging within the valve itself, enabling direct measurement of regurgitant flow volume as hemodynamic evidence of valve functionality. Third, TAVVE randomizes patients to enVVe or a standard-of-care control arm, and uses blinded rVCSS assessment, objective endpoints, and core-lab adjudication, allowing device effectiveness to be distinguished from potential expectation or observation effects.
Beyond addressing the three FDA concerns, enVVe offers several potential advantages over the first-generation surgical valve:
| 1. | Broader physician base. enVVe is designed for catheter-based delivery, which may allow interventional radiologists and interventional cardiologists, in addition to vascular surgeons, to perform the procedure. |
| 2. | Less invasive care setting. enVVe is designed to be implanted without general anesthesia or an overnight hospital stay. |
| 3. | Enhanced device design. enVVe is designed for improved performance, strength and durability. |
We believe that enVVe’s minimally invasive profile, potential applicability across multiple physician specialties, and large addressable market will also enhance its desireability to large strategic cardiovascular and vascular-device companies. These characteristics are consistent with the attributes that have attracted strategic interest in other innovative, category-creating medical-device businesses.
As our attention turned to enVVe, we continued to do what we do best, which is to execute. In April we received FDA IDE approval for the TAVVE pivotal study. In July, we were issued the first U.S. patent covering the enVVe System, with additional patent applications pending both in the U.S. and internationally. In August we published our health economic study in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, projecting healthcare savings from a replacement venous valve of approximately $32,000 over a five-year period, compared to standard-of-care treatments. These findings will support future discussions with payers regarding coverage and reimbursement for enVVe.
Our team remains focused on advancing enVVe as efficiently as possible. However, a scientifically rigorous pivotal study for a first-in-class medical device requires time and disciplined execution. We invested the time necessary to align with the FDA on key protocol-design considerations, and we will continue to prioritize the quality and integrity of the TAVVE study in order to generate clinically meaningful evidence. Innovative, class-leading cardiovascular technologies have the potential to create long-term value when supported by compelling clinical and economic evidence.
We remain committed to transparent, timely communication with our shareholders. As the TAVVE study advances, we intend to report material clinical, regulatory, and operational milestones in a manner consistent with our commitment to providing meaningful updates. We will also continue to engage directly and accessibly with shareholders through forums, such as the recently launched “WTF Rob Berman” investor series.
Our priorities in 2027 are to activate and enroll TAVVE clinical sites, maintain rigorous trial execution, continue to build the clinical and reimbursement evidence supporting enVVe, and preserve the capital discipline necessary to advance this pivotal program.
Please join us at our upcoming virtual annual meeting, which is scheduled for December 10, 2026 at 9:00 AM PST. Register for the webcast at www.virtualshareholdermeeting.com/NVNO2026.
Sincerely,
Robert A. Berman
Chief Executive Officer
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
To be held on Thursday, December 10, 2026
The 2026 Annual Meeting of Stockholders (the “Meeting”) of enVVeno Medical Corporation (the “Company”) will be held on a virtual basis on Thursday, December 10, 2026 at 9:00 A.M. PST, for the following purposes:
| 1. | To elect Robert C. Gray as a Class III Director of the Company, to hold office until the 2029 Annual Meeting of Stockholders or until his successor is elected and qualified or until his earlier death, incapacity, removal or resignation; |
| 2. | To approve on a non-binding, advisory basis the compensation of our named executive officers; |
| 3. | To ratify the appointment by the Audit Committee of the Company’s Board of Directors of CBIZ CPAs P.C. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026; |
| 4. | To approve the adoption of the enVVeno Medical Corporation 2026 Equity Incentive Plan; and |
| 5. | To transact, in the discretion of the Company’s Board of Directors, such other business as may properly come before the Meeting or any adjournment thereof. |
The Meeting will be a completely virtual meeting of stockholders, which will be conducted via live webcast. You will be able to attend the Meeting online, vote and submit your questions during the Meeting by visitingwww.virtualshareholdermeeting.com/NVNO2026. We are pleased to utilize the virtual stockholder meeting technology to provide ready access and cost savings for our stockholders and the Company. The virtual meeting format allows attendance from any location in the world.
The Board has fixed the close of business on October 16, 2026 as the record date (the “Record Date”) for the determination of stockholders entitled to notice of, and to vote at, the Meeting or any postponement or adjournment thereof. Accordingly, only stockholders of record at the close of business on the Record Date are entitled to notice of, and shall be entitled to vote at, the Meeting or any postponement or adjournment thereof.
We hope you will be able to attend the Meeting. Whether or not you plan on attending the Meeting online, please promptly submit your proxy vote via the Internet, by telephone or by completing, dating, signing and returning the enclosed proxy, so your shares will be represented at the Meeting. Instructions on voting your shares are on the proxy materials you received for the Meeting. Even if you plan to attend the Meeting online, it is strongly recommended you vote before the Meeting date, to ensure that your shares will be represented at the Meeting if you are unable to attend.
Details regarding admission to the Meeting and the business to be conducted at the meeting are more fully described in the accompanying Notice of Meeting of Stockholders and proxy statement.
The Board of Directors unanimously recommends a vote “FOR” the election of the Class III Director, “FOR” the approval, on a non-binding, advisory basis, of the compensation of our named executive officers, “FOR” the ratification of the appointment by the Audit Committee of the Company’s Board of Directors of CBIZ CPAs P.C. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026, and “FOR” the approval of the adoption of the Company’s 2026 Equity Incentive Plan.
This notice and the attached proxy statement are first being disseminated to stockholders on or about October 30, 2026.
BY ORDER OF THE BOARD OF DIRECTORS,
Robert A. Berman, Chief Executive Officer
IMPORTANT
WHETHER OR NOT YOU EXPECT TO ATTEND THE MEETING, PLEASE READ THE PROXY STATEMENT AND PROMPTLY VOTE YOUR PROXY VIA THE INTERNET, BY TELEPHONE OR, IF YOU RECEIVED A PRINTED FORM OF PROXY IN THE MAIL, BY COMPLETING, DATING, SIGNING AND RETURNING THE ENCLOSED PROXY IN ORDER TO ASSURE REPRESENTATION OF YOUR SHARES AT THE MEETING. YOUR PROXY, GIVEN THROUGH THE RETURN OF THE PROXY CARD, MAY BE REVOKED PRIOR TO ITS EXERCISE BY FILING WITH OUR CORPORATE SECRETARY PRIOR TO THE MEETING A WRITTEN NOTICE OF REVOCATION OR A DULY EXECUTED PROXY BEARING A LATER DATE, OR BY ATTENDING THE MEETING AND VOTING.
IF YOU HAVE ALREADY VOTED OR DELIVERED YOUR PROXY FOR THE MEETING, YOUR VOTE WILL BE COUNTED, AND YOU DO NOT HAVE TO VOTE YOUR SHARES AGAIN. IF YOU WISH TO CHANGE YOUR VOTE, YOU SHOULD REVOTE YOUR SHARES.
IF YOU RETURN YOUR PROXY CARD WITHOUT AN INDICATION OF HOW YOU WISH TO VOTE, YOUR SHARES WILL BE VOTED IN FAVOR OF EACH OF THE DIRECTOR NOMINEES, THE APPROVAL ON A NON-BINDING, ADVISORY BASIS OF THE COMPENSATION OF OUR NAMED EXECUTIVE OFFICERS, THE RATIFICATION OF THE APPOINTMENT OF THE AUDITOR AS THE COMPANY’S INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM FOR THE FISCAL YEAR ENDING DECEMBER 31, 2026, AND THE APPROVAL OF THE ADOPTION OF THE COMPANY’S 2026 EQUITY INCENTIVE PLAN.
IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE MEETING: THE PROXY STATEMENT, OUR FORM OF PROXY CARD, AND OUR ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 ARE AVAILABLE ON THE INTERNET AT HTTPS://ENVVENO.COM/SEC-FILINGS/ OR AT THE SEC’S WEBSITE AT HTTP://WWW.SEC.GOV.
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