enVVeno Medical Corp
For the period ended Dec 11, 2025. Filed Oct 30, 2025.
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Dec 11, 2025 · Filed Oct 30, 2025
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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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| ☒ | 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
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October 30, 2025
To Our Valued Shareholders:
As you read this letter, our appeal to over-turn the not-approvable decision to market and sell the VenoValve in the United States is pending before the U.S. Food and Drug Administration (FDA). Our formal request for the supervisory appeal (and supporting brief) was filed on September 18, 2025, and notwithstanding the government shut-down, we have completed our in-person meeting with the FDA. We are on track to hear from the FDA about this stage of the appeal process by the end of 2025.
In addition to our representatives from DuVal & Associates, our team at the Agency meeting included a patient from VenoValve U.S. pivotal study as well as one of our primary investigators from the trial. Several employees from the FDA attended the meeting including the Director of the Center for Devices and Radiological Health, who elected to hear the appeal and who will be issuing the appeal decision.
The FDA meeting provided us with the opportunity to put the major adverse events—those tied to the SAVVE study’s safety endpoints—into the proper context. It also allowed us to re-emphasize the multiple physician-and patient-reported clinical benefits that comprise the totality of the evidence from the study, supported by firsthand perspectives shared by both the SAVVE study patient and investigator in attendance.
Because there are no established industry or regulatory standards to determine the effectiveness for a replacement venous valve, it is necessary for the Sponsor and the Agency to establish a new regulatory pathway for VenoValve effectiveness. We worked collaboratively with the FDA over the past several years to help ensure that we were collecting the necessary data to support effectiveness of the VenoValve and that dialogue with respect to effectiveness is continuing as part of this appeal.
There are often multiple ways to satisfactorily address a given regulatory issue, and at the meeting, we presented evidence from an alternative effectiveness pathway for VenoValve, supported by data already collected in SAVVE. Although the subject of this appeal and the FDA meeting is specific to the VenoValve, the appeal does also have implications for enVVe, our next generation transcatheter replacement venous valve, and as a result, we are waiting for clarity from the FDA prior to filing the enVVe IDE application.
Support from the physician and patient communities for the VenoValve and our company continues to be strong. We look forward to receiving clarity from the FDA on a path forward for both the VenoValve and enVVe and remain committed to bringing relief to the 2.5 to 3.5 million patients suffering from deep venous CVI in the U.S. and who have no effective treatment options.
Please join us at our upcoming virtual annual meeting, which is scheduled for December 11, 2025 at 9:00 AM PST.
Sincerely,
Robert A. Berman
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
To be held on Thursday, December 11, 2025
The 2025 Annual Meeting of Stockholders (the “Meeting”) of enVVeno Medical Corporation (the “Company”) will be held on a virtual basis on Thursday, December 11, 2025 at 9:00 A.M. PST, for the following purposes:
| 1. | To elect Matthew M. Jenusaitis and Robert A. Berman as Class II Directors of the Company, to hold office until the 2028 Annual Meeting of Stockholders or until their successors are elected and qualified or until their 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, 2025; |
| 4. | To approve the adoption of the enVVeno Medical Corporation 2025 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/NVNO2025. 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 17, 2025 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 II Directors, “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, 2025, and “FOR” the approval of the adoption of the Company’s 2025 Equity Incentive Plan.
This notice and the attached proxy statement are first being disseminated to stockholders on or about October 31, 2025.
BY ORDER OF THE BOARD OF DIRECTORS,
Robert A. Berman,
Chief Executive Officer
October 30, 2025
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, 2025, AND THE APPROVAL OF THE ADOPTION OF THE COMPANY’S 2025 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, AS AMENDED, FOR THE FISCAL YEAR ENDED DECEMBER 31, 2024 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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