enVVeno Medical Corp

DEF 14A 1 ny20034132x1_def14a.htm DEF 14A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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enVVeno Medical Corporation

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November 19, 2024

To Our Valued Shareholders:

As you read this letter, our application seeking approval to market and sell the VenoValve in the United States is pending before the U.S. Food and Drug Administration (FDA), and we are about to present the definitive one-year clinical data from our SAVVE pivotal trial that supports the FDA application. This is an enormous accomplishment for our company. We have also begun what should be the last required preclinical study for enVVe, before we can seek FDA approval in the middle of next year to begin the enVVe U.S. pivotal study.

I’d like to take this opportunity to provide a brief history of how we got to where we are today, in addition to providing some insight about what to expect in 2025.

When we began to build the current iteration of our company back in 2018, we had no capital, and no infrastructure or leadership to support a publicly traded company. We had 3 conceptual products, no prototypes, and no suppliers willing to work with the company to provide the components necessary to build the products. Over the subsequent six years we added a new board of directors, new senior management team and many new employees, and also raised the capital that we needed to fund the company. Throughout this time, we progressed the VenoValve from a mere concept, to the subject of a successful first-in-human study, then to the first replacement venous valve approved by the FDA for a U.S. pivotal study, and then to full enrollment of the VenoValve pivotal trial. We also began the development of a transcatheter, next-generation replacement venous valve.

Our ultimate goal has always been to be the first device to receive FDA approval to treat the 2.5 million new patients each year that suffer the debilitating impact of severe chronic venous insufficiency. With four out of five modules of our PMA application already approved by the FDA, we are off to a great start, and with the fifth and final module now before the FDA, our goal is within reach.

Developing a new permanent medical implant is never easy and being the first to develop a new class of medical devices for a system of the body (the deep venous system) for which there are many unanswered questions, presents certain challenges. Decades of failed attempts throughout the industry to repair or replace venous valves in the deep venous system have resulted in no accurate or complete body of work to use as a reference, and no established standards or consensus about testing replacement venous valves among the scientific, clinical, and regulatory communities. Throughout the VenoValve development and clinical process, we continued to discover new information and needed to quickly process and share that information with the clinicians participating in our study, and the independent monitors and regulators overseeing the VenoValve pivotal study.

The premarket approval (PMA) application is the culmination of those efforts and our multi-year collaboration with the FDA to collect and process sufficient information to evaluate the safety and efficacy of the VenoValve. I am very pleased with the results from those efforts and look forward to our further interactions with the FDA throughout the remainder of the PMA process, from which we expect to have a final decision, or to at least receive sufficient feedback from the FDA to make a better assessment of the timing and outcome of a final decision, in the second half of 2025.

The next phase in preparing the VenoValve for commercialization is to create awareness among the clinical community and effectively disseminate the results of our study to begin a paradigm shift among the physicians that treat CVI, and to present compelling economic and clinical data to convince hospitals and the reimbursement community to purchase, pay for, and provide reimbursement of our device. We have commissioned a health economic study for the VenoValve that will be as compelling as the results from the VenoValve pivotal study which will be ready for publication at the end of this year. While conversations with the hospitals and reimbursement community cannot begin until after FDA approval, we will start therapy development and awareness efforts early in 2025.

Following a positive decision from the FDA, our company will be well positioned to benefit from the many advantages of having the only FDA approved device for the treatment of severe, deep venous CVI. If we continue to execute at a high level, our potential upside is enormous and similar to other successful companies who have launched first-in-class cardiovascular devices. During 2024, two of those companies (Shockwave and Silk Road) were acquired for very attractive valuations.

We ended the third quarter of 2024 with $48.4 million of cash and investments, which should be sufficient capital to see us through to an FDA decision on the VenoValve, finish the pre-clinical testing on enVVe, initiate the enVVe U.S. pivotal trial, and begin the therapy development and awareness activities referenced above. There has never been a more exciting time than now to be an enVVeno shareholder, I invite you to join us at our upcoming virtual annual meeting, which is scheduled for December 18, 2024 at 9:00 AM PST.

Sincerely,

Robert A. Berman

NOTICE OF ANNUAL MEETING OF STOCKHOLDERS

To be held on Wednesday, December 18, 2024

The 2024 Annual Meeting of Stockholders (the “Meeting”) of enVVeno Medical Corporation (the “Company”) will be held on a virtual basis on Wednesday, December 18, 2024 at 9:00 A.M. PST, for the following purposes:

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/NVNO2024. 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.

Even if you are planning 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.

We hope you will be able to attend the Meeting. Whether or not you plan to attend the Meeting, please promptly sign, date and return the enclosed proxy card or voting instruction card in the envelope provided, or submit your proxy over the Internet or by telephone (if those options are available to you) in accordance with the instructions on the enclosed proxy card or voting instruction card.

The Board of Directors unanimously recommends a vote “FOR” the director nominees, “FOR” the approval, on a non-binding, advisory basis, of the compensation of our named executive officers, “FOR” three (3) years for the frequency of conducting future stockholder advisory votes on named executive officer compensation and “FOR” the ratification of the appointment by the Audit Committee of the Company’s Board of Directors of Marcum LLP as the Company’s registered public accounting firm for the fiscal year ending December 31, 2024.

BY ORDER OF THE BOARD OF DIRECTORS,

Robert A. Berman,

Chief Executive Officer

November 19, 2024