Note 1 – Business Organization and Nature of Operations

The Company

enVVeno Medical Corporation (the “Company”) is a medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company is developing a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

The Company first developed the VenoValve®, which was a potential first-in-class surgical replacement venous valve (the Company received a not-approvable letter from the U.S. Food and Drug Administration (“FDA”) in response to its PMA application for the VenoValve in August 2025). The Company is now focused on its next-generation, non-surgical venous valve product, called the enVVe® system. The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System. The enVVe Valve is a first-in-class, non-surgical, transcatheter based replacement venous valve being developed for the treatment of severe CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The Company has completed pre-clinical testing on the enVVe System and has begun discussions with the FDA regarding the enVVe pivotal trial, which it expects to begin in 2026.

The enVVe System is being developed for approval by the FDA.

2026 Reverse Stock Split

At the annual meeting of the Company’s stockholders held on December 11, 2025 (the “2025 Annual Meeting”), the Company’s stockholders approved an amendment to the Company’s Restated Certificate of Incorporation, as amended (the “Restated Certificate of Incorporation”), to effect a reverse stock split of our common stock, at a ratio between one-for-five (1:5) and one-for-thirty-five (1:35).

On January 2, 2026, the Company’s board of directors (the “Board”) approved a one-for-thirty-five (1:35) reverse stock split of the outstanding shares of our common stock (the “Reverse Stock Split”). On January 16, 2026, the Company filed an amendment to the Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split, which became effective on January 20, 2026. The amendment did not change the number of authorized shares of our common stock.

Except as the context otherwise requires, all common stock share numbers, share price amounts (including exercise prices, conversion prices, and closing market prices) and shares issued upon the exercise of warrants contained in the audited consolidated financial statements and notes thereto have been retroactively adjusted to reflect the Reverse Stock Split.