News & Events

Regulation FD Disclosure. On 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 wit…

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

Results of Operations and Financial Condition. On February 4, 2026, enVVeno Medical Corporation (the “Company”) announced that as of December 31, 2025, the Company had a cash and investments balance of approximately $28 million.

Regulation FD Disclosure. On November 13, 2025, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing the Company had received an unfavorable appeal decision from the U.S. Food & Drug Administration in response to its Premarket Approval application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The press release is being furnished as Exhibit 99.1 to this report. Statements that are not hi…

Entry into a Material Definitive Agreement On October 30, 2025, enVVeno Medical Corporation (the “Company”) entered into an At-the-Market Offering Agreement (the “Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Agent”) to create an at-the-market equity program under which it may sell up to $50,000,000 of shares of the Company’s common stock (the “Shares”) from time to time through the Agent, as sales agent (the “ATM Offering”). Under the Agreement, the Agent will be entitled to a commiss…

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing On October 7, 2025, enVVeno Medical Corporation (the “Company”) received notification from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, because the closing bid price for the Company’s common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Capit…

Regulation FD Disclosure. On August 20, 2025, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing the Company had received a not approvable letter from the U.S. Food & Drug Administration in response to its Premarket Approval application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The press release is being furnished as Exhibit 99.1 to this report. Statements that are not historical…

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Appointment of Chief Financial Officer On May 19, 2025, the Board of Directors (the “ Board ”) of enVVeno Medical Corporation (the “ Company ”) appointed Jennifer Bright as Chief Financial Officer of the Company. Ms. Bright, 54, is a certified public accountant with more than 25 years of professional accounting and finance experience. Ms. Bright wa…

Changes in Registrant’s Certifying Accountant. On November 1, 2024, CBIZ CPAs P.C. acquired the attest business of Marcum LLP (“Marcum”) which was engaged as the independent registered public accounting firm of enVVeno Medical Corporation (the “Company”). As a result of this transaction, on April 17, 2025, Marcum resigned as auditors of the Company, and with the approval of the Audit Committee of the Company’s Board of Directors, CBIZ CPAs P.C. was engaged as the Company’s new independent reg…