Every 8-K that enVVeno Medical Corporation (NVNO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NVNO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NVNO filings page.
enVVeno Medical Corporation disclosed that on July 14, 2026 it issued an investor presentation that may be used in meetings with investors, analysts and others. The presentation is provided as Exhibit 99.1 and is furnished under Regulation FD, not deemed filed or incorporated by reference under the Exchange Act except if specifically referenced.
enVVeno Medical Corporation reported that the FDA approved its Investigational Device Exemption (IDE) application, allowing the Company to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study of its minimally invasive enVVe® replacement venous valve for severe deep Chronic Venous Insufficiency (CVI).
The study will start with 10 patients whose 30‑day safety data will be reviewed by the FDA, followed by a second stage enrolling 220 patients, including 165 treated with enVVe and 55 controls receiving standard care, at up to 40 U.S. clinical sites. One year after the 220th second‑stage patient is enrolled, the Company would be eligible to file for FDA post‑marketing approval.
enVVeno also disclosed that as of March 31, 2026, it had approximately $25 million in cash and investments, which it expects will fund operations into the third quarter of 2027.
enVVeno Medical Corporation reported that as of December 31, 2025, it held a cash and investments balance of approximately $28 million, highlighting its available liquidity at year end. The company also announced that it has regained compliance with the minimum bid price requirement and all other criteria for continued listing on The NASDAQ Stock Market, removing an immediate risk to its exchange listing. The announcement was made through a press release furnished as an exhibit to this report.
enVVeno Medical Corporation implemented a one-for-thirty-five reverse stock split of its common stock, effective January 20, 2026. Every 35 previously issued and outstanding shares were automatically combined into one share, with no change to the par value.
No fractional shares were issued; any fractional positions were rounded up to the nearest whole share. The number of common shares outstanding decreased from 22,946,223 to 655,606, while authorized common shares remain at 250,000,000.
The company proportionally adjusted outstanding stock options and warrants so that share amounts decreased by a factor of 35 and exercise prices increased by a factor of 35, preserving their overall economic value. The stock now trades on a reverse split-adjusted basis on Nasdaq under the symbol NVNO.
enVVeno Medical Corporation reported the results of its 2025 Annual Meeting of Stockholders. A total of 11,058,255 shares of common stock were represented in person or by proxy out of 20,216,176 shares outstanding and entitled to vote as of October 17, 2025, representing 54.70% of the voting power.
Stockholders voted on the election of two directors and several additional proposals. For the board seats, Matthew M. Jenusaitis received 3,468,484 votes for and 1,796,053 votes withheld, while Robert A. Berman received 4,727,591 votes for and 536,946 votes withheld. The filing also lists detailed vote totals for four other proposals, each showing the number of votes for, against, abstentions, and broker non-votes, providing transparency into stockholder participation and preferences.
enVVeno Medical Corporation reported that its Board of Directors approved an amendment to the company’s Amended and Restated Bylaws. The change updates the quorum requirement for stockholder meetings.
Under the revised Section 1.5, a stockholder meeting will have a quorum when holders present in person or by proxy represent thirty-three and one-third percent of the voting power of the outstanding shares entitled to vote, unless a higher threshold is required by law, the certificate of incorporation, or the bylaws. The amendment became effective immediately upon Board approval on November 17, 2025.
enVVeno Medical (NVNO) reported that it received an unfavorable appeal decision from the U.S. Food & Drug Administration regarding its Premarket Approval (PMA) application for VenoValve, a surgical replacement venous valve intended to treat severe deep chronic venous insufficiency. The company disclosed this update under Regulation FD.
The announcement was furnished via an accompanying press release included as Exhibit 99.1. The filing reiterates standard forward‑looking statement cautions.
enVVeno Medical Corporation established an at-the-market equity program, allowing it to sell up to $50,000,000 of common stock from time to time through Ladenburg Thalmann as sales agent. The agent will receive a fixed 3% commission on gross proceeds from each sale. Sales may be made as “at-the-market” offerings under Rule 415, including ordinary brokers’ transactions on the NASDAQ Capital Market at market prices or as otherwise agreed. The company is not obligated to sell shares and may suspend or terminate the program.
The shares are covered by enVVeno’s effective Form S-3 (File No. 333-273546) declared effective on August 23, 2023, and a Prospectus Supplement filed on October 30, 2025. An opinion of counsel regarding the legality of the shares and the ATM Agreement were filed as exhibits.
enVVeno Medical Corporation reported that it received a not approvable letter from the U.S. Food & Drug Administration regarding its Premarket Approval application for VenoValve, a surgical replacement venous valve intended to treat severe deep chronic venous insufficiency. This means the FDA has determined the application cannot be approved in its current form. The company disclosed this development through a press release attached to the report.
enVVeno also reminded readers that statements about future events, including those related to its clinical trials, are forward-looking and subject to significant risks and uncertainties described in its other SEC reports.