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…

Chief Financial Officer — Jennifer Bright: The company appointed Jennifer Bright as the new Chief Financial Officer.

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…

Entry into a Material Definitive Agreement. On September 30, 2024, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) closed its recently announced public offering (the “offering”) of common stock (and pre-funded warrants issued in lieu thereof) for gross proceeds of approximately $15 million. The pre-funded warrants are exercisable immediately on the date of issuance at an exercise price of $0.0001 per share and may be exercised at any time until all of the pre-funded warrants…

Regulation FD Disclosure. On April 24, 2024, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing the presentation of positive topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve® at the 2024 Charing Cross International Symposium in London, UK. The press release is being furnished as Exhibit 99.1 to this report. Statements that are not historical fact may be considered forward-looking…

Regulation FD Disclosure. On March 6, 2024, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing that positive topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve is being presented today at the 2024 American Venous Forum (AFV) Annual Meeting in Tampa, Florida. The press release is being furnished as Exhibit 99.1 to this report. Statements that are not historical fact may be considere…

Regulation FD Disclosure. On November 16, 2023, enVVeno Medical Corporation (“we,” “us,” “our,” or the “Company”) issued a press release announcing that positive preliminary device related Material Adverse Event (MAE) safety data from the SAVVE U.S. pivotal trial for the VenoValve is being presented today at the 50 th Annual VEITH symposium in New York. The press release is being furnished as Exhibit 99.1 to this report. Statements that are not historical fact may be considered forward-lookin…

Entry into a Material Definitive Agreement. On October 6, 2023, enVVeno Medical Corporation (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors (the “Investors”) for the purpose of raising approximately $28 million in gross proceeds for the Company. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell an aggregate of 3,844,704 shares (the “Shares”) of the Company’s common stock, par value $0.00001…

The Shares, Warrants, Placement Agent Warrants, Warrant Shares and Placement Agent Warrant Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Regulation FD Disclosure. At the conclusion of the Annual Meeting, the Company indicated that by the end of this week, the Company expects to have nine (9) sites active and available to enroll patients in the Company’s SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. clinical trial for its VenoValve. Cautionary Note on Forward-Looking Statements This Form 8-K contains, or may contain, certain “forward-looking statements” within the meaning of the Private Securities Litigation Ref…

Entry into a Material Definitive Agreement On September 3, 2021, Hancock Jaffe Laboratories, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a fund managed by Perceptive Advisors, an institutional investor (the “Investor”), for the purpose of raising approximately $20 million in gross proceeds for the Company. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell, in a registered direct offering priced at the market under…

Entry into a Material Definitive Agreement On August 12, 2021, Hancock Jaffe Laboratories, Inc. (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 $25,000,000 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 com…