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enVVeno Medical Corporation (NVNO) filed a replacement Form S-3 shelf registration allowing it to offer up to $100,000,000 of mixed securities, including common stock, preferred stock, warrants, debt securities and units. Under Rule 415(a)(6), this shelf carries forward $57,331,170 of unsold securities from a 2023 registration, which will terminate by the earlier of this shelf’s effectiveness or February 19, 2027.
The company is a late-stage medical device developer focused on the enVVe System, a transcatheter replacement venous valve for severe deep Chronic Venous Insufficiency. In April 2026, the FDA granted an Investigational Device Exemption for the pivotal TAVVE study, which will enroll 230 patients in two stages at up to 40 U.S. sites.
enVVeno ended 2025 with $28.2 million of cash and investments and held $21.5 million as of June 30, 2026. It expects quarterly cash burn to rise from approximately $3–4 million to $4–5 million in the second half of 2026, providing runway into the third quarter of 2027, and discloses that it will need to raise additional capital. Net proceeds from future shelf takedowns are expected to fund continued enVVe System development and general corporate purposes.
Perceptive Advisors LLC, Joseph Edelman and Perceptive Life Sciences Master Fund, Ltd. report beneficial ownership of 24,605 shares of enVVeno Medical Corporation common stock through warrants, representing 3.5% of the outstanding class. The percentage is based on 682,722 shares of common stock outstanding as of July 28, 2026 and assumes exercise of all 24,605 warrants held by the Master Fund. The warrants are immediately exercisable but are subject to a 9.99% Beneficial Ownership Limitation, which currently permits full exercise. Each reporting person has shared voting and dispositive power over the 24,605 underlying shares and reports ownership of 5 percent or less of the class.
enVVeno Medical Corporation develops the enVVe System, a first-in-class transcatheter replacement venous valve for patients with severe Chronic Venous Insufficiency. In April 2026, the FDA granted Investigational Device Exemption (IDE) approval for the TAVVE pivotal study, a two-stage trial of 230 patients at up to 40 U.S. sites that could support an FDA post-marketing submission one year after the 220th enrollment in stage two.
For the quarter ended June 30, 2026, enVVeno reported a net loss of $3.6 million, down from $6.7 million a year earlier, as operating expenses fell on lower VenoValve study costs and reduced stock-based compensation. Six-month net loss was $7.4 million versus $11.2 million. Cash and investments totaled $21.5 million with working capital of $20.2 million, and the company states these resources should fund operations into the third quarter of 2027, though it expects quarterly cash burn to rise to $4–$5 million in the second half of 2026 and acknowledges it will need additional capital over time.
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 Corp director Francis Duhay sold a small block of company stock in a pre-planned trade. On June 11, 2026, he completed an open-market sale of 140 shares of common stock at $10.305 per share. After this transaction, he directly holds 2,362 shares of enVVeno Medical Corp common stock. The sale was executed under a Rule 10b5-1 trading plan that he adopted in June 2025, indicating the trade was pre-scheduled rather than a discretionary decision based on recent developments.
enVVeno Medical Corporation reports a Schedule 13G/A disclosing that Perceptive Advisors, Joseph Edelman and Perceptive Life Sciences Master Fund, Ltd. each beneficially own 9.99% of Common Stock. The filing states the ownership percentages are based on 667,669 outstanding shares as of May 1, 2026 and assume exercise of Warrants for 18,267 shares, constrained by a Beneficial Ownership Limitation.
The Master Fund directly holds 50,258 shares and 24,605 Warrants; Perceptive Advisors is investment manager and Joseph Edelman is managing member. Shared voting and dispositive power is reported for 68,525 shares.
enVVeno Medical Corporation reports a Schedule 13G/A amendment showing Kingdon-related parties beneficially own 36,166 shares, representing 5.5% of the common stock. The filing lists Kingdon Capital Management, L.L.C., M. Kingdon Offshore Master Fund, L.P., Kingdon GP, LLC and Mark Kingdon each with shared voting and dispositive power over 36,166 shares. Signatures show the filing was executed by Richard Weinstein and Mark Kingdon on 05/15/2026.
enVVeno Medical Corporation reported a net loss of $3,849 thousand for the quarter ended March 31, 2026, narrowing from $4,503 thousand a year earlier as operating expenses fell. Research and development expenses declined to $2,111 thousand and selling, general and administrative costs decreased to $1,951 thousand, reflecting lower VenoValve study spending and reduced overhead.
The company held $24.9 million of cash and investments and $23.3 million of working capital as of March 31, 2026, and expects this to fund operations into the third quarter of 2027, even as quarterly cash burn is projected to rise to between $4 million and $5 million in 2026.
Strategically, enVVeno is pivoting from its surgical VenoValve, which received a non-approvable FDA letter in 2025, to the minimally invasive enVVe System. On April 29, 2026, the FDA approved its Investigational Device Exemption, allowing the pivotal TAVVE study of the transcatheter enVVe valve in severe deep Chronic Venous Insufficiency to begin, with up to 230 patients enrolled across as many as 40 U.S. sites.
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.