Envveno Medical Corporation SEC Filings

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.

enVVeno Medical Corporation files its annual report detailing a major strategic pivot after its surgically implanted VenoValve received a not-approvable letter from the FDA in August 2025 and a subsequent appeal was denied. The company is now concentrating on the enVVe System, a first-in-class, non-surgical, transcatheter replacement venous valve for severe chronic venous insufficiency, and has completed pre-clinical testing while beginning FDA discussions for a pivotal trial expected to start in 2026. enVVeno highlights that it has no product revenue, has incurred significant losses since inception, and may never achieve profitability without successful regulatory approval and commercialization of enVVe or future devices. The filing emphasizes substantial clinical, regulatory, manufacturing, reimbursement and financing risks, reliance on a small supplier base for porcine tissue and components, and the need for additional capital to continue development. As of June 30, 2025, non-affiliate common equity market value was $76.1 million, and as of March 24, 2026, there were 655,521 shares of common stock outstanding and 33 full-time employees.

Northstrive Fund II LP and Braeden Lichti filed a Schedule 13D on enVVeno Medical Corp after accumulating a 5.05% stake in its common stock. As of February 10, 2026, Lichti beneficially owned 33,151 shares, based on 655,606 shares outstanding as of January 20, 2026.

The investors sent a letter to enVVeno’s board recommending an immediate halt to all clinical operations and a formal strategic review. Their suggestions include returning capital to shareholders or pursuing a merger or reverse merger to preserve cash and limit further dilution, while reserving the right to increase or reduce their position.

Northstrive Fund II LP and Braeden Lichti have filed a Schedule 13D on enVVeno Medical Corp, shifting from a passive to an active investor stance. They report beneficial ownership of 33,151 common shares, representing 5.05% of enVVeno’s outstanding stock as of January 20, 2026.

The investors sent a letter to the company’s board on February 20, 2026 urging the board to immediately halt all clinical operations and begin a formal strategic review. Their recommendations include considering returning capital to shareholders or pursuing a merger or reverse merger to maximize shareholder value while preserving cash and limiting further dilution.

Perceptive Advisors LLC and related investors filed an amended ownership report showing beneficial ownership of 2,048,515 shares of enVVeno Medical Corporation common stock, representing 9.99% of the company. The stake is held through Perceptive Life Sciences Master Fund, which owns common shares and warrants.

The Master Fund directly holds 1,759,035 shares plus 861,192 warrants exercisable at $8.334 per share, but a 9.99% beneficial ownership limitation currently allows exercise of only 289,480 warrants. Perceptive Advisors is the investment manager and Joseph Edelman is its managing member.

Braeden Lichti and Northstrive Fund II LP have disclosed significant ownership stakes in enVVeno Medical Corp. Lichti reports beneficial ownership of 33,151 shares of common stock, representing 5.05% of the company, while Northstrive Fund II LP reports 20,129 shares, or 3.07%.

The percentages are based on 655,606 shares of enVVeno Medical Corp common stock issued and outstanding as of January 20, 2026, as reported by the company. Lichti, a Canadian citizen, is the manager of Northstrive Fund II LP, a Delaware entity, and holds both sole and shared voting and dispositive power over different portions of the shares.