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enVVeno Medical (NVNO) filed its 2025 proxy for a virtual annual meeting on December 11, 2025 at 9:00 AM PST via www.virtualshareholdermeeting.com/NVNO2025. Stockholders of record at the close of business on October 17, 2025 may vote; there were 20,216,176 shares outstanding on the record date.
Stockholders will vote on four items: elect two Class II directors (Matthew M. Jenusaitis and Robert A. Berman) to terms ending in 2028; approve, on a non-binding advisory basis, executive compensation; ratify CBIZ CPAs P.C. as independent auditor for the year ending December 31, 2025; and approve the 2025 Equity Incentive Plan. The Board unanimously recommends voting “FOR” all proposals.
The materials note an ongoing FDA supervisory appeal regarding the not‑approvable decision for the VenoValve in the U.S. The appeal request was filed on September 18, 2025, an in‑person FDA meeting was held, and the Company is on track to hear from the FDA about this stage of the appeal process by the end of 2025. The outcome may also inform enVVe, the next‑generation transcatheter valve.
enVVeno Medical (NVNO) filed its Q3 2025 10‑Q, reporting a net loss of $4.5 million as operating expenses declined. Research and development was $2.6 million and selling, general and administrative was $2.3 million for the quarter, reflecting lower legal costs and a partial recovery of previously reserved clinical prepayments.
Cash and investments totaled $31.0 million with working capital of $29.1 million as of September 30, 2025, and management believes resources are sufficient for at least one year. Shares outstanding were 20,216,176 as of October 28, 2025.
Regulatory updates: the FDA issued a not‑approvable letter for the VenoValve PMA on August 19, 2025; the company filed a supervisory appeal and met with FDA leadership in October, with a decision expected by year‑end 2025. Nasdaq notified the company on October 7, 2025 of non‑compliance with the $1.00 minimum bid price; NVNO has until April 6, 2026 to regain compliance.
Kingdon group disclosed a passive holding in enVVeno Medical Corporation (NVNO). The filing reports that Kingdon Capital Management, L.L.C. and affiliated entities and individual Mark Kingdon together hold shared voting and dispositive power over 1,359,261 shares, representing 7.1% of the outstanding common stock. M. Kingdon Offshore Master Fund, L.P. and Kingdon GP, LLC each report 1,265,845 shares (6.6%). The filing states the securities are owned by advisory clients and were not acquired to change or influence control of the issuer. Signatures from authorized representatives and exhibits (Joint Filing Agreement and Control Person Identification) are attached.
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.