enVVeno Medical Corp: insider trades · United States · SEC (Form 4)

About enVVeno Medical Corp

enVVeno Medical Corp. (NASDAQ: NVNO) is a United States-based medical device company focused on bioprosthetic, tissue-based solutions for venous disease. Listed on the NASDAQ market in the United States, the company operates in a highly specialized niche of cardiovascular and venous-care innovation, targeting severe chronic venous insufficiency (CVI), a major subset of chronic venous disease. In practice, NVNO is positioned as a clinical-stage medtech developer rather than a commercial device manufacturer, with value creation tied primarily to regulatory progress, clinical validation, and eventual product adoption. The company’s history has been shaped by an initial product, VenoValve®, a first-in-class surgical replacement venous valve. That program became a key reference point for the business, but it also highlighted the difficulty of the regulatory pathway. In August 2025, enVVeno received a not-approvable letter from the U.S. Food and Drug Administration (FDA) regarding its PMA submission for VenoValve, and in November 2025 the company reported an unfavorable outcome in its supervisory appeal. As a result, management has shifted emphasis toward the next-generation enVVe® System, which is now the central strategic asset. The enVVe platform is designed as a non-surgical, transcatheter-based replacement venous valve for severe CVI of the deep venous system. The system includes the enVVe Valve, Delivery System, Nose Cone, Delivery System Accessories, and Crimping System. From an investment standpoint, the key point is that the product is still in development and has not yet been approved. That means the company’s competitive position is not based on current sales scale, but on the potential to define an entirely new treatment category where, according to the company, no approved surgical or non-surgical replacement venous valves currently exist. Operationally, enVVeno develops and manufactures its products in Irvine, California, in a leased 14,507-square-foot facility certified to ISO 13485-2016 standards for tissue-based implantable medical devices. This gives the company a clearly American footprint, with its clinical, regulatory, manufacturing, and investor-relations activities anchored in the United States. The firm remains early stage and capital dependent, with no product revenue and continuing investment in R&D and regulatory work. Recent highlights include its full-year 2025 results, ongoing FDA discussions regarding a pivotal trial for enVVe expected in 2026, and a 1-for-35 reverse stock split that became effective in January 2026. For investors, NVNO should be viewed as a high-risk, high-upside regulatory development story on NASDAQ, where future value will depend on execution, FDA outcomes, and clinical adoption rather than current operating scale.