Core Viewpoint - enVVeno Medical Corporation has received an unfavorable decision from the FDA regarding its VenoValve® application, which indicates that the product does not meet the necessary safety and effectiveness standards [1] Company Summary - enVVeno Medical Corporation focuses on developing treatments for deep venous disease [1] - The company aimed to gain Premarket Approval (PMA) for its VenoValve®, a surgical replacement venous valve designed for severe deep chronic venous insufficiency (CVI) [1] Regulatory Summary - The FDA issued a not-approvable letter on August 19, 2025, which was upheld in a supervisory appeal [1] - The decision indicates that the VenoValve® failed to provide reasonable assurance of safety and effectiveness [1]

Core Insights - Shares of enVVeno Medical (NVNO) have experienced a significant decline of 76.1% since August 19 due to the FDA's not-approvable letter regarding its Premarket Approval (PMA) application for the VenoValve [1][8] Company Overview - enVVeno Medical submitted the PMA application for VenoValve, intended as a surgical replacement venous valve for severe chronic venous insufficiency (CVI), based on data from the successful SAVVE trial [2] - The FDA found the trial data insufficient to assess the benefit-to-risk profile of VenoValve, which is the company's most advanced pipeline candidate [3][9] Price Performance - Year-to-date, NVNO shares have declined by 66.9%, significantly underperforming the industry, which has seen a decline of 6.7%, while the S&P 500 Index has increased by 9.8% [4] Financial Outlook - The company has a cash burn rate of $4-$5 million per quarter, which is expected to sustain operations through Q3 2026, including activities related to VenoValve and another candidate, enVVe [5] - The FDA's decision is likely to delay VenoValve's commercialization, impacting NVNO's revenue generation potential [5] FDA's Denial Details - The FDA's not-approvable letter cited insufficient data from the SAVVE study and raised concerns about surgical safety, particularly regarding re-hospitalizations associated with the VenoValve procedure [8][10] - The FDA noted that clinical improvements observed may not correlate with the benefit-to-risk profile due to the lack of specific hemodynamic measurements [9][10] Future Steps - enVVeno Medical is reviewing FDA feedback and may seek a meeting to discuss potential resubmission or appeal regarding VenoValve [11] - The company is also advancing the enVVe valve, a non-surgical option, and plans to submit an IDE filing for its pivotal trial soon, which could positively impact NVNO's share price [12]