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]