enVVeno Medical Faces FDA Setback on VenoValve

enVVeno Medical ( (NVNO) ) just unveiled an announcement.

On November 13, 2025, enVVeno Medical Corporation announced that it received an unfavorable decision from the FDA regarding its appeal for the Premarket Approval of VenoValve®, a surgical replacement venous valve for severe deep chronic venous insufficiency. Despite the setback, the company gained valuable insights for its next-generation transcatheter-based valve, enVVe, which is ready for human testing. The company plans to focus resources on enVVe, aiming to align with the FDA on achievable endpoints. enVVeno reported having $31.5 million in cash and investments, sufficient to fund operations into 2027.

Spark’s Take on NVNO Stock

According to Spark, TipRanks’ AI Analyst, NVNO is a Neutral.

enVVeno Medical’s overall stock score is influenced by its robust technical performance, which is somewhat overshadowed by challenging financial metrics. The company faces significant profitability issues, as reflected by its negative income and cash flow figures, despite having a stable balance sheet. While technical indicators show strong upward momentum, valuation concerns due to a negative P/E ratio and lack of dividends weigh on the score.

To see Spark’s full report on NVNO stock, click here.

More about enVVeno Medical

enVVeno Medical Corporation, based in Irvine, California, is a late clinical-stage medical device company focused on developing innovative bioprosthetic solutions to enhance the treatment of deep venous disease. The company specializes in creating surgical and non-surgical replacement venous valves for severe deep chronic venous insufficiency (CVI).

Average Trading Volume: 998,193

Technical Sentiment Signal: Sell

Current Market Cap: $13.92M

For a thorough assessment of NVNO stock, go to TipRanks’ Stock Analysis page.