enVVeno Medical Receives FDA Setback for VenoValve

enVVeno Medical ( (NVNO) ) has shared an announcement.

On August 20, 2025, enVVeno Medical Corporation announced it received a not-approvable letter from the FDA for its Premarket Approval application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The FDA’s decision was based on concerns about the sufficiency of clinical improvement data and safety issues related to the surgical procedure. Despite the setback, enVVeno remains committed to addressing the needs of patients with severe deep venous CVI and plans to work with the FDA on new criteria for demonstrating the safety and effectiveness of its devices. The company is also preparing an IDE application for its non-surgical valve, enVVe®.

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 for the treatment of deep venous disease. The company’s lead product, VenoValve®, is a surgical replacement venous valve designed to treat severe deep Chronic Venous Insufficiency (CVI), and they are also developing a non-surgical replacement valve called enVVe®.

Average Trading Volume: 141,357

Technical Sentiment Signal: Hold

Current Market Cap: $96.14M

For detailed information about NVNO stock, go to TipRanks’ Stock Analysis page.