Risk factors
enVVeno Medical (NVNO) risk factors
Item 1A of every enVVeno Medical Corp. 10-K on file, and what changed from one year to the next. Readings are automated and can be wrong; check the filing for the exact wording.
- FY2025 10-K risk factors34 risks1 new4 reworded
The company received an FDA not-approvable letter for the VenoValve PMA application on August 19, 2025. The FDA cited insufficient hemodynamic correlation and surgical safety concerns, highlighting regulatory hurdles.
Filed Mar 26, 2026 - FY2024 10-K risk factors33 risks
enVVeno Medical faces extreme concentration risk relying on only two domestic suppliers for porcine tissue. The company relies entirely on its Irvine facility for manufacturing product candidates. Regulatory hurdles and capital raising needs dominate the risk profile.
Filed Feb 28, 2025