enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval [Yahoo! Finance]
enVVeno Medical Corporation (NVNO)
Company Research
Source: Yahoo! Finance
that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. The company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and physicians. The company expects enVVe to be ready for its own pivotal trial during the middle of 2025. The company expects to learn more and potentially have a decision in the second half of 2025. The VenoValve has been designated as a breakthrough device by the FDA and is therefore subject to priority review. Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, and walking, and is known to result in high rates of depression and anxiety. The company estimates that there are approximately 2.5 million candidates each year in the U.S.
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NVNO
News
- enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium [Yahoo! Finance]Yahoo! Finance
- enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH SymposiumAccesswire
- enVVeno Medical Submits the VenoValve PMA Application Seeking FDA ApprovalAccesswire
- Coronary Artery Bypass Graft Surgery Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2024 Report [Yahoo! Finance]Yahoo! Finance
- enVVeno Medical Reports Third Quarter 2024 Financial Results and Confirms Guidance for Release of Definitive VenoValve Data in November and Completion of FDA Premarket Approval Application for VenoValve in Q4 of this YearAccesswire
NVNO
Sec Filings
- 11/19/24 - Form DEF
- 11/14/24 - Form SCHEDULE
- 11/14/24 - Form SC
- NVNO's page on the SEC website