EnVVeno Medical Loses Appeal of FDA Not-Approvable Letter for VenoValve

Dow Jones

Nov 14

By Josh Beckerman

EnVVeno Medical received an unfavorable appeal decision from the Food and Drug Administration, which upheld an August not-approvable letter for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency.

The medical device company's shares fell 36% to 42 cents after hours.

The company said that, assuming it can reach alignment with the FDA on achievable endpoints for another product, enVVe, "it makes sense to turn our attention and devote our resources to enVVe." EnVVeno said "although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe."

The company said enVVe, a non-surgical replacement venous valve, should have a different safety profile than an open surgical device and is ready for human testing.

With $31.5 million in cash and investments at the end of the third quarter and a quarterly cash burn of $4 million to $5 million, the company said it has sufficient cash to fund operations into 2027.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

November 13, 2025 18:44 ET (23:44 GMT)

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Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4082","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2583322545","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2583322545","pubTimestamp":1763077440,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"EnVVeno Medical received an unfavorable appeal decision from the Food and Drug Administration, which upheld an August not-approvable letter for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency.The medical device company's shares fell 36% to 42 cents after hours.The company said that, assuming it can reach alignment with the FDA on achievable endpoints for another product, enVVe, \"it makes sense to turn our attention and devote our resources to enVVe.\" EnVVeno said \"although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe.\". The company said enVVe, a non-surgical replacement venous valve, should have a different safety profile than an open surgical device and is ready for human testing.With $31.5 million in cash and investments at the end of the third quarter and a quarterly cash burn of $4 million to $5 million, the company said ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4082":"医疗保健设备","NVNO":"enVVeno Medical Corp."},"translate_title":"EnVVeno Medical对FDA未批准VenoValve信函的上诉败诉","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NVNO":0.9},"content_text":"By Josh Beckerman \n\n\n \n\n\n  EnVVeno Medical received an unfavorable appeal decision from the Food and Drug Administration, which upheld an August not-approvable letter for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. \n\n\n  The medical device company's shares fell 36% to 42 cents after hours. \n\n\n  The company said that, assuming it can reach alignment with the FDA on achievable endpoints for another product, enVVe, \"it makes sense to turn our attention and devote our resources to enVVe.\" EnVVeno said \"although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe.\" \n\n\n  The company said enVVe, a non-surgical replacement venous valve, should have a different safety profile than an open surgical device and is ready for human testing. \n\n\n  With $31.5 million in cash and investments at the end of the third quarter and a quarterly cash burn of $4 million to $5 million, the company said it has sufficient cash to fund operations into 2027. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 13, 2025 18:44 ET (23:44 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}