enVVeno tanks after FDA rejects VenoValve approval

[Modern operating room in a hospital generated digitally]
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Shares of enVVeno Medical (NASDAQ: NASDAQ:NVNO [https://seekingalpha.com/symbol/NVNO]) plunged on Wednesday after it revealed that the FDA rejected pre-market approval of VenoValve, a surgical replacement venous valve for patients suffering from severe chronic venous insufficiency.

The FDA acknowledged that enVVeno’s trial showed some encouraging results. However, the agency said these outcomes were not sufficient to establish a clear benefit-risk profile for the device, noting the lack of specific hemodynamic data that directly connects the VenoValve to improved blood flow.

Regulators also raised safety concerns related to the open surgical procedure, leading to complications such as re-hospitalizations.

In response, enVVeno said it is reviewing the FDA’s feedback and exploring all possible paths forward. Options may include requesting a meeting to clarify resubmission requirements, appealing the decision, or pursuing other regulatory strategies.

The stock has fallen about 72% so far today.

MORE ON ENVVENO MEDICAL

* Seeking Alpha’s Quant Rating on enVVeno Medical [https://seekingalpha.com/symbol/NVNO/ratings/quant-ratings]
* Historical earnings data for enVVeno Medical [https://seekingalpha.com/symbol/NVNO/earnings]
* Financial information for enVVeno Medical [https://seekingalpha.com/symbol/NVNO/income-statement]