Shares in enVVeno Medical Corp. dropped nearly 30% during after hours trading today after the company announced that the FDA had denied an appeal related to its lead product.
After the announcement, the shares fell to 45 cents each. During regular trading hours, they declined 5.2% to 65 cents and a $13 million market cap (Nasdaq: NVNO).
In August, the FDA rejected the Irvine-based medical device maker’s Premarket Approval application for its lead product VenoValve, a surgical replacement valve for severe deep chronic venous insufficiency. EnVVeno immediately appealed the rejection of the product, which is crucial to the company’s future.
“We will continue to interact with the FDA on enVVe and will provide periodic updates on our progress,” enVVeno Chief Executive Robert Berman said in a statement.
Berman said that the company will use the feedback to inform its next-gen device enVVe.
