enVVeno Medical Corporation CEO Robert Berman said that the company will continue to work with the FDA on new criteria to demonstrate the safety and effectiveness of its VenoValve device.
Medical device company enVVeno Medical Corporation (NVNO) on Wednesday announced that the U.S. Food & Drug Administration (FDA) has refused to approve its application for its lead product, VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
Following the announcement, NVNO shares plunged 71% by Wednesday afternoon, at the time of writing.
Severe deep chronic venous insufficiency (CVI) is a long-term condition where the veins in the legs have difficulty returning blood to the heart, leading to blood pooling and various symptoms like swelling, aching, and skin changes. This occurs primarily due to damaged or weakened valves within the deep leg veins.
On Stocktwits, retail sentiment around NVNO rose from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while retail chatter rose from ‘low’ to ‘extremely high’ levels.
A Stocktwits user expressed optimism for the company renegotiating with the FDA.
Another user said that they see no value in the company with the VenoValve rejection.
The FDA said in a letter that it completed its review of the company’s application for VenoValve but has decided that it is unable to approve it in its current form. The agency said that data generated by the company for the application was not sufficient on its own to determine the favorability of the benefit-risk profile for VenoValve.
The FDA also raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study. The agency further raised safety concerns, which were attributed to the VenoValve open surgical procedure, and which required re-hospitalizations.
CEO Robert Berman said that the company is disappointed by the FDA’s decision and highlighted that a high percentage of patients in a study showed significant clinical improvement after receiving VenoValve. Berman added that the company will continue to work with the FDA on new criteria to demonstrate the safety and effectiveness of the device.
The firm’s next steps may include a meeting with the FDA to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision, along with appropriate next steps.
NVNO stock is down by 59% this year and by about 77% over the past 12 months.
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