Shares of enVVeno Medical Corporation (NASDAQ:NVNO) plunged roughly 70% following news that the U.S. Food and Drug Administration issued a not-approvable letter for the company’s VenoValve device.
The FDA concluded that the Premarket Approval (PMA) application for VenoValve—a surgical venous valve replacement intended to treat severe chronic deep venous insufficiency—could not be approved in its current form. Regulators noted that the submitted clinical improvement data was insufficient to demonstrate a favorable benefit-risk profile for the device.
According to the FDA’s feedback, although the revised Venous Clinical Severity Score data showed some improvement, alongside reduced pain scores and better quality-of-life indicators, it did not convincingly establish the device’s effectiveness. The agency also raised concerns about potential bias and questioned whether observed patient improvements were due to study participation rather than the device itself.
Safety issues were flagged as well. The FDA highlighted risks linked to the open surgical procedure required for VenoValve implantation, noting that several patients experienced complications requiring re-hospitalization.
“We are obviously disappointed by the FDA’s decision,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “The results showed that a high percentage of the patients in the SAVVE study, who all previously failed standard of care treatments, showed significant clinical improvement after receiving the VenoValve.”
The company is now reviewing the FDA’s feedback and evaluating next steps, which may include requesting a meeting to discuss resubmission requirements or appealing the agency’s decision. enVVeno also intends to apply lessons learned from this experience as it develops enVVe, its non-surgical venous valve replacement currently in the pipeline.
enVVeno Medical Corporation stock price
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