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Investing.com -- enVVeno Medical (TASE:BLWV) Corporation (NASDAQ:NVNO) stock plummeted 70% after the company received a not-approvable letter from the U.S. Food and Drug Administration for its VenoValve device.
The FDA determined it could not approve the Premarket Approval application for VenoValve, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency, in its current form. Regulators stated that the clinical improvement data was insufficient to establish a favorable benefit-risk profile for the device.
According to the FDA’s feedback, the favorable revised Venous Clinical Severity Score data, along with improvements in pain scores and quality of life indicators, failed to adequately demonstrate the device’s efficacy. The agency expressed concerns about potential bias and questioned whether patient improvements might have resulted simply from study participation rather than the device itself.
Regulators also highlighted safety concerns related to the open surgical procedure required for VenoValve implantation, noting that several patients required 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 currently reviewing the FDA’s feedback and considering various options, including requesting a meeting to discuss potential resubmission requirements or appealing the decision. enVVeno also plans to apply lessons from this process as it advances enVVe, its non-surgical replacement venous valve currently in development.
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