FDA rejects enVVeno Medical’s VenoValve for chronic venous insufficiency

IRVINE, California - The U.S. Food and Drug Administration has issued a not-approvable letter to enVVeno Medical Corporation (NASDAQ:NVNO), an $80.5 million market cap medical device company, for its VenoValve surgical replacement venous valve, the company announced Wednesday. The news sent the stock down over 8% in the past week, according to InvestingPro data.

The FDA determined it could not approve the Premarket Approval application for the device, which was designed to treat severe deep chronic venous insufficiency (CVI), in its current form. Despite the setback, InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 11.8, indicating substantial resources to pursue alternative strategies.

According to the company’s press release, regulators found that improvements in the revised Venous Clinical Severity Score, pain scores, and quality of life indicators were insufficient to determine a favorable benefit-risk profile. The FDA expressed concerns about potential bias and questioned whether clinical improvements might have resulted from study participation rather than the device itself.

Regulators also cited safety concerns related to the open surgical procedure, which led to some re-hospitalizations among study participants.

"We are obviously disappointed by the FDA’s decision," said Robert Berman, enVVeno Medical’s Chief Executive Officer, in the press release. "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 reviewing the FDA’s feedback and considering options, including a potential meeting to discuss resubmission requirements or appealing the decision.

enVVeno Medical is also developing enVVe, a non-surgical transcatheter-based replacement venous valve for treating deep venous CVI. The company stated it plans to apply lessons from the VenoValve regulatory process as it prepares an Investigational Device Exemption application for enVVe.

Severe deep CVI affects an estimated 2.5 to 3.5 million patients in the United States, according to the company. While enVVeno Medical holds more cash than debt on its balance sheet, InvestingPro analysis indicates the company is quickly burning through cash, with negative free cash flow of $17.1 million in the last twelve months. InvestingPro subscribers have access to 6 additional key insights about NVNO’s financial health and market position.

In other recent news, enVVeno Medical Corporation announced preliminary findings from a health economic study regarding its VenoValve. The study suggests that the VenoValve could be a cost-effective treatment option for patients suffering from severe Chronic Venous Insufficiency (CVI) due to deep valvular incompetency. According to the findings, the VenoValve demonstrated both clinical and economic advantages over standard care treatments. Specifically, it showed potential cost savings of $32,442 per patient over a five-year period. Additionally, the VenoValve was associated with the prevention of 2.2 venous ulcers per patient and an increase of 0.33 quality-adjusted life years per patient. These developments highlight the potential impact of the VenoValve on patient care and healthcare costs.

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