enVVeno Medical Seeks FDA Approval for VenoValve and Completes enVVe Study
Key Insights
enVVeno Medical (search) has submitted its PMA application to the FDA for VenoValve (search), a breakthrough device for severe deep venous Chronic Venous Insufficiency (search) (CVI (search)).
The FDA is expected to make a decision on VenoValve (search) in the second half of 2025, potentially offering a new treatment for 2.5 million U.S. candidates.
enVVeno Medical (search) also completed the final implants in its pre-clinical GLP study for enVVe (search), a transcatheter-delivered replacement venous valve.
enVVeno Medical (search) Corporation (NASDAQ:NVNO) has announced significant progress in its efforts to combat chronic venous insufficiency (search) (CVI (search)). The company has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its VenoValve (search) device, a potential first-in-class surgical replacement venous valve. Simultaneously, enVVeno has completed a crucial pre-clinical study for enVVe (search), its next-generation, non-surgical transcatheter-based replacement venous valve.
The VenoValve (search) is designed to treat severe deep venous CVI (search), a condition affecting an estimated 2.5 million people in the U.S. annually. The device has already received breakthrough designation from the FDA, potentially expediting its review process. The FDA is expected to make a decision on the VenoValve application in the second half of 2025.
Addressing Chronic Venous Insufficiency
Chronic Venous Insufficiency (search) (CVI (search)) typically arises from blood clots (deep vein thromboses or DVTs) that damage the valves within the deep veins of the leg. These damaged valves lead to blood flowing backward and pooling in the lower leg, causing venous hypertension. Symptoms of severe CVI include leg swelling, pain, edema, and, in the most severe cases, recurrent venous ulcers. These symptoms can significantly impair daily activities and are associated with high rates of depression and anxiety.
Robert Berman, enVVeno Medical (search)'s Chief Executive Officer, stated, "We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA." He added that the company expects to potentially have a decision in the second half of 2025.
enVVe Development
In parallel with the VenoValve (search) PMA submission, enVVeno Medical (search) has also completed the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe (search). The company anticipates submitting its IDE application to the FDA in mid-2025, which, if approved, would allow the company to initiate the pivotal clinical trial for enVVe.
"With the successful completion of all planned implants in the enVVe (search) GLP study, we have achieved the last of our milestones for 2024," said Robert Berman. "Our enhanced enVVe crimping and delivery system has performed very well throughout the study and is ready for the pivotal trial."
Market Opportunity
The company estimates that there are approximately 2.5 million potential new patients each year in the U.S. who could be candidates for the VenoValve (search). The successful development and approval of both VenoValve and enVVe (search) could position enVVeno Medical (search) as a leader in the treatment of deep venous CVI (search), addressing a significant unmet medical need.
About enVVeno Medical Corporation
enVVeno Medical (search) (NASDAQ:NVNO) is focused on developing innovative bioprosthetic solutions for venous disease. The VenoValve (search) is a surgical replacement venous valve for treating deep venous CVI (search), while enVVe (search) is a non-surgical, transcatheter-based replacement venous valve for the same condition. Both devices are designed to act as one-way valves, assisting in propelling blood up the leg and back to the heart and lungs.