VERIGRAFT has received Clinical Trial Application (CTA) approval for its Phase II/III study evaluating P-TEV in patients with chronic venous insufficiency (CVI).
The randomized controlled open-label study is designed to evaluate the efficacy and safety of P-TEV in patients with advanced chronic venous insufficiency and is intended to support future market approval in Europe and the United States.
P-TEV is VERIGRAFT’s personalized tissue engineered vein designed to restore native venous function using fully biological tissue without the need for immunosuppressive treatment.
VERIGRAFT continues operational preparations for patient enrollment in the clinical program.
Study details
- EU CT Number: 2025-524103-69-00
- Study design: Randomized controlled open-label Phase II/III study
- Indication: Chronic Venous Insufficiency (CVI)
- Product candidate: P-TEV (Personalized Tissue Engineered Vein)