VERIGRAFT’s previously announced pivotal Phase II/III study evaluating the Company’s personalized tissue engineered vein (P-TEV) in patients with chronic venous insufficiency (CVI) has received Clinical Trial Application (CTA) approval from the Spanish Agency of Medicines and Medical Devices (AEMPS).
The approval enables initiation of study activities in Spain under the EU Clinical Trials Regulation (EU CTR 536/2014).
The randomized controlled Phase II/III 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.
VERIGRAFT continues preparations for patient enrollment in the ongoing clinical program.