VERIGRAFT has submitted an application to initiate a multicenter Phase II/III clinical trial, marking an important milestone in the company’s ongoing clinical development.
The application relates to a pivotal clinical trial evaluating VERIGRAFT’s patient-specific tissue therapy, the Personalized Tissue Engineered Vein (P-TEV) for patients with severe chronic venous insufficiency. The application is now under regulatory review within the EU clinical trial framework, with involvement of relevant regulatory authorities.
The planned trial (TECVI-2) aims to confirm clinical efficacy and will continue to collect safety data in line with regulatory requirements. It builds on experience from previously completed first-in-human clinical trial (TECVI-1).
VERIGRAFT will provide further updates on the clinical trial as appropriate and in accordance with regulatory processes.