VERIGRAFT advances tissue‑engineered ATMP to pivotal trial

VERIGRAFT has taken an important step in its clinical program by submitting an application for a pivotal Phase II/III clinical trial in Europe, focused on a patient‑specific tissue‑engineered vein therapy for severe venous disease.

Pivotal trial application submitted

VERIGRAFT has submitted an application to initiate a multicenter Phase II/III clinical trial within the European Union. The submission marks a key milestone in the company’s clinical development pathway.

The planned trial will evaluate the Personalized Tissue‑Engineered Vein (P‑TEV). This patient‑specific tissue therapy is intended for individuals with severe chronic venous insufficiency. As a result, the program targets patients with significant unmet medical needs.

Advancing a tissue‑engineered ATMP

The Phase II/III study is designed to confirm clinical efficacy. At the same time, it will continue to generate safety data in line with regulatory expectations. The trial builds on experience gained from VERIGRAFT’s completed first‑in‑human study. That early clinical work provided initial safety insights and informed the design of the upcoming pivotal program.

The application is currently under review within the EU clinical trial framework.

Original announcement: https://verigraft.com/news/pivotal-phase-ii-iii-clinical-trial-application/