VERIGRAFT and TFS HealthScience partner on pivotal Phase II/III trial of personalized tissue-engineered vein for chronic

VERIGRAFT, a Swedish clinical-stage biotechnology company developing personalized, fully biological therapies, and TFS HealthScience, a full-service global contract research organization (CRO), today announced their collaboration on the pivotal Phase II/III trial of VERIGRAFT’s P-TEV (personalized tissue-engineered vein) in patients with chronic venous insufficiency (CVI). 

Chronic venous insufficiency is a progressive vascular disease in which the veins in the legs fail to return blood efficiently to the heart. It affects millions of people worldwide, and for those with failing deep venous valves, current options are largely limited to managing symptoms rather than treating the underlying cause. 

P-TEV is an advanced therapy medicinal product (ATMP) designed to replace a diseased vein segment that has a non-functioning valve with a graft containing a functioning one. The graft starts as donated venous tissue, which is decellularized to remove immunogenic material and then personalized using components from the patient’s own blood. Because the donor material is reconditioned in this way, the approach is designed to avoid the need for immunosuppression, with the aim of reducing the risk of rejection and infection associated with conventional approaches. ATMPs of this kind are among the most complex trials to run, with demanding manufacturing, logistics and regulatory requirements at every site. 

This Phase II/III trial is designed to evaluate the safety, functionality and long-term performance of P-TEV in a larger patient population. It will assess how well the engineered vessels remain open and support normal blood flow over time, with the goal of providing a more durable and biologically compatible option for patients with limited vascular reconstruction options. 

Link to: Full press release