Verigraft has announced the initiation of a pivotal phase 2/3 trial of its personalised tissue-engineered vein (P-TEV) transplant in patients with chronic venous insufficiency (CVI), supported by US$10 million from existing investors.
Verigraft’s fully biological approach opens the way for a potential curative treatment for CVI, using personalised tissues that eliminates the need for immunosuppressive therapy. The manufacturing process is completed within 10 days, making Verigraft’s offering both scalable and clinically feasible, according to the company. Trial sites for the phase 2/3 study are located in Spain, the Netherlands and Poland.
As an advanced therapy medicinal product (ATMP), Verigraft’s clinical development programme is designed to generate robust clinical data in a limited patient population. The company aims to achieve market approval in Europe and the USA in 2028.
Verigraft’s P‑TEV is designed to replace diseased venous segments with dysfunctional valves with vein segments containing functioning valves. The approach uses donor-derived venous material that is decellularised and subsequently personalised using the patient’s own blood, creating a patient‑specific graft. Once prepared, the P-TEV is surgically implanted to replace the diseased vein segment and restore venous function.
Unlike synthetic grafts or stenting approaches, P-TEV is designed to restore native biological function rather than relying on artificial materials or mechanical solutions.
Petter Björquist, chief executive officer of Verigraft said: “This financing enables a critical step forward in our clinical development and is a critical component in our journey to redefine how vascular disease can be treated by restoring natural biological function. With P-TEV, we are addressing a large, underserved patient population with a therapy designed to address the underlying cause of disease, not just manage the symptoms. The initiation of our pivotal trial brings us significantly closer to making this a clinical reality.”
Bryan Kluck, an interventional cardiologist, endovascular interventionalist and vascular medicine specialist at Lehigh Valley Hospital, Allentown, USA commented: “As an interventional cardiologist familiar with the technology, I believe it offers a new way forward. This is truly restorative, unlike so many of the available tools. Patency of the venous system, along with functional vein valves, has the potential to revolutionise venous therapy. This technology restores normal venous haemodynamics, a concept that, heretofore has been unimaginable.”
Andrés García León, head of the department of angiology and vascular surgery at Virgen de Valme University Hospital in Seville, Spain, associate professor at the University of Seville, and lead principal investigator (PI) added: “I am very pleased to be leading the phase 2/3 trial of P-TEV. In clinical practice, treatment options for patients with advanced CVI are limited. P-TEV represents a promising and scalable approach with the potential to restore physiological blood flow.”
