VERIGRAFT Initiates Pivotal Phase II/III Trial for First Potential Curative CVI Treatment
Key Insights
Swedish biotech VERIGRAFT (search) has launched a pivotal Phase II/III trial for P-TEV (search), a personalized tissue-engineered vein therapy targeting chronic venous insufficiency with no existing curative treatments.
The fully biological approach eliminates the need for immunosuppression by using donor-derived venous material personalized with the patient's own blood, with manufacturing completed within 10 days.
VERIGRAFT (search) aims for US and European market approval by 2028, targeting a CVI market projected to reach USD 5,951 million by 2034.
Swedish clinical-stage biotechnology company VERIGRAFT (search) has initiated a pivotal Phase II/III trial for its personalized tissue-engineered vein (P-TEV (search)) therapy in patients with chronic venous insufficiency (CVI), marking a significant milestone in the development of what could be the first curative treatment for this progressive vascular disease. The trial launch is supported by USD 10 million in financing from existing investors.
Revolutionary Approach to Vascular Disease
VERIGRAFT (search)'s P-TEV (search) represents a fully biological approach that eliminates the need for immunosuppressive therapy while restoring natural venous function. The therapy uses donor-derived venous material that is decellularized and subsequently personalized using the patient's own blood, creating a patient-specific graft designed to replace diseased venous segments with dysfunctional valves.
The manufacturing process is completed within 10 days, making the therapy both scalable and clinically feasible. Once prepared, the P-TEV (search) is surgically implanted to replace the diseased vein segment and restore venous function, addressing the underlying cause of disease rather than merely managing symptoms.
Addressing a Significant Unmet Medical Need
Chronic venous insufficiency is a progressive and under-recognized vascular disease in which the veins in the legs fail to efficiently return blood to the heart, leading to sustained elevated venous pressure in the leg veins. Driven by factors such as aging, obesity, and sedentary lifestyles, CVI represents a growing healthcare burden worldwide, with the market projected to reach USD 5,951 million by 2034.
"With P-TEV (search), we are addressing a large, underserved patient population with a therapy designed to address the underlying cause of disease, not just manage the symptoms," said Petter Björquist, CEO of VERIGRAFT (search). "The initiation of our pivotal trial brings us significantly closer to making this a clinical reality."
Clinical Development Strategy
The Phase II/III study is being conducted across trial sites in Spain, the Netherlands, and Poland. As an advanced therapy medicinal product (ATMP), VERIGRAFT (search)'s clinical development program is designed to generate robust clinical data in a limited patient population, with the company aiming to achieve market approval in Europe and the US in 2028.
Dr. Andrés García León, Head of the Department of Angiology and Vascular Surgery at Virgen de Valme University Hospital and Lead Principal Investigator, emphasized the clinical significance: "In clinical practice, treatment options for patients with advanced CVI are limited. P-TEV (search) represents a promising and scalable approach with the potential to restore physiological blood flow."
Expert Perspectives on Clinical Impact
The therapy has garnered attention from vascular specialists for its restorative potential. Dr. Bryan Kluck, an Interventional Cardiologist, Endovascular Interventionalist and Vascular Medicine Specialist at Lehigh Valley Hospital, commented: "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 revolutionize venous therapy. This technology restores normal venous hemodynamics, a concept that, heretofore has been unimaginable."
Intellectual Property and Market Position
VERIGRAFT (search)'s scalable process is protected by 92 granted patents, positioning the company to capitalize on the growing regenerative medicine market. The milestone comes at a time when regenerative medicine and personalized biologics are gaining significant traction among global investors and healthcare systems.
The company's fully biological approach represents what CEO Björquist describes as "a critical component in our journey to redefine how vascular disease can be treated by restoring natural biological function at scale," targeting a multi-million patient population with no existing curative treatment options.