Joint Press Release
Gothenburg, Sweden and Lund, Sweden – 28 May 2026
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.
“For people living with severe chronic venous insufficiency, the options today treat the symptoms, not the cause. P-TEV is built to change that. Reaching a pivotal trial is a real milestone and running it well across several countries takes a partner who understands how demanding a personalized therapy is to deliver. That is why we are working with TFS.”
Petter Björquist, CEO, VERIGRAFT
“Advanced therapies are among the hardest studies to run. The manufacturing, the logistics and the regulatory expectations are unforgiving. They have to hold at every site at once. That is the work we do well and we are excited for the partnership ahead.”
Åsa Carlsheimer, VP Internal Medicine, TFS HealthScience
About VERIGRAFT
VERIGRAFT is a Swedish clinical-stage biotechnology company developing personalized, fully biological therapies for diseases where current treatment options are limited. Rooted in research from Karolinska Institutet and headquartered in Gothenburg, the company has built a scalable platform for industrialized tissue engineering and advanced regenerative medicine.
VERIGRAFT’s lead program, P-TEV, is advancing through late-stage clinical development in chronic venous insufficiency, while the company’s broader R&D pipeline explores additional applications in cardiovascular and neuronal disease. With international investor backing and a platform designed for future product expansion, VERIGRAFT is positioned to address significant unmet medical needs in global markets.
For more information, visit www.verigraft.com.
About TFS HealthScience
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes. With over 800 professionals operating across 40 countries, TFS delivers tailored clinical research services in specialized therapeutic areas, including dermatology, internal medicine, neuroscience, oncology and ophthalmology.
Dedicated to empowering partners and enriching lives, TFS offers flexible clinical development and resourcing solutions that combine global reach with the agility and responsiveness of a mid-sized CRO.
For more information, visit www.tfscro.com.
Media contacts
VERIGRAFT
Cecilia Norling, Head of PR
TFS HealthScience
Paloma Redondo, Director, Marketing and Communication