VERIGRAFT has completed its first clinical trial with P-TEV — a personalized tissue therapy for patients with severe chronic venous insufficiency (CVI).
The P-TEV clinical trial results mark a major step forward in the clinical development of personalized tissue therapies for vascular disease. The study took place in Spain and represents the first time VERIGRAFT’s technology has been tested in humans.
Encouraging safety and effectiveness results
VERIGRAFT treated 11 patients with P-TEV after screening 18 participants. Each patient was closely monitored for twelve months to assess safety and performance. The P-TEV clinical trial results showed excellent safety and encouraging clinical outcomes.
Excellent safety: P-TEV graft did not cause graft occlusions, infections, or surgical failures.
Strong performance: Most grafts remained functional one year after surgery.
Clear patient benefit: Patients experienced healed ulcers, reduced swelling, and improved quality of life.
“Completing our first clinical trial marks a defining milestone for VERIGRAFT. These results confirm that personalized tissue therapy can become a true alternative for patients with severe vein disease — and bring us one step closer to changing the standard of care,” says Petter Björquist, CEO of VERIGRAFT.
A summary of the TECVI-1 trial report can be found HERE.
Next steps: Phase II/III clinical trial
Following these P-TEV clinical trial results, VERIGRAFT is preparing a multicenter, multi-country Phase II/III trial to confirm the benefits in a larger patient population.
In parallel, the company is expanding its manufacturing capacity and strengthening regulatory readiness — moving closer to offering a lasting solution for millions affected by CVI worldwide.
These results strengthen VERIGRAFT’s position in the field of personalized tissue therapy. The company continues to invest in process optimization, regulatory alignment, and collaboration with international clinical centers.
The goal is to bring P-TEV to more patients and demonstrate its long-term benefits for those living with chronic venous insufficiency.
About P-TEV
P-TEV (Personalized Tissue Engineered Vein) is VERIGRAFT’s proprietary tissue therapy designed to restore vein function using donated human tissue and the patient’s own blood.
By combining advanced tissue processing with patient-specific customization, P-TEV aims to eliminate rejection risk and provide long-term clinical benefit.