Today VERIGRAFT announces that the company has successfully reached the safety assessment milestone in the first patient of the TECVI-1 clinical trial in which the safety of P-TEV for the treatment of CVI is investigated.
The first patient with Chronic Venous Insufficiency (CVI) had VERIGRAFT’s lead product, the Personalized Tissue Engineered Vein (P-TEV), implanted in January 2022. At the four-week visit no safety concerns were identified and the graft was patent. Therefore, subsequent patients will be recruited into the trial.
P-TEV is an engineered human vein segment containing a functional venous valve that is implanted to replace a segment of a patient’s femoral vein carrying a defective valve. The TECVI-1 clinical trial is a Phase I/II open label exploratory study of P-TEV in which 15 patients suffering from CVI are assigned to a single treatment group to evaluate feasibility and safety of P-TEV. All subjects will be followed for twelve months regarding safety and efficacy.