Clinical Trials
Clinical development of P-TEV™ grafts is ongoing.
The first-in-human trial (TECVI-1), that was treating patients with severe chronic venous insufficiency (CVI) with P-TEV grafts, was completed during the summer of 2025. The clinical trial delivered compelling clinical data and clear patient improvement. All safety milestones were successfully met, demonstrating that P-TEV grafts are safe and well tolerated.
VERIGRAFT is now moving on with a multi-country pivotal clinical trial to confirm efficacy and to collect additional long-term safety data.
P-TEV Clinical Trial TECVI-1 – Phase I/II Study Summary
The P-TEV clinical trial TECVI-1 was a single-arm, open-label trial conducted in Spain to evaluate VERIGRAFT’s personalized tissue theraoy for patients with severe chronic venous insufficiency (CVI).
Each participant received implantation of a single P-TEV graft and was followed for twelve months to assess safety and efficacy. The P-TEV clinical trial TECVI-1 concluded in June 2025 and provided important evidence supporting VERIGRAFT’s approach to personalized tissue therapy.
- Sponsor: Verigraft Iberia S.L.
- EudraCT No.: 2020-003778-28
- Study End: June 11, 2025
- Participants: 18 screened / 11 treated / 12-month follow-up
- Design: Single-arm, open-label, first-in-man trial
- Indication: Severe chronic venous insufficiency (CEAP C4-C6) with no curative treatment available
Key Results
Safety profile
The P-TEV graft demonstrated an excellent safety profile.
The P-TEV graft did not cause graft occlusions, infections, or surgical failures.
A total of 49 adverse events were recorded — all expected for the patient population and the intensive follow-up schedule.
Three adverse events were product-related (all mild or moderate), and two serious events (one surgical, one possibly product-related) were both successfully resolved.
Significant and sustained clinical benefit
- Functional grafts: 82 % at 3 months, 64 % at 12 months
- Symptom reduction: Significant rVCSS improvement maintained through 12 months
- Clinical outcomes: Ulcer healing, reduction of swelling, reduced vein disease related QoL and stable overall QoL
Conclusion
The P-TEV clinical trial TECVI-1 demonstrated strong safety, feasibility, and durable function of VERIGRAFT’s personalized vein grafts. The results validate the company’s personalized tissue-therapy platform and support transition to the next development phase.
Next Steps
VERIGRAFT is now preparing a multicenter Phase II clinical trial to confirm long-term efficacy and expand patient inclusion.
In parallel, the company continues to scale manufacturing, enhance regulatory readiness, and explore strategic partnerships to advance clinical adoption.
More than millions of people worldwide live with CVI, and there is still no curative treatment.
P-TEV aims to provide a long-term, biological solution that restores vein function and improves quality of life.