VERIGRAFT Reports Strong Safety and Favorable Clinical Outcomes in First-in-Human TECVI-1 Trial

TECVI-1 showed very good safety outcomes and sustained clinical improvement through 12 months.

GOTHENBURG, SWEDEN, December 2, 2025 /EINPresswire.com/ -- VERIGRAFT AB today announced results from its first-in-human TECVI-1 clinical trial evaluating the company’s Personalized Tissue-Engineered Vein (P-TEV) in patients with severe chronic venous insufficiency (CVI; CEAP C4–C6). The trial demonstrated very good safety outcomes and encouraging clinical improvements over a 12-month follow-up period.

The study demonstrated very good safety outcomes. Most adverse events reflected either the underlying disease burden or the surgical procedure rather than the investigational product. A small number of events were assessed as product- or procedure-related; all were mild or moderate and all resolved. One possibly product-related serious adverse event occurred, and this too resolved. No unexpected safety signals were observed during the 12-month follow-up. Loss of transplant function occurred in some cases, as is clinically expected in this population, and these events were not classified as product-related.

Patients experienced significant and sustained improvements in symptoms as measured by the Venous Clinical Severity Score (VCSS). Additional improvements were observed in ulcer healing, alongside stable health-related quality-of-life scores. Overall, the trial concluded that P-TEV demonstrated a very good safety profile and a favorable therapeutic effect.

The Personalized Tissue-Engineered Vein (P-TEV) is created by removing all donor cells from a human vein —preserving the native valve structure—and reconditioning the matrix with the patient’s own blood. The resulting graft is designed to restore one-way venous flow and address deep venous reflux, the underlying driver of severe chronic venous insufficiency (CVI).

With the completion of the first-in-man TECVI-1 clinical trial, VERIGRAFT is preparing to advance to a multicenter pivotal trial focused on long-term efficacy, durability, and scalability. Chronic venous insufficiency and post-thrombotic syndrome affect millions worldwide, and no curative therapies currently exist, underscoring the potential impact of P-TEV as a personalized regenerative treatment option.

“These results are an important milestone for VERIGRAFT. P-TEV has shown very good safety outcomes and encouraging clinical benefit, and we look forward to advancing the next stage of development,” said Petter Björquist, CEO of VERIGRAFT.

VERIGRAFT develops personalized regenerative therapies based on advanced tissue engineering. By combining decellularized donor tissues with patient-specific biological reconditioning, the company aims to create safe, durable solutions for complex vascular and soft-tissue disorders.

Cecilia Norling
VERIGRAFT AB
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Explainer video describing the P-TEV technology and how a personalized vein graft is created.

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