SME Instrument

Personalized Tissue-Engineered Veins (P-TEV) as the first Cure for Patients with Chronic Venous Insufficiency

Part of the development of the P-TEV product is supported by the SME instrument grant under the Horizon 2020 program. The TECVI trial program (EudraCT No. 2015-004021-13) is evaluating P-TEV for the treatment of severe CVI. VERIGRAFTs goal is to deliver a life changing impact to patients and to provide major benefits for hospitals, healthcare providers and society.

The major objectives of the SME instrument project for P-TEV development are:
• Build a pan-European network for clinical trials and future clinical application of the P-TEV product
• Establish a quality management and regulatory structures and documents for clinical development
• Develop GMP compliant production processes
• Set-up the clinical development in the TECVI trial program (EudraCT No. 2015-004021-13) towards marketing authorization and perform a first TECVI clinical trial (Phase I trial to demonstrate safety)
• Prepare the commercialization of P-TEV

VERIGRAFT’s personalized tissue-engineered vein (P-TEV) has gone through preclinical development at the company in parallel to this grant. Safety data has been generated in-vitro and in large animals. Under the grant funding clinical networks in several EU countries have been established, ethical approval for the clinical protocol has been obtained and GMP compliant processes have been validated and set-up for manufacturing. Quality management and regulatory documentation has been generated and we are currently waiting for approval of our application for clinical trial authorization (CTA) in order to start a first-in-man phase 1 safety trial.