FamiCord AG and Verigraft Partner for P-TEV Phase II/III Clinical Trial Manufacturing
FamiCord AG announced on September 24, 2026, that its Contract Development and Manufacturing Organization (CDMO) brand, Bramble Bio, has entered into a manufacturing agreement with Swedish clinical-stage biotechnology company VERIGRAFT AB. Valued in the low single-digit millions of euros, the 18-month collaboration establishes the Good Manufacturing Practice (GMP) production process for VERIGRAFT’s lead product candidate, P-TEV, at Bramble Bio’s site in Warsaw, Poland. The project supports preparations for the upcoming multinational Phase II/III trial known as TECVI-2, which evaluates the personalized tissue-engineered vein as a treatment for severe chronic venous insufficiency.
- CDMO Expansion: FamiCord AG’s Bramble Bio brand will manage the technology transfer, process development, and GMP manufacturing for VERIGRAFT’s P-TEV at its Warsaw, Poland facility.
- Clinical Milestone: The collaboration supports the TECVI-2 Phase II/III trial, a randomized, controlled, open-label study intended to assess P-TEV efficacy across multiple European clinical sites ahead of regulatory filings in Europe and the United States.
- Advanced Regenerative Therapy: P-TEV is a personalized biological vein featuring a functional valve, created by decellularizing donated human vein tissue and reconditioning the resulting matrix with the recipient’s own blood.
Manufacturing Infrastructure for Advanced Therapy Medicinal Products
Under the terms of the agreement, Bramble Bio will perform process transfer, manufacturing preparation, and related GMP activities required to supply the multi-country clinical trial. The collaboration is expected to run for approximately 18 months, with a contract value in the low single-digit millions of euros dependent on clinical program progress, patient recruitment, and manufacturing requirements. Jakub Baran, CEO of FamiCord AG, stated in the announcement that supporting a critical Phase II/III program requires rigorous process control and reliable cross-border logistics, noting that the project broadens the company's portfolio with a late-stage clinical program.
Technology-transfer activities to the Warsaw GMP site begin immediately. In addition to production support, Bramble Bio will assist with the sourcing and qualification of donated human vein tissue utilized as the starting material for P-TEV manufacturing. Simon Boa, Managing Director of Bramble Bio, described the project as a fit for the division, highlighting that personalized tissue-engineered products demand close technical collaboration and carefully coordinated logistics.
Clinical Design and Regulatory Scope of the TECVI-2 Trial
The TECVI-2 study is a randomized, controlled, open-label clinical trial designed to assess the efficacy of P-TEV in an expanded patient population suffering from severe chronic venous insufficiency (CVI). Clinical sites are planned in Spain, Poland, and the Netherlands. Patient enrollment is scheduled to commence in the first quarter of 2027.
Petter Björquist, CEO of VERIGRAFT, emphasized the necessity of scalable production. Establishing a strong and scalable manufacturing capability is fundamental to delivering TECVI-2 and advancing P-TEV development, Björquist noted, adding that Bramble Bio provides specialized Advanced Therapy Medicinal Product (ATMP) manufacturing expertise and flexibility for complex personalized therapies. The trial’s data aims to support future marketing authorization applications with regulatory agencies in both Europe and the United States.
Biological Mechanism of Personalized Tissue-Engineered Veins
Severe chronic venous insufficiency often results from diseased vein segments containing non-functioning valves, leading to impaired blood return, venous hypertension, and debilitating symptoms. P-TEV offers a fully biological, personalized solution designed to replace damaged segments and restore normal venous hemodynamic function without requiring lifelong immunosuppressive treatment.
The manufacturing workflow begins with donated human venous tissue. Technicians decellularize the tissue to remove all donor cellular components while preserving the native extracellular matrix and delicate valve architecture. The resulting biological scaffold is then reconditioned using the individual patient’s own blood cells. This step populates the matrix, rendering the graft compatible with the recipient’s immune system prior to surgical implantation.