VERIGRAFT partners with Bramble Bio for GMP manufacturing of P-TEV

Technology transfer will begin immediately to establish GMP manufacturing of VERIGRAFT’s personalised tissue-engineered vein in Warsaw ahead of the multi-country TECVI-2 Phase II/III trial, expected to start in Q1 2027 Warsaw, Poland and Gothenburg, Sweden – 24 September 2026 – Bramble Bio, the cell and gene therapy contract development and manufacturing organisation and VERIGRAFT AB, a Swedish clinical-stage biotechnology company developing personalised, fully biological tissue therapies, today announced a manufacturing partnership supporting the clinical development of VERIGRAFT’s lead product candidate, P-TEV. Scope of the Agreement Under the agreement, VERIGRAFT will transfer its manufacturing process for P-TEV, a personalised tissue-engineered vein, to Bramble Bio’s GMP manufacturing site in Warsaw, Poland. Technology-transfer activities will begin immediately. Bramble Bio will undertake the process transfer, manufacturing preparation and related GMP activities required to support VERIGRAFT’s pivotal multi-centre Phase II/III clinical trial, TECVI-2. The collaboration also includes support for the sourcing and qualification of donated human vein tissue used as starting material for P-TEV manufacturing, strengthening an important part of the supply chain for the programme. “Establishing a robust and scalable manufacturing capability is fundamental to the successful delivery of TECVI-2 and to the future development of P-TEV. Bramble Bio combines specialist ATMP manufacturing expertise with the flexibility and commitment required for a complex, personalised therapy. We look forward to working closely with their team as we transfer our process and prepare to supply this important multi-country clinical trial.” Petter Björquist, CEO of VERIGRAFT Supporting a pivotal European clinical programme P-TEV is a personalised tissue-engineered vein with a functioning valve, being developed for patients with advanced chronic venous insufficiency (CVI),a progressive vascular condition in which the veins in the legs are unable to return blood efficiently to the heart. The therapy is designed to replace a diseased vein segment containing a non-functioning valve. P-TEV begins with donated venous tissue, which is decellularised to remove donor cells while preserving the native tissue and valve structure. The resulting matrix is then reconditioned with the patient’s own blood. The resulting fully biological graft is intended to restore venous function without requiring immunosuppressive treatment. “We are delighted that VERIGRAFT has selected Bramble Bio as its manufacturing partner for this pivotal programme. Technology transfer and clinical manufacturing for a personalised tissue-engineered product require close technical collaboration, rigorous process control and carefully coordinated logistics. These are core areas of expertise for our CDMO team. We look forward to establishing the process in Warsaw and supporting VERIGRAFT as P-TEV advances through clinical development.” Simon Boa, Managing Director of Bramble Bio TECVI-2 is a a randomised, controlled, open-label Phase II/III study designed to evaluate the efficacy of P-TEV in a larger patient population. The study is intended to support future applications for marketing authorisation in Europe and the United States. Clinical sites are planned in Spain, Poland and the Netherlands, with patient recruitment activities in Spain underway. The study builds on VERIGRAFT’s previously completed first-in-human TECVI-1 trial. The collaboration expands Bramble Bio’s portfolio of advanced therapy programmes and adds a pivotal Phase II/III project to its growing CDMO pipeline. It also reflects the increasing role of specialist European manufacturing partners in helping developers translate innovative tissue-engineering technologies into scalable clinical programmes. P-TEV is VERIGRAFT’s personalised tissue-engineered vein with a functioning valve and is designed to restore native venous function in patients with advanced chronic venous insufficiency. TECVI-2 is a randomised, controlled, open-label Phase II/III pivotal clinical trial evaluating the efficacy of P-TEV. The trial is currently authorized in Spain under the EU Clinical Trials Regulation and approval in Poland and the Netherlands is expected during Q4 2026. The trial is expected to start during Q1 2027. The registered EU Clinical Trial Number is 2025-524103-69-00. Further information: TECVI-2 clinical trial About VERIGRAFT AB VERIGRAFT is a Swedish clinical-stage biotechnology company developing personalised, fully biological therapies for diseases where existing treatment options are limited. Rooted in research from Karolinska Institutet and headquartered in Gothenburg, the company has developed a platform for industrialised tissue engineering and advanced regenerative medicine. Its lead programme, P-TEV, is in late-stage clinical development for chronic venous insufficiency, while its broader R&D pipeline includes potential applications in cardiovascular and neuronal diseases. For more information, visit www.verigraft.com. About Bramble Bio Bramble Bio is a specialist cell and gene therapy contract development and manufacturing organisation and part of FamiCord Group. The company supports biotechnology and pharmaceutical developers with technology transfer, process development and optimisation, GMP manufacturing, cellular starting-material sourcing, analytical services and international logistics. From its GMP sites in Warsaw, Poland and Cantanhede, Portugal, Bramble Bio supports the development and clinical manufacture of cell- and tissue-based advanced therapy medicinal products. For more information, visit www.bramble.bio. Media and investor enquiries Bramble Bio Simon Boa, Managing Director [email protected] | +48 732 080 842 VERIGRAFT AB Cecilia Norling, Head of PR [email protected]

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