VERIGRAFT Receives Regulatory Green Light: Patient Recruitment Completed in Groundbreaking Clinical Trial for Chronic Venous Insufficiency
Gothenburg, Sweden – May 27, 2025. VERIGRAFT AB is pleased to announce a major milestone in the development of its Personalized Tissue Engineered Vein (P-TEV) for the treatment of Chronic Venous Insufficiency (CVI). The Spanish Medicines Agency (AEMPS) has now formally approved an amendment confirming the completion of patient recruitment for the company’s ongoing Phase I/II clinical trial (TECVI-1), recognizing the strong safety profile of the P-TEV technology.
Severe CVI affects over four million people in the U.S. and Europe alone, leading to pain, immobility, and reduced quality of life. VERIGRAFT’s unique approach using natural personalized vascular grafts may offer the first true long-term curative option for these patients. The amendment – approved on May 14, 2025 – reflects the positive safety data accumulated in the trial to date. With this regulatory green light, VERIGRAFT can now officially conclude the recruitment phase and prepare for next steps toward pivotal efficacy trials in Europe and the United States. The milestone signals growing confidence from health authorities in VERIGRAFT’s ATMP platform and its clinical strategy, setting the stage for regulatory interactions and investor engagement in the upcoming studies.
“This is a critical moment for VERIGRAFT and for the millions of patients suffering from CVI without effective long-term treatment options,” says Dr. Petter Björquist, CEO of VERIGRAFT. “Our P-TEV product continues to demonstrate excellent safety and strong clinical potential. We are now accelerating toward late-stage development, with growing confidence and momentum.”
For more information, please contact
VERIGRAFT - Pernilla Gill – email pernilla.gill@verigraft.com
Media - Richard Hayhurst – richard.hayhurst@59north.bio
About VERIGRAFT
VERIGRAFT is a biotechnology company originating from Karolinska Institutet and has grown to become a forerunner in industrialized tissue engineering and advanced regenerative medicine. The company has a strategically focused R&D pipeline of personalized tissues, targeting areas such as cardiovascular and neuronal disease.
VERIGRAFT’s headquarters are located close to Gothenburg University and Sahlgrenska, Sweden’s biggest university hospital. Here the company has state-of-the-art preclinical laboratories and offices. VERIGRAFT is led by a team of experienced scientists and entrepreneurs, and is backed by investors from Europe, Asia and the US. www.verigraft.com
