GrownValve’s regenerative heart valve implanted in first human patient

Berlin, June 2025 — GrownValve, a pioneering heart valve company which evolved out of German Heart Center of the Charité–Universitätsmedizin Berlin, is proud to announce the first successful implantation of its regenerative, autologous heart valve in a human patient. This milestone marks the beginning of a first-in-human study evaluating the long-term safety of the GrownValve system, a living valve derived from the patient’s own tissue.

The procedure was performed as part of the GECT-DZHK28 clinical trial, which is assessing the GrownValve technology in seven young adults with congenital pulmonary valve defects. The implanted valve is designed to regenerate and integrate into the patient’s body – potentially lasting significantly longer than current heart valve prostheses and avoiding repeated surgeries commonly required in conventional heart valve therapy.

A new era for heart valve replacement

Unlike animal-derived prostheses that often eventually calcify and deteriorate, GrownValve’s innovation uses endogenous tissue processed and shaped with personalized 3D modeling. In preclinical studies, including in sheep, the valve demonstrated robust regeneration, endothelialization and mechanical durability over 21 months.

“Implanting our valve into a human patient for the first time is a huge leap forward; not just for our team, but for the future of regenerative medicine. Our goal has always been to offer a lifelong solution for patients born with heart valve defects. This is the beginning of what we hope will be a new standard in valve therapy: one that restores life with living tissue.”, states Dr. Boris Schmitt, Pediatrician at the German Heart Center of the Charité (DHZC) and Co-Founder of GrOwnValve. 

This breakthrough carries significant global relevance. Each year, more than 400,000 children are born with congenital heart valve defects—many of whom require repeated surgeries throughout their lives as current prosthetic valves fail to grow with them. GrownValve offers a new path forward: a patient-specific, regenerative heart valve built from the individual’s own tissue, designed to heal, adapt, and potentially last a lifetime. Delivered via a minimally invasive catheter-based procedure, the technology not only reduces surgical risk and recovery time, but also represents a fundamental shift in how structural heart disease can be treated across all ages.