GrOwnValve GmbH, a Berlin-based medical technology company developing personalized heart valves from patients' own tissue, announced the achievement of the primary safety endpoint in the initial five-patient cohort of its GECT-DZHK28 first-in-human clinical study at the German Heart Center of Charité (DHZC).

All five patients successfully completed six-month follow-up, with no prosthesis-related major complications as defined by the study's primary safety endpoint.

The milestone supports continued clinical evaluation of GrOwnValve's innovative autologous heart valve technology as a potential alternative to conventional prosthetic valves.

Unlike conventional biological or mechanical heart valves, GrOwnValve's technology uses the patient's own pericardial tissue to manufacture a personalized valve. Patient-specific anatomical data guide the manufacturing process, and the resulting prosthesis is implanted through a minimally invasive transcatheter procedure.

The technology aims to address major limitations of conventional valve replacements, including structural valve deterioration, repeated interventions and the inability of current prostheses to accommodate patient growth.

"Our vision is to fundamentally change heart valve replacement by creating personalized valves from patients' own living tissue," said Dr. Boris Schmitt, CEO and founder of GrOwnValve. "Achieving the primary safety endpoint in our first-in-human study is an important milestone and provides a strong foundation for our next phase of clinical development."