GrOwnValve Achieves Primary Safety Endpoint in First-in-Human Heart Valve Study

All five patients complete six-month follow-up without predefined prosthesis-related safety events

BERLIN, Oct. 26, 2026 /PRNewswire/ -- GrOwnValve GmbH, a Berlin-based medical technology company developing personalized heart valves from patients' own tissue, today 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 mayor 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.

A New Approach to Heart Valve Replacement

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."

Clinical Development and Scientific Progress

The GECT-DZHK28 study (NCT05809856), supported by the German Centre for Cardiovascular Research (DZHK), evaluates the safety and initial performance of GrOwnValve's transcatheter pulmonary valve in adult patients.

The initial five patients have completed their protocol-defined six-month safety assessment. The study is designed to enroll seven patients, with longer-term follow-up ongoing.

"These initial safety results are very encouraging," said Dr. Peter Kramer, Senior Cardiologist and GECT Study Investigator at the German Heart Center of Charité. "For patients with congenital heart disease, particularly those facing repeated valve interventions, a personalized valve made from their own tissue could represent an important advancement. Longer-term clinical evaluation will be essential."

The results build on the first published clinical case report of the GrOwnValve procedure in European Heart Journal – Case Reports.

Looking Ahead

GrOwnValve will continue long-term clinical follow-up while preparing the next stages of clinical and technological development.

The company's long-term objective is to develop heart valves offering improved durability, biological integration and potentially the ability to adapt to patient growth. These benefits remain to be established in further clinical studies.

"Heart valve replacement should not mean a lifetime of repeated interventions, particularly for children with congenital heart disease," added Schmitt. "This milestone brings us one step closer to a new generation of personalized heart valves."

About GrOwnValve

GrOwnValve GmbH is a Berlin-based medical technology company originating from research at the German Heart Center of Charité. The company develops personalized heart valve prostheses using autologous tissue, patient-specific manufacturing and transcatheter implantation technology. Its initial focus is pulmonary valve replacement, with future expansion into additional heart valve applications.

Website: www.grownvalve.com

GrOwnValve technology is investigational and not approved for general commercial use. Results are limited to five patients with six-month follow-up. Long-term safety, effectiveness, durability and growth potential remain under investigation.

 

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SOURCE GrOwnValve GmbH