Successful Clinical Trial for Antibacterial Implants by aap Implantate AG

aap Implantate AG announced the successful completion of patient recruitment for their clinical trial on antibacterial surface-treated implants. The Federal Office for Drugs and Medical Devices (BfArM) and the lead ethics committee approved the early termination of recruitment. The trial included 202 patients by August 6, 2024, and will follow up until August 2025.

This decision is a significant milestone for aap, which has invested EUR 15 million in this project. These results place aap in a strong position in the antibacterial trauma implant market. CEO Rubino Di Girolamo stated their commitment to addressing antibiotic resistance through persistent efforts.

The company is now entering the MDR registration phase. They aim to authorize the initial product group by 2026-2027. Estimated costs for product approval range between EUR 1 million and EUR 2 million. Additionally, aap plans to initiate small series production to meet demand and expand based on funding and licensing agreements.