EQS-News

Antibacterial silver coating technology: acceleration of human clinical trial through successfully implemented clinical trial protocol changes

EQS-News: aap Implantate AG / Key word(s): Study Antibacterial silver coating technology: acceleration of human clinical trial through successfully implemented clinical trial protocol changes 25.11.2022 / 16:27 CET/CEST The issuer is solely responsible for the content of this announcement. aap Implantate AG ("aap" or the "Company") announces that with the recent approval for an amendment to the clinical trial plan by the BfArM and the Ethics Committee, an important step towards accelerating the human clinical trial of the antibacterial silver coating technology developed by aap could be implemented. The changes to the clinical trial plan were deemed necessary by the Company because it has become apparent during the conduction of the trial to date that the originally envisaged number of patients with fractures exclusively of the distal tibia cannot be achieved within a reasonable period of time.

The two crucial changes at a glance concern:

• Removal of double blinding: The previous situation with an unblinded surgeon who then cannot perform follow-up visits has proven difficult to implement in practice. Unblinding the entire study team and the sponsor will simplify planning and patient care. Furthermore, this allows for smaller study teams and more flexible handling in case of vacation or illness of the investigators.
• Adjustment of target fracture: Due to the significantly higher incidence of fractures of the fibula, a faster inclusion of a significant number of patients is expected. In addition, it will facilitate the planning and execution of the surgeries, which will reduce the workload on the investigators.

Following approval by the BfArM and the Ethics Committee, the Company has started production of a sufficient number of study implants for the adapted target fracture. Based on the changes to the clinical trial plan, aap plans to complete the number of patients to be included under the human clinical trial in mid-2024, after which the mandatory follow-up year will begin.