DGAP-News

Disruptive antibacterial silver coating technology: Very good results after use of 3 silver-coated implants as positive indication for start of human clinical study in Q4/21

DGAP-News: aap Implantate AG / Key word(s): Study Disruptive antibacterial silver coating technology: Very good results after use of 3 silver-coated implants as positive indication for start of human clinical study in Q4/21 21.09.2021 / 07:30 The issuer is solely responsible for the content of this announcement. aap Implantate AG ("aap" or the "Company") announces that three implants coated with the Company's innovative antibacterial silver technology have already been implanted in patients. With its antibacterial silver coating technology, aap addresses one of the greatest and as yet inadequately solved challenges in traumatology: the reduction of surgical site infections (SSI).

In all three surgeries very good healing processes have been recorded so far and no indications of infections have been detected. In addition, measurements of the silver concentration in two of these operations showed that there was only a relevant increase in the silver concentration locally in the area of the wound where the antibacterial effect is needed. The very good overall results are a positive indication for the planned human clinical study that aap intends to launch in Germany in the fourth quarter of 2021 to obtain CE approval.
 

The interventions were performed as part of an IIT study and two individual healing trials at the University Hospital Regensburg and the Dill Clinics in Dillenburg. These involved particularly severe infections and complex bone fracture healing disorders in which the therapeutic measures used were specifically supplemented by aap's innovative antibacterial silver coating technology to increase the chances of healing.
 

"In addition to the very good healing processes after the operations at our hospital, the results of the silver concentration analysis are particularly positive from my point of view," says Prof. Dr. Dr. Volker Alt, Director of the Clinic for Trauma Surgery at the University Hospital Regensburg and expert in the field of antimicrobial coatings. "Here, there was a desired significant increase in the local silver concentration in the wound, whereas the systematic silver concentration in the rest of the body was very low and therefore completely unproblematic. These are very positive findings that show that the silver ions are released by aap's special coating and essentially only appear where they are actually supposed to act." "I can only confirm the colleague Alt: I also saw an excellent healing process during my operation and could no longer detect any infection activity after ten days," adds Dr. med. Rene Burchard, head physician at the Clinic for Orthopedics & Trauma Surgery at the Dill Clinics in Dillenburg. "If the results are confirmed in the upcoming human clinical study, I see a good chance that such a technology has the potential to become the market standard."