DGAP-News: aap Implantate AG / Key word(s): Regulatory Admission
19.12.2018 / 15:30
The issuer is solely responsible for the content of this announcement.
aap Implantate AG (“aap”) announces that the application for approval to conduct a human clinical study for its antibacterial silver coating technology was today submitted to the Federal Institute for Drugs and Medical Devices (BfArM). aap has thus reached a further important milestone on the way to start a human clinical study as precondition for the targeted market approval of the silver coating technology.
From the company’s viewpoint all the requisite preclinical data and internal validations for the application for approval of the study are now in place so that submission to the BfArM could be undertaken before the year’s end. The next step is to submit applications in the United States and to the ethics commissions of the different German federal states where the hospitals in which the human clinical study is to be undertaken are located. On the basis of the documents submitted there will then be an interaction phase with all the authorities involved on the results of which aap will report in due course.
The silver coating technology developed by aap, which is covered by international patents, is intended to protect the surface of implants from bacteria colonisation. Thereby aap is addressing one of the biggest not adequately solved challenges in trauma: the reduction of surgical site infections (SSI).
aap‘s silver coating technology has several unique selling propositions such as a high coating stability as well as a good biocompatibility and effectiveness. These properties have been demonstrated in a number of different preclinical test series. Furthermore, it is a cost-effective coating technology that is scalable to higher production volumes with reasonable expense.
Furthermore, the silver coating technology developed by the company has, as a platform technology, a wide range of potential applications and can be used not only in orthopaedics but also in further areas such as cardiology, dentistry or for medical instruments.
About aap Implantate AG
19.12.2018 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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|Company:||aap Implantate AG|
|Phone:||+49 (0) 30 75 01 90|
|Fax:||+49 (0) 30 75 01 91 11|
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|End of News||DGAP News Service|