aap Implantate AG receives BfArM approval for human clinical study for its antibacterial silver coating technology
aap Implantate AG / Key word(s): Study
aap Implantate AG ("aap") announces that it has received the approval to conduct a human clinical study for its antibacterial silver coating technology by the Federal Institute for Drugs and Medical Devices ("BfArM") today. aap has thus reached a decisive milestone on the way to the targeted market approval.
With a view to the start of the human clinical study in Germany, aap now still needs the approval of the ethics commissions, which has already been applied for. In addition, the application for approval of the human clinical study in the US has been submitted at the Food and Drug Administration (FDA) at the beginning of August 2019.
The antibacterial silver coating technology developed by aap has, as a platform technology, a wide range of applications. Besides trauma, it can be used in further areas of orthopaedics as well as in cardiology, dentistry or for medical instruments, thus offering aap an enormous market potential. The developments in silver coating technology are pursued with keen interest by global medical technology companies which confirmed their interest in the innovative silver coating technology in continuous talks. In detail, the company discusses in addition to joint product development and approval projects also distribution partnerships as well as licensing deals up to the sale of the technology for specific application areas. Against the background of the approval of the human clinical study, aap will further intensify talks and negotiations with the global medical technology companies.
For further details, please refer to the press release published following this release.
08-Aug-2019 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
|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|
|EQS News ID:||854483|
|End of Announcement||DGAP News Service|