DGAP-News: Antibacterial silver coating technology: Application for approval of human clinical study submitted to Federal Institute for Drugs and Medical Devices (BfArM)

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.
 

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aap Implantate AG (ISIN DE0005066609) - Prime Standard/Regulated Market - All German stock markets -

About aap Implantate AG
aap Implantate AG is a globally operating medical device company headquartered in Berlin, Germany. The company develops, manufactures and markets trauma products for orthopaedics. The IP protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) and trauma complementary biomaterials a wide range of cannulated screws as well as standard plates and screws. Furthermore, aap Implantate AG has an innovation pipeline with promising development projects as the antibacterial silver coating technology and magnesium based implants. These technologies address critical problems in surgery that haven't yet been resolved adequately. In German-speaking Europe aap Implantate AG directly sells its products to hospitals, buying syndicates and hospital groups while it uses a broad network of distributors in more than 25 countries at the international level. aap Implantate AG's stock is listed in the Prime Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit www.aap.de, or download the Company's investor relations app from the Apple's App Store or Google Play.

Forward-looking statement
This release may contain forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments.
Contact:
aap Implantate AG; Fabian Franke; Investor Relations; Lorenzweg 5; D-12099 Berlin Tel.: +49/30/750 19 - 134; Fax.: +49/30/750 19 - 290; Email: f.franke@aap.de