DGAP-News: aap Implantate AG

aap Implantate AG ("aap") has made substantial progress in preparing the human clinical study for the aimed CE and FDA approval of its antibacterial silver coating technology in recent months. Against this backdrop the company aims to start the human clinical study in the course of the current financial year.
 

At present, aap is still in intensive coordination with the involved authorities regarding scope and design of the clinical study. Based on the information currently available, the company plans the implementation of a multicentric two arm single blind study with about 200 patients in several countries. aap expects a duration of about two years for patient acquisition, implantation and subsequent patient follow-up. In a next step the collected data will be prepared and evaluated. All information is currently still subject to approval by the involved authorities. In this connection the company notes in particular the hardly predictable response times of the European notified body involved, the regulatory authorities BfArM (= Federal Institute for Drugs and Medical Devices) and FDA (= Food and Drug Administration) as well as the ethics commissions of the different German federal states where the hospitals in which the human clinical study is to be undertaken are located.
 

aap has already selected a renowned internationally active CRO (= clinical research organisation) with extensive experience in approval studies of this kind. Together with the CRO and a group of well-known physicians the study design has been drawn up and, for example, inclusion and exclusion criteria for the study have been discussed. In this constellation various documents have also been prepared for the authorities involved. They include documents on, for instance, proof of biocompatibility and mechanical stability. aap has also already lined up many large and well-known university hospitals in different countries to carry out the human clinical study. Furthermore, aap has made great progress on internal validation of processes and products in recent months. That is necessary in order to ensure the availability of a sufficient number of silver-coated LOQTEQ(R) 3.5 distal tibia and fibula plates for the human clinical study.
 

The internationally IP-protected silver coating technology developed by aap protects the surface of implants from bacterial colonisation. Thereby aap is addressing one of the biggest not adequately solved challenges in trauma: the reduction of surgical site infections (SSI). Surgical site infections are burdening global health care systems enormously. According to World Health Organization (WHO)^[1], in the US alone, SSI cases were associated with 406,730 extra hospital days and hospital costs of more than US$ 900 million. In Europe economic costs caused by SSI are between EUR 1.47 to EUR 19.1 billion.
 

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 test series. Furthermore, it is a cost-effective coating technology that is scalable to higher production volumes with reasonable expense.
 

As a platform technology aap's silver coating technology has a wide range of applications and can be used not only in orthopaedics but also in different further areas such as cardiology, dentistry or for medical instruments.
 

Alongside the preparations for the human clinical study the company is engaged in ongoing talks with various global companies on potential joint development projects in the field of silver coating technology.

^[1] Source: WHO's Global Guidelines For The Prevention Of Surgical Site Infection, 2016
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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.
For inquiries please contact: aap Implantate AG, Fabian Franke, Investor Relations, Lorenzweg 5, 12099 Berlin, Germany
Tel.: +49 30 7501 9-134, fax: +49 30 7501 9-290, e-mail: f.franke@aap.de