DGAP-News: aap receives BfArM approval for human clinical study and becomes global bellwether in antibacterial coating for trauma implants

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. From today's perspective, it is not possible to predict when approval for the study will be granted in the US.
 

aap's antibacterial silver coating technology 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.
 

"The approval of the human clinical study is a very important step for the market approval of the silver coating technology", 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. "This allows a reduction of the risks of major complications during operations, especially from infections. Patients will enormously benefit thereof in future."
 

With its innovative silver coating technology, aap addresses one of the biggest challenges in trauma that has not yet been adequately solved: the reduction of surgical site infections (SSI). Surgical site infections impose a heavy burden on global health care systems. According to World Health Organization (WHO)^[1], in the United States alone, SSI lead to costs for health care systems of up to US$ 18.6 billion. In Europe economic costs caused by SSI are up to EUR 19.1 billion. Based on this and due to the wide range of applications, the antibacterial silver coating technology offers aap an enormous market potential.
 

By focussing on hitherto inadequately addressed needs and challenges in trauma and the progress regarding its internationally patent protected silver coating technology, aap has aroused interest among global medical technology companies. In this regard, aap is aware that its silver coating technology is predestined to unfold its full value potential in cooperation with global partners. Product development and approval projects in cooperation with other companies would facilitate a much faster marketing of the silver coating technology, especially in respect of additional areas such as cardiology, dentistry or medical instruments. Against this background, aap will further intensify talks and negotiations with global medical technology companies. In detail, the company is discussing 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.

^[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.

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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.
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