aap Implantate AG ("aap") announces that it has received yesterday approval from the ethics commissions to conduct a human clinical study for its innovative antibacterial silver coating technology. Now that the German Federal Institute for Drugs and Medical Devices ("BfArM") has already given its approval, all the regulatory requirements for starting the study in Germany have been fulfilled. aap is the first company worldwide to test an antibacterial silver coating on anatomical plates for fracture treatment in a study of this kind.
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In view of the significant effects of the corona pandemic on both aap and the participating clinics, coupled with the uncertainty as to the exact time of a return to normality, no statement can be made at present about a specific date for the start of the human clinical study in Germany. In the meantime, the Company will press ahead with all preparations for the study in the best possible way so that it will be able to act immediately once the situation eases. With a view to financing the human clinical study, aap can initially draw on further funding from the German Federal Ministry of Education and Research ("BMBF"). Here, the Company has been granted up to approximately EUR 2.7 million to cover expenses incurred by carrying out the study. In addition, aap is still in talks with interested global medical technology companies about potential co-financing and other cooperation options (e.g. joint product development or licensing deal) and will now intensify these further against the background of the approval from the ethics commissions.
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As a platform technology, aap's antibacterial silver coating technology has a broad spectrum of applications. In addition to trauma, it can be used in other areas of orthopaedics as well as in cardiology, dentistry or for medical instruments.
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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 are a major burden on healthcare systems worldwide. According to the World Health Organization (WHO), SSI result in costs to health care systems of up to USD 18.6 billion in the USA alone. In Europe, the economic costs caused by surgical site infections are up to EUR 19.1 billion. In view of this and of its broad spectrum of applications, aap's antibacterial silver coating technology offers enormous market potential.
[1] Source: WHO's Global Guidelines For The Prevention Of Surgical Site Infection, 2016.
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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German stock markets -
About aap Implantate AG
aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The Company develops, manufactures and markets products for trauma. The IP-protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as the antibacterial silver coating technology and magnesium-based implants. These technologies address critical and unmet needs in trauma. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups, and hospital groups, while at international level it primarily uses a broad network of distributors in around 25 countries. In the US the Company pursues a hybrid distribution strategy with its subsidiary aap Implants Inc. Distribution is carried out both through distribution agents and partnerships with global orthopedic companies. aap Implantate AG's stock is listed in the General Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at .
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; Manager Investor Relations; Lorenzweg 5; 12099 Berlin, Germany; Tel.: +49/30/750 19 - 134; Fax.: +49/30/750 19 - 290;
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