aap Implantate AG (“aap”) is about to start the human clinical study for its innovative antibacterial silver coating technology following today’s approval by the Federal Institute for Drugs and Medical Devices (“BfArM”). With the approval of the study, the company has reached a decisive milestone on the way to the targeted market approval. aap is thus the first company worldwide to test an antibacterial silver coating on anatomical plates for fracture treatment in a study of this kind.
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.