Germany takes lead in testing innovative antibacterial implant coating
The Berlin-based medical device company aap Implantate AG (app) is becoming the first company in the world to conduct human clinical trials for an antibacterial silver coating on anatomical plates for treating broken bones. In August, Germany's Federal Institute for Drugs and Medical Devices (BfArM) approved the company's testing plan.
The company has also applied to the US Food and Drug Administration (FDA) to carry out human clinical trials there. Testing in Germany will begin when aap receives the go ahead from Germany's ethics commissions.
According to aap, the innovative anti-bacterial silver coating is a platform with a broad spectrum of applications. It can be used, says aap, in general orthopedics, cardiology, dentistry, and to make medical instruments as well. The director of trauma surgery at the University of Regensburg, Prof. Dr. Dr. Volker Alt, commented, saying, "The approval for a human clinical trial is a very significant step for the market licensing of silver coating technology." An expert in the field of anti-bacterial coatings, Alt added that the coating would "… allow the reduction of serious surgical complications, above all, infections. Patients will profit greatly from this reduction in future."
The coating technology has the potential to resolve an ongoing trauma surgery challenge – infection following the placement of an implant in the body. Known as surgical site infections (SSI), these generate millions of euros in extra healthcare costs annually around the globe.
Since its founding in 1990, aap has been engaged in international cooperation. As the company furthers the development of its innovation, aap says it will work together with global partners to ensure the innovation achieves its full potential. Part of this strategy is to join in product development and licensing projects with other companies, in particular to allow the technology to be included in the additional fields of cardiology, dentistry, and the making of medical instruments.
In addition to being innovative and outward looking like many of its German counterparts in medical technology, aap also has experience in providing contract manufacturing services for companies at home and abroad. The Export Initiative for the German Healthcare Industry, HEALTH MADE IN GERMANY, has published a profile of Germany's medical technology sector. It contains key facts about Germany's strong and highly innovative medical technology industry. The brochure is part of a series published by HEALTH MADE IN GERMANY on the country's healthcare sectors and can be downloaded below.