First Case with aap Implantate Silver-Coated Implant

aap Implantate announces that as part of a non-commercial study (so-called IIT study; IIT = Investigator Initiated Trial) at University Hospital Regensburg, an implant coated with the Company’s innovative antibacterial silver technology has been implanted in a patient for the first time ever. In the surgery the silver coated LOQTEQ® Distal Tibial/Fibula Plate System 3.5 for the treatment of ankle fractures was used. The IIT study aims to demonstrate that the use of silver coated implants in complex initial situations, such as chronic bone infections, leads to a good treatment outcome with avoidance of amputations in the affected patients.

With its innovative antibacterial silver coating technology, aap is addressing one of the greatest and as yet inadequately solved challenges in traumatology: the reduction of surgical site infections (SSI). Surgical site infections represent a major burden both for the patients affected and for global healthcare systems. Antibiotic-resistant bacteria pose a particular threat here. For example, in its annual report on the state of research to overcome antibiotic resistance, the WHO recently found that some of the world’s most dangerous bacteria have developed resistance to known agents. Moreover, according to the WHO, nearly all antibiotics currently in development work little better than existing agents.

aap’s innovative antibacterial silver coating technology represents an alternative solution in the fight against bacterial infections that is not based on antibiotics and therefore offers enormous market potential. As a platform technology, the technology has a broad range of applications and can be used not only in traumatology but also in other areas of orthopedics as well as in cardiology and neurology, dentistry, or medical instruments. Against this background, aap will also make its silver coating technology available to non-competing markets while exploiting its unique competitive advantage exclusively for aap’s product portfolio. In areas of application outside traumatology, aap has already launched collaborations with leading medical technology companies and carried out initial test coatings. The aim is to demonstrate the potential use of the silver coating technology on products not manufactured by aap and thus create the preconditions for concluding joint development projects in the second half of 2021.

To obtain CE approval for its innovative antibacterial silver coating technology, aap plans to conduct a human clinical study in Germany for which all regulatory requirements have already been met (BfArM and ethics committee approvals). In view of the current forecasts for the COVID-19 pandemic, which show a clear easing of the infection situation and allow further easing in everyday life, aap will start the clinical study this year after a necessary preparatory phase. For the intended market approval in the U.S., aap intends to finalize the approval pathway with FDA in financial year 2021 and prepare necessary documents for submission to the agency.

Source: aap Implantate