aap Implantate AG
- WKN: 506660
- ISIN: DE0005066609
- Land: Deutschland
Nachricht vom 08.11.2018 | 07:42
Antibacterial silver coating technology: Convincing results of animal study by aap and AO Research Institute Davos - Completion of preclinical data base on the way to the targeted market approval
DGAP-News: aap Implantate AG / Key word(s): Study results
aap Implantate AG ("aap") has achieved convincing results for its antibacterial silver coating technology in an animal study undertaken with the renowned AO Research Institute Davos. The study proved that the silver coating developed by aap does not have a negative influence on bone healing. The company has thereby fulfilled one of the central requirements of the competent authorities, reaching an important milestone on the way to start a human clinical study as prerequisite for the targeted market approval.
The antibacterial efficacy of aap's silver coating technology has already been proven in various in-vivo and in-vitro studies. In addition, the competent authorities required an animal trial to show that a silver coated implant does not have a negative effect on fracture healing compared to an uncoated implant ("non-inferiority"). Against this background, aap has undertaken jointly with the AO Research Institute Davos a GLP conform study (GLP = "Good Laboratory Practice") on rabbits. Fractures were treated in one group with silver coated implants and in the other group with uncoated implants. As a result, no difference could be noted in course of the healing between the two groups and successful consolidation of the fracture was reached after ten weeks in all animals of both groups. In addition to the antibacterial effect demonstrated in previous trials, these data provide further evidence for the good biocompatibility of the coating developed by aap without negative influence on bone healing.
aap deliberately chose the AO Research Institute Davos as its partner for this study. The AO Foundation standing behind is a medical non-profit organisation based in Chur, Switzerland, led by an international group of surgeons specialized in the treatment of bone fractures and disorders of the musculoskeletal system. The AO Research Institute Davos is among the leading research facilities for traumatological studies of so-called "breakthrough technologies". The results of the study will shortly be published jointly with the aap Clinical Advisory Board in various scientific journals.
With the positive results of the animal study, aap has made further important progress in preparing the human clinical study for the targeted CE and FDA approval of its antibacterial silver coating technology. aap is now in the finalisation phase of the required validations and documents for submission for approval of the human clinical study. On the basis of the current status of these preparations and in particular against the background of the required time for interaction with the competent authorities, which is hardly predictable, aap targets to start the study in the first half of 2019.
The silver coating technology developed by aap, which is covered by international patents, is intended to protect the surface of implants from bacteria colonisation. Thereby aap is addressing one of the biggest not adequately solved challenges in trauma: the reduction of surgical site infections (SSI).
aap's silver coating technology has several unique selling propositions such as a high coating stability as well as a good biocompatibility and effectiveness. These properties have been demonstrated in a number of different preclinical test series. Furthermore, it is a cost-effective coating technology that is scalable to higher production volumes with reasonable expense.
Furthermore, the silver coating technology developed by the company has, as a platform technology, a wide range of potential applications and can be used not only in orthopaedics but also in further areas such as cardiology, dentistry or for medical instruments.
|Company:||aap Implantate AG|
|Phone:||+49 (0) 30 75 01 90|
|Fax:||+49 (0) 30 75 01 91 11|
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|End of News||DGAP News Service|
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