DGAP-News: aap Implantate AG / Key word(s): Study
aap Implantate AG ("aap" or the "Company") announces that three implants coated with the Company's innovative antibacterial silver technology have already been implanted in patients. With its antibacterial silver coating technology, aap addresses one of the greatest and as yet inadequately solved challenges in traumatology: the reduction of surgical site infections (SSI).
In all three surgeries very good healing processes have been recorded so far and no indications of infections have been detected. In addition, measurements of the silver concentration in two of these operations showed that there was only a relevant increase in the silver concentration locally in the area of the wound where the antibacterial effect is needed. The very good overall results are a positive indication for the planned human clinical study that aap intends to launch in Germany in the fourth quarter of 2021 to obtain CE approval.
The interventions were performed as part of an IIT study and two individual healing trials at the University Hospital Regensburg and the Dill Clinics in Dillenburg. These involved particularly severe infections and complex bone fracture healing disorders in which the therapeutic measures used were specifically supplemented by aap's innovative antibacterial silver coating technology to increase the chances of healing.
"In addition to the very good healing processes after the operations at our hospital, the results of the silver concentration analysis are particularly positive from my point of view," 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. "Here, there was a desired significant increase in the local silver concentration in the wound, whereas the systematic silver concentration in the rest of the body was very low and therefore completely unproblematic. These are very positive findings that show that the silver ions are released by aap's special coating and essentially only appear where they are actually supposed to act." "I can only confirm the colleague Alt: I also saw an excellent healing process during my operation and could no longer detect any infection activity after ten days," adds Dr. med. Rene Burchard, head physician at the Clinic for Orthopedics & Trauma Surgery at the Dill Clinics in Dillenburg. "If the results are confirmed in the upcoming human clinical study, I see a good chance that such a technology has the potential to become the market standard."
Surgical site infections represent a major burden both for the patients concerned and for global healthcare systems. Antibiotic-resistant bacteria pose a particular threat. 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 drugs. Moreover, according to the WHO, almost all antibiotics currently in development work little better than existing drugs. 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, dentistry or medical instruments. Against this background aap will exploit the unique competitive advantage of its silver coating technology exclusively for aap's product portfolio and at the same time make the technology available to non-competing markets. In areas of application outside traumatology aap is already in contact with leading medical technology companies and has carried out initial test coatings. The aim is to demonstrate the possible use of silver coating technology on products that do not belong to aap and thus to create the preconditions for the conclusion of joint development projects in the next twelve to 18 months.
To obtain CE approval for its innovative antibacterial silver coating technology, aap plans to start a human clinical study in Germany in the fourth quarter of this year for which all regulatory requirements have already been met (BfArM and ethics committee approvals) and which is being funded by the German Federal Ministry of Education and Research ("BMBF"). However, this presupposes that the infection situation does not deteriorate again in the context of the COVID 19 pandemic and that corresponding lockdown measures are imposed.
As a matter of principle, aap is striving for co-financing of the human clinical study by third parties and is also evaluating further cooperation opportunities. Against this background, a new subsidiary, MCTeQ GmbH (MCTeQ = Medical Coating Technologies), was founded at the end of the financial year 2020, into which the silver coating technology will be incorporated. This should make it possible to manage the technology development more flexibly and in a more targeted manner and to implement the desired co-financing. Currently, aap is examining the short-term implementation of equity-based transactions via the capital market, such as a capital increase, to finance further growth and also to provide start-up financing for the study.
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21.09.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
aap Implantate AG
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