DGAP-News: aap Implantate AG
/ Key word(s): Study
18.06.2021 / 07:30
The issuer is solely responsible for the content of this announcement.
aap Implantate AG (“aap“) 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. The implantation is part of a clinical study led by 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. In the surgery the silver coated LOQTEQ(R) 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.
“Three weeks after the first use of a silver coated implant from aap, the healing process looks very encouraging regarding the skin and wound conditions. The wound conditions are inconspicuous and there is no indication of infection so far. Overall, the course is very satisfactory up to now,” says Prof. Dr. Dr. Volker Alt. “Silver is excellently suited for coating medical implants because it has a very broad spectrum of activity and, unlike antibiotics, there is currently no relevant resistance to silver. Thus, in addition to its use as a coating for bone implants, silver is also interesting for other implants, such as in cardiac or neurosurgery, and therefore has very great future potential.”
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 the FDA in financial year 2021 and prepare necessary documents for submission to the agency.
In principle, aap strives 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 (=Medical Coating Technologies), was founded at the end of the financial year 2020, into which the silver coating technology will be incorporated. This shall make it possible to manage technology development in a more flexible and targeted manner and to implement the desired co-financing.
 2020 Antibacterial agents in clinical and preclinical development: an overview and analysis. Geneva: World Health Organization; 2021.
About aap Implantate AG
For queries, please contact: aap Implantate AG; Fabian Franke; Head of Investor Relations; Lorenzweg 5; 12099 Berlin, Germany; Phone: +49 (0)30 75019 – 134; Fax: +49 (0)30 75019 – 290; Email: firstname.lastname@example.org
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|Company:||aap Implantate AG|
|Phone:||+49 (0) 30 75 01 90|
|Fax:||+49 (0) 30 75 01 91 11|
|Listed:||Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||1209410|
|End of News||DGAP News Service|