DGAP-News

Antibacterial silver coating technology: aap's silver coated implant used for first time in patient - Seite 2

 

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.




^[1] 2020 Antibacterial agents in clinical and preclinical development: an overview and analysis. Geneva: World Health Organization; 2021.

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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German stock markets -

About aap Implantate AG
aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The Company develops, manufactures and markets products for trauma. The IP-protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as the antibacterial silver coating technology and magnesium-based implants. These technologies address critical and unmet needs in trauma. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups, and hospital groups, while at international level it primarily uses a broad network of distributors in around 25 countries. In the US the Company pursues a hybrid distribution strategy with its subsidiary aap Implants Inc. Distribution is carried out both through distribution agents and partnerships with global orthopedic companies. aap Implantate AG's stock is listed in the General Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.