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PRESS RELEASE : Antibacterial silver coating technology: aap's silver coated implant used for first time in patient

06/18/2021 | 01:31am EDT
DGAP-News: aap Implantate AG / Key word(s): Study 
Antibacterial silver coating technology: aap's silver coated implant used for first time in patient 
2021-06-18 / 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.^[1] 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. 
^[1] 2020 Antibacterial agents in clinical and preclinical development: an overview and analysis. Geneva: World Health 
Organization; 2021. 
=--------------------------------------------------------------- 
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. 
Forward-looking statement 
This release may contain forward-looking statements based on current experience, estimates and projections of the 
management board and currently available information. They are not guarantees of future performance. Various known and 
unknown risks, uncertainties and other factors could lead to material differences between the actual future results, 
financial situation, development or performance of the company and the estimates given here. Many factors could cause 
the actual results, performance or achievements of aap to be materially different from those that may be expressed or 
implied by such statements. These factors include those discussed in aap's public reports. Forward-looking statements 
therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking 
statements contained in this release or to conform them to future events or developments. 
 
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: f.franke@aap.de 
 
=---------------------------------------------------------------------------------------------------------------------- 
2021-06-18 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
=---------------------------------------------------------------------------------------------------------------------- 
Language:     English 
Company:      aap Implantate AG 
              Lorenzweg 5 
              12099 Berlin 
              Germany 
Phone:        +49 (0) 30 75 01 90 
Fax:          +49 (0) 30 75 01 91 11 
E-mail:       info@aap.de 
Internet:     www.aap.de 
ISIN:         DE000A3H2101 
WKN:          A3H210 
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 
=------------ 

1209410 2021-06-18

 
Image link: 
https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1209410&application_name=news 
 

(END) Dow Jones Newswires

June 18, 2021 01:30 ET (05:30 GMT)

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