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Antibacterial silver coating technology: acceleration of human clinical trial through successfully implemented clinical trial protocol changes

EQS-News: aap Implantate AG / Key word(s): Study
Antibacterial silver coating technology: acceleration of human clinical trial through successfully implemented clinical trial protocol changes
25.11.2022 / 16:27 CET/CEST
The issuer is solely responsible for the content of this announcement.


aap Implantate AG ("aap" or the "Company") announces that with the recent approval for an amendment to the clinical trial plan by the BfArM and the Ethics Committee, an important step towards accelerating the human clinical trial of the antibacterial silver coating technology developed by aap could be implemented. The changes to the clinical trial plan were deemed necessary by the Company because it has become apparent during the conduction of the trial to date that the originally envisaged number of patients with fractures exclusively of the distal tibia cannot be achieved within a reasonable period of time.

The two crucial changes at a glance concern:

  • Removal of double blinding: The previous situation with an unblinded surgeon who then cannot perform follow-up visits has proven difficult to implement in practice. Unblinding the entire study team and the sponsor will simplify planning and patient care. Furthermore, this allows for smaller study teams and more flexible handling in case of vacation or illness of the investigators.

  • Adjustment of target fracture: Due to the significantly higher incidence of fractures of the fibula, a faster inclusion of a significant number of patients is expected. In addition, it will facilitate the planning and execution of the surgeries, which will reduce the workload on the investigators.

Following approval by the BfArM and the Ethics Committee, the Company has started production of a sufficient number of study implants for the adapted target fracture. Based on the changes to the clinical trial plan, aap plans to complete the number of patients to be included under the human clinical trial in mid-2024, after which the mandatory follow-up year will begin.

All previous applications of silver-coated implants in the context of individual healing trials showed very good healing processes and no evidence of infections could be detected. These overall very good results are a positive indication for the ongoing clinical human study.

With its antibacterial silver coating technology, aap is addressing one of the greatest and 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. 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, dentistry, or medical instruments.

The conduction of the clinical study is funded by the German Federal Ministry of Education and Research ("BMBF"). The grant awarded to the company (grant numbers 13GW0313A+B, 13GW0449A+B) is part of the BMBF's field of action "Healthcare Industry in the Health Research Framework Program". According to the BMBF, projects on the topic of "Transferring medical technology solutions into patient care - proving clinical evidence without delay" are being funded. For further information, please refer to the corresponding guideline on the BMBF website: https://www.bmbf.de/foerderungen/bekanntmachung-1376.html.





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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German Stock Exchanges -

 

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 traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while at international level it primarily uses a broad network of distributors in around 25 countries. In the USA, the company relies on a hybrid sales strategy through its subsidiary aap Implants Inc. This involves sales both via distribution agents and as part of partnerships with global orthopedic companies. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www. aap.de.

 

The figures presented in this press release may be subject to technical rounding differences which do not affect the overall presentation.

 

Forward-looking statements

This release may contain forward-looking statements based on current expectations, beliefs and projections of the Management Board and currently available information. The forward-looking statements are not guarantees of future performance or results. 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. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. We assume no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

 

 

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




Contact:
aap Implantate AG; Marek Hahn; Member of the Management Board/ CFO; Lorenzweg 5; 12099 Berlin
Tel.: +49 (0)30 75019 - 134; Fax: +49 (0)30 75019 - 290; Email: m.hahn@aap.de


25.11.2022 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

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:

1498061


 

End of News

EQS News Service

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