Accelerate human clinical trials with successfully implemented clinical trial protocol changes

EQS-News: aap Implantate AG / Key word(s): Study
Antibacterial silver coating technology: Accelerating human clinical trials 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 Implants AG (“aap” or the “Company”) announces that with the recent approval of an amendment to the clinical trial plan by the BfArM and the Ethics Committee, an important step has been taken in accelerating the human clinical trial for the antibacterial silver coating technology developed by aap could be implemented. The company considered the changes to the clinical study plan to be necessary because during the course of the study it became apparent that the originally planned number of patients with fractures of only the distal tibia could not be reached within a reasonable period of time.

The two key changes at a glance relate to:

  • Abolition of the double blinding: The previous situation with an unblinded surgeon who was then unable to carry out follow-up care has proven to be difficult to implement in practice. Unblinding the entire study team and sponsor simplifies planning and patient care. This also enables smaller study teams and more flexible handling when investigators are on vacation or ill.

  • Adaptation of the target fracture: Due to the significantly higher incidence of fibula fractures, a faster inclusion of a significant number of patients can be expected. In addition, it will facilitate the planning and execution of the operations, which will reduce the investigators’ workload.

After approval by the BfArM and the ethics committee, the company has started the production of a sufficient number of study implants for the adapted target fracture. Based on the changes to the clinical investigation plan, aap plans to complete the number of patients to be enrolled in the human clinical trial in mid-2024, after which the mandatory year of follow-up will begin.

All previous applications of silver-coated implants in the context of individual healing attempts have shown very good healing processes and no indications of infections could be found. These overall very good results are a positive indication for the ongoing clinical study on humans.

With its antibacterial silver coating technology aap is tackle one of the greatest challenges in traumatology that has not yet been adequately resolved: the reduction of Surgical Site Infections (SSI). Wound infections represent a major burden for both patients and global health 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 active substances.[1] In addition, according to the WHO, almost all antibiotics currently in development work little better than existing active ingredients. aapThe innovative antibacterial silver coating technology from 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 wide 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 implementation of the clinical study is funded by the Federal Ministry of Education and Research (“BMBF”). The funding awarded to the company (funding code 13GW0313A+B, 13GW0449A+B) is part of the BMBF field of action “Health economy in the framework program health research”. According to the BMBF, projects on the topic of “transferring medical solutions to patient care – proving clinical evidence without delay” are being funded. For more information, please refer to the relevant guideline on the BMBF website: https://www.bmbf.de/foerderungen/Announcement-1376.html.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

Around aap Implant Inc

aap Implantate AG is a global medical technology company based in Berlin, Germany. The company develops, produces and sells products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of cannulated screws. Additionally, 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 addressed. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while internationally it relies primarily on a broad dealer network in around 25 countries. The company is based in the USA a Hybrid sales strategy through its subsidiary aap Implants Inc. This includes sales both through sales agents and through partnerships with global orthopedic companies. That aap The shares of Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more 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 press release may contain forward-looking statements that are based on current expectations, beliefs and projections of management and information currently available. 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 the aaps 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 Antibiotics in Clinical and Preclinical Development: Overview and Analysis. Geneva: World Health Organization; 2021

Contact:
aap Implants AG; Mark Hahn; Member of the Board of Directors/CFO; Lorenzweg 5; 12099Berlin
Phone: +49 (0)30 75019 – 134; Fax: +49 (0)30 75019 – 290; Email: [email protected]

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

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