EQS-News: aap successfully completes human clinical trial for antibacterial surface technology

• Last patient released from human clinical trial in August 2025
• Study results conclude positively, the set study goal has been achieved
• Positive effects of treated implants compared to untreated implants
• Study report expected by the end of 2025
• Publication of clinical trial data planned for 2026
• MDR and US FDA approval in progress
• Potential for massive cost savings in healthcare

In August 2025, aap Implantate AG ("aap" or "Company") successfully completed the clinical human study co-funded by the BMBF, which was conducted at 13 leading German clinical centers. The study results achieved meet the set goals with regard to the demonstration of safety and equivalence with the existing implant standard. Positive effects have also been demonstrated in implants treated with aap’s antibacterial surface technology. The statistical analyses and the study report are expected by the end of 2025, so that the study results are expected to be published in 2026 and presented at specialist conferences.

This successful completion has marked a significant milestone in the new technology and reduced the risk to technological development, allowing the company to fully focus on the approval of the first product group. The aim is to approve antibacterial plates and screws for the treatment of ankle fractures, as ankle injuries are very common. Currently, the European CE approval according to the MDR regulations as well as the US FDA approval is being advanced. In addition, approval in China is planned together with the Chinese partner Youshi Medical. Due to the novelty of the technology and the considerable delays in approvals due to the implementation of the MDR Directive in Europe, the company cautiously expects an initial approval from 2028 and thus first sales. The sales potential is considered to be very high, as the products can be used preventively in any surgery or for high-risk patients and there is therefore a need to keep them available in clinical care. This development is driven by the potential savings for each infection prevented. As the number of post-operative infections is increasing worldwide and antibiotic resistance^[1] is also increasing, aap expects high interest in its innovative antibacterial surface technology. This is also driven by increasing cost pressure in the healthcare sector.

aap will have to raise funds on the market to finance the investments in the approval and industrialization of the technology, whereby early license sales could also contribute to this. Furthermore, aap is considering options to enable investments directly in its antibacterial surface technology. The company has already prepared a corresponding structure.

Such a step would open up the opportunity for investors to invest specifically in the new technology and, in addition, the licensing business could be easily expanded to other areas of medical technology such as orthopedics, dental implants, pacemakers and other titanium implants. For licensees, there would be the opportunity to introduce a technologically completely new premium product line and to be able to tap into a very large market potential. aap will market the Trauma segment itself. To ensure a successful market launch and to arouse great interest in the technology among distributors, aap is continuously expanding its distribution network.

The clinical trial is funded by the German Federal Ministry of Education and Research ("BMBF"). The grant granted to the company (funding codes 13GW0313A+B, 13GW0449A+B) is part of the BMBF's field of action "Healthcare Economics in the Health Research Framework Programme" (= funding body). According to the BMBF, funding is provided for projects on the topic of "Transferring medical technology solutions into patient care - proving clinical evidence without delay". For further information, please refer to the corresponding guideline on the BMBF website: https://www.bmbf.de/foerderungen/bekanntmachung-1376.html.

^[1] Report on the Burden of Endemic Health Care-Associated Infection Worldwide

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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 global medical technology company headquartered 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 perforated screws. In addition, aap Implantate AG has an innovative pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical and not yet adequately solved problems in traumatology.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 25 countries. In the USA, the company and its subsidiary aap Implants Inc. are focusing on a sales strategy via distribution agents. The shares of aap 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.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo, Chairman/ CEO, Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 170; Fax: +49 (0)30 75019 – 290; Email : r.digirolamo@aap.de