Very successful human clinical trial with the innovative antibacterial surface-treated implants receives approval for quick end of recruitment. – Biotech Investments

• BfArM and lead ethics committee approve early end of recruitment
• Last patient included on 6 August 2024;
• A total of 202 patients were included in the study;
• Start of the MDR registration phase

aap Implantate AG (“aap” or “Company”) informs that due to the ongoing good results the patient recruitment of the human clinical trial could be terminated early. After the incidence rate remained at a very low level and more than 200 patients were recruited for the study, an application to discontinue patient recruitment was submitted in July 2024. This application was approved by the Federal Office for Drugs and Medical Devices (BfArM) and the lead ethics committee. The study has a follow-up period of one year and will end in August 2025. aap would like to thank all participating clinics for their excellent performance in the context of patient recruitment and the very good cooperation to date. 

The decision represents a milestone for aap after the company has invested around EUR 15 million in development work and associated costs in the years since the start of the project. This makes aap the only company with a nearly completed human clinical study on an antibacterial trauma implant, which puts it in an excellent starting position in a market worth billions.

Rubino Di Girolamo (CEO) comments on this success: “We are very pleased about the approval granted by the BfArM and the leading ethics committee. This underlines a successful intermediate step, which was achieved after several obstacles through persistent adherence to the goal and brings aap‘s opportunity to make a significant contribution to the fight against antibiotic resistance closer.”

In the next step, aap is preparing the MDR registration of the technology with the aim of authorising an initial product group in the 2026 – 2027 timeframe, depending on the regulatory requirements, and subsequently generating initial sales. The company anticipates that the funds required for product approval in the period 2025 – 2027 will amount to between EUR 1 million and EUR 2 million. With additional, manageable funds, aap can also initiate its own small series production, which will enable an adequate level of sales. Doctors and clinics that took part in the study have already signalled great interest in the product.  Depending on funding commitments or licence agreements with strategic market participants, the scope of product approvals and production capacities can be expanded considerably.

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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, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, 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 internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment 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 that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

Contact:

aap Implantate AG; Rubino Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; 12099 Berlin
Phone: +49 (0)30 75019 – 170; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de