After a mixed 2023 financial year, aap makes a strong start to the 2024 financial year – Biotech Investments

• Silver: significant acceleration in patient recruitment with over 130 patients
  as of the end of January 2024.
• Sales: very good start to the 2024 financial year
• Start of MDR certification

In the past financial year, aap Implantate AG (“aap” or “Company”) was able to significantly accelerate patient recruitment with the realignment of the world’s first clinical human study for its innovative antibacterial implant technology. At the same time, the number of predefined, product-related incidents has so far been significantly lower than assumed values, which, if the results remain the same, would enable early completion of patient recruitment in mid-2024 and thus the completion of the study after the end of the follow-up period in mid-2025. Building on these promising developments, aap will continue its efforts to attract significant third-party funding for the industrial expansion of the technology in the 2024 financial year.

After a mixed 2023 financial year in the LOQTEQ® trauma division, aap was able to make a positive start to the new 2024 financial year. In January, sales in Germany increased significantly by 30% compared to sales in January 2023. International business was up 10% year-on-year and the U.S. stayed within budget for Q1 with the aim of increasing profitability and consolidating sales. With the conclusion of a distribution agreement with a leading global medical technology company and supplier of products in the field of spine treatment and orthopedics for the French market with the highest-selling system LOQTEQ® VA-Radius system, a further step in the sustainable sales development could be made. Due to the difficult forecast for annual sales, aap is cautiously optimistic about sales in 2024 of between EUR 11.5 million and EUR 13.0 million.

In the operational area, the looming delay in MDR certification could be used for a successful re-certification according to ISO 13485 and monitoring under MDD. The process with the Notified Body for MDR certification has been started and is expected to be completed in 2024 according to the timetable agreed with the Notified Body.

To strengthen the liquidity base, aap evaluates the timely implementation of an initial capital measure. These and other measures are primarily necessary to finance the ongoing activities for aap’s antibacterial implant technology, which is causing increased costs due to the acceleration, and secondarily to manage the additional burdens in the trauma business due to the MDR changeover.

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

——————————————————————————————————————————————-

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 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 affiliated clinics, while on an international level it primarily uses a broad network of distributors in around 25 countries. In the U.S., the company and its subsidiary aap Implants Inc. are pursuing a hybrid sales strategy. Distribution is carried out both through distribution agents and through partnerships with global orthopaedic companies. 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.

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

Forward-Looking Statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not guarantees of future developments and results. Various known and unknown risks, uncertainties and other factors may cause the actual results, financial position, 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 speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements contained 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, CEO, Lorenzweg 5; 12099 Berlin

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