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21-Mar-2023

aap receives US-American clearance (FDA) for polyaxial LOQTEQ® VA Elbow system; launch planned for Q4 2023

EQS-News: aap Implantate AG / Key word(s): Regulatory Approval/Market Launch
aap receives US-American clearance (FDA) for polyaxial LOQTEQ® VA Elbow system; launch planned for Q4 2023
21.03.2023 / 09:08 CET/CEST
The issuer is solely responsible for the content of this announcement.


aap Implantate AG (“aap”) announces that its new system LOQTEQ® VA Elbow 2.7/3.5 has been cleared by the US-American Food and Drug Administration (FDA). The Company plans to launch the system LOQTEQ® VA Elbow 2.7/3.5 in the fourth quarter of 2023 in the United States and in other markets that accept FDA clearances. The system enables flexible treatment of fractures of the distal humerus and olecranon important to the elbow function and stability. The LOQTEQ® VA Elbow plates 2.7/3.5 belong to the LOQTEQ® VA (VA = Variable Angle) product family. These are polyaxial implants that facilitate inserting angle-stable screws at different angles, thereby improving flexibility within the application.

With its new distal humerus and olecranon system, aap addresses the upper extremity segment, which accounts for approx. 34% of trauma surgeries[1]. The treatment of distal humeral fractures remains a challenge in trauma surgery. The incidence rates range up to 7% of all fractures and 30% of elbow fractures[2]. The distal humerus holds great importance in the mobility and function for the elbow, requiring innovative fixation solutions to support effective surgical treatment. To meet patients’ growing demands, a swift and stable treatment is required that enables an early restoration of mobility. The system LOQTEQ® VA Elbow 2.7/3.5 comprises a variety of plate solutions for the distal humerus, enabling 90°and 180° treatment options, as well as solution for the olecranon. The anatomical plate design in conjunction with excellent plate-screw connection, choice of screw angles, as well as the incorporated locking and compression technology (LOQTEQ®) in the shaft area, are just a few of the main features incorporated in the system, contributing to great surgical outcome and high comfort of patients.

With the LOQTEQ® VA Elbow 2.7/3.5 aap takes a further important step on the way to the completion of its portfolio in the polyaxial range. In addition, it is coming one step closer in offering an attractive range of products for its antibacterial silver treated solution, currently in human clinical trial phase.





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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 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 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 within the framework 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.



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] Source: Global Trauma Fixation Device Market Insights, Forecast to 2025, page 16; released by QYResearch

[2] Source: https://www.orthobullets.com/trauma/1017/distal-humerus-fractures, viewed 19.03.2023




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

21.03.2023 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.

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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: 1587437

 
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Last Updated: 21-Mar-2023