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aap receives US-American clearance (FDA) for polyaxial LOQTEQ(R) VA calcaneus system; market launch planned for beginning of 2020

DGAP-News: aap Implantate AG / Key word(s): Product Launch/Market launch

21.08.2019 / 07:29
The issuer is solely responsible for the content of this announcement.

aap Implantate AG ("aap") announces that its new LOQTEQ(R) VA calcaneus plates 3.5 have been cleared by the US-American Food and Drug Administration (FDA). The Company plans to launch the LOQTEQ(R) VA calcaneus system at the beginning of 2020 in the United States and in other markets that accept FDA clearances. The system enables flexible treatment of fractures of the heel bone, which is one of the important load-bearing joints of the lower extremity. The LOQTEQ(R) VA calcaneus plates 3.5 belong to the LOQTEQ(R) 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 calcaneus system, aap addresses the foot and ankle segment, which with an average annual growth rate of around 9% is one of the fastest growing segments of the trauma market[1] and accounts for almost half of the total extremities market. The treatment of calcaneus or heel bone fractures is very often performed surgically, as these have a high joint involvement rate of 75%. To meet patients' growing demands, a swift and stable treatment is required that enables an early restoration of mobility. The anatomically preformed, angle-stable plates of the LOQTEQ(R) VA systems in conjunction with freely selectable screw angles, user-friendly instruments and a high stability fulfils all the requirements of modern surgery. The LOQTEQ(R) VA calcaneus system 3.5 contains different plates for the treatment of the heel bone in two different sizes and designs, whose low profile height of only 1.6 mm with a type II anodization contributes to the comfort of users and patients.

In view of launching the calcaneus plates in the European market, aap is currently preparing the documents for the corresponding conformity assessment procedure for the CE label. With the LOQTEQ(R) VA calcaneus system 3.5 aap takes a further important step on the way to the completion of its portfolio, which will increase the attractiveness for full-service clinics and purchasing groups as well.

[1] Compound Annual Growth Rate (= CAGR) of the years 2019 - 2025; Source: Global Foot and Ankle Devices Market Forecast up to 2025, February 2019.

Implantate AG (ISIN DE0005066609) - Prime Standard/Regulated Market - All German stock markets -

About aap Implantate AG
aap Implantate AG is a globally operating medical device company headquartered in Berlin, Germany. The company develops, manufactures and markets trauma products for orthopaedics. The IP protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) and trauma complementary biomaterials a wide range of cannulated screws as well as standard plates and screws. Furthermore, aap Implantate AG has an innovation pipeline with promising development projects as the antibacterial silver coating technology and magnesium based implants. These technologies address critical problems in surgery that haven't yet been resolved adequately. In German-speaking Europe aap Implantate AG directly sells its products to hospitals, buying syndicates and hospital groups while it uses a broad network of distributors in more than 25 countries at the international level. aap Implantate AG's stock is listed in the Prime Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit, or download the Company's investor relations app from the Apple's App Store or Google Play.

Forward-looking statement
This release may contain forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. 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. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments.

For inquiries please contact: aap Implantate AG; Fabian Franke; Manager Investor Relations; Lorenzweg 5; 12099 Berlin, Germany; Tel.: +49/30/750 19 - 134; Fax.: +49/30/750 19 - 290;

21.08.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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Language: English
Company: aap Implantate AG
Lorenzweg 5
12099 Berlin
Phone: +49 (0) 30 75 01 90
Fax: +49 (0) 30 75 01 91 11
ISIN: DE0005066609
WKN: 506660
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 860567

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Last Updated: 21-Aug-2019