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DGAP-News: aap receives US-American approval (FDA) for polyaxial LOQTEQ(R) VA foot system; market launch planned for beginning of 2020

Nachricht vom 12.07.2019 12.07.2019 (www.4investors.de - in Kooperation mit DGAP - EQS Group):

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

aap receives US-American approval (FDA) for polyaxial LOQTEQ(R) VA foot system; market launch planned for beginning of 2020
12.07.2019 / 11:53

The issuer is solely responsible for the content of this announcement.
aap Implantate AG ("aap") announces that its new LOQTEQ(R) VA foot plates 2.5 have been approved by the US-American Food and Drug Administration (FDA). The company plans to launch the LOQTEQ(R) VA foot system at the beginning of 2020 in the United States and in other markets that accept FDA approvals. The system enables flexible treatment of fractures as well as correction of malpositions in the fore- and midfoot area. The LOQTEQ(R) VA foot plates 2.5 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 foot system aap is addressing the foot and ankle segment, which belongs with an annual average growth rate of about 9% to the fastest growing fields of the trauma market[1]. With a view to the foot segment, the backgrounds are not least the demographic change and the increased requirements of patients in the industrialised countries which constantly increase in particular the number of surgically performed corrections in the fore- and midfoot area. To meet patients' growing demands, a swift and stable treatment is required that enables an early restoration of mobility. The special combination of anatomically preformed, angle-stable plates of the LOQTEQ(R) VA foot system in conjunction with freely selectable screw angles, user-friendly instruments and a high stability fulfils all the requirements of modern foot surgery. The LOQTEQ(R) VA foot system 2.5 contains different fracture as well as arthrodesis and osteotomy plates for correcting joint malpositions of the foot. Revision plates for repeat foot operations complete the set.

In view of launching the foot 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 foot system 2.5 aap takes an important step on the way to the completion of its portfolio, which will further increase the attractiveness for full-service clinics and purchasing groups.[1] Compound Annual Growth Rate (= CAGR) of the years 2019 - 2025; Source: Global Foot and Ankle Devices Market Forecast up to 2025, February 2019.

aap Implantate AG (ISIN DE0005066609) - Prime Standard/Regulated Market - All German stock markets -About aap Implantate AGaap 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 www.aap.de, 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; Investor Relations; Lorenzweg 5; 12099 Berlin, Germany; Tel.: +49/30/750 19 - 134; Fax.: +49/30/750 19 - 290; f.franke@aap.de

12.07.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de

aap Implantate AG

Lorenzweg 5

12099 Berlin

+49 (0) 30 75 01 90
+49 (0) 30 75 01 91 11
Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID:

End of News
DGAP News Service

840511  12.07.2019 

Weitere DGAP-News von aap implantate

12.07.2019 - DGAP-News: aap erhält US-amerikanische Zulassung (FDA) für polyaxiales LOQTEQ(R) VA Fußsystem; Markteinführung für Anfang 2020 geplant
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