aap Implantate AG Receives Initial FDA 510(k) Clearance for its LOQTEQ Trauma Plating System
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aap Implantate AG /
aap Implantate AG Receives Initial FDA 510(k) Clearance for its LOQTEQ Trauma
Plating System
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Small Fragment Plating Line is First in New LOQTEQ Product Family to Receive FDA
Clearance
aap Implantate AG, (XETRA: AAQ.DE), a global medical device company focused on
innovative trauma products and biomaterials for the orthopaedic market,
announced that it has received 510(k) clearance from the United States Food &
Drug Administration (FDA) for the small fragment plating line of its LOQTEQ®
product family. LOQTEQ® is an anatomic, angle-stable orthopaedic trauma plating
system that enables lock and compression with a single hole, which enhances ease
of use for surgeons. The LOQTEQ® system also provides surgeons with variable
compression from 0 mm to 2 mm.
Biense Visser, Chief Executive Officer of aap Implantate AG, said, "This first
510(k) clearance for the LOQTEQ® system marks a major milestone in international
marketing of aap's LOQTEQ® trauma portfolio and another step forward in our
strategy to focus on our core business and expand outside of Europe. The LOQTEQ®
system was developed from proprietary locking-compression technology, which is
already patented and used in Europe. We anticipate that the rest of the LOQTEQ®
product family will subsequently receive FDA clearance, providing a substantial
enhancement of aap's trauma portfolio in the U.S. We are currently evaluating
potential marketing partners and distribution opportunities for LOQTEQ® in the
U.S. and believe it will be successful based on its innovative features."
The 510(k) cleared small fragment LOQTEQ® system consists of a straight plate, a
reconstruction plate, a one-third tubular plate and LOQTEQ® cortical screws.
This 510(k) clearance is one of six clearances anticipated for the LOQTEQ®
portfolio, with the remaining expected to be granted in the coming weeks.
At present, six LOQTEQ® systems (small and large fragments, humerus, femur,
proximal lateral and distal medial tibia) are marketed internationally in the CE
region. The worldwide launch of an additional eight LOQTEQ® systems that are
currently under development is planned for financial year 2013.
About aap Implantate AG
aap is a global medical device company headquartered in Berlin, Germany that
develops, manufactures and markets innovative biomaterials and implants that are
used in orthopedic procedures. The Company's products, which include a full line
of plating systems, cannulated screws and bone cement products, are primarily
used in the orthopedic specialty areas of trauma and spine repair. The Company's
products are sold through its direct sales force, distribution partners and
license agreements with OEM partners. aap's stock is listed in the Prime
Standard segment of the Frankfurt Stock Exchange. For more information, please
visit www.aap.de.
This release contains 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, Marc Heydrich, Investor Relations, Lorenzweg 5, 12099 Berlin,
Germany
Tel.: +49 30 7501 9-134, fax: +49 30 7501 9-290, m.heydrich(at)aap.de
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: aap Implantate AG via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 05.09.2012 - 15:26 Uhr
Sprache: Deutsch
News-ID 180536
Anzahl Zeichen: 5152
contact information:
Town:
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Kategorie:
Business News
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