Mittwoch, 18. Oktober 2017


  • Pressemitteilung BoxID 345748

aap Implantate AG Receives Initial FDA 510(k) Clearance for its LOQTEQ Trauma Plating System

Small Fragment Plating Line is First in New LOQTEQ Product Family to Receive FDA Clearance

Berlin, (lifePR) - 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.

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.

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