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OXPEKK-IG Device Viking Gains Regulatory Approval in Korea
Date:7/8/2010

KFDA Acceptance of OXPEKK-IG Implantable Polymer

(PRWEB) July 8, 2010 -- Oxford Performance Materials (OPM) is very pleased to announce that the firm’s OXPEKK-IG long-term implantable polymer has been accepted by the Korean Food and Drug Administration (KFDA). The KFDA approved the Viking interspinous spinal device made by OPM’s customer Sintea Plustek.

Acceptance by the KFDA effectively opens the Korean market for Sintea Plustek and is at the same time a major milestone for OPM. “Gaining regulatory approval for our products requires long-term commitment and focus,” said Scott DeFelice, President and CEO of OPM. “With broad acceptance of OXPEKK-IG in Europe and South America, we are delighted that our Asian strategy is now moving to a commercial phase.” OPM has numerous maturing developments in the Korean market and this approval is expected to have near-term commercial impact.

The Viking device produced by Sintea Plustek is, according to excellent reviews from leading surgeons at the Hesperia Hospital and the S. C. Ortopedia and Traumatologia in Milan, a sophisticated device with a brilliant design and optimal biochemical and biomechanical features. “Sintea has been a customer of OPM for more than four years and we find their products, organization and business approach to be very desirable,” said Franco Ronchi, Technical Manager at Sintea Plustek. “We are of course very pleased that we can now expand the markets available to us and look forward to further cooperation with OPM, which we feel enables efficient technical and commercial expansion.”

OPM’s OXPEKK-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of Polyaryletherketone polymers (PAEK). OXPEKK-IG has been extensively implanted
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