TITAN SPINE ANNOUNCES IMPACTION DEBRIS STUDY NOW PUBLISHED IN PRINT IN THE SPINE JOURNAL Research Demonstrates Titanium-Coated PEEK Interbody Devices Generate Debris during Simulated Impaction into Disc Space

MEQUON, Wis., March 2, 2016 -  Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that the previously-announced biomechanical study data demonstrating that titanium coated polyetheretherketone (PEEK) implants generate particulate debris during impaction into the disc space have been published in the print February 2016 issue of The Spine Journal

Results of the study, “Does Impaction of Titanium-Coated Interbody Fusion Cages into the Disc Space Cause Wear Debris or Delamination?” were first published online as an accepted manuscript and subsequently announced by Titan Spine on October 9th, 2015.

The study subjected both Titan’s Endoskeleton® titanium interbody fusion devices and titanium-coated PEEK implants to a simulated biomechanical impaction process into the disc space. While the study demonstrated that the titanium implants featuring Titan’s unique surface technology showed no signs of impaction debris, it found 26% of the teeth on the titanium-coated PEEK implants lost coating material, with more than half of the particles of a size range allowing for phagocytosis, an osteolytic process that occurs when macrophage cells are unable to safely digest foreign material.

The full line of Endoskeleton® devices features Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels created by a subtractive process. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), and creating the potential for a faster and more robust fusion.1,2

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require interbody fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. The company will also be launching its next-generation nanoLOCK® surface that features various topographies at the macro, micro, and nano (MMN™) levels in Q4, 2015. To learn more, visit www.titanspine.com

1Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D.  (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone.  The Spine Journal, 12, 265-272.2Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D.  (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

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