UPCOMING ARTICLE IN THE SPINE JOURNAL SHOWS TITANIUM-COATED PEEK INTERBODY FUSION DEVICES GENERATE DEBRIS DURING STIMULATED IMPACTION INTO DISC SPACE Biomechanical Study Demonstrates Titan Spine Endoskeleton ® Titianium Devices Produce No Impaction-Related Debris or Other Surface Damage

MEQUON, Wis., October 9, 2015 - Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that a new biomechanical study demonstrates that titanium coated polyetheretherketone (PEEK) implants are susceptible to the generation of particulate debris during impaction into the disc space.  Conversely, the Company’s Endoskeleton® titanium interbody fusion devices showed no signs of impaction debris.

Rhein-Vitro research, titled “Does Impaction of Titanium-Coated Interbody Fusion Cages into the Disc Space Cause Wear Debris and/or Delamination?” is currently available online as an accepted manuscript in The Spine Journal and awaiting publication in an upcoming issue.

The study, which subjected the devices to a simulated biomechanical impaction process into the disc space, showed that 26% of the teeth on the titanium-coated PEEK implants lost coating material ranging in size from 1μm to 191μm (microns). More than half of the particles were of a size range (less than 10μm) that allows for phagocytosis, an osteolytic process that occurs when macrophage cells are unable to safely digest foreign material.

Professor Hans-Joachim Wilke, Ph.D., an author of the study, commented, “We undertook this study to investigate the possibility of impaction-generated debris since the FDA currently does not require interbody fusion devices to be tested in this fashion prior to regulatory clearance. Our findings suggest that different surface manufacturing processes have a large effect on whether the material stays bound during impaction or not.”

Peter Ullrich, Chief Executive Officer of Titan Spine, added, “Reducing the risk of debris-induced inflammation at the site of implantation is essential to patient safety. This study clearly indicates that the proprietary subtractive manufacturing process used to create Titan’s Endoskeleton® devices produces absolutely no impaction-related debris whereas the additive coating process used to create the coated PEEK devices do. We are pleased that this important research is slated for publication in an upcoming issue of The Spine Journal so spine surgeons can make more informed decisions on what technologies to implant in their patients.”

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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