Award Winning Titan Spine Data Demonstrating PEEK Produces an Inflammatory Environment Favoring Cell Death Published in "Spine" Study Won Whitecloud Award for Best Basic Research at IMAST 2014

MEQUON, Wis. - Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that data from a study comparing its proprietary surface technology to polyetheretherketone (PEEK) have now been published in the March 15 print issue of Spine.

The data demonstrate that Titan’s line of Endoskeleton® Interbody Devices promote osteoblastic differentiation and enhanced bone-forming environment compared to devices made from PEEK. Specifically, the data show that fibrous tissue formation around PEEK implants may be due to the creation of an inflammatory environment.

Barbara Boyan, Ph.D., Dean of the School of Engineering at Virginia Commonwealth University, and lead author of the study, said, “These results indicate that Titan’s surface reduces production of inflammatory mediators and increases production of anti-inflammatory mediators compared to PEEK, thus creating an enhanced environment for bone growth and fusion. Fibrous tissue formation around PEEK spinal implants is due to several factors including increased inflammatory cytokines and decreased cell viability. These data add to the growing body of medical knowledge supporting the use of titanium implants featuring a complex roughened topography at the macro-micro-nano (MMN) levels that induce healing on the cellular level where it is critical for early bone formation.”

The study was granted the prestigious Whitecloud Award for Best Basic Science Research from the Scoliosis Research Society when they were initially presented at the 21st International Meeting on Advanced Spine Techniques (IMAST) in 2014.

Peter Ullrich, MD, former surgeon and Chief Executive Officer of Titan Spine, commented, "This study is yet another example in a rapidly growing body of evidence that PEEK is a poor material for promoting bone growth. Until recently, PEEK was thought to be inert at best. We now understand that is not the case. Dr. Boyan’s research demonstrates that PEEK is actually inhibitory to bone forming cells, called osteoblasts, through the upregulation of pro-inflammatory markers. This leads to fibrous tissue formation, rather than bone formation, as the body attempts to protect itself from PEEK through encapsulation. We were pleased when the IMAST program committee recognized the importance of these data by granting it with the Whitecloud Award. Titan will continue to be at the forefront of scientifically engineering superior interbody fusion devices and promoting titanium as the preferred material for bone growth and fusion.”

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. 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), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.1,2,3

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 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. To learn more, visit www.titanspine.com.

1Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404. 2Olivares-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. 3Olivares-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.

# # #