Titan Spine Secures CMS New Technology ICD-10 Code for Nanotextured Surface on Interbody Fusion Devices

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative surface-enhanced spinal interbody fusion implants, reports that the U.S. Centers for Medicare & Medicaid Services (CMS) has announced the creation of a new technology ICD-10 code for a nanotextured surface on an interbody fusion device. Titan Spine’s nanoLOCK™ surface technology, which was the first FDA-cleared nanotechnology for interbody fusion devices, has been given access to use this code.

The “Interbody Fusion Device, Nanotextured Surface” code was approved as an XRG code by CMS and will be able to be used starting October 1, 2016. This code was approved based on information presented by Titan Spine on its nanoLOCK™ surface that demonstrated it as a unique and differentiated technology. Other technologies may be added to this code but must first either demonstrate equivalence to nanoLOCK™, or demonstrate superiority to all other market alternatives through the CMS designated processes.

Several steps were required to procure the nanotextured code. Titan Spine has dedicated years researching and evaluating surface nanotechnology, including extensive scientific research, safety evaluations, and clinical retrospective assessments linking cellular response to clinical outcomes. All supporting studies were completed on Titan Spine’s proprietary surface topography. Next, Titan Spine gained a nanotechnology clearance from the FDA that required the establishment of nanoLOCK™’s safety profile through extensive in-vivo testing. In late 2015, Titan Spine completed the CMS New Technology Procedural Coding System Application and ICD-10 Code Request, which was further supported in early 2016 through two CMS Public Forums: i) the CMS New Technology Add-On Payment Town Hall and ii) the CMS ICD-10 Coordination & Maintenance Committee. The culmination of these steps resulted in a Section X New Technology ICD-10 code which aligns hospital coding to nanoLOCK™’s product distinctiveness.

Peter Ullrich, M.D., Chief Executive Officer of Titan Spine, commented, “We are very pleased with the new nanotextured category designation that CMS has created. And I am extremely proud of the entire Titan team who worked tirelessly to create our nanoLOCK™surface technology and to procure its code.”

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). 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.^1,2,3,4 The company will soon be launching its next-generation nanoLOCK™ surface technology, which has been shown to create superior osteogenic and angiogenic environments when compared to PEEK and the company’s current surface technology.⁵ All Endoskeleton® devices are covered by the company’s risk share warranty.

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.

¹ Olivares-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.

² Olivares-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.

³ Olivares-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.

⁴ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

⁵ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.