Interview
SSN: How do you plan to market your implants in Europe? Europe is a much different market than the United States. Titani- um is far more accepted already in their market, so we do not have to reintroduce titanium as a material for interbody fusion. Our selling cycle in Europe is therefore a lot shorter, and the surgeons only need to be educated about our nanoFIX™ Surface Technolo- gy and what it can do in terms of eliciting endogenous recruitment of bone-producing cells. PEEK is still fairly popular in Europe, but market data suggests its popularity is waning, most likely due to its inert properties. Allograft bone is difficult to come by and is quite expensive, so we don’t see it as a prevalent option moving forward. As a result of these factors, we established Titan Spine Europe, GmbH, earlier this year, which is located in Laichingen, Germany. We have already brought several influential distributors on board, are about to hire a European Vice President of Sales, and have seen sales in our devices exponentially rise in Europe.
SSN: Why do you feel PEEK has been the material of choice for interbody devices over the past several years? PEEK became popular in the United States when allograft bone shortages occurred, and after titanium interbody devices fell out of favor due to the issues with threaded titanium cages I previous- ly mentioned. Some of the larger spinal implant suppliers at that time did a good job of selling the idea that threaded titanium cag- es subsided and failed because titanium as a material was too stiff for the intervertebral space. The truth is that these same problems existed in threaded PEEK and allograft cages. The main problem was not the stiffness (modulus of elasticity) of the material, but rather the design of the cages. Through our biomechanical testing and FEA analysis, we have found a big difference between modu- lus of elasticity and an engineered modulus. The biggest factor in stress sharing of the bone graft is not determined by how soft or stiff the cage is, but rather by how large of a continuous open aperture there is within the cage. Because of the strength of tita- nium, we can manufacture a much larger open area without sacri- ficing the overall strength of the cage. This concept has not only been proven on the bench, but also clinically, as we have seen an exceptionally low subsidence rate and excellent fusion rate with our devices over the past six years in-vivo.
SSN: Why do you feel that nanotechnology is such a buzzword in the spinal industry right now?
Cell processes and signaling have recently become much more important in medicine. Using devices that cause the endogenous recruitment of cells for a specific purpose (i.e., osteoblasts for fusion surgery) allow the devices to participate in the fusion pro- cess. Nanotechnology allows the creation of particles that are small enough that they are able to interact with the host’s cell membranes and signal the cell to ramp up production of proteins. In the case of nano-structured titanium, cell attachment to the im- plant ramps up the production of mRNA , which, in turn, leads to an increase in the production of bone-producing proteins, which then signal osteoblasts to mature and produce bone.
SSN: Why do you feel the timing is right for a return to tita- nium interbody implants?
As a market, the United States tends to follow Europe in terms of the popularity of spinal devices, and the European market has al- ready returned to titanium as the dominant material for interbody fusions. As U.S. surgeons continue to see interbody cages as more than a spacer, titanium will begin to enjoy a greater acceptance and will gain a larger percent of the market that is commensurate with their European colleagues.
SSN: What are some of the most common objections you hear about your devices?
One of the most common misperception of titanium is that it makes it difficult to assess spinal fusions on CT-scan. This was based on experience with threaded cages, which had a much higher ratio of metal to bone graft. Our Endoskeleton® interbody devices use significantly less titanium and feature much larger windows and internal spaces, so assessing the bone graft is not a problem on CT. We recently completed a prospective fusion study on our ALIF device, in which two independent radiologists were able to assess fusion on 98% of the CT scans. MRI technology has improved significantly to where very little scatter is produced by our cages.
Also, there are some physicians who do not like to see their cages on x-ray. To these physicians, we ask them to consider what their patients would want more: an invisible cage on x-ray or a cage that participates in the fusion process. We find that patients mostly care that their pain goes away, not what they can see on x- ray. The other objection surrounds the modulus of elasticity issue I address earlier.
SSN: What does the future hold for Titan Spine? Right now we are focused mainly on filling out our line of na- no-textured interbody implants, bolstering our sales force, and continuing to own the vast majority of intellectual property on our surface and design technologies. We are also working up a business plan to apply our nanoFIX™ surface technology to other spinal and orthopedic devices.
SSN: How can our readers find out more about your technology? They can go to our recently revamped website at www.titanspine. com to find out more about our nanoFIX™ Surface Technology and our company.
Titan Spine Europe, GmbH Gottlieb-Daimler-Straße 43 D-89150 Laichingen Germany
+49(0) 7333 925 998 32
www.titanspine.com
Titan Spine, LLC 6140A West Executive Drive Mequon, WI 53092 USA
+1 (866) 822 7800
Autumn 2012 | SpinalSurgeryNews | 19
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