The nanoLOCK surface technology is manufactured through a proprietary subtractive process. It's the only technology with the added FDA clearance for a "nano-textured surface," which was secured in 2014. The device also received its own new technology category and code from CMS earlier this year.
Titan Spine has been a stalwart for titanium technology since 2006, in a time when nearly all interbody companies promoted PEEK as their implant material. Some of these companies have recently responded to titanium’s resurgence by coating their PEEK devices with titanium. However, concerns have been raised whether the titanium remains bound to the implant during insertion in to the disc space. A study published in the February 2016 edition of The Spine Journal compares titanium implants to titanium-coated PEEK implants to examine particulate debris during impaction. The study subjected Titan's Endoskeleton titanium interbody fusion device and a titanium-coated PEEK implant to a simulated biomechanical impaction process into the disc space.
The Endoskeleton implant showed no signs of impaction debris, but 26 percent of the teeth on the titanium-coated PEEK implant lost coating material; more than half of the particles lost into the disc space had a size range allowing for phagocytosis, an insidious osteolytic reaction.
The company is looking forward to additional studies in the future, but currently relies on anecdotal evidence about patients recovering more quickly from surgery with the titanium implants. And the larger companies are taking notice.
"There is a significant shift going on right now in interbody devices as the market is moving away from PEEK," says Andrew Shepherd, vice president of marketing for Titan Spine. "You see it in the market data and you see it from the podium at most conferences. Our competitors are coming out with titanium products, and that's validating. We have put enough of a dent in the market place that we are now seeing legacy companies heavily investing in producing and marketing titanium products."
"I think they recognize that surgeons no longer buy in to the holdover concerns about titanium from the cylindrical cage era. The marketed concept of modulus of elasticity-related subsidence has been proven to be false. And visualization concerns are no longer an issue since there is so much less metal in our implants than in the threaded implants of the past. The scatter effect on CT and MRI is virtually non-existent."
However, the company's challenge will be to remain differentiated from other products as titanium becomes more popular. Their competitive edge? Their ability to orchestrate cellular behavior for rapid bone growth through nanotechnology.
"In the company’s early days, it was difficult to convince a surgeon of the importance of the nanoarchitecture of an interbody device in its ability to drive bone growth. It’s just not something that they were trained to think about," says Mr. Shepherd. "However, as we produced more and more science on the topic, it became easier to talk to surgeons about our technology and how something so small can have such a big impact on their patients. The key is to prompt the body’s natural bone forming and healing processes the moment our device is implanted in to the disc space. That’s exactly what nanoLOCKis designed to do.”
The Endoskeleton devices with nanoLOCK surface technology combine roughened topographies at the macro, micro and nano levels, designed for optimal host-bone response. The technology actively participates in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth and fusion.
"Provisions of the Affordable Care Act have incentivized healthcare providers and surgeons to look for high-value technology: devices that provide good outcomes for a fair cost. There is now a higher emphasis on the 30- and 60-day episode of care, and the implant type can make a difference." As the paradigm shifts from looking at one or two-year outcomes to short-term results following surgery, we have data to suggest that we can help reduce length of stay, readmissions, post-op injections, and other metrics that affect short term outcomes and cost," says Mr. Shepherd. "That's where we think we can really help both patients and surgeons."
Titan Spine experienced a 51 percent sales increase in 2015 over the previous year and continues to report strong demand. In October, the company expanded its sales team to include nine new members to meet the growing demand for Endoskeleton and support the nanoLOCK full launch.
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