Live from NASS: Five-year Data From Mobi-C Trial Concludes Successful Year for LDR

LDR Holding Corporation had a significant presence at this year’s North American Spine Society (NASS) Annual Meeting in San Francisco, Calif. The company’s artificial disc, Mobi-C, was the subject of five paper presentations, one of which was part of NASS’s “best paper” series.

The Mobi-C cervical disc is the only U.S. Food and Drug Administration-approved disc for both one and two-level use. LDR demonstrated how the device looks when implanted on a larger than life, moving model dubbed the “dancing spine” on the conference floor at NASS. The model swayed back and forth, snake-like, to demonstrate the range of motion enabled by the Mobi-C discs.

This year, LDR was able to present five-year data from its prospective randomized clinical trial, and the data suggest that disc replacement with Mobi-C is a more effective treatment for disc degeneration than fusion, especially when used on two levels of vertebrae. Five-year data is considered the standard for long-term success. Results from the study so far concluded that Mobi-C patients maintained segmental range of motion through 60 months compared to anterior cervical discectomy and fusion (ACDF) patients, where motion was eliminated.

Hyun W. Bae, M.D., of The Spine Institute in Santa Monica and The Spine Center at Cedars Sinai Medical Center (California) presented a paper that compared one- and two-level cervical total disc replacement with Mobi-C and one- and two-level ACDF procedures. The paper was nominated as a “best paper” by NASS. In his presentation, Bae noted that there is no statistically significant reduction in efficacy or increase in complications as the number of levels treated with Mobi-C increases from one to two levels, but ACDF patients demonstrate a reduction in treatment effectiveness when the number of levels operated on is increased from one to two.

“The evidence supports an advantage of Mobi-C over ACDF, especially for treating two-level disease,” he said.

“The takeaway from the data sets for both the one- and two- level is that the results remain consistent, consistently favoring disc replacement with Mobi-C over fusion,” Joe Ross, executive vice president of global marketing for LDR, told ODT at NASS. “That’s what people what to see: Do those early results support the same level of efficacy long-term? The study is demonstrating that it does.”

Mobi-C was approved for use in the United States in August last year, and the company went public two months after that. The last year has proven a “very exciting time of growth and change” for LDR, said Ross, and the company plans to focus on internal developments and top line expansion in the coming years.

“Our PMA (pre-market approval) provides us with a strong competitive advantage and serves as a high barrier to entry for any potential competitors due to the lengthy multi-year PMA process for both clinical trials and FDA review,” said President and CEO Christophe Lavigne during the company’s third quarter 2014 earnings call in early November. “We are capitalizing on our ‘first mover’ advantage by investing in sales and marketing, physician education and training, and the establishment of a reimbursement group via our Horizon 2016 initiative.”

That “first mover” advantage is hoped to give LDR a very strong market position in the near future, as the market for disc replacement is small, allowing for significant advantage for differentiated products such as Mobi-C.

“Because cervical discs are class III devices and they require an IDE (investigative device exemption) trial which takes seven to nine years, there are only a few devices currently approved for use, and all of them currently for one-level only,” Ross told ODT. “When you compare that to the interbody cage or pedicle screw markets for which there are hundreds of products available, cervical discs is a very limited marketplace. Within that marketplace we have that unique position with the only device approved for one- and two-level replacement, and within the two-level trial Mobi-C demonstrated overall clinical superiority to fusion. That’s a very powerful resource for LDR to communicate and promote the technology.”

LDR Holding Corporation is a French spine device company with U.S. headquarters in Austin, Texas.