Becker's Spine Review

26 Executive Briefing: Trends in Artificial Disc Replacement ® LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR's primary products are based on its exclusive VerteBRIDGE® fusion and Mobi non- fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies are designed to enable products that are less invasive, provide greater intra-operative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. In August 2013, LDR received approval from the U.S. Food and Drug Administration (FDA) for the Mobi-C® Cervical Disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR Holding, visit www.ldr.com. al library of Level 1 clinical evidence, now including data from the one and two-level Mobi-C IDE trials. In this era of evidence-based medicine, surgeons look to cervical disc replacement as a proce- dure behind which they can stand." LDR has gone further with its technology than any other company in the marketplace today by obtaining FDA approval for both one and two-level disc replacement. Mobi-C is currently the only FDA- approved device for two-level disc replacement. "We feel that the clinical data demonstrates clear areas of patient benefits over fusion, especially for two-level indications," says Mr. Lavigne. "The data has also been well received and appreciated by spine surgeons." Economic impact The clinical benefits may lead to economic benefits. Last year a study was published in JAMA Surgery examining the cost-effec- tiveness of two-level disc replacement with Mobi-C. Healthcare providers are focused on both clinical quality and cost-effective- ness today, and proving cost-savings to the healthcare system is a valuable tool. The study showed the incremental cost-effectiveness ratio of cer- vical total disc replacement was $24,594 per quality-adjusted life year (QALY) over anterior cervical discectomy and fusion. This is lower than the commonly used threshold of $50,000 per QALY— the baseline for effectiveness. Cervical disc replacement, as a result, is a highly cost-effective option. From a societal perspective, the study also found two-level cervi- cal disc replacement offered a greater quality of life at a lower cost over a two-year period. "This makes a strong argument for using disc replacement on ap- propriately indicated patients," says Mr. Lavigne. Reimbursement Two-level cervical disc replacement received a Category I CPT code on January 1, 2015, following establishment of a Category 1 CPT code for one-level on January 1, 2009.The Category I codes provide surgeons with greater certainty as to what they will be paid for performing cervical disc replacement and is a big step forward to consistent spinal arthroplasty reimbursement. "While it is difficult to quantify coding changes as they relate to our business, it's fair to say the impact can only be positive," com- mented Mr. Lavigne. Training and support for the future Beyond the technology, LDR is continuing to invest in expand- ing medical education and training programs for surgeons. The company provides training courses and cadaveric labs for surgeons to learn disc replacement technique with the Mobi-C Cervical Disc. "Relative to disc replacement we have an extraordinary opportu- nity to expand the market and increase our presence," says Mr. Lavigne. "We believe that the coverage environment for cervical disc replacement will continue to improve. Additional long term evidence will support increased surgeon adoption and patient de- mand." LDR's business model focuses on a small number of highly differ- entiated technologies with the core being VerteBRIDGE ® Plating Technology for spinal fusion and Mobi-C for cervical disc replace- ment. Mr. Lavigne says, "The company will continue to focus on novel technologies and plans to introduce new products in the next 18 to 24 months." "We are enthusiastic about the products in our pipeline, including the InterBRIDGE ® Interspinous Fusion Device that is undergoing evaluation," says Mr. Lavigne. "We foresee continued, excep- tional opportunities for LDR in both the lumbar and cervical seg- ments." n "We believe that the coverage environment for cervical disc replacement will continue to improve. Additional long term evidence will support increased surgeon adoption and patient demand." — Christophe Lavigne, President and CEO of LDR

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