NuVasive Files IDE for Cervical Disc
BY JOHN MCCORMICK, JULY 6, 2005
This morning NuVasive announced that that it filed for an IDE from the FDA to investigate the safety and efficacy of its Cerpass(TM) ceramic-on-ceramic cervical disc. The filing was completed at the end of June.
Approval of the IDE from the FDA would allow the Company to initiate a pivotal human clinical study of the device in the U.S. The Company plans on discussing the details of the FDA study once the IDE is approved.
NuVasive is focusing its disc efforts on the cervical markets as opposed to lumbar. The HealthpointCapital proprietary spine market model is currently estimating a market size equivalence between cervical and lumbar discs (approximately $700 million each by the year 2014). It stands to reason that the cervical volume could outpace lumbar by a factor of three since adoption by surgeons leverages the familiar anterior approach to the cervical spine. Cervical discs are also expected to be priced substantially lower than their lumbar counterparts. If CMS continues to deny add-on payments for the lumbar technology, we would consider revising our estimates, however.
