NuVasive’s Cervical Disc Approved

The FDA is raining PMAs (Premarket Approval) on the cervical spine industry.

NuVasive Inc.’s PCM Cervical Disc System has joined Globus’s Secure-C and Paradigm Spine’s Coflex in receiving recent approvals from the FDA. The company announced the approval on October 26 during the annual meeting of the North American Spine Society.

NuVasive acquired the PCM when it acquired Cervitech in 2009 for up to $80 million. The company, according to Wells Fargo’s analyst Larry Biegelsen, has previously stated it anticipates the product can generate close to $200 million of the life of the product. The market is currently dominated by DePuy/Synthes and Medtronic.

Alex Lukianov, the company’s chairman and CEO, said the PCM Cervical Disc is a “game changing solution” for the cervical spine. “This device has many design considerations that make it a truly unique product offering compared to other cervical motion preserving devices. Its low-profile design enables it to be minimally disruptive to the adjacent anatomy and a viable treatment option for levels adjacent to prior fusions.”

The company’s regulatory and clinical affairs vice president, Laetitia Cousin, said investigators contributed over 17 peer-reviewed publications on the PCM in internationally recognized journals.

The FDA approval comes after successful completion of a prospective, multicenter randomized investigational device exemption (IDE) clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.

Biegelsen believes sales of the PCM will be modest over the next five years and estimates the product can generate about $6 million in revenue in 2013, increasing to about $19 million in 2016 with NuVasive capturing 10% of the market.

The FDA is sitting on other artificial cervical disc PMA applications and analysts are expecting more approvals in the near future.