Originally Published MDDI September 2004

NEWSTRENDS

Erik Swain

Device industry investors have considered the spinal market a hot one for several years now. That proved true again in July when orthopedics giant Stryker Corp. (Kalamazoo, MI) announced its plans to buy SpineCore, an emerging spine-technology company located in Summit, NJ. Like several companies that are working to develop products for the spine market, SpineCore's technology purports to replace degenerated disks and alleviate spinal pain without immobilizing any spinal segments. 

The company is currently developing two potentially significant products. One, FlexiCore, is a lumbar artificial disk. The other, CerviCore, is a cervical artificial disk. Both products could emerge as alternatives to spinal fusion and other procedures that often result in loss of spinal motion. The nonfusion spine-technology market, virtually nonexistent now, could reach nearly $1 billion by 2008. (See “Market Snapshot,” MD&DI, July 2004, p. 114.)

Under terms of the acquisition, Stryker will pay $120 million in cash up front and could pay as much as $240 million more, depending on whether the technologies receive FDA approval. 

A clinical trial is currently being held for FlexiCore under an investigational device exemption (IDE). An IDE application for CerviCore is expected to be filed by the end of 2004, and its trial should begin in 2005. Stryker said it expects to be able to submit PMA applications for FlexiCore and CerviCore in 2007 and 2008, respectively.

“We believe SpineCore's products represent the first of a next generation of artificial disks,” said Stephen P. MacMillan, Stryker's president and COO. “These products, with patented features, embody the latest design advances so as to better restore natural range of motion and allow for simpler, safer insertion.” 

“The SpineCore team is delighted to join forces with Stryker in our effort to bring motion preservation technology to market,” added spine surgeon Thomas J. Errico, a founder and director of SpineCore. He went on to say that “the combination of our technology and Stryker's experience and resources will allow the SpineCore products to achieve their full potential. We believe strongly in the future role of motion preservation products in the spine.”

However, SpineCore's products could have competition when they enter the marketplace. Johnson & Johnson's Depuy Spine Inc. (Raynham, MA) expects its artificial disk to receive marketing clearance early next year. In addition, Medtronic Sofamor Danek Inc. (Richmond, VA) could have its disk approved as early as 2006. Also in the artificial-disk sector are Cervitech Inc. (Rockaway, NJ); Synthes Inc. (Oberdorf, Switzerland); and Scient'X (Guyancourt, France).

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