Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a leading medical technology company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that it received U.S. Food and Drug Administration (FDA) 510(k) market clearance for its Novel(r) Cervical Interbody implant. The Novel Cervical Interbody implant is the latest product in Alphatec Spine's pipeline that provides solutions for disorders affecting the cervical spine.
The Novel Cervical Interbody is offered in three footprints in both PEEK and titanium. The implant is designed to optimize endplate contact and has windows that increase the surgeon's ability to insert grafting material into the implant. The Novel Cervical Interbody has been cleared by the FDA as a cervical interbody device, complementing existing Alphatec Spine products, including the Trestle(tm) Anterior Cervical Plating System, the Solanas(tm) Posterior Cervico-Thoracic Fixation System, and the AlphaGRAFT ProFUSE(tm) demineralized bone scaffolds.
"We are very pleased to be one of the few companies to have an implant receive FDA clearance as a cervical interbody device," said Dirk Kuyper, President and Chief Executive Officer of Alphatec Spine. "The addition of the new Novel Cervical Interbody implant to our product portfolio is an extremely positive step in our company's commitment to bringing a full-line of spinal solutions to the surgeon community."
The Novel Cervical Interbody implant is used when performing an anterior cervical discectomy and fusion (ACDF) procedure. This procedure is used to treat a damaged disc in the cervical region due to either a bulging or herniated disc, or due to degenerative disc disease.
The total interbody market in the U.S. is estimated to be valued at more than $930 million in 2008, and forecasted to approach $1 billion by 2010. In 2008, cervical interbody procedures in the U.S. are estimated to account for 49% of all the interbody procedures performed.
