CE Mark for OsseoScrew, GLIF/ARC System

Alphatec Holdings Inc., the parent company of Alphatec Spine Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced that the Company has received the CE Mark for commercial sale in the European Union and other jurisdictions for its OsseoScrew Spinal Fixation System and its Guided Lumbar Interbody Fusion (GLIF) System / Arc Portal System. The receipt of the CE Mark allows Alphatec Spine to begin selling these implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval.

The OsseoScrew Spinal Fixation System is an innovative concept in pedicle screw fixation. The OsseoScrew provides three points of fixation; the pedicle, the transverse/superior facet, and the junction of the anterior pedicle and vertebral body. This is in contrast to a standard pedicle screw that only has one point of fixation the pedicle itself. The OsseoScrew implant is an expandable pedicle screw that addresses the challenges of demanding spinal fusion constructs in which there is a need for fixation with clinically proven technology that enhances the fixation in the bone-implant interface by 30%.

"We are pleased to announce that the second product from our Aging Spine development pipeline is available for commercial release in the European Union. The OsseoScrew Spinal Fixation System is the only available option for patients that adequately addresses the challenging spinal fusion constructs that need an increased level of fixation," says Dirk Kuyper, the Company's President and CEO. Mr. Kuyper added, “The OsseoScrew has an expandable region that locks the screw into the neck of the pedicle, in a manner that is similar to how a molly bolt is used in dry wall. Our biomechanical testing has confirmed that the expanded screw provides a 30% improvement of the bone/implant interface as compared to a standard pedicle screw.“

The OsseoScrew system is scheduled for its first European clinical use in February 2010. The OsseoScrew system is not available for sale in the U.S. and the Company is in discussions with the FDA to obtain 510(k) clearance for the product.

The Guided Lumbar Interbody Fusion (GLIF) technique and ARC Portal Access System is designed to provide surgeons with trans-psoas access and direct visualization to the intervertebral disc space while allowing the patient to remain in a prone position during lumbar interbody fusion procedures.

The GLIF surgery technique is a minimally invasive extracavitary approach to the anterior spine designed for intervertebral body fusion. The GLIF system is designed to reduce intra-operative blood loss and minimize tissue disruption while decreasing the post-operative recovery time for most patients. 

When augmented with posterior pedicle fixation, the GLIF system eliminates the need to reposition the patient intra-operatively, thereby reducing the overall length of the lateral lumbar fusion procedure and potentially reducing operating room costs.

The Company expects to begin a limited market release of the GLIF system in Europe during the second half of 2010.