Helifix and Helifuse (Prod 9898)

Helifix is a non-fusion interspinous device designed to provide relief from the symptoms of LSS by providing flexion in the posterior elements. Helifuse is similar in design to Helifix, but will be a fusion device that may be combined with percutaneous spinal fixation. Alphatec Spine expects to submit Helifuse to the U.S. Food and Drug Administration (FDA) for a 510K clearance in the fourth quarter of 2009. Helifix, as a non-fusion device, will likely require an IDE/PMA approval before it can be sold in the U.S., and Alphatec Spine expects to launch the product initially in Europe under a CE mark in the first quarter of 2010, and subsequently submit a clinical trial protocol to the FDA thereafter. Alphatec Spine has entered into a license agreement with Helix Point, LLC, which provides Alphatec Spine with rights to develop and commercialize Helifix and Helifuse, proprietary concepts for two interspinous devices to treat lumbar spinal stenosis (LSS). Pursuant to the license agreement, Alphatec Spine is the exclusive worldwide licensee of the intellectual property, excluding the right to sell the product in the People's Republic of China.