CARLSBAD, Calif., Feb 23, 2009 (GlobeNewswire via COMTEX News Network) — Alphatec Holdings, Inc. (Nasdaq:ATEC), 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 today that it had 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.
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.
Lumbar spinal stenosis arises from age-related changes to the facets and the intervertebral disc that eventually can lead to a reduction in the patient’s quality of life. In 2008, in the U.S. more than two million people 65 years and older were diagnosed with spinal stenosis. Traditionally, lumbar spinal stenosis has been treated with a laminectomy. There were more than 145,000 of these procedures performed on lumbar spinal stenosis patients age 65 years and older in 2008, and it is estimated that this number will grow to over 160,000 procedures by 2012. Recently, less invasive, potentially reversible procedures have been adopted by many physicians; especially for the aging spine patient. With the introduction of the X-STOP device from St. Francis Medical Technologies (now Medtronic Sofamor Danek), there has been substantial surgeon adoption of these types of devices. In 2009 the U.S. market for devices of this nature is estimated to grow to $309M.