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 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.
“We are extremely excited about the innovative design of both Helifix and Helifuse, and that James J. Yue, M.D., a long standing member of Alphatec Spine’s Scientific Advisory Board and Associate Professor at Yale University, will be actively supporting the development of these devices for the market,” said Dirk Kuyper, Alphatec Spine’s President and CEO. “It is estimated that 37% of surgeries on patients age 65 or older are for spinal stenosis,” Mr. Kuyper continued “Helifix and Helifuse will allow surgeons to treat the older patient with spinal stenosis in a minimally invasive manner. These products complement our growing portfolio of aging spine products.”
“Neural passageways are compromised by aging and exacerbated by extension in patients with spinal stenosis,” said Dr. Yue, an internationally renowned spine surgeon who teaches and lectures throughout the world on new technology in spine surgery. Dr. Yue continued “Clinical observations of patients show they experience relief in their symptoms with flexion. So it stands to reason that by preventing extension at the level of interest, symptoms may be reduced or eliminated. The Helifix and Helifuse products are designed to provide this relief. I am pleased to work with Alphatec Spine to develop this product for the market and I am impressed with the level of commitment that the company has demonstrated in developing products to treat the particular conditions of the aging spine.”
“The Helifix device will be unique in that it can be inserted and removed percutaneously. It is self distracting and can be made from a variety of materials including titanium, PEEK and or bone,” said JP Timm, Alphatec Spine’s Vice President of Research & Development. Mr. Timm continued “The Helifix can be inserted by spine surgeons and/or interventional radiologists and the procedure can be performed on an inpatient or outpatient basis. Because of the design and the different materials that can be used, the device can be used for fusion or non-fusion procedures.”
Source: Alphatec Holdings