Alphatec Spine Announces Four New Product Launches in the MIS, Biologics and Thoracolumbar Market Segments at the North American Spine Society (NASS) Annual Meeting
BY EDITOR, OCTOBER 6, 2010
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, today announced that the Company has received CE Mark approval for commercial sale in the European Union and other jurisdictions for its HeliFix Interspinous Spacer System and Solus ALIF System. The receipt of the CE Mark allows Alphatec Spine to begin selling HeliFix and Solus implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval.
The HeliFix Interspinous Spacer System is a minimally invasive non-fusion solution for lumbar spinal stenosis (LSS). Lumbar Spinal Stenosis is a degenerative condition that affects the aging population worldwide. It is estimated that nearly 600 million people aged 60 years or older are diagnosed with LSS. The 2009 market size in Europe for interspinous devices was approximately $50 million with estimated growth of 12%. The HeliFix implant acts as an extension blocker at the affected vertebral levels and relieves symptoms associated with LSS. The HeliFix System is an innovative concept that features an implant with a self-distracting helical tip. HeliFix is not available for sale in the U.S.
The Solus ALIF System is a zero-profile, single-action locking implant that is used in anterior lumbar interbody fusion (ALIF) procedures. Unlike other products that are currently on the market, which require screws or complicated locking mechanisms, the Solus implant can be secured into position in a single step. This single-step mechanism is a significant improvement over similar devices. The 2009 market size for anterior degenerative thoracolumbar fixation in Europe was approximately $45 million. The Solus ALIF System is under FDA review for 510(k) clearance and is currently not available for sale in the U.S.
Additionally, Alphatec Spine announces two new product releases in the U.S. market, the Aspida Anterior Lumbar Plating System and the PureGen Osteoprogenitor Cell Allograft. The Aspida System has a 510(k) clearance and features a slim profile, a single-action self-locking mechanism and a dual-lead threaded screw, all of which are designed to minimize the disruption of tissue near the implant and reduce operating time for the surgeon. PureGen, the release of which was announced earlier this week, is a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality. Unlike stem cell products that are currently commercially available, which have an unknown population of mesenchymal stem cells (MSCs) and are harvested from cadaveric donor tissue, PureGen delivers a similar potency of pure adult MSCs without the need for cultural expansion. PureGen is the first pure adult stem cell to be released in the spinal market.
The HeliFix Interspinous Spacer System, Solus ALIF System, Aspida Anterior Plating System and PureGen Osteprogenitor Cell Allograft will be on display at the North American Spine Society (NASS) Annual Meeting, which is being held from October 6th through October 9th in Orlando, Florida.
