Becker's Spine Review

Sign up for Becker's Orthopedic, Spine Business & Pain Management E-Weeklies at www.BeckersOrthopedicandSpine.com or call (800) 417-2035 35 Spine Device Companies Making a Difference By Carrie Pallardy Sponsored by: H ere are 35 device companies focused nearly exclusively on spine surgery. Many of these device companies have had multiple patents, FDA clearances and market launches in the past year. Others have announced company expansions and clinical trials placing them at the forefront of spinal technology today. Accel Spine, based in Dallas, is a medical device company serving the spine market. The company offers a range of products including cervical and thoracolumbar devices, a minimally invasive system, biologics and non-narcotic pain management device. The cervical products include an interbody fusion device, an anterior plate system and a posterior fixation system. The thoracolumbar products include an open fixation system and an interbody device. Accel Spine's Picasso is a minimally invasive system created to treat deformity and degenerative conditions of the lumbar and thoracic spine. Accel Spine received a total of eight FDA clearances last year. Alliance Spine, based in San Antonio, is a company created from the collaboration of the academic world, spine surgeons and manufacturers. The company works to take a product idea from the research stage to the manufacturing stage and finally to the hands of surgeons. The company has an interbody line of products and a biologics product line. Alamo C, a cervical intervertebral body fusion device, is manufactured from PEEK Optima and is designed to create a large graft area allowing for optimal bone graft placement. The company's biologics include Cyclone, Osteo Strip and SwannShidi. Cyclone is a bone marrow concentrate system. Osteo Strip is a compressive graft material specifically designed for spinal fusions and orthopedic surgeries. SwannShidi is a vertebral bone marrow aspiration device. Alliance Spine is also working on developing a full line of PLIF and TLIF interbody devices and a cranial plate. In 2012, the company received FDA 510(k) approval for two interbody Alamo devices. 35 Spine Device Companies Making an Impact 34 Alphatec Spine, headquartered in Carlsbad, Calif., is a medical device company that produces devices intended to treat spine disorders and improve the quality of patient life. The Alphatec Spine product portfolio has a wide range of devices including thoracolumbar, cevico-thoracic, interbody, minimally invasive and vertebral compression fracture treatments. The company also produces biologics and solutions for the aging spine. The company recently received FDA 510(k) clearance for Pegasus, an anterior anchored cervical interbody device, and ILLICO FS Facet Fixation System, a minimally invasive device that eliminates the need for a pedicle screw and rod constructs during the immobilization of spinal segments. Alphatec Spine reported a nearly 7 percent increase in global revenue for the fourth quarter of 2012, as compared to the fourth quarter of 2011. Amedica, based in Salt Lake City, is a medical device company that creates silicon nitride spinal and arthroplasty applications. Amedica is currently the only company with FDA clearance to create and market implants made from silicon nitride. The company's products include Valeo Interbody Fusion Devices, Facet Fixation, Preference 2 Pedicle Screw System and Origin Orthobiologics. Amedica expanded its executive team in January with the addition of legal, compliance, marketing and sales executives. In February, the company received a patent for a silicon nitride total disc implant to treat back and neck pain. Apollo Spine, based in Newport Beach, Calif., is a company centered on serving the spine industry with solutions for scoliosis, trauma, degeneration and spondylolisthesis. The company's product portfolio includes the Eclipse-C Cervical Interbody Spacer, the Eclipse-L Lumbar Interbody Spacer, the Comet Cervical Plate and the Zenith Pedicle System. Apollo Spine designs the products to be minimally invasive, to improve current fusion treatments and to preserve motion. The company is currently working on developing its Venus Facet Screw and its Jupiter Modular Spacer System, which will serve as a treatment for patients suffering from deformity or degenerative conditions. Ascendx Spine, based in Winter Park, Fla., is a medical device company focused on the development and marketing of VCF Repair Systems and the Acu-Cut Vertebral Augmentation System, both designed to treat vertebral compression fractures. A prospective, multicenter clinical study conducted on the results of the Ascendx VCF Repair System found patients to have considerable lessening of pain and improvement of function. Both the VCF Repair Systems and the Acu-Cut Vertebral Augmentation System have received FDA 510(k) clearance and the CE Mark. Back 2 Basics Spine, based in Cleveland, is a medical device company that primarily focuses on providing

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