♦ Ascendx Spine™ is a medical device company focused on development and commercialization of innovative orthopaedic devices for the spine and trauma markets. Its initial focus is the Ascendx VCF Repair System for treatment of vertebral compression fractures (VCF) caused predominantly by osteoporosis. VCF forces a vertebra to collapse and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a hunchbacked appearance.
♦ The current standard procedures for treating VCFs are vertebroplasty and vertebral augmentation (kyphoplasty).
While the Ascendx VCF Repair System accesses the vertebral body in a similar manner to the traditional therapies, the Ascendx system is designed to enable the precise placement of the cement at the site of the fracture while the balloon is still inflated.
♦ A 60-patient, multicenter clinical trial has been successfully completed in the U.S. Patient follow-ups occurred at 30 days, three months, six months and 12 months.
♦ Ascendx Spine™ received CE marking in September 2011 and expects to receive FDA clearance in 2012.
