Executive Summary

Spine Wave has received US FDA clearance to market two complementing products for treating vertebral compression fractures - the StaXx FX structural kyphoplasty system and the CapSure PS pedicle screw. The minimally invasive StaXx FX system will allow Spine Wave to enter "a large, rapidly growing market" with what it claims is "a highly differentiated technology". The product features PEEK wafers that are stacked in situ to simultaneously distract and support the fractured vertebral body, providing pain relief and a controlled vertical fracture reduction. The CapSure product, the company adds, has a unique design that allows it to maintain maximum polyaxial angulation even when the screw is fully seated into the pedicle. The Shelton, Connecticut, firm is initiating a controlled release of both products during the second quarter of 2007, and anticipates a broader market launch by the end of this year.