By: 1 March 2007

BioDisc Spinal Disc Repair System, manufactured by CryoLife, Inc. (Kennesaw, GA, USA), is a protein-based hydrogel device intended for use in post-discectomy patients for preservation of disc height, the prevention and reduction of lumbar motion segment instability, and the prevention of recurrent disc herniation. BioDisc is intended to fill the void space within the spinal disc following removal of the nucleus pulposus in the treatment of lumbar intervertebral disc herniations at the L4/L5 and L5/S1 levels. Following a discectomy, the device delivery tip is placed directly into the disc space through the annulotomy and the implant material is easily dispensed into all areas of the nuclear void. Currently, BioDisc is undergoing an investigational trial in the UK to gather basic safety and performance information in a limited number of patients over two years. CryoLife anticipates filing for a CE Mark in the fourth quarter of 2006, with anticipated European commercial distribution of BioDisc early in 2007.