Ranier Technology gets green light to start Cadisc™ European clinical trial

Cambridge, UK based Ranier Technology today confirmed that it has received clearance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence the clinical trial of its Cadisc™- L replacement lumbar spine disc implant.

The trial is planned to take place in five European spinal surgical centres and is anticipated to lead to CE marking, and subsequent sales of the Cadisc™-L product in European markets during 2010.

CAdisc™- L is designed to treat Degenerative Disc Disease, a debilitating condition causing severe back pain which seriously impairs the lives of millions. Over a million surgical procedures are undertaken globally each year to treat the condition, usually on patients aged 25 – 50. Conventional surgery removes the diseased disc and fuses the two adjacent vertebrae, precluding further motion at the operative level. In contrast, Ranier’s Cadisc™- L is designed to restore the full natural motion of the spine, and to reduce patients’ pain , allowing them to regain their active lifestyles. The global market for lumbar spinal disc implants is set to grow to $1.1 bn by 2017.

CAdisc™- L is the world’s first all polymer, compliant lumbar total replacement disc implant and is designed both to mimic the dynamic mechanical and motion characteristics under loading of the natural disc, and to transmit loads physiologically to adjacent vertebrae. When two lumbar spinal vertebrae are fused together, discs at adjacent levels in the spine are themselves likely to degenerate more rapidly. By sharing loads more naturally and restoring natural motion, it is anticipated that Cadisc™- L will also protect discs at adjacent levels, and to avoid or delay subsequent surgery.

Dr Geoffrey Andrews, CEO of Ranier Technology commented:

”I am delighted that the MHRA has recognised the validity and value of the body of scientific work underpinning our Cadisc™-L design. I look forward to Cadisc™-L transforming the lives of patients currently debilitated by severe back pain.”

ENDS

For further information please contact:

Dr Geoffrey Andrews, CEO Ranier Technology Limited on +44 (0) 1223 505045 geoffrey.andrews@ranier.co.uk

Website: www.ranier.co.uk

Notes to Editors

About Ranier Technology Limited Ranier Technology, located in Cambridge, England, is a medical device developer utilising its proprietary Precision Polyurethane Manufacturing (PPM) technology to bring next generation, motion preservation spinal implants to clinical use. The PPM technology enables the design and production of load sharing, polyurethane devices with regions of graduated hardness which confer both programmable mechanical properties and high durability under load. Ranier’s lead products are a compliant lumbar total disc replacement implant, Cadisc™-L, and Cadisc™-C, the company’s total replacement disc for the cervical spine.