Ranier Technology commences European clinical trial on new spinal disc technology

Cambridge, UK based Ranier Technology confirmed that it has started its clinical trial of the Cadisc™- L replacement lumbar spine disc implant. Two centres in Europe have already begun implanting the new technology into humans, with 3 more centres planned for inclusion in the very near future. As previously announced, 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 this year.

CAdisc™- L is designed to treat Degenerative Disc Disease, a debilitating condition causing severe back & leg pain which seriously impairs the lives of millions. Currently over half a million patients every year undergo the conventional surgery which removes the diseased disc and fuses the two adjacent vertebrae together, restricting further motion. More recently, engineers have developed articulating metal disc implants which allow motion to a limited degree, but which place additional loads on adjacent tissues.

In contrast, by mimicking more closely the performance of the natural disc, Ranier’s Cadisc™- L is designed to restore the full natural motion of the spine, to share the high loads encountered in the lumbar spine with adjacent tissues and to reduce patients’ pain, allowing them to regain their former active lifestyles.

Dr Geoffrey Andrews, CEO of Ranier Technology commented:

“It is gratifying to see the years of scientific and clinical research necessary to develop such a novel spinal disc implant culminate in the technology being used in people to transform their quality and enjoyment of life. At the completion of this clinical trial later in the year, we will have the evidence for just how transformational the Cadisc™- L implant can be, and an idea of how many of those millions of people suffering from debilitating back pain may be helped by our technology”.

Dr Robert Hes MD, of Middelheim Hospital Belgium, who with Dr Bart Conix MD conducted the first Cadisc™- L surgery added:

”We have been treating lumbar disc disease for many years and Cadisc™- L is the first device we have used which is designed to reproduce the full kinematics of the lumbar spine. The Cadisc™- L surgical technique was straightforward and all of our patients are doing very well”

ENDS

For further information please contact:

Louisa Harris, Communications

louisa.harris@ranier.co.uk

+44 1223 707 866

Website: www.ranier.co.uk

Ranier Technology

Ranier Technology, located in Cambridge, UK, 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 implants with regions of graduated hardness which confer both programmable mechanical properties and high durability under load.

How many patients are treated per year?

About 1 million people are surgically treated every year globally for lumbar disc defects, with over 500,000 patients receiving a spinal fusion procedure in which the diseased disc is removed and replaced with a rigid fixture which eliminates motion at the operative level. Millions more back pain sufferers are either on pain medication or waiting to be treated.

Is this the only product Ranier is developing?

Ranier’s lead products are a compliant lumbar total disc implant, Cadisc™-L and Cadisc™-C, the company’s total replacement disc for the cervical spine. Whilst Ranier’s current focus is on the total disc implants, the PPM technology platform is suited to a wide range of orthopaedic applications. Ranier also produces a range of surgical instruments in support of its Cadisc™-L and CAdiscTM-C products.