AXIOMED’S FREEDOM CERVICAL DISK IMPLANTED IN SWITZERLAND

A MEDICAL DEVICE DAILY STAFF REPORT

February 13, 2013

AxioMed Spine (Garfi eld Heights, Ohio) reported the introduction of its Freedom cervical disc in Europe with an implantation in Switzerland. The Freedom cervical disc received the CE mark in 2012. AxioMed will also conduct a multi-center Freedom cervical disc study as a post-market assessment of the total disc replacement device for the treatment of cervical degenerative disc disease. The study’s clinical results are expected to be used in support of a future Investigational Device Exemption (IDE) application to the FDA and to support regulatory approval in other markets outside of the EU.

Patrick McBrayer, AxioMed’s president/CEO said: “AxioMed supported a clinical study of its Freedom Lumbar Disc in Europe, and we are likewise committed to a European clinical study of our latest product, the Freedom cervical disc. Our European lumbar clinical data was published in a respected peer-reviewed spine journal and demonstrated that the Freedom technology has provided patients lumbar pain relief, reduced disability and improved lifestyle, based on monitored outcomes. We expect similar results from our Freedom cervical disc. Spine surgeons at clinics in Switzerland, Germany, and the UK will participate in this study.”

AxioMed’s fi rst product, the Freedom Lumbar Disc, received CE Mark in 2009. Results from the lumbar European post-market assessment study were published in the SAS Journal in December 2011.

“The Freedom Cervical Disc’s unique asymmetrical design and resulting biomechanics represent an advancement beyond the fi rst generation total disc technologies, and better accommodate the cervical anatomy and spinal function. The differentiated design, with multiple footprints and heights combined with a wedge angle, provide the surgeon with an array of implants to address patient specifi c surgical requirements. First generation total disc replacement devices incorporate a metal-onmetal or metal-on-polyethylene ball and socket design and have resulted in design and functional limitations. The Freedom Lumbar and cervical disc technology is a second generation, viscoelastic polymer one-piece spinal disc replacement prosthesis that provides a combination of stability, compressibility and controlled motion that closely replicates the natural function of the native disc. The surgical procedure requires a limited number of instruments, is simple and reproducible, and requires no bone-milling or excess sculpting of the intervertebral body endplates to implant the device,” said Jim Kuras, the company’s COO.

AxioMed’s mission is to develop products focused on spinal function for patients with degenerative spine disease.