GARFIELD HEIGHTS, Ohio, May 15, 2012 (BUSINESS WIRE) — AxioMed(R) Spine Corporation ( www.axiomed.com ) announces the receipt of CE Mark approval for its Freedom(R) Cervical Disc, an elastomeric total spinal disc replacement device. The CE Mark approval was received as a result of an accredited European Notified Body conformity assessment of the Company’s complete portfolio of biocompatibility and biomechanical cervical disc testing and supporting data regarding the Freedom(R) technology. AxioMed’s first product was the Freedom(R) Lumbar Disc which received CE Mark in 2009. The CE Mark clears AxioMed for the introduction of the Freedom(R) Cervical Disc into the EU Market. AxioMed is an ISO 13485:2003 certified manufacturer of the Freedom Lumbar and Cervical Discs.
Patrick McBrayer, AxioMed’s President and CEO stated, “With the Freedom(R) Lumbar and Cervical Discs now both CE Marked, we will be able to provide a complete next generation elastomeric disc product line for patients and surgeons in the EU. Our EU lumbar clinical data, published in peer reviewed spine journals, demonstrate that Freedom technology has been shown to provide patients pain relief, reduced disability and improved lifestyle, based on monitored outcomes and feedback. We are also active in our multi-center pivotal clinical study under an Investigational Device Exemption for our Freedom Lumbar Disc with both efficacy and economic endpoints. Our goal is to have the most advanced and complete total disc product line in the US and EU.”
Jim Kuras, the Company’s Chief Operating Officer added, “The Freedom(R) Cervical Disc was developed by an experienced team of surgeons and engineers, taking advantage of the attributes of the lumbar technology and advancing the technology platform into the cervical spine. The cervical disc’s unique asymmetrical design and biomechanics evolve beyond first generation total disc technologies, better accommodating the cervical anatomy and spinal function. Complementing the differentiated design, multiple footprints and heights with wedge angles provide the surgeon with an array of implants to address the patient specific surgical requirements.”
Neal Defibaugh, AxioMed’s Vice President of Clinical and Regulatory Affairs, went on to comment, “AxioMed’s extensive pre-clinical and clinical experience with the Freedom(R) technology was instrumental in providing a solid regulatory foundation for achieving a CE Mark approval on our Freedom(R) Cervical Disc. We have leveraged our Freedom technology for the cervical disc regulatory pathway and timing in obtaining the CE Mark and we anticipate a similar advantage for our future US FDA IDE approval efforts.”
The Freedom(R) Cervical Disc is a viscoelastic one-piece, next generation total disc replacement featuring a polymer core, designed with the goal of restoring function of the spine and reducing pain and disability. CE Mark approval allows for the commercial distribution of the Freedom Cervical Disc throughout the European Union. AxioMed’s Freedom(R) Lumbar Disc has also attained a CE Mark, is commercially available in select countries in the EU and is under evaluation in an ongoing multi-center US and EU IDE pivotal clinical study designed with efficacy, safety and economic endpoints.
About AxioMed(R) Spine Corporation
AxioMed’s mission is to develop products focused on spinal function for patients with degenerative spine disease, thus advancing the standard of care beyond fusion and first generation discs. The Freedom(R) Lumbar and Cervical Discs have been developed and designed by a team of clinicians and experts in the fields of biomechanics, pathology, spinal surgery and polymer science. Focusing on restoration of the natural function of the spine, AxioMed will enhance human health through research, innovation, development and service world-wide. For more information about AxioMed, please visit our web site at www.axiomed.com .
SOURCE: AxioMed Spine Corporation
AxioMed(R) Spine Corporation
Gerald Baty, Chief Financial Officer, 216-587-5566
Facsimile: 216-587-3388
Jbaty@axiomed.com
