Medical device developer AxioMed Spine has received European regulatory approval to market its cervical spinal disc replacement device.
The CE Mark for AxioMed’s Freedom cervical disc complements the earlier European regulatory approval for the company’s Freedom lumbar spinal disc replacement, according to a statement from the Cleveland-area company.
AxioMed is currently selling the lumbar disc in three countries: Germany, Switzerland and the United Kingdom, chief financial officer Jerry Baty said. The company is still evaluating its options on where to kick off European commercialization of the cervical disc.
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As for U.S. commercialization, AxioMed is conducting a pivotal clinical study of the lumbar disc and hopes to obtain regulatory approval in 2014, Baty said.
AxioMed describes its spinal discs as being viscoelastic (possessing both viscous and elastic properties) and featuring a core made of polymer.
In 2010, AxioMed, a Cleveland Clinic spinoff, raised a $14.5 million series D round of investment to support European commercialization.
