Despite the fact that only about three quarters of patients who undergo spinal-fusion procedures receive appreciable benefits, nearly 400,000 of the operations are performed annually. The odds are even grimmer for those hoping for complete recovery, with only half of the patients reporting total pain relief.
Companies like Cleveland-based AxioMed Spine Corporation will soon offer a new solution with more promising outcomes: total disk replacement.
Unlike the first generation of artificial disks that utilized ball-and-socket articulating bearings, the latest "next-gen" devices better replicate the natural function of the native disk. AxioMed's patented polymeric core, along with the device's unique design, provides three-dimensional motion that reduces pain and increases mobility.
Following a successful European clinical study, the company's Freedom Lumbar Disc received CE Mark approval, signifying that the product meets European Union consumer safety standards.
"The Freedom Lumbar Disc is the only elastomeric lumbar total disk replacement device to receive CE Mark approval based on a rigorous multi-center clinical study conducted in the European Union," explains Patrick McBrayer, AxioMed's president and CEO. "We are particularly pleased to be able to provide surgeons in Europe with the Freedom technology that has been shown to provide patients pain relief, reduced disability and improved lifestyle."
The company recently completed the first part of its third financing round. An unnamed venture capital firm that participates in the Ohio Capital Fund has invested $6.4 million toward a Series C goal of $18.5 million. The lumbar disk is still a few years away from approval for a U.S. launch, McBrayer says.
Source: Patrick McBrayer, AxioMed
Writer: Douglas Trattner