Updated 8:38 p.m.
GARFIELD HEIGHTS, Ohio – This fall, AxioMed Spine Corp. in suburban Cleveland could start selling for the first time its spinal disc replacement after winning regulatory approval in Europe.
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AxioMed on Tuesday said it has received Europe’s CE Marking — much like Food and Drug Administration market clearance in the United States. The company plans in the fall to introduce its lower-spine disc replacement, which uses a rubberized polymer, to the 27 European Union countries.
It’s the first market clearance for Freedom — one of a small group of next-generation spinal disc replacements designed to function more like the natural spine.
The approval likely will boost job growth as AxioMed gears up manufacturing for the product’s release, said Patrick McBrayer, the company’s president and chief executive who took over in 2006. AxioMed now employs 15 people at its Garfield Heights headquarters, research, development and manufacturing facility.
The company is working out the details with companies in the United Kingdom and Germany to distribute the device.
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P&M Corporate Finance LLC estimated this year’s worldwide market for lumbar disc replacements at $176 million, up 43 percent from last year. P&M presented its market information at the Spine Technology Summit last month in London.
AxioMed will continue to follow patients from its European clinical study for several years. The company submitted initial results from the study to regulators in the fall, McBrayer said.
These results also are contributing to AxioMed’s efforts to get FDA approval to market its spinal disc replacement at home. The company is enrolling patients for its pivotal clinical study in the United States, McBrayer said.
The Freedom lumbar disc replacement likely is at least “a couple of years” away from market launch here, he said. In addition to clinical effectiveness, AxioMed also must show the FDA and insurers that its device is cost-effective.
AxioMed is also following a parallel development and regulatory track with its disc replacement for the cervical — or middle — spine. “The cervical market is considered larger than the lumbar market, McBrayer said.
AxoidMed’s investors include the CID Equity Partners, EarlyStage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners. Altogether, the company’s won $34 million in venture capital. Its last round, a $10 million fund-raise, was in July.
AxioMed, which uses more than 60 Ohio suppliers to make its disc replacements, also received a $750,000 Innovation Ohio Loan from the state’s Third Frontier Project in late 2007 to help expand (pdf) its Garfield Heights testing and manufacturing floor.
So, how is McBrayer feeling about his company’s accomplishment?
“Good, good,” he said, laughing. “There’s a lot going on here. Investors are thrilled. It’s important in this economic time that you show you’re more than an investigating company. We actually have a marketing opportunity now.”