As it finishes up a pivotal study to support an application to the U.S. Food and Drug Administration for marketing clearance of its first product, medical device company AxioMed Spine Corp. has brought in $3.6 million in fresh capital.
The Cleveland-area company develops products focused on restoring spinal function in patients with degenerative spine disease. Its first product, the Freedom Lumbar Disc, is an artificial disc made of a patented polymer that’s designed to provide 3-D motion that mimics the natural biomechanics of the spine. CE Marked in 2009, the device is in limited use by surgeons in Germany, Switzerland and the UK, chief financial officer Jerry Baty said.
The number one goal, though, is a full-scale commercial launch in the U.S. AxioMed will wrap up a pivotal study in the U.S. before the end of this quarter and then file for FDA clearance, which it hopes to receive in late 2014.
A second product, the Freedom Cervical Disc, is the focus of an EU study that’s set to begin enrolling patients soon, Baty said.
The new round of financing saw participation from existing investors as well as a few new investors. It follows a $20 million series D that AxioMed closed in May of last year. Since its founding in 2001, the device company has raised more than $34 million in private financing from investors including CID Equity Partners, Early Stage Partners LP, Investor Growth Capital, MB Venture Partners, Primus Capital Funds, Reservoir Venture Partners, Thomas, McNerney & Partners LLC, Charter Oak Equity and Blue Chip.
Artificial disc replacement is an alternative to the gold standard of spinal fusion surgery in patients with lower back pain who have not responded to nonsurgical treatment. DePuy Synthes is the market leader, but SpinalMotion is a team from Brigham Young University among others working on innovative disc replacements. Estimates on the value of the spine surgery market range from $6.5 billion to $13 million, but market research firms agree that it’s growing somewhere between 5 percent and 9 percent annually.