AxioMed Spine Corporation announced on May 22 that the company has completed the final closing of its Series D financing, raising $5 million in two tranches from current and new investors. This funding augments the previously announced $15 million Series D financing.
AxioMed’s Freedom Lumbar Disc (FLD) is currently on the market in the EU and advancing toward completion of its Investigational Device Exemption (IDE) pivotal study in the U.S. The company says it intends to follow a similar regulatory and marketing pathway as the FLD with its Freedom Cervical Disc, which recently received a CE Mark for introduction in the EU.
The FLD study is a multi-center, prospective, randomized clinical trial that will compare the safety and effectiveness of the FLD to a control disc replacement device in the treatment of single level (L3-S1) symptomatic lumbar degenerative disc disease. Approximately fifteen 15 centers will participate with an enrollment of a minimum of 300 patients.
Randomization will be in a 1:1 ratio of FLD versus a control total disc replacement device.
The study is expected to last about five years in total, however, there is a possibility this study may last up to ten years due to post-approval study requirements. After discharge from the hospital, patients will have study visits at six weeks, three months and six months post-operatively, then annually for five years.
Since its inception, AxioMed has secured over $34 million in private equity financing from venture capitalists.