AxioMed gathered all of the two-year follow-up data on the Freedom Lumbar Disc for its USA investigational device exemption clinical study.
Here are six observations:
1. AxioMed now hopes to receive FDA premarket approval for its viscoelastic lumbar disc.
2. The viscoelastic disc, called the Freedom Disc, already received the CE Mark in 2009.
3. Surgeons have implanted the disc in more than 500 patients in Europe with more than seven-year follow-up data.
4. International Journal of Spine Surgery published the results of the European post-market study, revealing significant improvement in pain and disability in patients with the disc.
5. The study also found the disc helped restore the center of rotation.
6. Malden, Mass.-based KICVentures acquired AxioMed in 2014, but AxioMed still owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.