AxioMed Accomplishes Significant Milestone: Two-Year USA IDE Clinical Study Follow-Up Completed for Viscoelastic Lumbar Disc
AxioMed announced today that all two-year follow up data for their USA lumbar IDE clinical study has been collected and analyzed. This is an important milestone for the company as it seeks FDA PMA clearance of the viscoelastic lumbar device this year in the USA. “This is a pivotal moment towards motion-preservation technology in spine. This milestone brings us much closer to providing our next generation viscoelastic disc to patients in the USA,” said Jake Lubinski, president of AxioMed.
The AxioMed viscoelastic lumbar disc received CE Mark in 2009 and has been used to treat over 500 patients with follow-up exceeding 7 years. Results from the lumbar European post-market assessment study showing clinically significant improvements in pain and disability were published in the International Journal of Spine Surgery. One of the key conclusions of the study was the restoration of a center of rotation, which mimics a healthy human disc and correlates in a clinically significant improvement in patient disability.
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.