AxioMed Gets Closer to FDA Market Approval for its Lumbar Disc Replacement

AxioMed has announced progress on its FDA submission of documents required to complete the last Module III of its FDA application needed to get approval to market its viscoelastic lumbar disc replacement in the U.S.
 
The company is actively engaged with the FDA to complete responses to all their queries from its previously submitted Module I and II while also completing its final clinical data analyses required for the last Module III submission targeted on or before June 2022. This will allow the company to focus on manufacturing in anticipation of U.S. FDA on-sight inspection and for producing inventory to go to market in the U.S. and internationally.
 
“We are excited to replenish our team with former AxioMed experts who are helping us to respond to queries from the FDA from our Module I submission,” said VP of Innovations, Vito Lore.
 
“We have had recent success with individual investors to complete the previously submitted Modules I-II and upcoming final Module III which gives us the confidence to raise the remaining capital that will be dedicated to manufacturing the disc to go to market as soon as we get FDA approval,” commented chief financial officer, Aditya Humad.

Meeting a Demand for Disc Replacements

There is growing demand among spine surgeons for disc replacements to substitute for spinal fusions. The AxioMed viscoelastic disc replacement is widely anticipated in the U.S. and internationally as a major advance in disc replacement motion preservation technology.
 
“The current ball and socket disc designs on the market are seeing superior results over spinal fusions. However, there is still need for improvement in disc technology and there is consensus that the answer is to move to viscoelastic elastomeric disc replacements as shock absorbers allowing natural motion,” said Board-Certified orthopedic spine surgeon and professor, Dr. Kingsley R. Chin.
 
AxioMed has strong clinical and biomechanical data that show a lack of production of wear debris that causes inflammatory osteolysis and minimal formation of heterotopic bone formation in cervical or lumbar patients. In contrast, ‘ball and socket’ articulating disc replacements have been plagued by heterotopic bone formation and by the production of microscopic wear debris beyond 5 year follow ups, which causes bone osteolysis.
 
AxioMed stands as the only viscoelastic disc replacement to complete a U.S. IDE Clinical study and will be only one of three lumbar discs expected to be on the U.S. market in 2023. The AxioMed clinical data is strong with no reported device related failures, no revisions and rare cases of heterotopic bone formation. Outside the U.S., the cervical and lumbar discs have been used clinically in Australia, Europe, and the Caribbean.