AxioMed seeks to secure FDA clearance in 2022 to press its leadership position as the only viscoelastic total disc replacement to complete a lumbar IDE clinical study in the USA. This submission of over 3,700 pages of Module I documents was submitted to FDA at the end of October 2021.
Competitive ball and socket designs on the market have been plagued by heterotopic bone formation and microscopic wear debris, which causes bone osteolysis, as was seen in hip and knee joint replacements in the early years.
AxioMed reportedly stands as the only viscoelastic lumbar disc replacement to complete a U.S. IDE Clinical study and will be only one of three lumbar discs expected to be on the market in 2022. The clinical data is robust, with no reported device-related failures, revisions, and rare cases of heterotopic bone formation. Outside the USA, the cervical and lumbar discs have been used clinically in Australia, Europe, and the Caribbean.
"We are continuing to work on module submission per the structured agreement with FDA, with the next two modules planned for January and April 2022," says John Sullivan, VP of Global Quality, Regulatory Affairs and Compliance for the KICVentures Group.