AxioMed has announced that it has submitted to the US Food and Drug Administration (FDA) all the required documents for PMA Module III, as the company moves closer to market approval of its lumbar viscoelastic disc replacement in the USA.
This is the final module containing all the data tables comparing AxioMed to the Prodisc (Centinel Spine) as the control.
Vito Lore, vice president of innovations at AxioMed, said: “We were dedicated and determined to continue answering questions from the FDA on the Module I and II submissions while completing the clinical data analyses and documentation required to submit the final Module III package by August 2022. Now, the last step remaining is an FDA site inspection of the cleanroom manufacturing facilities to complete the full submission process.”
“Lumbar disc replacement is a disruptive enabling technology with a growing global market valued at an estimated US$1.8 billion by 2027,” added the firm’s chief financial officer, Aditya Humad.
AxioMed state that they are the only viscoelastic disc replacement to ever complete a US investigational device exemption clinical study. The clinical data is strong with greater than five-year follow-up data showing no reported device related failures, no revisions and rare cases of heterotopic bone formation, add AxioMed. Outside the USA, the cervical and lumbar discs have been used clinically in Australia, Europe and the Caribbean.
Kingsley Chin, a board-certified orthopaedic spine surgeon (Hollywood, USA), said: “We are preparing to begin training surgeons early 2023 in anticipation of FDA approval.”
“There is growing demand among spine surgeons for disc replacements to substitute for spinal fusions,” added fellow surgeon, Erik Spayde (Thousand Oaks, USA).