AxioMed LLC Submits Module III to FDA for Lumbar Viscoelastic Disc Replacement

AxioMed LLC has submitted the Module III documents needed to get FDA approval to market its lumbar viscoelastic disc replacement in the USA.
 
“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, ” says Vito Lore, VP of Innovations.
 
“Lumbar disc replacement is a disruptive enabling technology with a growing global market valued at an estimated $1.8 Billion by 2027,” says CEO, Aditya Humad.
 
AxioMed stands as the only viscoelastic disc replacement to ever complete a U.S. IDE Clinical study. The clinical data is strong with greater than five-year followup data showing no reported device related failures, no 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 preparing to begin training surgeons early 2023 in anticipation of FDA approval,“ said Professor Dr. Kingsley R Chin, a board-certified orthopedic spine surgeon.
 
“There is growing demand among spine surgeons for disc replacements to substitute for spinal fusions,” added Dr. Erik Spayde, a board-certified orthopedic spine surgeon and prolific disc replacement surgeon.

An Advancement in Disc Replacement Technology

The AxioMed viscoelastic disc replacement is anticipated worldwide as a major advance in disc replacement technology. The current ‘ball and socket’ designs on the market are seeing favorable results and growing adoption over traditional spinal fusion. However, there is still need for improvement in disc technology and the consensus is to move to viscoelastic elastomeric disc replacement solutions with natural spine motion.
 
AxioMed’s Module III lumbar clinical data shows no production of wear debris, and minimal formation of heterotopic bone in patients. In contrast, ‘ball and socket’ articulating disc replacements have been plagued by heterotopic bone formation and by the production of microscopic wear debris which causes bone osteolysis as we saw in hip and knee joint replacements in the early years.
 
Currently, only two lumbar disc replacements are being commercialized in the USA. More and more health insurance companies are reimbursing lumbar disc replacement and this trend will likely accelerate with the drive to do more surgeries in outpatient ambulatory surgery centers where cost is lower and outcomes are better with fewer complications.