10 Aug AxioMed LLC Submits Final Module III to the FDA Becoming the First and Only Lumbar Viscoelastic Total Disc Replacement Company to Complete a USA IDE Clinical Trial
On August 8, 2022, AxioMed LLC submitted to the FDA all the required documents for Module III. This is the final Module containing all the data tables comparing AxioMed to the Prodisc as the control. The final step for AxioMed to get USA market approval will be an FDA site inspection of the cleanroom manufacturing facilities in Massachusetts.
MALDEN, MASS. (PRWEB) AUGUST 08, 2022
AxioMed LLC shows its determination to press forward on its FDA submission of 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 Chief Financial Officer, Aditya Humad.
AxioMed stands as the only viscoelastic disc replacement to ever complete a US 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,” said Dr. Erik Spayde, a board-certified orthopedic spine surgeon and prolific disc replacement surgeon.
The AxioMed viscoelastic disc replacement is widely anticipated in the USA and internationally 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.
AxioMed was founded in 2001 by surgeons at Cleveland Clinic and engineers who previously worked with Dr. Art Steffee and Acroflex viscoelastic disc replacement. The current AxioMed disc comprises of a proprietary silica-based viscoelastic material proven in extensive biomedical/biocompatible testing to mimic the human disc in all planes and 50+ years of longevity testing. The viscoelastic material is radiolucent and thus X-ray and MRI compatible. Over 800 discs have been implanted worldwide with zero failures or revisions. It is the only viscoelastic lumbar disc to complete a USA IDE clinical study with 10+ years of follow-up.
About KICVentures Group
Our founders have been investing in spine surgery 2000 makes us the most experienced healthcare investment holding company with the largest portfolio of medical device technologies focused on solutions for less invasive outpatient spine surgery. Our investment strategy is to acquire or invent disruptive technologies using our own capital or partner with private individual investors. This allows us the freedom to make quick and nimble decisions such as when we acquired AxioMed Viscoelastic Disc Technologies while other companies invested in spinal fusion.
SOURCE: AxioMed, PR Web, August 10 2022.
To find out more news from the industry head over to our news section – orthocg.com/news