AxioMed presses forward on its FDA submission of documents needed to complete the last Module III of its FDA application needed to get approval to market its viscoelastic lumbar disc replacement in the USA. AxioMed 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 US FDA on-sight inspection and for producing inventory to go to market in the US and internationally.
MALDEN, MASS. (PRWEB) APRIL 18, 2022
“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”, says VP of Innovations, Vito Lore. Three Modules are required to complete the full FDA submission while a the only remaining step would be an FDA on-sight audit of the AxioMed manufacturing to achieve FDA approval.
“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,” says Chief Financial Officer, Aditya Humad.
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 USA 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 no 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 up, which causes bone osteolysis as we saw in hip and knee joint replacements in the early years.
AxioMed stands as the only viscoelastic disc replacement to complete a US IDE Clinical study and will be only one of three lumbar discs expected to be on the US 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 USA, the cervical and lumbar discs have been used clinically in Australia, Europe, and the Caribbean.
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 device failures or revisions. It is the only viscoelastic lumbar disc to complete a USA IDE clinical study with 10+ years of follow-up. http://www.AxioMed.com
About KICVentures Group
Our founders have been investing in spine surgery since 2000, which 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. http://www.KICVenturesGroup.com