08 Dec AxioMed LLC Reports Landmark Filing of Initial PMA Module to FDA as the First Viscoelastic Lumbar Artificial Disc Replacement to Complete an IDE Clinical Study
AxioMed seeks to get 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 the FDA at the end of October 2021.
MALDEN, MASS. (PRWEB) DECEMBER 01, 2021
There is a growing demand among spine surgeons and patients for artificial disc replacements to substitute for spinal fusions in the treatment of degeneration of lumbar intervertebral disc. Therefore, the AxioMed viscoelastic lumbar and cervical artificial disc replacements are widely anticipated in the USA and internationally as a significant advance in artificial disc replacement technology. Competitive ball and socket designs on the market have been plagued by heterotopic bone formation and microscopic wear debris, which causes bone osteolysis, as we saw in hip and knee joint replacements in the early years.
Spinal fusion industry leaders are increasingly investing in pedicle screws and interbody cages for spinal fusions to drive immediate revenues, which drives up the overall cost of patient care with little improvement to patient outcomes. More data is now showing superior outcomes for disc replacements over spinal fusions for intervertebral disc disorder. However, the focus has been on cervical artificial disc replacements because of the insurance reimbursement pressures on the lumbar artificial disc replacement since the Charite lumbar disc replacement failure. Today, almost all major insurance companies are covering artificial disc replacements, but most companies have not invested in lumbar disc replacements and are relying on M&A. AxioMed stands as the only viscoelastic lumbar disc replacement to complete a US 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.
” Our clinical data demonstrate the AxioMed Freedom Lumbar Disc (FLD) mimics the natural function of an intervertebral disc, safety, and effectiveness. Our team of medical writers are currently completing their efforts to summarize the clinical data and are on track to be ready in front of the January 2022 due date for the Clinical Module (Module 2)” – says Vito Lore, VP of Innovation.
“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.
“We extend gratitude to all our private investors who have patiently stood alongside us and never waivered in their belief in the superiority and impact of the AxioMed technology,” says Chief Financial Officer, Aditya Humad.
“Patients, Key Opinion Leaders (KOLs), and investment analysts recognize disc replacements as the future of spine treatments, and thus companies lacking disc replacements should be concerned with Axiomed’s potential for disruption of the spinal fusion market,” says CTO, Prof. Dr. Kingsley R. Chin.
Harvard-trained orthopedic spine surgeon Dr. Erik Spayde performs lumbar disc replacements using the current ball and socket discs and says, “the AxioMed FreedomTM Disc is just different from the other discs.”
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.
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.
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SOURCE: PR Web, 1st December 2021