AxioMed LLC Files PMA Module II of III targeting 2022 FDA Approval of The First and Only Viscoelastic Lumbar Disc Replacement to Complete an IDE Clinical Study
AxioMed takes another historic step towards achieving FDA approval of its lumbar viscoelastic total disc replacement after submitting PMA Module II to the FDA on January 28th, 2022. The clinical data is strong with range of motion identical to the range of the normal lumbar disc, with no reported device-related failures or revisions and rare cases of heterotopic bone formation.
MALDEN, MASS. (PRWEB) FEBRUARY 02, 2022
AxioMed’s lumbar viscoelastic total disc replacement PMA Module II was submitted to the FDA on January 28th, 2022.
“The demand for disc replacement has been compounding over years in the USA, Europe and Australia and will J curve with the FDA approval of the superior AxioMed lumbar viscoelastic disc at the same time that we see more insurance coverage of disc replacement and patient awareness of the pitfalls of spinal fusions versus greater benefits of total disc replacements,” says Chief Technology Officer and Harvard-trained orthopedic spine surgeon professor Kingsley R Chin MD, MBA.
Harvard-trained orthopedic spine surgeon Dr Erik Spayde and Dr William Costigan, MBA are two leading board-certified orthopedic spine surgeons who see their practices immediately moving towards more outpatient lumbar surgeries using the AxioMed viscoelastic lumbar disc replacement.
“With FDA approval of the AxioMed anterior lumbar disc, and to follow next with a lateral lumbar disc would allow me to perform my own access above L5-S1, so my fusion cases for degenerated intervertebral disc disease would soon be replaced by the AxioMed disc” said Dr Spayde.
“We are grateful for the consistency demonstrated by our team to execute on the completion of each module to meet our targeted FDA submission dates” says Vito Lore, VP of Innovation for the KICVentures Group.
There is increasing demand for cervical disc replacements among spine surgeons and patients to treat degenerative disc disease. We anticipate similar demand to follow with introduction of the AxioMed lumbar disc replacement and more positive insurance reimbursement. The amount of lumbar spinal fusions is increasing but we expect reimbursement and margins to decrease with bundling and price contraction from competition and commoditization.
“We are already working on the third and final module to submit by April to complete the full FDA submission,” says John Sullivan, VP of Global Quality Affairs and Regulatory Compliance for the KICVentures Group.
USA surgeons can soon join surgeons in Australia, Europe and the Caribbean who have used the cervical and lumbar discs in spine surgery clinically.
The AxioMed viscoelastic disc replacement is widely anticipated in the USA and internationally as a major innovation and advance in disc replacement technology. The viscoelastic properties allow for a single-piece design with 4-12 degrees of lordosis and acts identical to the normal human disc to restore disc height and provide for shock absorption. The competition are ball and socket designs based on copying knee replacements so there are multiple pieces moving against surfaces with NO shock absorption property. Published clinical studies are showing incidences of implant dislocation, heterotopic bone formation and microscopic wear debris production which causes bone osteolysis, all complications similar to what we saw with their hip and knee joint replacement cousins. See Osteolysis, infection reported in M6-C, Prestige cervical discs
“This accomplishment is comforting for our private investors who can now see the end in sight toward FDA approval and commercialization of the AxioMed anterior lumbar disc in the USA” says Aditya Humad, Chief Financial Officer for the KICVentures Group.
For more information, contact Investor@KICVentures.com
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 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.