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's lumbar viscoelastic total disc replacement PMA Module II was submitted to the FDA on
"The demand for disc replacement has been compounding over years in the
Harvard-trained orthopedic spine surgeon Dr
"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
"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
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
The AxioMed viscoelastic disc replacement is widely anticipated in the
Investors
"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
For more information, contact [email protected]
About AxioMed
AxioMed was founded in 2001 by surgeons at
http://www.AxioMed.com
About
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.
https://www.kicventuresgroup.com/
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