On August 8, 2022, AxioMed LLC submitted to the FDA all of the required paperwork for Module III. That is the ultimate Module containing all the info tables evaluating AxioMed to the Prodisc because the management. The ultimate step for AxioMed to get USA market approval shall be an FDA web site inspection of the cleanroom manufacturing services in Massachusetts.
MALDEN, MASS. (PRWEB) AUGUST 08, 2022 –
AxioMed LLC exhibits its dedication to press ahead on its FDA submission of Module III paperwork wanted to get FDA approval to market its lumbar viscoelastic disc substitute within the USA.
“We have been devoted and decided to proceed answering questions from the FDA on the Module I and II submissions whereas finishing the scientific information analyses and documentation required to submit the ultimate Module III bundle by August 2022. Now, the final step remaining is an FDA web site inspection of the cleanroom manufacturing services to finish the complete submission course of, ”says Vito Lore VP of Improvements.
“Lumbar disc substitute is a disruptive enabling expertise with a rising international market valued at an estimated $1.8 Billion by 2027,” says Chief Monetary Officer, Aditya Humad.
AxioMed stands as the one viscoelastic disc substitute to ever full a US IDE Medical examine. The scientific information is powerful with higher than 5 12 months followup information displaying no reported system associated failures, no revisions and uncommon instances of heterotopic bone formation. Exterior the USA, the cervical and lumbar discs have been used clinically in Australia, Europe and the Caribbean.
“We’re making ready to start coaching surgeons early 2023 in anticipation of FDA approval,“ mentioned Professor Dr. Kingsley R Chin, a board-certified orthopedic backbone surgeon.
“There’s rising demand amongst backbone surgeons for disc replacements to substitute for spinal fusions,” mentioned Dr. Erik Spayde, a board-certified orthopedic backbone surgeon and prolific disc substitute surgeon.
The AxioMed viscoelastic disc substitute is extensively anticipated within the USA and internationally as a significant advance in disc substitute expertise. The present ‘ball and socket’ designs in the marketplace are seeing favorable outcomes and rising adoption over conventional spinal fusion. Nevertheless, there may be nonetheless want for enchancment in disc expertise and the consensus is to maneuver to viscoelastic elastomeric disc substitute options with pure backbone movement. AxioMed’s Module III lumbar scientific information exhibits no manufacturing of wear and tear particles, and minimal formation of heterotopic bone in sufferers. In distinction, ‘ball and socket’ articulating disc replacements have been tormented by heterotopic bone formation and by the manufacturing of microscopic put on particles which causes bone osteolysis as we noticed in hip and knee joint replacements within the early years. At the moment, solely two lumbar disc replacements are being commercialized within the USA. An increasing number of medical insurance corporations are reimbursing lumbar disc substitute and this development will seemingly speed up with the drive to do extra surgical procedures in outpatient ambulatory surgical procedure facilities the place price is decrease and outcomes are higher with fewer problems.
AxioMed was based in 2001 by surgeons at Cleveland Clinic and engineers who beforehand labored with Dr. Artwork Steffee and Acroflex viscoelastic disc substitute. The present AxioMed disc contains of a proprietary silica-based viscoelastic materials confirmed in in depth biomedical/biocompatible testing to imitate the human disc in all planes and 50+ years of longevity testing. The viscoelastic materials is radiolucent and thus X-ray and MRI suitable. Over 800 discs have been implanted worldwide with zero failures or revisions. It’s the solely viscoelastic lumbar disc to finish a USA IDE scientific examine with 10+ years of follow-up.
About KICVentures Group
Our founders have been investing in backbone surgical procedure 2000 makes us probably the most skilled healthcare funding holding firm with the biggest portfolio of medical system applied sciences centered on options for much less invasive outpatient backbone surgical procedure. Our funding technique is to amass or invent disruptive applied sciences utilizing our personal capital or companion with non-public particular person traders. This enables us the liberty to make fast and nimble selections corresponding to once we acquired AxioMed Viscoelastic Disc Applied sciences whereas different corporations invested in spinal fusion.