FDA Clearance for Expanding Orthopedics’ Flxfit 3D Expandable Interbody Cage
Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgeries, is excited to announce that its FLXfit, the world's first 3D expandable interbody cage, is cleared for commercialization in the US.
Ofer Bokobza, CEO of Expanding Orthopedics, said that "I am extremely proud of the EOI team and our KOLs worldwide enabling us to reach this significant milestone. The FLXfit™ is the first TLIF cage available worldwide with the 3D expansion capability. This unique and patented technology combines minimal invasive access, maximum footprint support and large bone graft chamber with unique lordotic expansion for sagittal balance correction."
Dr. Hansen Yuan, a worldwide recognized spine surgeon and one of the leading industry experts as well as a Director at EOI explained that "I don't know of any other cage commercially available in the US combining this many critical and beneficial features as the FLXfit™. Minimal invasive through a single, small port, self-steering articulation for optimal placement, large footprint for best stability and a large plate to plate bone graft chamber for solid bone fusion." Additionally, Dr. Yuan explained that the "real revolution of the FLXfit™ is the combination of these features with the unique lordotic expansion technology which enables an optimal press fit while restoring the anatomy of the spine and lordotic angle correction." He added that "the FLXfit™ has the potential to change the way spine surgeons treat their patients today."
Mr. Bokobza stated "EOI is already in the process of signing distribution agreements with leading US spine distributors and I expect the FLXfit™ to quickly become a significant player in the fast growing expandable cage's segment based on its unique capabilities. This segment shows a steady 30% CAGR with an established reimbursement codes."
Mr. Bokobza, concluded "as part of our continuous strive to improve spine's standard of care, the EOI's team together with its distinguished advisors is going to execute on our product pipeline and deliver a complete family of expandable cages based our expanding devices IP Platform. The expanding cages' product family, coupled with the CE Marked XPED™ Expandable Pedicle Screw System, will reinforce our position as a leading company delivering innovative expanding devices and strengthen our vision as a driver for continuous improvement in spine care solutions."