08.04.14
Expanding Orthopedics Awarded CE Mark, FDA Clearance for 3-D Expandable Interbody Cage
Expanding Orthopedics Inc. (EOI) has been awarded the CE mark from EU regulators and 510(k) clearance from the U.S. Food and Drug Administration for its FLXfit 3-D expandable interbody cage.
“We are very excited with this significant milestone as the FLXfit will be the first TLIF (transforaminal lumbar interbody fusion) cage available worldwide with the 3-D expanding capability,” said CEO Ofer Bokobza.
“FLXfit’s innovative design is based on EOI’s expanding devices’ IP (intellectual property) portfolio enabling an ‘all-in-one’ solution for interbody fusion. The FLXfit combines minimal invasive access, maximum footprint support and a large bone graft chamber with unique lordotic expansion for optimal anatomical fit.”
“The $2 billion market for interbody fusion devices has experienced very limited innovation over the last few decades, considering cages only as spacers or bone graft chambers,” commented Mike Sherman of MB Venture Partners, longtime spine industry veteran, investor and director at EOI. “New technologies that enable in-situ expansion are now driving amazing growth in this market segment, leading to active and aggressive M&A (merger and acquisition) activity in the last 18 months. My past involvement in the development of minimally invasive spinal implants has confirmed to me that surgeons are looking for solutions that enable them to restore the anatomical balance in the lumbar spine instead of only stabilizing it. I’m very excited about EOI’s FLXfit, as it will enable surgeons to provide gentle correction with an intra-operative expanding device while restoring the patient’s anatomy with FLXfit’s unique lordotic expansion.”
According to Bokobza, FLXfit represents a “game-changer” for minimally invasive treatment of lumbar degenerative disc disease while restoring sagittal balance.
“The articulated self-guidance feature enables easy and optimal access while providing a large footprint coupled with controlled expansion for lordotic correction,” he said. “We plan to initiate surgeries in Europe in the coming weeks with pre-defined centers followed by full release in selected territories. We feel a lot of excitement from the medical community and distributors and believe that the FLXfit will provide a revenue boost in combination with our unique XPED expandable pedicle screw system.”
Expanding Orthopedics makes expandable devices for spine surgery, and is based in Or Akiva, Israel.
Expanding Orthopedics Inc. (EOI) has been awarded the CE mark from EU regulators and 510(k) clearance from the U.S. Food and Drug Administration for its FLXfit 3-D expandable interbody cage.
FLXfit 3D expandable interbody cage. Image courtesy of Expanding Orthopedics. |
“FLXfit’s innovative design is based on EOI’s expanding devices’ IP (intellectual property) portfolio enabling an ‘all-in-one’ solution for interbody fusion. The FLXfit combines minimal invasive access, maximum footprint support and a large bone graft chamber with unique lordotic expansion for optimal anatomical fit.”
“The $2 billion market for interbody fusion devices has experienced very limited innovation over the last few decades, considering cages only as spacers or bone graft chambers,” commented Mike Sherman of MB Venture Partners, longtime spine industry veteran, investor and director at EOI. “New technologies that enable in-situ expansion are now driving amazing growth in this market segment, leading to active and aggressive M&A (merger and acquisition) activity in the last 18 months. My past involvement in the development of minimally invasive spinal implants has confirmed to me that surgeons are looking for solutions that enable them to restore the anatomical balance in the lumbar spine instead of only stabilizing it. I’m very excited about EOI’s FLXfit, as it will enable surgeons to provide gentle correction with an intra-operative expanding device while restoring the patient’s anatomy with FLXfit’s unique lordotic expansion.”
According to Bokobza, FLXfit represents a “game-changer” for minimally invasive treatment of lumbar degenerative disc disease while restoring sagittal balance.
“The articulated self-guidance feature enables easy and optimal access while providing a large footprint coupled with controlled expansion for lordotic correction,” he said. “We plan to initiate surgeries in Europe in the coming weeks with pre-defined centers followed by full release in selected territories. We feel a lot of excitement from the medical community and distributors and believe that the FLXfit will provide a revenue boost in combination with our unique XPED expandable pedicle screw system.”
Expanding Orthopedics makes expandable devices for spine surgery, and is based in Or Akiva, Israel.