FBC Device ApS, a medical device company focused on restoring natural alignment of the spine through innovative interbody implants, has received its first US FDA clearance for its technology, enabling access to the US market.
Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device says: “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:
- Regulatory approval, now in the US along with a second implant that has been CE marked since 2013.
- Patents granted around the world to protect these two implant designs as well as others to follow.
- Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”
The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the Company will immediately engage interested parties capable of bringing the technology to large markets across the world.