OssDsign Catalyst nanosynthetic bone graft receives FDA clearance for new indication
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Key takeaways:
- The OssDsign Catalyst can now be used on-label in interbody cages cleared for use with synthetic bone grafts.
- The OssDsign Catalyst is designed to stimulate the formation of healthy bone tissue.
OssDsign AB has announced FDA clearance of the OssDsign Catalyst, a nanosynthetic bone graft, for use in interbody cages during spinal surgery, according to a press release.
The OssDsign Catalyst, designed to stimulate the formation of healthy bone tissue, can now be used with any interbody cage cleared for use with synthetic bone grafts, according to the release.
“This decision by the FDA represents one of the most important events in the history of OssDsign. It establishes OssDsign Catalyst in the exceptional class of synthetic bone grafts that may be used by surgeons on-label in the interbody space,” Morten Henneveld, CEO of OssDsign, said in the release. “As there is a huge demand for interbody use of synthetic bone grafts, believed to represent as much as 50% of all bone graft usage in spine surgeries, the new clearance marks a major market opportunity and sets us up for further commercial acceleration. The FDA clearance is based on our compelling data and it clearly strengthens and differentiates us in the market. We look forward to working with all hospitals and surgeons on this opportunity,” Henneveld added.
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