OssDsign Catalyst Bone Graft OK’ed for Interbody Cages

OssDsign has gained U.S. Food and Drug Administration clearance for its Catalyst bone graft for use in interbody cages in spinal surgery, allowing surgeons to use it on-label in any interbody cage cleared for use with synthetic bone grafts.
 
The company said Catalyst is the first synthetic bone graft to be cleared for the market for interbody use, based on bone graft intrinsic safety and efficacy data alone.
 
“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. 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,” Morten Henneveld, CEO of OssDsign told the press.
 
OssDsign Catalyst is a nanosynthetic bone graft engineered to stimulate formation of healthy bone tissue in spinal fusion surgeries. In most spinal fusion procedures, a cage is used to stabilize the anterior spinal column. The extended clearance is based on “outstanding” bone regeneration results that the company said surpassed those usually seen with other synthetic bone grafts in challenging evaluation models.
 
OssDsign is gathering clinical evidence for Catalyst anchored on its U.S.-based PROPEL study, in which over 200 patients are enrolled, as well as the TOP FUSION study, which completed enrollment in April 2022.