KAROLINSKA DEVELOPMENT AB Karolinska Development AB announced that its portfolio company OssDsign has received clearance from FDA for the use of OssDsign Catalyst in interbody cages in spinal surgery. The FDA clearance creates possibilities in a new indication with major market potential for the company's innovative nanosynthetic bone graft. The clearance from the U.S. Food and Drug Administration (FDA) allows surgeons to use the OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts.
OssDsign Catalyst is the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone. The decision by the FDA is based on OssDsign's outstanding bone regeneration results which surpass other synthetic bone grafts in challenging evaluation models.
