OssDsign announced that the first 100 patients in the U.S. have now been treated with the company’s synthetic bone graft OssDsign Catalyst. The product was launched in the U.S. market in 2021, and has since then been adopted by surgeons for use in spinal fusion surgeries.
OssDsign Catalyst synthetic bone graft stimulates the formation of healthy bone tissue in spinal fusion. The graft is composed of a proprietary nanocrystalline structure which is resorbed and replaced by new bone tissue.
The market clearance in the U.S is based on preclinical results that surpass other synthetic bone grafts in the most established and demanding pre-clinical model for spinal fusion – the Boden model. To collect clinical data, OssDsign is currently running PROPEL, a U.S.-based multi-center prospective spinal fusion registry. In parallel, the company is conducting the clinical trial TOP FUSION in Hungary, in which patient enrolment was completed in April 2022, with patient follow-up over 24 months under the leadership of experts in spinal surgery.
“The high rate of adoption of OssDsign Catalyst among surgeons in the U.S. is a clear acknowledgement of our innovative product offering and imperative for our continued success,” said Morten Henneveld, CEO of OssDsign.