OssDsign has enrolled all patients in the clinical study TOP FUSION, which will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery.
OssDsign will now follow the patients recruited for the study for 24 months. The outcome of the study will primarily focus on healing between the vertebrae and the lack of treatment-related side effects. The company’s nanosynthetic bone graft OssDsign Catalyst received FDA 510(k) clearance in 2020 and was launched in the U.S. in 2021.
"OssDsign builds a comprehensive package of clinical data for OssDsign Catalyst, now with a fully recruited TOP FUSION study. The study will generate important clinical information that paves the way for establishing the product in the global market,” said Viktor Drvota, CEO of parent company, Karolinska Development.
Source: Karolinska Development