OssDesign’s Catalyst nanosynthetic bone graft putty saw an 88.4% fusion rate in highly complex spine patients, according to results from its Propel study.
The data comes from the first 108 patients in its Propel study, according to a June 26 news release. Patients in the cohort are “highly complex” with an average BMI of 31.9, and most of them had at least one comorbidity. Half of the cohort had previous spine surgery.
At the 12-month follow-up all patients had improvements in assessed health status categories, no unexpected device-related adverse events and fusion rates of 88.4%.
“These results are a crucial building block in OssDsign’s clinical strategy, showing OssDsign Catalyst to be a robust, differentiated nanosynthetic bone graft that performs as intended regardless of patient profile,” Morten Henneveld, CEO of OssDesign, said in the release. “Previously, our TOP FUSION first-in-human study reported a 93% fusion rate and improvements in all health status categories at the 12-month follow-up. Although we anticipated strong real-world performance, the remarkable consistency with our clinical trial results exceeds our expectations.”