Sam Brusco, Associate Editor01.04.23
OssDsign announced a first-in-patient case report from its TOP FUSION clinical study was published in Biomedical Journal of Scientific & Technical Research.
The article presents data demonstrating complete spinal fusion six months after surgery using the company’s novel nanosynthetic bone graft, OssDsign Catalyst. Evidence of progression to fusion was observed at three months after surgery.
Results were assessed by independent radiologists from the imaging core lab Medical Metrics.
“Even though this is our first case report, we are very encouraged to see that the results from this case study are not only meeting but even surpassing our expectations for OssDsign Catalyst. The consistency between our preclinical data and the first in-patient results is an important checkpoint in the efforts to document the success of our unique synthetic bone graft, thereby paving way for continued rapid market uptake,” Morten Henneveld, CEO of OssDsign told the press.
The OssDsign Catalysts nanosynthetic bone graft stimulates formation of healthy bone tissue in spinal fusion procedures. It’s composed of a proprietary nanocrystalline structure that is resorbed and replaced by new and healthy bone tissue in the body.
The TOP FUSION study includes 17 degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis patients and was initiated in September 2021. The primary endpoints will be assessed by rate of bone fusion at 12 months, as well as the lack of device-related adverse events.
The article presents data demonstrating complete spinal fusion six months after surgery using the company’s novel nanosynthetic bone graft, OssDsign Catalyst. Evidence of progression to fusion was observed at three months after surgery.
Results were assessed by independent radiologists from the imaging core lab Medical Metrics.
“Even though this is our first case report, we are very encouraged to see that the results from this case study are not only meeting but even surpassing our expectations for OssDsign Catalyst. The consistency between our preclinical data and the first in-patient results is an important checkpoint in the efforts to document the success of our unique synthetic bone graft, thereby paving way for continued rapid market uptake,” Morten Henneveld, CEO of OssDsign told the press.
The OssDsign Catalysts nanosynthetic bone graft stimulates formation of healthy bone tissue in spinal fusion procedures. It’s composed of a proprietary nanocrystalline structure that is resorbed and replaced by new and healthy bone tissue in the body.
The TOP FUSION study includes 17 degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis patients and was initiated in September 2021. The primary endpoints will be assessed by rate of bone fusion at 12 months, as well as the lack of device-related adverse events.