Michael Barbella, Managing Editor03.27.24
Data from OssDsign AB's TOP FUSION clinical study show a 93 % spinal fusion rate at 12 months as assessed with computed tomography (CT) after surgery with the nanosynthetic bone graft OssDsign Catalyst.
The data indicates the use of OssDsign Catalyst leads to consistent and rapid bone healing and remodeling, with improved patient outcomes as a result. The results also confirm previously reported best-in-class pre-clinical results achieved in the most demanding preclinical model for spinal fusion—the BODEN model.
“I am very encouraged to see the solid consistency between the clinical results in TOP FUSION, the previously published first in-patient case report and our pre-clinical data. The successful outcome of this first clinical study marks an important milestone for OssDsign Catalyst and will boost our efforts to establish our nanosynthetic bone graft on the U.S. market,” OssDsign CEO Morten Henneveld said.
TOP FUSION is a first-in-patient open-label, prospective, single-center clinical study led by Drs. Péter Pál Varga and Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure that is resorbed and replaced by new and healthy bone tissue in the body.
Begun in September 2021, the TOP FUSION study includes 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis. TOP FUSION is evaluating the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoint is assessed by the rate of bone fusion at 12 months by CT as well as the lack of device-related adverse events within the study period.
The data indicates the use of OssDsign Catalyst leads to consistent and rapid bone healing and remodeling, with improved patient outcomes as a result. The results also confirm previously reported best-in-class pre-clinical results achieved in the most demanding preclinical model for spinal fusion—the BODEN model.
“I am very encouraged to see the solid consistency between the clinical results in TOP FUSION, the previously published first in-patient case report and our pre-clinical data. The successful outcome of this first clinical study marks an important milestone for OssDsign Catalyst and will boost our efforts to establish our nanosynthetic bone graft on the U.S. market,” OssDsign CEO Morten Henneveld said.
TOP FUSION is a first-in-patient open-label, prospective, single-center clinical study led by Drs. Péter Pál Varga and Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure that is resorbed and replaced by new and healthy bone tissue in the body.
Begun in September 2021, the TOP FUSION study includes 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis. TOP FUSION is evaluating the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoint is assessed by the rate of bone fusion at 12 months by CT as well as the lack of device-related adverse events within the study period.