OssDsign announced that the first patient has been included in the company’s clinical study TOP FUSION to investigate the long-term safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery.
OssDsign Catalyst is a market cleared synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone tissue. Data from a recently published preclinical study show that OssDsign Catalyst induced rapid and reliable bone formation and that successful fusion was achieved in all subjects included in the treatment group. The product received market clearance from FDA in 2020 and was recently launched in the U.S. The initiation of TOP FUSION together with world-renowned experts in spinal surgery is an important step in OssDsign’s efforts to establish OssDsign Catalyst on the global market.
The clinical study will run over 24 months and include 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis or lumbar spinal stenosis. TOP FUSION will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoints will be assessed by the rate of bone fusion as well as device-related adverse events within the study time period.
OssDsign announced that the first patient has been included in the company’s clinical study TOP FUSION to investigate the long-term safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery.
OssDsign Catalyst is a market cleared synthetic bone graft based on a patented nanocrystalline solution that stimulates the...
OssDsign announced that the first patient has been included in the company’s clinical study TOP FUSION to investigate the long-term safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery.
OssDsign Catalyst is a market cleared synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone tissue. Data from a recently published preclinical study show that OssDsign Catalyst induced rapid and reliable bone formation and that successful fusion was achieved in all subjects included in the treatment group. The product received market clearance from FDA in 2020 and was recently launched in the U.S. The initiation of TOP FUSION together with world-renowned experts in spinal surgery is an important step in OssDsign’s efforts to establish OssDsign Catalyst on the global market.
The clinical study will run over 24 months and include 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis or lumbar spinal stenosis. TOP FUSION will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery. The study’s primary endpoints will be assessed by the rate of bone fusion as well as device-related adverse events within the study time period.
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