Michael Barbella, Managing Editor03.30.23
OssDsign AB has released encouraging data from the first post-market safety report of OssDsign Catalyst, a nanosynthetic bone graft putty that stimulates bone growth in spinal fusion. The report, which covers a 12-month period from August 2021 (product launch) until Aug. 31, 2022, did not record any device-related complaints nor device-related adverse events.
“When a new product is launched, surgeons will always ask about the safety of usage. This post-market safety review strongly supports the safety profile of OssDsign Catalyst and gives me high confidence in the product going forward. Together with our ongoing clinical trial TOP FUSION and our patient registry PROPEL, solid data like this continues to strengthen our competitiveness on the U.S. market,” OssDsign CEO Morten Henneveld said.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. Similar to the body’s own bone mineral structure, the patented nanocrystalline structure of OssDsign Catalyst provides a favorable bone biology environment inducing rapid and reliable bone formation. The first post-market safety review shows that 511 units of OssDsign Catalyst have been sold since the product launch in August 2021, and no device-related complaints or adverse events have been reported.
U.S. market approval is based on preclinical results that surpass other synthetic bone grafts in the most established and demanding pre-clinical model for spinal fusion—the Boden model. To collect clinical data, OssDsign is currently running PROPEL, a U.S. based multi-center prospective spinal fusion registry. In parallel, the company is conducting the clinical trial TOP FUSION in Hungary, in which patient enrolment was completed in April 2022, with patient follow-up over 24 months under the leadership of spinal surgery experts.
OssDsign is a Swedish innovator, designer, and manufacturer of personalized bone replacement technology for cranial repair.
“When a new product is launched, surgeons will always ask about the safety of usage. This post-market safety review strongly supports the safety profile of OssDsign Catalyst and gives me high confidence in the product going forward. Together with our ongoing clinical trial TOP FUSION and our patient registry PROPEL, solid data like this continues to strengthen our competitiveness on the U.S. market,” OssDsign CEO Morten Henneveld said.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. Similar to the body’s own bone mineral structure, the patented nanocrystalline structure of OssDsign Catalyst provides a favorable bone biology environment inducing rapid and reliable bone formation. The first post-market safety review shows that 511 units of OssDsign Catalyst have been sold since the product launch in August 2021, and no device-related complaints or adverse events have been reported.
U.S. market approval is based on preclinical results that surpass other synthetic bone grafts in the most established and demanding pre-clinical model for spinal fusion—the Boden model. To collect clinical data, OssDsign is currently running PROPEL, a U.S. based multi-center prospective spinal fusion registry. In parallel, the company is conducting the clinical trial TOP FUSION in Hungary, in which patient enrolment was completed in April 2022, with patient follow-up over 24 months under the leadership of spinal surgery experts.
OssDsign is a Swedish innovator, designer, and manufacturer of personalized bone replacement technology for cranial repair.
