First Post-Market Safety Report on OssDsign Catalyst shows zero percent device related complication rate
Uppsala, November 17, 2022. OssDsign AB (publ.) today announces data from the first post-market safety report of the company's innovative product OssDsign Catalyst, that stimulates bone growth in spinal fusion. The report, which covers the time from product launch in August 2021 until August 31, 2022, did not record any device related complaints nor device related adverse events.
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. During this time, no device related complaints nor device related adverse events have been reported.
“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,” commented Morten Henneveld, CEO.
The market approval in the U.S. 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 world-leading experts in spinal surgery.
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