Therapy Areas: Devices
OssDsign completes patient enrolment for TOP FUSION clinical study
25 April 2022 -

OssDsign AB (FN Stockholm:OSSD), a developer and provider of next generation bone replacement products, announced on Monday that its clinical study TOP FUSION is fully enrolled and patient follow-up will continue to run over 24 months.

This trial will primarily evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal fusion surgery.

OssDsign Catalyst is a synthetic bone graft based on a patented nanocrystalline solution that stimulates the formation of healthy bone. It received FDA clearance in 2020 and was launched on the US market in August 2021.

According to the company, the study's primary endpoint will be assessed by the rate of bone fusion as well as a lack of device-related adverse events.