Regulatory

Graftys' products are registered in more than 30 countries worldwide, including Europe, the U.S., Canada and South America.

MagnetOs Granules and MagnetOs Putty received TGA approval in Australia. Initial market launch is scheduled for late 1Q21.

Canada will be the first commercial market to launch i-FACTOR+ Matrix. The technology is currently being studied in an FDA IDE trial targeting lumbar fusion.

OsteoFlo NanoPutty bone graft features the world's first quadphasic synthetic bone graft particles with nano-surface technology.

The IDE Supplement allows for a reduction in the number of patients required to be enrolled in the ASPIRE IDE Study on P15-L bone graft in the lumbar spine.

Bioventus received FDA 510(k) clearance to market SIGNAFUSE® Bioactive Bone Graft in a strip format. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips....

Osteo3 ZP Putty combines best-in-class bone repair with intraoperative ease-of-use for spine and trauma bone grafting applications.

Enrollment of the FORTIFY study on CERAMENT G has been completed, with 198 subjects enrolled. BONESUPPORT expects to submit a PMA application in late 2021.

Funds will support studies of ALLOB allogeneic cell therapy to treat difficult tibial fractures and JTA-004 protein to treat for osteoarthritic knee pain.

Carmell will begin enrolling in a pivotal clinical program for Plasma-based Bioactive Material used in long-bone fractures as an adjunctive treatment.