Regulatory

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.

This represents the first calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue.

New preclinical data confirms that local delivery of a bisphosphonate in combination with CERAMENT can regenerate cancellous bone.

Bone Therapeutics received regulatory approvals for next studies of both of its lead therapeutic candidates to treat osteoarthritic knee pain.

BONESUPPORT will submit a De Novo application for approval of CERAMENT® G in the treatment of osteomyelitis.