Regulatory

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. 

In the race to capitalize on patient-driven interest in stem cells, biologic solutions and “regeneration” of a more vital, healthy and functional body, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence.

Biogennix received FDA 510(k) clearance to market Agilon™ moldable bone graft for use in posterolateral spine procedures when mixed with autograft.

GreenBone Ortho received approval under the CE Mark for GreenBone Bone Substitute™.

Carmell Therapeutics announced FDA clearance of an Investigational New Drug application for the company's Bone Healing Accelerant and enrollment in a pivotal study for long bone fractures.