Orthofix, CGBio Ink Licensing Deal for Novosis Bone Graft

Orthofix has entered a strategic partnership with CGBio, developer of synthetic bone grafts used in Asia for spine, orthopedic, and dental applications.
 
The two companies will collaborate to clinically develop and commercialize the Novosis recombinant human bone morphogenic protein-2 (rhBMP-2) bone growth materials as well as other future tissue regenerative solutions in the U.S. and Canadian markets.
 
Orthofix will conduct clinical studies, get regulatory approvals, and commercialize Novosis rhBMP-2 tech in the U.S. and Canada. CGBio will receive upfront payment and poetential development milestone payments as regulatory milestones are achieved.
 
“This announcement represents the start of an exciting partnership to bring the next evolution of recombinant bone growth factor technology to the market,” Orthofix president and CEO Jon Serbousek told the press. “Pending successful U.S. clinical trials and subsequent approvals, this surgeon-driven biologic solution will provide a moldable, flowable, bioactive rhBMP-2 bone graft material in the U.S. and fits well within our comprehensive portfolio of allografts with viable cells, demineralized fiber allografts, DBMs, synthetic scaffolds, and spinal constructs. Expanding our regenerative technology portfolio will further provide important procedural options for surgeons to enhance the clinical outcomes for their patients.”
 
“We are pleased to collaborate with Orthofix who has a long history of success in the U.S. biologics market,” said CGBio CEO Hyun Seun Yu. “The potential to bring our solutions to the U.S. and Canadian markets is exciting and aligns well with our strategic goal of broadening the availability of our regenerative biopharmaceuticals.”
 
“In order to have the best clinical outcomes, it is important to have multiple options as no single bone growth solution fits all patients’ needs,” added Dr. Jeffrey Wang, Professor of Orthopaedic Surgery and Neurosurgery, Keck Medical Center at the University of Southern California (USC) and co-director of the USC Spine Center in Los Angeles. “Novosis has been well studied in Asia and a U.S. IDE clinical trial could potentially fill an unmet need for a moldable form of rhBMP-2, making this promising new technology available to more patients.”
 
Orthofix celebrated the first clinical use and limited market release of its Virtuos Lyograft autograft substitute for spine and orthopedic procedures a few weeks ago.