Orthofix Medical and CGBio Announce Strategic Partnership Agreement for Novosis rhBMP-2 Bone Graft Solutions
Wednesday, August 03, 2022
Orthofix Medical Inc., a global medical device company with a spine and orthopedics focus, today announced a strategic partnership agreement with CGBio, a developer of innovative, synthetic bone grafts currently used clinically in Asia for spine, orthopedic, trauma and dental applications. The two companies will work together for clinical development and commercialization of Novosis™ recombinant human bone morphogenetic protein-2 (rhBMP-2) bone growth materials and other future tissue regenerative solutions for the U.S. and Canadian markets.
Under the terms of the license and distribution agreement, Orthofix will conduct clinical studies, obtain regulatory approvals, and commercialize the Novosis’ rhBMP-2 technology in the U.S. and Canada. As a consideration of the agreement, CGBio will receive an upfront payment and potential development milestone payments upon achievement of regulatory milestones.
“This announcement represents the start of an exciting partnership to bring the next evolution of recombinant bone growth factor technology to the market,” said Orthofix President and CEO Jon Serbousek. “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,” said 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.”