Orthofix has signed a strategic partnership agreement with CGBio, a developer of synthetic bone grafts currently used clinically in Asia for spine, orthopaedic, trauma and dental applications.
The two companies will work together for clinical development and commercialisation of Novosis recombinant human bone morphogenetic protein-2 (rhBMP-2) bone growth materials and other future tissue regenerative solutions for the US and Canadian markets.
Under the terms of the license and distribution agreement, Orthofix will conduct clinical studies, obtain regulatory approvals, and commercialise the Novosis’ rhBMP-2 technology in the two countries. As a consideration of the agreement, CGBio will receive an upfront payment and potential development milestone payments upon achievement of regulatory milestones.
Orthofix president and CEO, Jon Serbousek, said: “This announcement represents the start of an exciting partnership to bring the next evolution of recombinant bone growth factor technology to the market.
“Pending successful US clinical trials and subsequent approvals, this surgeon-driven biologic solution will provide a mouldable, flowable, bioactive rhBMP-2 bone graft material in the US and fits well within our comprehensive portfolio of allografts with viable cells, demineralised fibre allografts, demineralized bone matrixes, 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.”
CGBio CEO, Hyun Seun Yu, added: “We are pleased to collaborate with Orthofix who has a long history of success in the US biologics market. The potential to bring our solutions to the US and Canadian markets is exciting and aligns well with our strategic goal of broadening the availability of our regenerative biopharmaceuticals.”
Jeffrey Wang, professor of orthopaedic surgery and neurosurgery at Keck Medical Center (Los Angeles, USA), commented: “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.
“Novosis has been well studied in Asia and a US investigational device exemption clinical trial could potentially fill an unmet need for a mouldable form of rhBMP-2, making this promising new technology available to more patients.”