Orthofix and CGBio Pair Up for Novosis rhBMP-2 Bone Graft Solutions

By Julie A. Vetalice

Orthofix and CGBio Pair Up for Novosis rhBMP-2 Bone Graft Solutions

Orthofix Medical entered into a strategic partnership agreement with CGBio to develop and commercialize 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.

Orthofix will conduct clinical studies, obtain regulatory approvals and market  Novosis’ rhBMP-2. CGBio will receive an upfront payment and potential development payments upon achievement of regulatory milestones.

Novosis is a novel composite bone graft material consisting of a synthetic carrier and rhBMP-2. During surgery, it is applied to the implant site and acts as a scaffold for the formation of new bone. This combination provides moldable handling that is unique compared to what is currently on the market. Novosis is approved for use and currently marketed in South Korea, Southeast Asia, Mexico and India, with approval pending in Australia. To date, approximately 50,000 patients have received a Novosis bone graft.

Orthofix President and CEO Jon Serbousek said, “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.”

Source: Orthofix Medical Inc.

Product Labels: PRP/Cell-Based/Osteoinductive Materials