CGBio said it has signed a strategic partnership agreement with Orthofix Medical, a U.S.-based global medical device company, to license out its Novosis Putty, a bone substitute, and supply its finished products to the U.S. and Canada.
According to the company, Novosis Putty is a next-generation recombinant human bone morphogenetic protein-2 (rhBMP-2) bone substitute that applies Slorel, a sustained release carrier technology. Hospitals can mold and inject the product in any form required by the patient.
Under the accord, CGBio will receive an upfront payment and milestones for each development stage Orthofix completes.
CGBio will supply the finished products to Orthofix and the latter will conduct necessary clinical trials and seek approval and commercialization for Novosis Putty in the U.S. and Canada after receiving a premarket approval (PMA) from the U.S. FDA.
However, the company did not disclose the exact license fee, citing contractual reasons.
“We are excited to work with CGBio to bring the Novosis recombinant bone growth factor technology to the U.S. market,” Orthofix Medical President and CEO Jon Serbousek said. “Pending successful clinical trials and subsequent approvals, the Novosis solution will provide an important new offering in our biologics portfolio to meet the needs of surgeons and their patients.”
CGBio CEO Yu Hyun-seung also said, “Orthofix has a strong bone regeneration treatment portfolio in the field of spinal and traumatic diseases, which are indications for bone substitutes loaded with rhBMP-2, and has the best understanding of the clinical value of the Novosis Putty.”
With the signing of a licensing-out agreement for Novosis in North America and the supply of finished products, CGBio has laid a foothold in North America, which is the world’s largest bone substitute market, Yu added.
According to Fortune Business Insights, a global market research firm, the global bone substitute market will grow from $3.78 billion in 2022 to $5.71 billion in 2029, with an average annual growth rate of 6.1 percent. The North America has the largest global bone substitute market with total sales reaching $1.53 billion in 2021.