Lewisville, Texas-based Orthofix Medical Inc. and Seoul, South Korea-based CGBio have entered into a strategic partnership to add a moldable, flowable, bioactive recombinant human bone morphogenetic protein-2 (rhBMP-2), brand named Novosis™ to its future product portfolio.
Orthofix Adds rhBMP-2 to Its (Future) Product Line
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CGBio creates synthetic bone grafts that have clinical use in Asia for the following applications: spine, orthopedic, trauma, and dental. It developed the first bone graft in South Korea to contain rhBMP-2.
CGBio’s Novosis is an rhBMP-2 which, of course, is used at the implant site to enhance the body’s ability to form new bone. Currently, Novosis is approved for use in South Korea, Southeast Asia, Mexico and India. According to the Orthofix press release, 50,000 patients to date have received a Novosis bone graft.
Together, Orthofix and CGBio will further Novosis’ clinical development with an eye to commercialization in the United States. “Orthofix will conduct clinical studies, obtain regulatory approvals, and commercialize the Novosis’ rhBMP-2 technology in the U.S. and Canada.”
CGBio received an upfront payment as consideration for the agreement. The company may also receive “development milestone payments upon achievement of regulatory milestones.”
Orthofix President and CEO Jon Serbousek commented, “This announcement represents the start of an exciting partnership to bring the next evolution of recombinant bone growth factor technology to the market.”
Serbousek continued, “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.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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