CGBio Signing a North America Out-license Contract on "Novosis rhBMP-2," a Bone Substitute with Orthofix, USA

CGBio is to receive upfront payment and milestones as per each future development stage from Orthofix under the agreement. CGBio will supply the finished products to Orthofix, which will then conduct necessary clinical trials and seek for U.S. approval and commercialization of the Novosis technology in the U.S. and Canada followed by acquisition of the Premarket Approval (PMA) from the U.S. FDA.

According to SmartTrak, the North American market for growth factor bone substitutes is expected to grow from USD 0.66 billion (about KRW 0.9 trillion) in 2022 to $0.78 billion (about KRW 1.2 trillion) in 2029 (KRW 120 billion), with an average annual growth rate of 4.7%.

Such feats are considered a success story in that it was achieved in the medical device industry where licensing out is quite rare compared to the pharmaceutical industry, and that licensing-out and finished product supply agreements were made with a company in the U.S. being the largest market in the world.

Brand new NOVOSIS Technology is a next- generation bone morphogenetic protein (rhBMP-2)-loaded bone substitute where the sustained release carrier technology (SLOREL™) is applied to Novosis, a bone substitute currently on the market. It has a property to mold and inject in a form in need.

Orthofix President and CEO Jon Serbousek said, "We are excited to work with CGBio to bring the Novosis recombinant bone growth factor technology to the U.S. market. 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."

"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 Orthopedic Surgery and Neurosurgery, Keck Medical Center at the University of Southern California (USC) and co-director of the USC Spine Center in Los Angeles. He added, "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."

Hyun Seung Yu, CEO of CGBio, 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 technology. He added, "With the signing of a licensing-out agreement for Novosis in North America and the supply of finished products, we can say that we have laid a foothold in North America, which is the world's largest bone substitute market."

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company's mission is to deliver innovative, quality-driven solutions while partnering with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix's spine and orthopedics products are distributed in more than 60 countries via the Company's sales representatives and distributors. For more information, please visit www.Orthofix.com.

About CGBio

CGBio was established as a company that produces and sells therapeutic materials necessary for reconstruction of musculoskeletal tissue damage due to diseases under the mission of "seeking for a higher quality of life." It has recently expanded its scope to treatment materials in beauty and plastic surgery. Based on biomaterial-based technology, it supplies products that are essential for clinical use and products that are convenient for clinical use through various collaborations with clinical experts. More information can be found at http://www.cgbio.co.kr/en/.

SOURCE CGBio