CGBio (CEO Hyun Seung Yu)
CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, “NOVOSIS PUTTY”, has been granted ‘Breakthrough Device Designation’ (BDD) by the U.S. Food and Drug Administration (FDA). This material incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2).
On September 15, 2023, FDA published an update to the guidance document – “Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA, 510(k), and De Novo, consistent with the Agency’s mission to protect and promote public health.
The FDA considers all of these factors to determine whether a device is ‘reasonably expected to provide more effective treatment or diagnosis,’” according to the guidance.
NOVOSIS PUTTY’s Designation
NOVOSIS PUTTY’s designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY’s efficacy and innovative aspects are recognized internationally.
Devices with ‘Breakthrough Device Designation’ benefit from prioritized FDA support during the approval process. This support includes continuous communication with the FDA, assignment of a specialized review team, and prioritized review of everything from clinical trial design to approval. This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices.
According to SmartTrak, the market for growth factor bone substitutes in North America is expected to grow from USD 0.66 billion in 2022 to USD 0.78 billion in 2029, with an average annual growth rate of 4.7%.
NOVOSIS PUTTY, a second-generation product, features a ceramic-based synthetic scaffold with superior moldability and osteoconductive properties, and incorporates advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho.
A key ingredient in NOVOSIS PUTTY is rhBMP-2, mass-producedx by Daewoong Pharmaceutical Co., Ltd., a leader in the South Korean pharmaceutical industry. This protein plays a crucial role in bone regeneration, transforming stem cells into bone cells in cases of bone defect. Known internationally as ‘Nebotermin’ and recognized by organizations including the WHO, Daewoong’s rhBMP-2 has earned global acclaim for its impact on health.
Hydroxyapatite (HA) ceramic material, bone graft substitute that acts as a scaffold of rhBMP-2 at the same time, allows for controlled release of rhBMP-2, reducing the risk of unwanted bone growth and surrounding soft tissue swelling, unlike collagen sponge-based scaffolds. It enables high-density bone formation with lower rhBMP-2 doses. Its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, also allows customizable shaping.
CGBio has completed preclinical studies for U.S. confirmatory clinical trials of NOVOSIS PUTTY and is conducting clinical trials to determine the optimal dosage, with plans to apply for U.S. confirmatory clinical trials in the first half of 2024.
“The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio’s technological prowess, innovation, and potential. With the designation’s emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY.”
Jumi Han, head of CGBio’s U.S. Development Center, stated,
“The ‘Breakthrough Device Designation’ for NOVOSIS PUTTY confirms that regulatory authorities are prioritizing support for our product development. We are accelerating U.S. clinical trials to demonstrate its efficacy and safety.”