CGBio, under the leadership of CEO Hyun Seung Yu, a South Korean bio-regenerative medicine company, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY," has received the 'Breakthrough Device Designation' (BDD) from the U.S. Food and Drug Administration (FDA). This designation is noteworthy, marking the first instance for an implantable device from Korea to obtain such recognition.
The Breakthrough Devices Program, outlined in the FDA's updated guidance document on September 15, 2023, aims to expedite the development and approval process for medical devices, ensuring timely access for patients while maintaining regulatory standards. The designation for NOVOSIS PUTTY acknowledges its potential to offer more effective treatment or diagnosis, making it a groundbreaking case in the realm of implantable devices in Korea.
NOVOSIS PUTTY incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2) and stands out as a high-risk permanent implant with recognized efficacy and innovative features globally.
Being granted the 'Breakthrough Device Designation' comes with notable advantages, including prioritized support from the FDA throughout the approval process. This entails continuous communication, a specialized review team, and expedited review procedures from clinical trial design to approval. This support expedites NOVOSIS PUTTY's entry into the U.S. market compared to other devices.
SmartTrak predicts growth in the market for growth factor bone substitutes in North America, projecting an increase 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, the second-generation product, boasts a ceramic-based synthetic scaffold with exceptional moldability and osteoconductive properties. It also incorporates advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho.
A pivotal component in NOVOSIS PUTTY is the rhBMP-2, mass-produced by Daewoong Pharmaceutical Co., Ltd. This protein plays a crucial role in bone regeneration, earning global acclaim for its impact on health and recognition by organizations like the WHO.
The use of Hydroxyapatite (HA) ceramic material as a scaffold for rhBMP-2 facilitates controlled release, reducing the risk of unwanted bone growth and soft tissue swelling. The synthetic polymer hydrogel component, Poloxamer 407 hydrogel, allows for customizable shaping.
CGBio has completed preclinical studies for U.S. confirmatory clinical trials of NOVOSIS PUTTY and is actively engaged in clinical trials to determine the optimal dosage. The company plans to apply for U.S. confirmatory clinical trials in the first half of 2024.
CEO Hyun Seung Yu expressed pride in the 'Breakthrough Device Designation' for NOVOSIS PUTTY, highlighting CGBio's technological prowess and commitment to bringing beneficial products to market swiftly. Jumi Han, head of CGBio's U.S. Development Center, emphasized the regulatory authorities' prioritized support for their product development, indicating an accelerated pace in U.S. clinical trials to demonstrate efficacy and safety.
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