CGBio's 'Novosis Putty' Receives U.S. FDA Pivotal Clinical Trial Approval

IDE Approval for Novosis Putty
Signals Entry into the $1 Billion U.S. Bone Substitute Market

CGBio announced on April 21 that its next-generation bone substitute for spinal fusion surgery, 'Novosis Putty,' received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) on April 17.

With this approval, CGBio has now entered the pivotal clinical trial phase, which is the final clinical step required for Pre-Market Approval (PMA) in the United States. This marks the beginning of a substantial step toward entering the U.S. medical device market. Among bio-composite medical devices developed in Korea, 'Novosis Putty' is the first to receive pivotal clinical trial approval from the U.S. FDA.

IDE approval is a mandatory procedure in the United States that requires formal FDA authorization before testing a medical device on humans. For implantable medical devices such as bone substitutes, pivotal clinical trials are an essential step for PMA. This is considered one of the highest entry barriers to the U.S. market.

Previously, in December 2023, 'Novosis Putty' was designated as a Breakthrough Device by the FDA, demonstrating its technological competitiveness. With the latest IDE approval, the possibility of entering the world's largest market, the United States, has increased even further. In particular, the U.S. bone substitute market is valued at approximately KRW 1 trillion annually, making this approval a significant starting point for entering a high value-added market.

This product is a next-generation bone substitute developed based on CGBio's flagship product, 'Novosis.' It is characterized by both structural stability and user convenience. The original Novosis is a single-component product that applies bone morphogenetic protein to a hydroxyapatite (HA) ceramic scaffold that mimics human bone structure, making it suitable for use over large areas.

In contrast, 'Novosis Putty' features a dual scaffold structure that combines mineral-based tricalcium phosphate (TCP), which provides moldability, with HA. It is designed as a moldable, viscous form that can be tailored to the surgical site. Notably, the putty product incorporates CGBio's proprietary sustained-release formulation technology, 'SLOREL™,' enabling even more precise control over the release rate and efficiency of bone morphogenetic protein, which promotes new bone formation. This technology induces high-density bone formation while reducing the risk of adverse reactions such as unwanted bone growth in non-target areas. The related effects have already been validated by human clinical results published in the SCI-level international journal 'Journal of Clinical Medicine,' thereby establishing technical reliability.

CGBio is currently conducting regulatory clinical trials for Novosis Putty in Japan through its local partner Nihon Zoki, and recently completed Phase 1/2 clinical trials successfully in Japan. Novosis Putty was developed targeting advanced markets, including the United States, and with this IDE approval, the company plans to expand regulatory approvals and business operations in major markets such as Europe and Australia.

Han Joomi, Head of Development at CGBio's U.S. subsidiary, who oversaw this approval process, stated, "Receiving approval to initiate pivotal clinical trials by meeting the FDA's stringent requirements is a signal that CGBio's technology and quality systems are at a global standard. From now on, we will do our utmost to accelerate development so that our products can enter the U.S. and other advanced global markets as quickly as possible."

Yoo Hyunseung, CEO of CGBio, commented, "Obtaining this IDE approval is an important outcome of CGBio's technology-driven development strategy that has been built up over the years. In particular, the bio-composite bone substitute market in the United States has extremely high entry barriers, so this approval itself is further international validation of CGBio's technological strength and the competitiveness of the Novosis Putty product."