CGBio’s Novosis Putty Gains FDA IDE Approval

CGBio’s Novosis Putty stands at the forefront of medical device innovation. This next-generation bone graft received an IDE (Investigational Device Exemption) from the US FDA. This milestone marks a key step in seeking premarket approval (PMA) in the US and challenges the high barriers to entry in the US spine fusion market.

What is an IDE Approval?

• IDE: Investigational Device Exemption, a necessary step for clinically testing medical devices on humans in the US.
• Purpose: Required for US market entry and involves extensive regulatory review.
• Challenges: Especially tough for implantable devices like bone substitutes.

Novosis Putty is the first composite medical device from Korea to receive this approval, paving the way for its entry into the US market. This IDE allows CGBio to embark on pivotal trials—the final stage before obtaining full market approval.

Novosis Putty’s Advanced Features

Novosis Putty differs from its predecessor by using a dual support structure featuring mineral-based tricalcium phosphate (TCP) and hydroxyapatite (HA), providing enhanced moldability and versatility.

• Formulation: Putty form, compatible with various surgical sites.
• Technology: Employs CGBio’s proprietary sustained-release system, SLOREL™, enabling precise control over the release of bone-forming protein rhBMP-2.
• Benefits: Promotes dense bone formation while minimizing ectopic bone growth risks.

The Significance of FDA Breakthrough Device Designation

In December 2023, the FDA labeled Novosis Putty as a Breakthrough Device, highlighting its innovative competitive edge. This showcases its advanced technology that meets high regulatory standards and boosts its potential in the world’s largest medical device market.

Global Expansion Plans

CGBio is actively expanding beyond the US, targeting advanced markets like Europe and Australia. The IDE approval is a critical step in accelerating regulatory and business expansion into these regions.

• Current Trials: Clinical trials under way in Japan with partner Nihon Zoki, successfully completing phases 1 and 2.
• Market Focus: The US and other developed countries are primary targets to expand CGBio’s reach.

Key Takeaways for Healthcare Professionals

• Innovation and Trust: CGBio’s IDE approval underscores the company’s reputation for innovative and reliable medical devices.
• Clinical Relevance: The controlled release of rhBMP-2 offers significant clinical benefits, reducing unwanted side effects while supporting more effective treatments.
• Strategic Market Presence: This milestone reinforces CGBio’s strategic intent to establish a strong presence in the high-demand field of biomaterial implants.

Market Implications and Future Prospects

CEO Hyun-seung Yoo emphasizes the IDE approval as a pivotal achievement reflecting CGBio’s long-standing dedication to innovation and quality. This success signals a robust entry into the competitive US market, validating the Novosis Putty as a competitive and transformative option in regenerative medicine.

Key Attributes of Novosis Putty:

1. Sustained Release Technology: Allows precise control of rhBMP-2 protein release.
2. Composite Design: Offers versatility and adaptability with its dual-structure formulation.
3. Innovation Recognition: Breakthrough Device designation reflects its superior technology edge.

CGBio’s trajectory toward global market integration showcases their commitment to advancing patient care through pioneering medical solutions. With Novosis Putty, the company sets a precedent for future development in the regenerative medical field, advancing both technological and therapeutic frontiers.