CGBIO, a leading Korean company specializing in bio-regenerative medicine, proudly announces that its innovative bone graft substitute, NOVOSIS PUTTY, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This pivotal approval paves the way for a clinical trial in spinal fusion procedures within .

CGBIO，这是一家领先的韩国公司，专注于生物再生医学，自豪地宣布其创新的骨移植替代品NOVOSIS PUTTY已获得美国食品药品监督管理局（FDA）的试验性器械豁免（IDE）批准。这一关键批准为在脊柱融合手术中的临床试验铺平了道路。

Rendering of NOVOSIS PUTTY applied during spinal fusion

脊柱融合期间应用NOVOSIS腻子的渲染

NOVOSIS PUTTY, previously designated as a Breakthrough Device by the FDA in

NOVOSIS PUTTY，之前被FDA指定为突破性设备

December 2023

2023年12月

, leverages novel technology to address unmet needs in bone regeneration. This milestone marks NOVOSIS PUTTY as the first Korean-developed bio-combined medical device to reach this stage in the U.S., signifying a significant step toward Premarket Approval (PMA) and subsequent commercialization.

，利用创新技术满足骨再生领域未被满足的需求。这一里程碑标志着NOVOSIS PUTTY成为首个在美达到此阶段的韩国自主研发生物组合医疗器械，是迈向上市前批准（PMA）及后续商业化的重要一步。

The product features a dual-carrier system utilizing Hydroxyapatite (HA) and Tri-Calcium Phosphate (TCP), combined with CGBIO's proprietary sustained-release technology, SLOREL™, to control the release of recombinant human bone morphogenetic protein-2 (rhBMP-2). This system is engineered to enhance high-density bone formation while minimizing ectopic bone growth, a common adverse effect in earlier rhBMP-2-based products. The safety and efficacy of NOVOSIS PUTTY have been validated in peer-reviewed publications, including the Journal of Clinical Medicine. .

该产品采用双载体系统，利用羟基磷灰石 (HA) 和三磷酸钙 (TCP)，结合CGBIO专有的缓释技术SLOREL™，以控制重组人骨形态发生蛋白-2（rhBMP-2）的释放。该系统旨在促进高密度骨形成，同时尽量减少异位骨生长，这是早期基于rhBMP-2的产品常见的不良反应。NOVOSIS PUTTY的安全性和有效性已在同行评审的出版物中得到验证，包括《临床医学杂志》。

The rhBMP-2 protein used in NOVOSIS PUTTY is manufactured by Daewoong Pharmaceutical, a strategic partner of CGBIO. During the IDE application process, the FDA conducted an in-depth review of the manufacturing process and Chemistry, Manufacturing, and Controls (CMC) data, reflecting the FDA's heightened scrutiny for bio-combined implants..

NOVOSIS PUTTY中使用的rhBMP-2蛋白由CGBIO的战略合作伙伴大熊制药生产。在IDE申请过程中，FDA对生产工艺和化学、制造与控制（CMC）数据进行了深入审查，反映了FDA对生物组合植入物的更严格审查。

Jumi Han

韩菊米

, Head of U.S. Development at CGBIO

CGBIO美国开发部负责人

USA

美国

, overseeing the pivotal clinical program, commented, 'Securing IDE approval for this pivotal trial validates our global clinical infrastructure and product quality. We are fully committed to executing a robust clinical trial and expanding NOVOSIS PUTTY's reach across the U.S. and other major markets'..

`,负责监督关键的临床项目，评论道：‘为这个关键试验获得IDE批准验证了我们的全球临床基础设施和产品质量。我们完全致力于执行一项强有力的临床试验，并扩大NOVOSIS PUTTY在美国及其他主要市场的覆盖范围。’`

Hyun Seung Yu

尹贤胜

, CEO of CGBIO, stated, 'This IDE approval reflects years of consistent R&D efforts and strengthens our global competitiveness. The U.S. bone graft market is notoriously difficult to penetrate, and this achievement underscores the global potential of NOVOSIS PUTTY. We will continue to provide transformative treatment options that improve quality of life for patients worldwide'..

CGBIO首席执行官表示：“此次IDE批准反映了我们多年持续的研发努力，并增强了我们的全球竞争力。美国骨移植市场以难以渗透著称，这一成就突显了NOVOSIS PUTTY的全球潜力。我们将继续提供改善全球患者生活质量的变革性治疗选择。”

In

在

February 2025

2025年2月

, CGBIO and its subsidiary CG MedTech signed a partnership agreement with Johnson & Johnson MedTech for the exclusive supply of NOVOSIS and NOVOSIS TRAUMA products across Korea and other Asian territories. The new IDE approval for NOVOSIS PUTTY is expected to accelerate the global expansion of the entire NOVOSIS product family..

CGBIO及其子公司CG MedTech与强生医疗科技公司签署了合作伙伴协议，独家供应NOVOSIS和NOVOSIS TRAUMA产品，覆盖韩国及其他亚洲地区。NOVOSIS PUTTY的新IDE批准预计将加速整个NOVOSIS产品系列的全球扩展。

About CGBIO

关于CGBIO

CGBIO is a global medical device company specializing in advanced biomaterials and regenerative medicine technologies. With a robust product portfolio and numerous successful clinical cases, CGBIO is committed to delivering innovative medical solutions that enhance patient outcomes and quality of life.

CGBIO是一家全球性的医疗器械公司，专注于先进的生物材料和再生医学技术。凭借强大的产品组合和众多成功的临床案例，CGBIO致力于提供创新的医疗解决方案，以改善患者的治疗效果和生活质量。

And to support growing gloval demand, CGBio has begun construction of a new manufacturing facility. While .

为了满足不断增长的全球需求，CGBio已经开始建设一个新的生产设施。尽管如此。