The first Korean developed medical device for spine implantation

韩国首创脊柱植入医疗器械

Expecte to receive faster approval in the U.S. by priority support from the FDA

通过FDA的优先支持，有望在美国更快获得批准

NOVOSIS PUTTY, combining bone-forming proteins and ceramic scaffolds, induces rapid bone formation

NOVOSIS腻子结合了成骨蛋白和陶瓷支架，可诱导快速成骨

SEOUL, South Korea, Jan. 2, 2024 /PRNewswire/ -- 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).

韩国首尔，2024年1月2日，专门从事生物再生医学的韩国公司CGBio（首席执行官Hyun Seung Yu）2日宣布，其先进的骨替代材料“NOVOSIS PUTTY”已被美国食品和药物管理局（FDA）授予“突破性设备指定”（BDD）。

This material incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2)..

该材料包含重组人骨形态发生蛋白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..

2023年9月15日，美国食品和药物管理局（FDA）发布了指导文件的更新版本——“突破设备计划，工业和食品药品管理局工作人员指南”。突破计划旨在通过加快患者的开发，评估和审查，帮助患者更及时地获得医疗设备，同时保持PMA，510（k）和从头开始的法定标准，符合该机构保护和促进公共卫生的使命。。

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.

根据指南，FDA考虑了所有这些因素，以确定设备是否“合理预期提供更有效的治疗或诊断”。

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.

NOVOSIS PUTTY的命名标志着韩国首例植入式设备。尽管是一种高风险的永久性植入物，但NOVOSIS腻子的功效和创新方面在国际上得到了认可。

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.

具有“突破性设备指定”的设备在批准过程中受益于FDA的优先支持。这种支持包括与FDA的持续沟通，分配专门的审查团队，以及优先审查从临床试验设计到批准的一切。这种简化的方法加快了FDA的批准速度，从而可以更快地进入美国。

market compared to other devices..

与其他设备相比的市场。。

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%.

根据SmartTrak的数据，北美生长因子骨替代品市场预计将从2022年的6.6亿美元增长到2029年的7.8亿美元，年均增长率为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.

NOVOSIS腻子是第二代产品，具有陶瓷基合成支架，具有优异的可塑性和骨传导性，并结合了先进的缓释配方技术（SLOREL™) 来自其前身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..

NOVOSIS腻子的关键成分是rhBMP-2，由韩国制药行业的领导者大宇制药有限公司大规模生产。这种蛋白质在骨再生中起着至关重要的作用，在骨缺损的情况下将干细胞转化为骨细胞。大宇的rhBMP-2在国际上被称为“Nebotermin”，并得到了包括世界卫生组织在内的组织的认可，因其对健康的影响而赢得了全球赞誉。。

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.

与胶原海绵支架不同，羟基磷灰石（HA）陶瓷材料是一种骨移植替代物，可同时作为rhBMP-2的支架，可控制rhBMP-2的释放，降低不必要的骨生长和周围软组织肿胀的风险。它能够以较低的rhBMP-2剂量形成高密度骨。

Its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, also allows customizable shaping..

它的合成聚合物水凝胶成分泊洛沙姆407水凝胶也可以定制形状。。

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.

CGBio已经完成了美国NOVOSIS腻子验证性临床试验的临床前研究，并正在进行临床试验以确定最佳剂量，计划于2024年上半年申请美国验证性临床试验。

Hyun Seung Yu, CEO of CGBio, commented, '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.'.

CGBio首席执行官玄承宇（Hyun Seung Yu）评论道：“诺沃西腻子的突破性设备设计进一步证明了CGBio的技术实力、创新和潜力。随着该名称强调快速将有益产品推向市场，我们致力于通过NOVOSIS PUTTY帮助更多患者克服疾病并恢复健康生活。”。

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.'

CGBio美国开发中心负责人Jumi Han表示，“NOVOSIS PUTTY的“突破性设备指定”证实了监管机构正在优先支持我们的产品开发。我们正在加速美国的临床试验，以证明其有效性和安全性。”

About CGBio

关于CGBio

CGBio began with the mission of 'Pursuing the Improvement of Quality of Life,' specializing in the production and sale of therapeutic materials for reconstructing musculoskeletal tissues damaged by diseases. Expanding its scope, the company now also provides materials for the beauty and plastic surgery sectors.

CGBio以“追求生活质量的改善”为使命，专注于生产和销售用于重建疾病损伤的肌肉骨骼组织的治疗材料。该公司扩大了业务范围，现在还为美容整形行业提供材料。

Building on biomaterial-based technology, CGBio collaborates with clinical experts to supply essential products for clinical use and products that are convenient for use in clinical settings. More detailed information can be found at (http://www.cgbio.co.kr/en/)..

CGBio以基于生物材料的技术为基础，与临床专家合作，提供临床使用的基本产品和便于临床使用的产品。更多详细信息请访问(http://www.cgbio.co.kr/en/)。。

About Daewoong Pharmaceutical

关于大宇制药

Daewoong Pharmaceutical, a leading global pharmaceutical company based in South Korea, is dedicated to improving consumer quality of life through its innovative products. Its self-developed NABOTA, a botulinum toxin type-A, is Asia's first FDA-approved botulinum toxin, and Daewoong has also developed novel drugs for GERD, using the active ingredient Fexuprazan, and for diabetes with Enavogliflozin for two consecutive years.

大宇制药是一家总部位于韩国的全球领先制药公司，致力于通过其创新产品改善消费者的生活质量。其自主开发的NABOTA是一种a型肉毒杆菌毒素，是亚洲第一种FDA批准的肉毒杆菌毒素，大宇还连续两年开发了使用活性成分Fexuprazan治疗GERD和使用Enavogliflozin治疗糖尿病的新药。

For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]..

有关更多信息，请访问大宇制药的网站和LinkedIn页面。媒体查询可通过[电子邮件保护]直接联系大宇公关。。

SOURCE CGBio

来源CGBio