<ul>
<li><strong>针对颅骨和颅面重建的患者特定钛植入物</strong></li>
<li><strong>首家获得美国市场定制钛植入物 FDA 510(k) 批准的韩国公司</strong></li>
</ul>
<p>, /PRNewswire/ -- CGBIO（首席执行官：Hyunseung Yu）宣布，其患者特定钛植入物 EASYMADE TI 于 4 月 9 日获得美国食品药品监督管理局（FDA）的 510(k) 批准。FDA 510(k) 途径是一种上市前的批准流程，证明与合法上市的对照设备具有实质等同性，从而允许在美国进行商业化。</p>
<p>继续阅读</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null"/></p>
<p>EASYMADE TI 的产品图像</p>
<p>这一里程碑标志着韩国公司首次获得 FDA 510(k) 批准，用于美国市场的患者特定钛植入物。这突显了 CGBIO 在全球市场的技术能力和监管专业知识。这一成就尤其在患者特定的颅骨和颅面重建领域具有重要意义。</p>
<p>EASYMADE TI 是一种基于个体 CT 数据设计的患者特定钛植入物，旨在重建颅骨和非承重的颅面缺损。该植入物采用医用级钛合金制造，并通过激光粉末床熔融（LPBF）这一先进的金属 3D 打印技术生产。</p>
<p>产品交付流程也是一个关键的差异化因素。一旦美国临床医生提供患者的 CT 图像，定制设计将在 CGBIO 位于韩国的设计中心完成，成品植入物将在五天内送达美国医院。经过医院的消毒后，植入物可以直接用于手术。</p>
<p>公司预计这一批准将成为其在美国扩展患者特定植入物业务的转折点。由于创伤、肿瘤切除和减压颅骨切除等病例，颅骨和颅面重建的需求在美国持续增长。同时，针对个体解剖结构量身定制的患者特定重建解决方案的兴趣也在增加。</p>
<p>CGBIO 首席执行官 Hyunseung Yu 表示：“EASYMADE TI 获得 FDA 510(k) 批准是一个重要的成就，展示了 CGBIO 在患者特定重建解决方案方面的全球竞争力。我们将以这一里程碑为基础，扩展我们在美国的定制颅骨和颅面植入物业务，并加速我们管线产品的监管批准和商业化。”</p>
<p>CGBIO 计划在获得这一批准的基础上积极扩展其在美国市场的存在，同时继续加强其在患者特定医疗设备领域的全球地位。</p>
<p>来源 CGBIO</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDI0Jk5ld3NJdGVtSWQ9Q040MjgwMCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjQwODAwUFJfTkVXU19VU1BSX19fX19DTjQyODAw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDI0Jk5ld3NJdGVtSWQ9Q040MjgwMCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjQwODAwUFJfTkVXU19VU1BSX19fX19DTjQyODAw"/></p>

Compugen医疗

GBIO

CBIO

<p>CGBIO 已获得 FDA 510(k) 认证，批准其患者特定的钛植入物 EASYMADE TI，这标志着韩国公司首次在美国市场上实现定制钛植入物的这一成就。该植入物专为颅骨和颅面重建设计，使用个体 CT 数据进行定制，并通过先进的 3D 打印技术生产。此项认证预计将促进 CGBIO 在美国市场的扩展，以满足日益增长的个性化重建解决方案的需求</p>

<ul>
<li><strong>Patient-specific titanium implant designed for cranial and craniofacial reconstruction</strong></li>
<li><strong>First Korean company to obtain FDA 510(k) clearance for a customized titanium implant in the U.S. market</strong></li>
</ul>
<div class="lb-trans"><ul>
<li><strong>针对颅骨和颅面重建的患者特定钛植入物</strong></li>
<li><strong>首家获得美国市场定制钛植入物 FDA 510(k) 批准的韩国公司</strong></li>
</ul>
</div><p>, /PRNewswire/ -- CGBIO (CEO: Hyunseung Yu) announced that its patient-specific titanium implant, EASYMADE TI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 9. The FDA 510(k) pathway is a premarket clearance process that demonstrates substantial equivalence to a legally marketed predicate device, allowing commercialization in the United States.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- CGBIO（首席执行官：Hyunseung Yu）宣布，其患者特定钛植入物 EASYMADE TI 于 4 月 9 日获得美国食品药品监督管理局（FDA）的 510(k) 批准。FDA 510(k) 途径是一种上市前的批准流程，证明与合法上市的对照设备具有实质等同性，从而允许在美国进行商业化。</p>
</div><p>Continue Reading</p>
<div class="lb-trans"><p>继续阅读</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null" alt="" original-src="https://www.prnewswire.com/news-releases/null"/></p>
<p>Product Image of EASYMADE TI</p>
<div class="lb-trans"><p>EASYMADE TI 的产品图像</p>
</div><p>This milestone marks the first case of a Korean company obtaining FDA 510(k) clearance for a patient-specific titanium implant intended for the U.S. market. It highlights CGBIO's technological capabilities as well as its regulatory expertise in global markets. The achievement is particularly notable in the field of patient-specific cranial and craniofacial reconstruction.</p>
<div class="lb-trans"><p>这一里程碑标志着韩国公司首次获得 FDA 510(k) 批准，用于美国市场的患者特定钛植入物。这突显了 CGBIO 在全球市场的技术能力和监管专业知识。这一成就尤其在患者特定的颅骨和颅面重建领域具有重要意义。</p>
</div><p>EASYMADE TI is a patient-specific titanium implant designed based on individual CT data and intended for reconstruction of cranial and non-load-bearing craniofacial defects. The implant is manufactured using medical-grade titanium alloy and produced through Laser Powder Bed Fusion (LPBF), an advanced metal 3D printing technology.</p>
<div class="lb-trans"><p>EASYMADE TI 是一种基于个体 CT 数据设计的患者特定钛植入物，旨在重建颅骨和非承重的颅面缺损。该植入物采用医用级钛合金制造，并通过激光粉末床熔融（LPBF）这一先进的金属 3D 打印技术生产。</p>
</div><p>The product delivery process is also a key differentiator. Once patient CT images are provided by U.S.-based clinicians, customized design is completed at CGBIO's design center in Korea, and the finished implant is delivered to hospitals in the U.S. within five days. After sterilization at the hospital, the implant can be used directly in surgical procedures.</p>
<div class="lb-trans"><p>产品交付流程也是一个关键的差异化因素。一旦美国临床医生提供患者的 CT 图像，定制设计将在 CGBIO 位于韩国的设计中心完成，成品植入物将在五天内送达美国医院。经过医院的消毒后，植入物可以直接用于手术。</p>
</div><p>The company expects this clearance to serve as a turning point for expanding its patient-specific implant business in the United States. Demand for cranial and craniofacial reconstruction continues to grow in the U.S., driven by cases such as trauma, tumor resection, and decompressive craniectomy. At the same time, interest in patient-specific reconstruction solutions tailored to individual anatomy is increasing.</p>
<div class="lb-trans"><p>公司预计这一批准将成为其在美国扩展患者特定植入物业务的转折点。由于创伤、肿瘤切除和减压颅骨切除等病例，颅骨和颅面重建的需求在美国持续增长。同时，针对个体解剖结构量身定制的患者特定重建解决方案的兴趣也在增加。</p>
</div><p>Hyunseung Yu, CEO of CGBIO, said, &#34;The FDA 510(k) clearance of EASYMADE TI is a meaningful achievement that demonstrates CGBIO's global competitiveness in patient-specific reconstruction solutions. We will use this milestone as a foundation to expand our customized cranial and craniofacial implant business in the U.S. and accelerate regulatory approvals and commercialization of our pipeline products.&#34;</p>
<div class="lb-trans"><p>CGBIO 首席执行官 Hyunseung Yu 表示：“EASYMADE TI 获得 FDA 510(k) 批准是一个重要的成就，展示了 CGBIO 在患者特定重建解决方案方面的全球竞争力。我们将以这一里程碑为基础，扩展我们在美国的定制颅骨和颅面植入物业务，并加速我们管线产品的监管批准和商业化。”</p>
</div><p>CGBIO plans to actively expand its presence in the U.S. market based on this clearance, while continuing to strengthen its global position in the field of patient-specific medical devices.</p>
<div class="lb-trans"><p>CGBIO 计划在获得这一批准的基础上积极扩展其在美国市场的存在，同时继续加强其在患者特定医疗设备领域的全球地位。</p>
</div><p>SOURCE CGBIO</p>
<div class="lb-trans"><p>来源 CGBIO</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNDI0Jk5ld3NJdGVtSWQ9Q040MjgwMCZUcmFuc21pc3Npb25fSWQ9MjAyNjA0MjQwODAwUFJfTkVXU19VU1BSX19fX19DTjQyODAw" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN42800&amp;Transmission_Id=202604240800PR_NEWS_USPR_____CN42800&amp;DateId=20260424"/></p>

ETCGBIO 获得 FDA 510(k) 批准用于患者定制的钛植入物'EASYMADE TI'