<p>监管批准使得 MAVERICS 冠状动脉再血管化研究的启动成为可能，推动公司下一代合成小直径旁路移植物的评估。</p>
<p>, /PRNewswire/ -- Medical 21, Inc.是一家私人医疗技术公司，正在开发一种新型再生小直径冠状动脉旁路移植物，今天宣布已获得西班牙根据欧盟医疗器械法规（EU MDR）的监管批准，以启动公司首个针对 MAVERICS 移植物的人体临床试验，即_MAVERICS 冠状动脉再血管化研究_。</p>
<p>MAVERICS 移植物是一种下一代再生血管支架，旨在解决创建耐用小直径导管用于冠状动脉旁路移植（CABG）的长期挑战。其设计将可吸收聚合物支架与镍钛合金线框结合，提供早期机械支持，并引导患者的自然愈合过程。支架结构旨在促进细胞浸润、新血管生成和原生血管组织的逐步形成。通过提供一种一致、随时可用的替代选择，MAVERICS 移植物旨在简化 CABG 手术，减少取材相关的发病率，并扩大需要冠状动脉旁路手术患者的再血管化选择。</p>
<p>“我们很高兴在西班牙获得了所有必要的监管批准，以开始我们的首个针对人类的研究，”<strong>Medical 21 首席执行官 Manny Villafaña 博士</strong> 表示。“这一里程碑标志着验证 MAVERICS 移植物临床潜力的重要一步，并推动我们改变冠状动脉旁路手术的使命。几十年来，外科医生在可用导管的质量和数量上面临限制。MAVERICS 移植物旨在解决这些长期存在的挑战，我们迫切希望开始评估其在患者中的安全性、性能和生物整合。”</p>
<p>MAVERICS 移植物是一种研究性设备，尚未获得美国食品药品监督管理局（FDA）或任何其他监管机构的商业销售批准。</p>
<p><strong>关于 Medical 21, Inc.</strong> Medical 21, Inc.是一家致力于重塑心脏旁路手术未来的医疗技术公司。该公司正在推进其 MAVERICS 再生平台，其首个产品——MAVERICS 冠状动脉移植物，旨在作为一种小直径血管导管，消除 CABG 手术中对血管取材的需求。Medical 21 总部位于明尼阿波利斯，明尼苏达州。</p>
<p><strong>前瞻性声明</strong> 本新闻稿包含关于 MAVERICS 移植物的开发、临床评估和监管审查的前瞻性声明。这些声明基于当前的预期，并受到风险和不确定性的影响，这可能导致实际结果与预期有重大差异，包括与首个针对人类研究的启动和进展、临床数据的解读以及监管互动的时间或结果相关的风险。Medical 21 没有义务更新前瞻性声明，除非法律要求。</p>
<p>有关 Medical 21, Inc.的更多信息，请访问 www.Medical21.com。</p>
<p>Medical 21 投资者联系：</p>
<p>Andrea Sweeney</p>
<p>业务管理副总裁</p>
<p>[email protected]</p>
<p>+1-612-429-7630</p>
<p>来源：Medical 21, Inc.</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE1Jk5ld3NJdGVtSWQ9UEg0NTk4MCZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTUwODQzUFJfTkVXU19VU1BSX19fX19QSDQ1OTgw?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-RGF0ZUlkPTIwMjUxMjE1Jk5ld3NJdGVtSWQ9UEg0NTk4MCZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTUwODQzUFJfTkVXU19VU1BSX19fX19QSDQ1OTgw"/></p>

<p>Medical 21, Inc. 已获得西班牙的监管批准，启动其首个人体临床试验，进行 MAVERICS 冠状动脉再血管化研究。该研究将评估公司下一代再生小直径冠状动脉旁路移植血管，旨在改善冠状动脉旁路移植（CABG）手术。MAVERICS 移植物旨在提供一种耐用的替代选择，以替代采集的血管，从而改善患者的治疗效果。这一批准标志着 Medical 21 在推进其转变冠状动脉旁路手术使命方面的重要里程碑</p>

<p><em>Regulatory clearance enables launch of the MAVERICS Coronary Revascularization Study, advancing evaluation of the Company's next-generation synthetic small-diameter bypass graft.</em></p>
<div class="lb-trans"><p>监管批准使得 MAVERICS 冠状动脉再血管化研究的启动成为可能，推动公司下一代合成小直径旁路移植物的评估。</p>
</div><p>, /PRNewswire/ -- Medical 21, Inc., a private medical technology company developing a novel regenerative small-diameter coronary bypass graft, today announced that it has received regulatory approval in Spain under the European Union Medical Device Regulation (EU MDR) to initiate the Company's first-in-human, multicenter clinical trial of the MAVERICS graft, the <em>MAVERICS Coronary Revascularization Study.</em></p>
<div class="lb-trans"><p>, /PRNewswire/ -- Medical 21, Inc.是一家私人医疗技术公司，正在开发一种新型再生小直径冠状动脉旁路移植物，今天宣布已获得西班牙根据欧盟医疗器械法规（EU MDR）的监管批准，以启动公司首个针对 MAVERICS 移植物的人体临床试验，即_MAVERICS 冠状动脉再血管化研究_。</p>
</div><p>The MAVERICS graft is a next-generation regenerative vascular scaffold engineered to address the long-standing challenge of creating durable, small-diameter conduits for coronary artery bypass grafting (CABG). Its design integrates an absorbable polymeric scaffold with a nitinol wire frame, combining early mechanical support with a structure intended to guide the patient's natural healing process. The scaffold architecture is designed to encourage cellular infiltration, neovascularization, and the gradual formation of native vascular tissue. By providing a consistent, readily available alternative to harvested vessels, the MAVERICS graft aims to streamline CABG procedures, reduce harvest-related morbidity, and broaden revascularization options for patients requiring coronary bypass surgery.</p>
<div class="lb-trans"><p>MAVERICS 移植物是一种下一代再生血管支架，旨在解决创建耐用小直径导管用于冠状动脉旁路移植（CABG）的长期挑战。其设计将可吸收聚合物支架与镍钛合金线框结合，提供早期机械支持，并引导患者的自然愈合过程。支架结构旨在促进细胞浸润、新血管生成和原生血管组织的逐步形成。通过提供一种一致、随时可用的替代选择，MAVERICS 移植物旨在简化 CABG 手术，减少取材相关的发病率，并扩大需要冠状动脉旁路手术患者的再血管化选择。</p>
</div><p>&#34;We are pleased to have received all necessary regulatory clearances in Spain to begin our first-in-human study,&#34; said <strong>Dr. Manny Villafaña, Ph.D. Sc., Chief Executive Officer of Medical 21</strong>. &#34;This milestone marks an important step forward in validating the clinical potential of the MAVERICS graft and advancing our mission to transform coronary bypass surgery. For decades, surgeons have faced limitations in available conduit quality and quantity. The MAVERICS graft is designed to address these longstanding challenges, and we are eager to begin assessing its safety, performance, and biological integration in patients.&#34;</p>
<div class="lb-trans"><p>“我们很高兴在西班牙获得了所有必要的监管批准，以开始我们的首个针对人类的研究，”<strong>Medical 21 首席执行官 Manny Villafaña 博士</strong> 表示。“这一里程碑标志着验证 MAVERICS 移植物临床潜力的重要一步，并推动我们改变冠状动脉旁路手术的使命。几十年来，外科医生在可用导管的质量和数量上面临限制。MAVERICS 移植物旨在解决这些长期存在的挑战，我们迫切希望开始评估其在患者中的安全性、性能和生物整合。”</p>
</div><p>The MAVERICS graft is an investigational device and has not been approved for commercial sale by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.</p>
<div class="lb-trans"><p>MAVERICS 移植物是一种研究性设备，尚未获得美国食品药品监督管理局（FDA）或任何其他监管机构的商业销售批准。</p>
</div><p><strong>About Medical 21, Inc.</strong> Medical 21, Inc. is a medical technology company dedicated to reshaping the future of cardiac bypass surgery. The Company is advancing its MAVERICS regenerative platform, with its first product—the MAVERICS coronary graft—designed as a small-diameter vascular conduit intended to eliminate the need for vessel harvesting in CABG procedures. Medical 21 is headquartered in Minneapolis, Minnesota.</p>
<div class="lb-trans"><p><strong>关于 Medical 21, Inc.</strong> Medical 21, Inc.是一家致力于重塑心脏旁路手术未来的医疗技术公司。该公司正在推进其 MAVERICS 再生平台，其首个产品——MAVERICS 冠状动脉移植物，旨在作为一种小直径血管导管，消除 CABG 手术中对血管取材的需求。Medical 21 总部位于明尼阿波利斯，明尼苏达州。</p>
</div><p><strong>Forward-Looking Statements</strong> This press release contains forward-looking statements regarding the development, clinical evaluation, and regulatory review of the MAVERICS graft. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to the initiation and progress of the first-in-human study, the interpretation of clinical data, and the timing or outcome of regulatory interactions. Medical 21 undertakes no obligation to update forward-looking statements except as required by law.</p>
<div class="lb-trans"><p><strong>前瞻性声明</strong> 本新闻稿包含关于 MAVERICS 移植物的开发、临床评估和监管审查的前瞻性声明。这些声明基于当前的预期，并受到风险和不确定性的影响，这可能导致实际结果与预期有重大差异，包括与首个针对人类研究的启动和进展、临床数据的解读以及监管互动的时间或结果相关的风险。Medical 21 没有义务更新前瞻性声明，除非法律要求。</p>
</div><p>For additional information about Medical 21, Inc., please visit www.Medical21.com.</p>
<div class="lb-trans"><p>有关 Medical 21, Inc.的更多信息，请访问 www.Medical21.com。</p>
</div><p>Medical 21 Investor Contact:</p>
<div class="lb-trans"><p>Medical 21 投资者联系：</p>
</div><p>Andrea Sweeney</p>
<div class="lb-trans"><p>Andrea Sweeney</p>
</div><p>VP Business Administration</p>
<div class="lb-trans"><p>业务管理副总裁</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>+1-612-429-7630</p>
<div class="lb-trans"><p>+1-612-429-7630</p>
</div><p>SOURCE Medical 21, Inc.</p>
<div class="lb-trans"><p>来源：Medical 21, Inc.</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE1Jk5ld3NJdGVtSWQ9UEg0NTk4MCZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTUwODQzUFJfTkVXU19VU1BSX19fX19QSDQ1OTgw" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=PH45980&amp;Transmission_Id=202512150843PR_NEWS_USPR_____PH45980&amp;DateId=20251215"/></p>

Medical 21, Inc. 宣布获得监管批准，将在西班牙启动首次人体临床研究