/PRNewswire/ -- TransMedics Group, Inc. ('TransMedics') (Nasdaq:

/PRNewswire/ -- TransMedics集团有限公司（“TransMedics”）（纳斯达克：

TMDX

TMDX

), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial..

），这是一家正在改变终末期肺、心脏和肝衰竭患者的器官移植疗法的医疗技术公司，今天宣布美国食品和药物管理局 (FDA) 已对其研究设备豁免 (IDE) 给予有条件批准，允许该公司启动其下一代OCS ENHANCE心脏试验。

The ENHANCE trial is a two-part clinical trial. Part A is designed to support prolonged heart perfusion using OCS™ Heart System. Part B is intended to demonstrate the superiority of OCS Heart perfusion in donation after brain death (DBD) cases when compared to DBD cases using static cold storage methods.

ENHANCE 试验是一项分为两部分的临床试验。A 部分旨在支持使用 OCS™ 心脏系统进行延长的心脏灌注。B 部分旨在证明在脑死亡（DBD）案例中，与使用静态冷存储方法的 DBD 案例相比，OCS 心脏灌注的优越性。

Part B is intended to support the potential expansion of OCS Heart clinical indications to include DBD hearts that are not currently eligible for OCS perfusion and preservation. The trial's total sample size, across both Part A and Part B, is expected to exceed 650 patients. TransMedics believes this would constitute the largest heart preservation for transplant trial ever, worldwide.

B部分旨在支持OCS Heart临床适应症的潜在扩展，以包括目前不符合OCS灌注和保存条件的DBD心脏。该试验的总样本量（包括A部分和B部分）预计将超过650名患者。TransMedics认为，这将成为全球有史以来规模最大的心脏保存移植试验。

Details of the OCS ENHANCE Heart trial will be made available on .

OCS ENHANCE Heart 试验的详细信息将在 上提供。

'The recent FDA approvals to initiate our Next-Gen OCS ENHANCE Heart and DENOVO Lung trials mark key milestones in our ongoing commitment to transforming the standard of care and address the major clinical needs of the cardiothoracic transplant community,' said Waleed Hassanein, MD, President and Chief Executive Officer.

“最近FDA批准我们启动下一代OCS ENHANCE心脏和DENOVO肺部试验，标志着我们在持续致力于改变护理标准及满足心胸移植领域主要临床需求方面的重要里程碑，”总裁兼首席执行官瓦利德·哈桑尼医学博士表示。

'We are thrilled to be in a position to initiate both trials in the fourth quarter of 2025 while we continue to work collaboratively with the FDA to address any remaining questions related to pre-clinical testing. As I have stated before, we hope these two trials will be major catalysts for clinical adoption for both heart and lung throughout 2026 and beyond.'.

“我们很高兴能够在2025年第四季度启动这两项试验，同时我们将继续与FDA合作，解决与临床前测试相关的任何剩余问题。正如我之前所说，我们希望这两项试验将成为2026年及以后心脏和肺临床应用的主要推动力。”

About TransMedics Group, Inc.

关于TransMedics集团，Inc.

TransMedics is the world's leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in

TransMedics是便携式体外温热灌注和移植供体器官评估领域的全球领导者，总部位于

Andover, Massachusetts

马萨诸塞州安多弗

, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure..

，该公司成立的目的是解决移植器官供不应求的问题，并开发了保存器官质量、在移植前评估器官活力以及潜在提高供体器官利用率的技术，用于治疗终末期心脏、肺和肝衰竭。