In December 2024, the XenoSure cardiac biological patch, developed by our important partner—Lemai Medical Technology (Shanghai) Co., Ltd., was officially approved for marketing by the National Medical Products Administration (NMPA). The Huangtu-Totrial team served as the full executor of this pivotal clinical trial (randomized, controlled, single-blind, multicenter, non-inferiority study) and was deeply involved in the project.

Leveraging advanced project management models, profound clinical operation experience, and a highly professional and responsible team, we provided Lemai Medical with core services including clinical trial protocol design, full-cycle project management, efficient execution, and strict monitoring. We successfully ensured the smooth progress of the trial and data quality, providing solid support for the final approval of this innovative product.

This cardiac biological patch is used to repair key parts of the heart (such as the atrial septum, ventricular septum, and aortic root). It combines tissue engineering technology and holds significant value in the field of cardiac surgery. The Totrial team is honored to have participated in and contributed to this milestone achievement, fulfilling our mission of "enabling patients to access safe and effective medicines."