On October 12, TH MEDICAL-B (02697) announced that its organ perfusion system research has achieved a significant breakthrough, having successfully completed six preclinical experiments of ex vivo cross-perfusion support therapy using gene-edited pig livers to assist non-human primate models of acute liver failure, setting a record for stable liver function perfusion support therapy lasting up to 144 hours, with all six cases exceeding 72 hours, marking the world's first long-duration efficacy validation of this technology.
The experiments were conducted in accordance with the relevant requirements of the State Council Order No. 818 regarding the filing guidelines for clinical research on new biomedical technologies and clinical translation involving xenotransplantation, and were jointly completed with research teams from Yunnan Agricultural University, Kunming First People's Hospital, and the First Affiliated Hospital of Anhui Medical University.
During the experiments, the animals' vital signs remained stable, the donor livers continued to secrete bile, and core biochemical indicators were generally stable, effectively compensating for liver physiological functions. At the same time, immune rejection reactions were controllable, with no hyperacute or acute rejection damage occurring, effectively overcoming the core technical challenges of xenogeneic liver transplantation.
Liver failure is a severe disease with high mortality risk, and acute liver failure progresses particularly rapidly. Existing artificial liver support technologies are still unable to fully replace the complex physiological functions of the liver, while liver transplantation is limited by donor liver resources, patient conditions, and transplantation timing, leaving a clinical gap for effective emergency bridging treatment options.
The ex vivo perfusion support therapy technology using gene-edited pig livers aims to explore the use of an ex vivo perfusion system connected to a biologically active isolated liver to achieve potential liver function support, buying a window period for critically ill liver failure patients to either recover liver function or receive a liver transplant.
The organ perfusion system underlying this research is a modular organ medical device platform that uses a universal core main unit paired with replaceable specialized tubing, organ chambers, perfusion fluids, and other consumables and configuration modules. Without replacing the main unit, it can conduct research applications related to normothermic perfusion preservation and ex vivo life support for multiple organs including liver, kidney, heart, and lung, demonstrating technical potential for expansion from isolated organ perfusion preservation to ex vivo perfusion support therapy research.
Industry experts stated that this achievement confirms the feasibility and safety of ex vivo perfusion support therapy technology using gene-edited pig livers for bridging treatment of liver failure, providing a new technical pathway for treating critically ill liver failure patients.
The announcement stated that related technology research is expected to explore applications in various severe liver dysfunction-related diseases and clinical scenarios, including acute liver failure, subacute liver failure, acute-on-chronic liver failure, severe liver function decompensation and related critical liver diseases, critically ill patients awaiting liver transplantation, and severe liver dysfunction after liver transplantation. The above applications are currently exploratory research directions and are not approved clinical indications.
TH MEDICAL-B is committed to building a high-end medical equipment industrial system centered on "intelligent surgical robots + full life support systems." The company's independently developed "puncture surgery navigation and positioning system" and "navigation and positioning microwave ablation system" have both obtained Class III innovative medical device registration certificates, and were respectively recognized by the National Medical Products Administration as "domestically first-of-its-kind" and "internationally first-of-its-kind." They have been clinically applied in more than 100 high-level hospitals nationwide, with a cumulative total of over 8,000 completed surgeries and a 100% success rate, receiving high recognition from clinical physicians.
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