Major breakthrough! Zhen Health Medical (02697) organ perfusion system completes preclinical experiments of extracorporeal perfusion support therapy using gene-edited pig livers in six cases

On October 12, Zhen Health Medical (02697) announced a major breakthrough in its organ perfusion system research. The company has successfully completed preclinical experiments of extracorporeal cross-perfusion support therapy using genetically edited pig livers to assist non-human primate acute liver failure models in six cases, setting a record for stable liver function perfusion support therapy of up to 144 hours, with all six cases exceeding 72 hours. This marks the world's first long-duration efficacy validation of this technology. The experiment was conducted in accordance with the relevant requirements of the State Council's Order No. 818 regarding the filing guidelines for clinical research on new biomedical technologies, specifically the clinical research filing for xenotransplantation new technologies in clinical research and clinical translation. It was 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 experiment, the animals' vital signs remained stable, the donor livers continuously secreted bile, and core biochemical indicators remained generally stable, effectively compensating for liver physiological functions. At the same time, immune rejection reactions were controllable, with no hyperacute or acute rejection damage observed, effectively overcoming the core technical challenges of xenogeneic liver transplantation. Liver failure is a severe disease with a high risk of death, 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 factors such as donor liver resources, patient condition, and transplantation timing. There is a lack of effective emergency bridging treatment options in clinical practice. Genetically edited pig liver extracorporeal perfusion support therapy aims to explore the use of an extracorporeal perfusion system connected to a biologically active isolated liver to achieve potential liver function support, buying time for critically ill liver failure patients to undergo liver repair 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 and applications related to normothermic perfusion preservation and extracorporeal life support for multiple organs including the liver, kidney, heart, and lungs, demonstrating the technical potential to expand from isolated organ perfusion preservation to extracorporeal perfusion support therapy research. Industry experts stated that this achievement confirms the feasibility and safety of genetically edited pig liver extracorporeal perfusion support therapy for bridging treatment of liver failure, providing a new technical pathway for treating critically ill liver failure patients. The announcement stated that future research on the relevant technology 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. Zhen Health Medical is committed to building a high-end medical equipment industry system centered on "intelligent surgery Siasun Robot&Automation + full life support system." 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 Management 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 surgeries completed, a 100% success rate, and high recognition from clinical physicians.