A major breakthrough! True Health Medicine (02697) Organ perfusion system completed preclinical trials of six cases of gene-edited pig liver with in vitro perfusion to support treatment

Zhitong Finance App learned that on October 12, True Health Care (02697) issued an announcement stating that the company has made a major breakthrough in organ perfusion system research and has successfully completed preclinical trials of six gene-edited pig liver-assisted non-human primate acute liver failure models, setting records for stable liver function perfusion support treatment for up to 144 hours and 6 cases all exceeding 72 hours. This is the first time in the world that the long-term efficacy of this technology has been verified.

The experiment was carried out in accordance with the relevant requirements of Order No. 818 of the State Council relating to the filing guidelines for clinical research on new biomedical technologies and clinical research on new techniques of heterologous transplantation in clinical transformation, and was jointly completed by research teams from Yunnan Agricultural University, Kunming First People's Hospital, and the First Affiliated Hospital of Anhui Medical University. During the experiment, animal vital signs were stable, liver bile continued to be secreted, and core biochemical indicators were generally stable, which can effectively compensate for liver physiological function; at the same time, the body's immune rejection response was controllable, and no hyperacute or acute rejection damage occurred, effectively overcoming the core technical problems of heterologous liver transplantation.

Liver failure is a serious disease with a high risk of death. Acute liver failure progresses particularly rapidly. Existing artificial liver support technology is still difficult to completely replace the complex physiological functions of the liver. Liver transplantation is limited by factors such as liver resources, patient conditions, and timing of transplantation, and there is no effective emergency bridging treatment in clinical practice. Gene-edited porcine liver in vitro perfusion support treatment technology aims to explore the use of in vitro perfusion systems to connect biologically active isolated liver to achieve potential liver function support, and secure a window for patients with severe liver failure to undergo liver repair or liver transplantation.

The organ perfusion system based on this study is a modular organ medical equipment platform. Using a common core host with replaceable consumables and configuration modules such as special pipelines, organ tanks, perfusion fluid, etc., it is possible to carry out research applications related to room temperature perfusion storage and in vitro life support for multiple organs such as liver, kidney, heart, and lungs without changing the host. It has the technical potential to support the expansion of treatment research from isolated organ perfusion preservation to extracorporeal infusion support treatment research development.

Industry experts said that the results confirmed the viability and safety of gene-edited porcine liver in vitro perfusion support treatment technology for liver failure bridging treatment, and provided a new technical path for the treatment of patients with critical liver failure.

According to the announcement, relevant technical research is expected to explore applications in the future to various diseases and clinical scenarios related to severe liver dysfunction, such as acute liver failure, subacute liver failure, severe liver failure and related severe liver disease, severe patients awaiting liver transplantation, and severe liver dysfunction after liver transplantation; these applications are currently all exploratory research directions and are not approved clinical indications.

True Health Care is committed to building a high-end medical equipment industry system with “intelligent surgical robot+whole life support system” as the core. The company's self-developed “puncture navigation and positioning system” and “navigation and positioning microwave ablation system” have all been approved for three types of innovative medical device registration certificates, recognized by the State Drug Administration as “the first in China” and the “first in the world” respectively. They have been clinically applied in more than 100 high-level hospitals across the country. More than 8,000 surgeries have been completed, with a success rate of 100%, and highly recognized by clinicians.