True Health Medical-B (02697): Completed a preclinical trial of 6 cases of genetically-edited pig liver in vitro, verifying long-term efficacy for the first time in the world

Zhitong Finance App News, True Health Medical-B (02697) announced that, based on a self-developed organ perfusion system, it has successfully completed pre-clinical trials of six cases of gene-edited pig liver-assisted acute liver failure in non-human primate models to support treatment. The experiment referred to the relevant requirements of State Council Order No. 818 on clinical research and filing guidelines for clinical research on new biomedical transplantation techniques in clinical transformation, and collaborated with research teams from Yunnan Agricultural University, Kunming First People's Hospital, and the First Affiliated Hospital of Anhui Medical University to set a record of stable liver function infusion support treatment for up to 144 hours and 6 cases exceeding 72 hours. This is the first time in the world that the long-term effectiveness of this technology has been verified.

The experimental results showed that during the experiment, animal vital signs were stable, liver bile continued to be secreted, and core biochemical indicators were generally stable, which could effectively compensate for liver physiological function. At the same time, the body's immune rejection response was manageable, and no hyperacute or acute rejection damage occurred, effectively overcoming the core technical problems of heterologous liver transplantation.

This study relied on an organ perfusion system independently developed by True Health Medical and combined with 8 gene-edited medical donor pig liver developed by Yunnan Agricultural University to establish a safe and stable liver in vitro perfusion support treatment system. The system is a modular organ medical equipment platform. It uses a general core host with a technical architecture that can replace consumables and configuration modules such as special pipelines, organ tanks, perfusion fluid, etc., and can 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, and has the potential to expand technology from perfusion preservation of isolated organs to extracorporeal perfusion support treatment research.

Liver failure is a serious disease with a high risk of death. Existing artificial liver support technology is still limited in completely replacing complex physiological functions of the liver, while liver transplantation is limited by factors such as liver resources, patient condition, and timing of transplantation. 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 obtain time for patients with severe liver failure to recover liver function or receive liver transplantation.

Relying on relevant technical research carried out by organ perfusion systems, it is expected to be applied to various diseases and clinical scenarios related to severe liver dysfunction in the future, including but not limited to: acute liver failure, subacute liver failure, severe liver failure, severe liver failure and related severe liver disease, severe patients awaiting liver transplantation, and severe liver dysfunction after liver transplantation. The relevant applications are currently in the direction of exploratory research and are not approved clinical indications.

The Board of Directors hereby reminds that the six trials described in this announcement are pre-clinical studies. The completion of the trials does not mean that the relevant technology has proven safety and efficacy in humans, nor does it mean that the relevant products have obtained medical device registration certificates or clinical application licenses. There is uncertainty about the potential indications, clinical transformation direction and commercialization prospects. Shareholders and potential investors should act carefully when trading the company's securities.