Guangdong True Health Medical Technology Development Co., Ltd. (HKG: 2697) issued a voluntary announcement that, leveraging its self‑developed organ perfusion system, the Company has successfully completed six preclinical cases of cross‑organ perfusion support therapy using an ex vivo model of genetically edited porcine liver for non‑human primate acute liver failure – achieving stable liver function perfusion support lasting up to 144 hours, with all six cases exceeding 72 hours, representing the first global demonstration of prolonged efficacy validation for this technology.
Research Milestone
| Item | Detail |
|---|---|
| Company | Guangdong True Health Medical Technology Development Co., Ltd. (HKG: 2697) |
| Announcement Type | Voluntary announcement on significant research progress |
| Technology | Extracorporeal liver perfusion support therapy using a self‑developed organ perfusion system |
| Study Model | Ex vivo genetically edited (8‑gene) porcine liver supporting non‑human primates with acute liver failure |
| Cases Completed | Six preclinical cases |
| Duration Record | Stable perfusion support up to 144 hours; all six cases >72 hours |
| Regulatory Framework | Conducted in accordance with State Council Order No. 818 – Guidelines for the Record‑Filing of Clinical Research on New Xenotransplantation Technologies |
| Collaborators | Yunnan Agricultural University; The First People’s Hospital of Kunming; The First Affiliated Hospital of Anhui Medical University |
| Global First | First global demonstration of prolonged efficacy validation for extracorporeal gene‑edited pig liver perfusion support |
Preclinical Evidence – Ex Vivo Liver Perfusion Support Study
| Endpoint | Result |
|---|---|
| Cases Completed | Six – all exceeding 72 hours of stable perfusion support |
| Longest Support Duration | 144 hours – a new record for this technology |
| Physiological Parameters | Stable throughout the study period |
| Donor Bile Secretion | Continuous – evidence of viable, functioning donor liver tissue |
| Key Biochemical Indicators | Overall stable, effectively compensating for hepatic physiological functions |
| Immune Rejection | Controllable – no hyperacute or acute rejection‑related injuries |
The study integrated the Company’s independently developed organ perfusion system with the 8‑gene‑edited medical donor pig liver developed by Yunnan Agricultural University, establishing a safe and stable extracorporeal liver perfusion support therapy platform. By overcoming critical technical challenges in xenogeneic liver transplantation – notably rejection control over extended perfusion periods – the research group, in collaboration with The First People’s Hospital of Kunming and The First Affiliated Hospital of Anhui Medical University, set a record consistent with the record‑filing requirements of State Council Order No. 818.
Platform Profile – Modular Organ Perfusion System
- Modular Architecture: The system constitutes a modular organ medical equipment platform – a universal core host unit paired with interchangeable specialized pipelines, organ chambers, perfusion solutions and other consumables and configuration modules.
- Multi‑Organ Capability: Without replacing the core host unit, the platform enables research and applications in normothermic perfusion preservation and extracorporeal life support for multiple organs – including liver, kidney, heart and lung.
- Therapeutic Extension: Demonstrates significant technical potential for extending from organ perfusion preservation into extracorporeal perfusion support therapy.
- Self‑Developed IP: The organ perfusion system was independently developed by True Health Medical Technology.
Clinical Rationale & Prospective Applications
- Unmet Need in Liver Failure: Liver failure carries a high risk of mortality; existing artificial liver support technologies remain limited in fully replacing the liver’s complex physiological functions, while liver transplantation is constrained by donor availability, patient clinical condition and optimal transplant timing.
- Bridging Concept: The gene‑edited pig liver extracorporeal perfusion support technology connects a biologically viable ex vivo liver to the patient’s circulation, providing potential liver function support and securing critical time for severe liver failure patients to either restore native liver function or bridge to transplantation.
- Exploratory Indications: Future application areas under exploration include acute liver failure, subacute liver failure, acute‑on‑chronic liver failure, severe hepatic decompensation and related critical liver diseases, critically ill patients awaiting liver transplantation, and severe hepatic dysfunction following transplantation – all currently in the exploratory research phase and not yet approved as clinical indications.
- Path to Clinic: The study provides a scientific foundation for subsequent technical optimization, system performance validation, and the initiation of clinical trials; the Company will continue refining research data, evaluating safety and efficacy, and collaborating with healthcare institutions and research institutes on clinical translation feasibility.
Market Impact & Outlook
- China Liver Disease Burden: China has a vast patient population suffering from chronic liver disease, giving novel ex vivo liver function perfusion support technologies promising clinical application prospects worthy of further investigation.
- Global Xenotransplantation Momentum: As the first global prolonged efficacy validation of extracorporeal gene‑edited porcine liver support, the result positions True Health Medical (HKG: 2697) at the frontier of the emerging xenotransplantation and bioartificial organ support field.
- Regulatory Alignment: Conducting the research under State Council Order No. 818 record‑filing requirements signals an orderly, compliance‑anchored path toward clinical research translation in China’s newly regulated xenotransplantation landscape.
- Platform Economics: The modular host‑plus‑consumables design – one core unit serving liver, kidney, heart and lung applications – supports scalable equipment placement with recurring consumables revenue potential across perfusion preservation and life‑support use cases.
- Collaborative Ecosystem: Partnerships spanning Yunnan Agricultural University (gene‑edited donor pigs) and leading hospitals in Kunming and Anhui establish a vertically integrated research chain from donor organ engineering to clinical application.
Forward‑Looking Statements
The Board reminds shareholders and potential investors that the six studies described are preclinical; their completion does not indicate that the relevant technologies have demonstrated safety and efficacy in human beings, nor that any product has obtained medical device registration certificates or clinical application approvals. Significant uncertainties remain regarding potential indications, clinical translation pathways and commercialization prospects. Shareholders and potential investors are advised to exercise caution when dealing in the Company’s securities.-Fineline Info & Tech
