MAaGI Medical’s “ Multimodal Tumor Thermal Therapy System Approved for Market Launch

2023-06-12

On June 9, 2023, MAaGI Medical’s “ Multimodal Tumor Thermal Therapy System” successfully passed the special review process for National Innovative Medical Devices and was approved for market launch (National Device Registration No. 20233010773). It is now officially applied in clinical settings, bringing transformative breakthroughs to the treatment of solid tumors.

Led by Professor Xuemin Xu from the School of Biomedical Engineering (Med‑X Research Institute) at Shanghai Jiao Tong University, a multidisciplinary team spanning tumor ablation therapy, immunotherapy, biothermal physics, and medical imaging conducted over two decades of research. By integrating tissue cryoablation and radiofrequency heating through precise thermal dose control technology, the team introduced—for the first time internationally—the concept and methodology of multimodal thermophysical immunotherapy. This approach not only significantly enhances the precision, safety, and efficacy of local tumor ablation, but also in situ disrupts tumor cells and the microvascular system, releasing a large number of specific antigens and stimulating the body to generate durable, specific T‑cell‑mediated anti‑tumor immunity. This effectively controls tumor recurrence and metastasis, improving patient survival rates. Research results of this technology have been published in high‑level journals such as Science special issues, with dozens of invention patents authorized. Its breakthrough clinical value has been widely recognized by experts both in China and abroad, and it has received support from multiple national‑level projects, including the Key Program and the Distinguished Young Scholars Program of the National Natural Science Foundation of China.


Collaborating with the team of Professor Wentao Li from Fudan University Shanghai Cancer Center, and supported by the National Key R&D Program “Clinical Solution for Image‑Guided Multimodal Ablation Therapy of Solid Tumors”—one of the Ministry of Science and Technology’s first batch of digital medical diagnosis and treatment equipment initiatives—Professor Xu’s team built upon the multimodal thermophysical immunotherapy platform. Through multiple rounds of technological iteration and five years of clinical translation and validation, they successfully developed the  Multimodal Tumor Thermal Therapy System, which integrates ultralow‑temperature cryoablation and radiofrequency heating. This achievement represents an innovation from theory to practice, has formed expert consensus, and provides a reliable clinical solution for solid tumor treatment.

                                       

The National Medical Products Administration fully recognizes the technical advantages and clinical value of the  Multimodal Tumor Thermal Therapy System. The system combines liquid‑nitrogen‑based cryoablation and radiofrequency heating. By first freezing the target lesion and subsequently applying precisely controlled radiofrequency heating, it achieves multimodal tumor ablation in which the heated zone overlaps with the frozen zone, resulting in precise therapeutic outcomes. Through optimized probe design, the system effectively overcomes gas‑blocking issues and enables highly efficient phase‑change heat transfer. Radiofrequency interference is shielded in the treatment segment of the probe, allowing accurate temperature measurement and real‑time feedback during therapy. In the non‑treatment segment, high‑vacuum processing technology is employed to create an ultrathin vacuum insulation layer, which also shields radiofrequency electromagnetic fields. This ensures complete tumor ablation while minimizing damage to surrounding tissues. The integrated control system further enables visualization of the ablation zone through precise regulation of both pre‑freezing and radiofrequency heating processes. The system has completed clinical trials at five top‑tier hospitals: Fudan University Shanghai Cancer Hospital, Chinese PLA General Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Zhejiang Cancer Hospital, and Shanghai Changhai Hospital. These trials verified the safety and efficacy of the  Multimodal Tumor Thermal Therapy System in clinical application. Experts unanimously agree that the system represents a technological innovation from theory to practice, offering a reliable clinical solution for solid tumor treatment that effectively controls tumors and improves patient survival rates. Physicians involved in the clinical validation noted that the system provides the possibility of achieving systemic therapeutic effects through local minimally invasive ablation, representing an innovative concept and methodology in oncology.

                                       

The  Multimodal Tumor Thermal Therapy System has also drawn attention and recognition from several leading enterprises in the fields of tumor precision energy‑based surgery and immune cell therapy.        In the near future, MAaGI Medical will combine the  Multimodal Tumor Thermal Therapy System with intelligent medical imaging technology, medical robotics, and biotherapeutic approaches to build a novel ecosystem for autologous specific immuno‑oncology therapy. We will work together with partners to advance innovative tumor therapies, strive to become a leader in oncology innovation, and provide clinicians with new diagnostic and therapeutic tools that benefit cancer patients worldwide.