Breakthrough in Non-Invasive Treatment: SJTU's "Magnetic Knife" Successfully Conducts Preclinical Trials on Non-human Primate

May 13, 2024

In a significant advancement for non-invasive medical treatments, a team led by Academician Chen Yazhu and Researcher Shen Guofeng from Shanghai Jiao Tong University (SJTU) School of Biomedical Engineering, in collaboration with Professor Chen Yao's team and the team of Professor Wang Han, Deputy Director of the First People's Hospital of Shanghai and Head of the Radiology Department, has achieved a breakthrough in the development of a domestic "Magnetic Knife" system. The system, also known as "Magnetic Resonance Guided Phased-Array Focused Ultrasound" (MRgFUS), has been successfully tested in preclinical experiments on primates, marking a crucial step towards clinical trials and domestication of the technology. The MRgFUS technology has emerged as a promising treatment for essential tremor and tremor-dominant Parkinson's disease, offering non-invasive, controllable, and highly penetrative treatment options. The recent success builds upon the existing MRgFUS technology, which has been imported into China, and aims to create a domestic alternative. The collaboration with Shunde Non-Invasive Era Medical Technology Co., Ltd. has resulted in the first successful preclinical trials on rhesus monkeys, which tested the safety, efficacy, and stability of the system. Notable medical professionals such as Director Zhang Yuqing from Xuanwu Hospital of Capital Medical University, Deputy Director Zhang Xiaohua from Xuanwu Hospital Jinan Branch, Director Tao Wei from Shenzhen University Affiliated South China Hospital, Dr. Wei Mingyi, Director Zhou Shouguo, Director Wang Juan, and Director Huang Yaoqu from Foshan Hospital of Traditional Chinese Medicine participated in the experiments.

Essential tremor is a prevalent neurological condition that severely impacts daily activities such as eating, drinking, and writing, affecting approximately 15%-25% of patients to the point of disrupting their normal life and work. While surgical and medical treatments for essential tremor are well-established, with Deep Brain Stimulation (DBS) being a significant minimally invasive intervention, many patients are hesitant due to its invasive nature. The "Magnetic Knife" system operates under real-time imaging guidance from a superconducting magnet, emitting hundreds to thousands of ultrasonic beams that are precisely focused through real-time phase control. With real-time temperature measurement via magnetic resonance, the system achieves accurate ablation of the brain's treatment target. Patients can undergo MRgFUS treatment without the need for craniotomy or general anesthesia, making it a convenient outpatient procedure. Under the guidance of Academician Chen Yazhu, the team, in collaboration with the First People's Hospital of Shanghai and Shunde Non-Invasive Era Medical Technology Co., Ltd., has overcome key technical challenges and successfully developed a fully proprietary MRgFUS non-invasive treatment technology. The technology, akin to phased array radar, can actively sense and adjust the position of the ultrasonic focus, enabling rapid movement and transition of the focus. During treatment, the "Magnetic Knife" can non-invasively detect various parameters such as temperature, with the entire surgical operation being fully visualized. Doctors can guide the surgery and assess the effectiveness in real-time through the live magnetic resonance images displayed on the monitor, significantly enhancing the safety and efficacy of focused ultrasound treatments. The team's domestically developed MRgFUS products have already completed all clinical work for the indication of uterine fibroids and are in the process of applying for a Class III medical device registration certificate.

The first generation of the "Magnetic Knife" system, designed for the treatment of brain diseases, will initially focus on thermal ablation treatment for essential tremor, tremor-dominant Parkinson's disease, and movement disorder-dominant Parkinson's disease upon market launch. The technology is expected to expand in the future to include innovative techniques such as thermal ablation, neural modulation, and targeted drug delivery through the blood-brain barrier for the non-invasive treatment of brain tumors, epilepsy, Alzheimer's disease, depression, obsessive-compulsive disorder, and neuropathic pain, among other neurological and mental health conditions, indicating a broad application prospect for the technology.