Shanghai Jiao Tong University Licenses Four Patents for RMB 2.3 Million to Shende Non-Invasive Era Medical for Its Innovative MR-guided Focused Ultrasound Platform

Recently, Shanghai Jiao Tong University issued a public announcement stating its intention to transfer four invention patents, including “A Magnetic Resonance-Guided Superficial Tumor Ultrasound Hyperthermia Treatment System,” to Shende Green Medical Era Co., Ltd. (hereinafter referred to as “Green Medical Era”), with the transaction amount reaching RMB 2.3 million.

Green Medical Era is a high-end medical device R&D company specializing in the development of non-invasive therapeutic devices for Magnetic Resonance-guided Phased Array Focused Ultrasound (“Magnetic Wave Knife”). The company was founded through the joint entrepreneurial efforts of nearly 20 master’s and doctoral graduates from Shanghai Jiao Tong University, who possess interdisciplinary expertise in medicine and engineering.

The Magnetic Resonance-Guided Phased-Array Focused Ultrasound Precise Non-Invasive Treatment System, also known as the "Magnetic Wave Knife," integrates focused ultrasound with magnetic resonance imaging (MRI). It utilizes MRI for precise localization of the treatment target, accurately focusing ultrasound waves on tumor tissue. By generating temperatures exceeding 65°C, it induces protein denaturation, apoptosis, and coagulative necrosis in tumor cells, thereby achieving the therapeutic goal of tumor ablation.

The greatest advantage of magnetic wave knife technology lies in its non-invasiveness, which avoids invasive procedures such as craniotomy or puncture associated with traditional surgery, significantly reducing patient suffering and the risk of complications.

Compared with traditional ultrasound imaging-guided techniques, magnetic wave knife technology offers the following advantages: it not only achieves millimeter-level precision, but also visualizes the ultrasonic treatment path, thereby avoiding damage to normal tissue cells outside the treatment area. In addition, the magnetic wave knife enables real-time monitoring of intraoperative temperature to ensure that each treatment point achieves the desired effect; postoperatively, the overall ablation efficacy can be assessed immediately without the need for contrast-enhanced MRI.

The advent of the Magnetic Wave Knife has undoubtedly provided a new therapeutic option for clinical practice. According to a report in the journal *Informatization Construction*, the device currently has over 120 clinical indications, covering gynecological tumors, urological tumors, abdominal tumors, cervical tumors, and neurological disorders of the brain.

Taking the field of uterine fibroid treatment as an example, approximately 11.21% of women in China suffer from uterine fibroids, with the estimated number of patients exceeding 60 million. Current treatment modalities for uterine fibroids include surgical intervention, ablation techniques, and embolization techniques. Among these, surgical intervention accounts for the largest share, reaching 58.46% of the market in 2021. According to the latest research, the sales revenue of China’s uterine fibroid treatment market reached USD 4.846 billion in 2021 and is projected to reach USD 9.49 billion by 2028. This indicates that if Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS), commonly known as the "Magnetic Wave Knife," becomes a primary clinical treatment modality and replaces invasive surgeries, its commercial potential will be substantial.

With the deepening of future market development and clinical education, the market potential and economic benefits are enormous. According to Frost & Sullivan’s assessment report, the potential market size for Green Medical Era’s magnetic wave knife could reach RMB 70 billion.

Given that magnetic wave knife technology requires the participation of numerous interdisciplinary talents and has high R&D barriers, with technical challenges involving precise positioning and treatment target selection, implementation of focused ultrasound technology, monitoring and adjustment during treatment, and determination of indications and contraindications, there are few participants in the vast market. Currently, the global magnetic wave knife market is mainly dominated by three companies: Green Medical Era, Insightec, and Profound Medical.

Green Medical Era aims to tackle key technical challenges and commercialize the Magnetic Wave Knife, a major scientific achievement resulting from 40 years of research by a professorial team at Shanghai Jiao Tong University. It is committed to the research, development, and production of high-end, domestically manufactured non-invasive medical equipment with independent intellectual property rights, for the non-invasive treatment of major diseases such as tumors and neurological disorders.

The magnetic wave knife developed by Green Medical Era is the first domestically produced device of its kind approved for the treatment of uterine fibroids in China. It has resolved technical challenges related to phased-array focused ultrasound, MRI guidance and monitoring, and MRI electromagnetic compatibility. The device features multiple patents with independent intellectual property rights in key technologies, achieves breakthroughs in several core technical areas, and fills the gap in the domestic market for magnetic wave knife products.

In April 2024, China’s domestically developed Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system, commonly known as the “Magnetic Wave Knife,” achieved a significant breakthrough. A professorial team from Shanghai Jiao Tong University, in collaboration with Shanghai General Hospital and Green Medical Era, successfully completed the first preclinical primate experiments for the treatment of essential tremor and tremor-dominant Parkinson’s disease. This milestone provides crucial practical support for advancing the “Magnetic Wave Knife” system into human clinical trials for neurological disorders, thereby paving the way for its domestic commercialization.

In June, the Center for Medical Device Technical Evaluation of the National Medical Products Administration (NMPA) announced that Green Medical Era’s non-invasive Magnetic Wave Knife had officially passed the special review application for innovative medical devices and entered the “green channel” for special review of innovative medical devices.

Founded in 1999, Insightec is the global leader in Magnetic Resonance-guided Focused Ultrasound (MRgFUS) technology. The company operates dual headquarters in Israel and the United States, with offices and subsidiaries in Munich, Germany; Dallas, USA; Shanghai, China; and Tokyo, Japan.

Since its inception, Insightec has completed multiple rounds of financing totaling approximately $600 million, with GE Healthcare participating in several of these rounds. On June 20, Insightec announced the completion of a new $150 million funding round to further support its incisionless ultrasound neurosurgery technology.

Insightec has launched three types of MR-guided focused ultrasound systems: Exablate Neuro for the brain, Exablate Body for the body, and Exablate Prostate for the prostate.

Body Magnetic Wave Knife was approved by the FDA in 2004 for the treatment of uterine fibroids, and its indication was expanded by the FDA in 2012 to include palliative treatment for pain associated with metastatic bone cancer. In 2013, the Body Magnetic Wave Knife was approved by the NMPA for the treatment of uterine fibroids.

Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the brain was approved by the NMPA in 2021 for the clinical treatment of drug-refractory essential tremor and tremor-dominant Parkinson’s disease. In 2023, the product also received additional CE Mark approval for the treatment of essential tremor.

The Prostate Magnetic Wave Knife received FDA 510(k) clearance in November 2021 and was granted an Investigational Device Exemption (IDE) by the FDA in June 2022 for comparative studies on the treatment of diseased prostate tissue.

Currently, Insightec’s Exablate Neuro system has been deployed in more than 200 medical institutions worldwide, including dozens of hospitals in China such as Shanghai International Medical Center, the Chinese PLA General Hospital, Shenzhen Hospital of Hong Kong University, and Foshan Hospital of Traditional Chinese Medicine. It has performed safe, non-invasive brain surgeries on over 30,000 patients with neurological disorders globally.

In December 2023, Insightec formally signed a cooperation agreement with the medical device subsidiary of Fosun Pharma, jointly establishing Fosun Yishite Medical Technology Co., Ltd. in China. The partnership aims to advance commercial expansion and clinical application collaboration in the treatment of neurological disorders, including essential tremor and Parkinson’s disease, thereby benefiting a broader patient population.

Profound Medical, founded in Toronto, Canada, in 2008, is a publicly listed company specializing in the development of innovative minimally invasive surgical devices. Its core technology integrates real-time MR imaging with ultrasound energy therapy.

Its flagship product, the TULSA-PRO system (Transurethral Ultrasound Ablation PRO), is specifically designed for the ablation of prostate tissue, enabling precise ablation through real-time MR imaging and thermal ultrasound. In 2019, the product received FDA approval for market launch, indicated for the treatment of intermediate-to-advanced prostate cancer, local recurrence of prostate cancer, and benign prostatic hyperplasia.

Furthermore, the company has developed the Sonalleve MR-HIFU treatment platform for managing gynecological conditions such as uterine fibroids. By integrating real-time MR imaging and thermometry with high-intensity focused ultrasound, Sonalleve MR-HIFU enables precise, incision-free ablation of pathological tissue. This technology provides a non-invasive alternative to conventional surgical treatments for uterine fibroids and offers incision-free, radiation-free palliative care for pain associated with bone metastases.

In 2016, Profound partnered with Siemens to jointly develop an innovative magnetic resonance imaging-guided ultrasound therapy for the treatment of prostate cancer patients.

In the same year, the company reached an agreement with Philips to acquire its magnetic resonance-guided high-intensity focused ultrasound business in exchange for 7.4 million shares of its stock. This acquisition also positioned Profound as a company capable of providing precise MRI-guided ultrasound directional (inside-out) and focused (outside-in) ablation technologies, enabling non-incisional ablation of diseased tissue.

In 2022, Profound entered into a strategic agreement with GE Healthcare to achieve compatibility between its TULSA-PRO system and specific GE Healthcare magnetic resonance imaging (MRI) systems.

With continuous technological advancements and deeper clinical adoption, magnetic wave knife technology is poised to play a significant role in treating a broader range of diseases, bringing greater benefits to more patients.