Shen De Non-Invasive Era: China's First MR-Guided High-Intensity Focused Ultrasound Therapy System! [Artery New Product Showcase Episode 77]

The Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) released the “Public Notice on Review Results of Special Examination Applications for Innovative Medical Devices (No. 5, 2024).” Among them, the Magnetic Resonance-Guided High-Intensity Focused Ultrasound Treatment System, independently developed by Shanghai Shende Non-Invasive Era Medical Technology Co., Ltd. (hereinafter referred to as “Shende Non-Invasive Era”), has passed the NMPA’s special examination application for innovative medical devices and entered the “green channel” for special examination of innovative medical devices.

This product isThe first magnetic resonance-guided phased-array high-intensity focused ultrasound (MRgPHIFU) product for the treatment of uterine fibroids in China,Resolved key challenges such as phased-array focused ultrasound, MRI guidance and monitoring, and MRI electromagnetic compatibility."Multiple patents with independent intellectual property rights have been developed in key technologies."Breakthroughs have been achieved in multiple key core technologies, filling the gap in domestically produced magnetic wave knife products.

In April this year, Shende Non-Invasive Era’s “Magnetic Wave Knife” system successfully completedThe First Preclinical Primate Study for the Treatment of Essential Tremor and Tremor-Dominant Parkinson's Disease,It has provided crucial practical support for the “Magnetic Wave Knife” system, used in the treatment of neurological disorders, to enter human clinical trials and thereby achieve domestic production.

July 22 (Monday) at 19:30, the 77th Session of VCBeat Select New Product Appreciation, featuringShen DeProfessor Shen Guofeng, Founder and Chairman of Non-Invasive Era; Cui Lei, Director and Executive CEO of Shende Non-Invasive Era; Tao Jian, Senior Director of the Second Product Division of Shende Non-Invasive Era; Li Jiayue, Senior Deputy Director of the Second Product Division of Shende Non-Invasive Era, presenting the product introduction of Shende's non-invasive era.

Application Area 1:Tumor Therapy (Hyperthermia/Non-hyperthermia)

Application Area 2:Treatment of Neurological Disorders (Ablation/Neuromodulation)

Application Area 3:Opening the Blood-Brain Barrier (BBB)

Application Area 4:RDN: Non-invasive Thermal Ablation of Renal Artery Sympathetic Nerves

Application Area 5:Thrombolysis, Lithotripsy, Atherosclerosis

Application Area 6:Ultrasound Aesthetics

Non-invasive:The phased-array focused ultrasound technology employed in this technique primarily utilizes high-intensity focused ultrasound to penetrate human tissue and achieve thermal ablation at the focal target, offering the advantages of being non-invasive, non-open, and incision-free.

Low Risk:This technology can significantly minimize damage to critical human tissues. For instance, in the treatment of abdominal tumors, it can deactivate specific transducer elements to bypass the ribs and prevent rib injury. Similarly, in the treatment of neurological disorders, it employs phase compensation and calibration techniques to address defocusing issues caused by ultrasound penetration through the skull. Furthermore, as a non-invasive therapeutic approach, it allows for outpatient treatment with immediate discharge and carries a lower risk of complications.

Smart and Green:The software system integrated with this technology provides intelligent treatment plans for clinical practice. Clinicians can conduct comprehensive efficacy assessments throughout the entire process using real-time image fusion technology, which involves no ionizing radiation, making the treatment procedure greener and safer.

Technical Advantages of MRI-Guided Technology:

· Achieve Precise Localization and Marking of the Target Volume

· Real-Time Efficacy Assessment Using Multiple Imaging Modalities

· Achieving Non-invasive Temperature Measurement and Real-time Monitoring

Advantages of Phased-Array HIFU:

· Within a certain range, rapid and precise focal spot movement is achieved through electronic scanning.

· Multifocal, Multimode Focusing

· By regulating the amplitude and phase of each ultrasound array element, focusing errors are corrected and compensated to achieve transribial and transcranial focused ultrasound.

· Protect critical brain functional areas from damage by deactivating selected transducer elements

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Shen Guofeng

Founder and Chairman of Shende Non-Invasive Era

Professor and Doctoral Supervisor at the School of Biomedical Engineering, Shanghai Jiao Tong University; Visiting Associate Professor at Harvard University, USA; Shanghai Technical Leader; Chair of the Program Committee for the 13th International Symposium on Therapeutic Ultrasound (ISTU); Founder and Chairman of Shanghai Shende Non-invasive Era Medical Technology Co., Ltd.

Cui Lei

Director and Executive CEO of Shende Non-invasive Era

Party Branch Secretary, Director, and Executive CEO of Shanghai Shende Non-invasive Era Medical Technology Co., Ltd.; Ph.D. candidate in Business Administration at EM Lyon Business School; Dual Master’s degree holder in EMBA from Antai College of Economics and Management, Shanghai Jiao Tong University; Entrepreneurship Mentor at the Bank of China Institute of Technology and Finance, Shanghai Jiao Tong University; Professional Manager; Senior Translator.

Tao Jian

Shen De, Senior Director of the Second Non-invasive Product Division

Senior Director of the Second Product Division at Shanghai Shende Non-Invasive Era, and Rotating Chairman of the Standards Committee. Holds a master’s degree in Mechatronics from Newcastle University, UK. Possesses seven years of R&D experience in large-scale Class III active medical devices and two years of operational management experience in product divisions. Demonstrates profound expertise in the full lifecycle management of the “Magnetic Wave Knife” product and the integrated model of industry-academia-research-clinical collaboration.

Li Jiayue

Shen De, Senior Deputy Director of the Second Non-Invasive Product Division

Organization Committee Member of the Party Branch of Shanghai Shende Non-invasive Era, Senior Deputy Director of the Second Product Division, Rotating Chairman of the Strategy and Execution Committee; holds a bachelor’s and master’s degree from the School of Automation Science and Electrical Engineering at Beihang University; Certified International Project Manager.

Shanghai Shende Non-Invasive Era Medical Technology Co., Ltd. was established in May 2013. The company is based on Shanghai Jiao Tong UniversityAcademician Chen YazhuAs Chief Advisor,ShenProf. GuofengLed by a pioneer and comprising an innovation and entrepreneurship team of nearly 20 PhDs and master’s graduates trained by Shanghai Jiao Tong University, the company leverages the major scientific and technological achievements accumulated over 40 years by Academician Chen Yazhu’s team—Magnetic Resonance-Guided Phased-Array Focused Ultrasound Precision Non-Invasive Therapy SystemUndertake technological breakthroughs and product commercialization, dedicated to the research, development, and production of domestically produced high-end non-invasive medical devices with full independent intellectual property rights, for the non-invasive treatment of major diseases such as tumors and neurological disorders.

Shen De’s non-invasive era “Magnetic Wave Knife” integrated diagnosis and treatment series products includeChildUterine fibroids, adenomyosis, pain relief for metastatic bone tumors, cervical tumors, RDN (renal denervation) non-invasive thermal ablation of renal sympathetic nerves for refractory hypertension, neurological disorders, abdominal malignant tumors, cardiovascular and cerebrovascular diseasesEight products spanning multiple therapeutic areas have gradually established a core innovation platform for magnetic resonance-guided phased-array focused ultrasound technology. This platform covers the entire industry chain, including high-end medical device manufacturing, commercial sales, and after-sales services. Driven by technological innovation, this initiative aims to build a leading national medical device brand into an internationally competitive enterprise, delivering significant benefits to patients while generating substantial social and economic returns, in alignment with China’s strategic needs in the healthcare sector.

 “VCBeat New Product Showcase” is a live-streaming program under VCBeat that supports medical enterprises in launching innovative products. The program’s mission is to support the milestone launch of every medical innovation product.

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