RuDi Bio's Domestically Developed Nanosecond Pulsed Electric Field Tumor Ablation System Featured in Arterial Selection New Product Showcase Episode 55

Incomplete tumor ablation and high postoperative recurrence rates have long been major factors limiting the widespread adoption of ablative therapies. Unlike conventional ablation modalities such as radiofrequency, cryoablation, and laser ablation,Pulsed Field AblationIt exhibits high tissue selectivity, preserving normal human tissues and organs during ablation while ensuring clear ablation boundaries. Furthermore, as a non-thermal ablation technique, pulsed field ablation generates no heat during the procedure, offering enhanced safety and enabling treatment in “no-go zones” inaccessible to conventional thermal or cryoablation methods.

As the first company to apply nanosecond pulsed electric field technology in the fields of oncology, cardiovascular disease, and brain-computer interfaces,Hangzhou Ruidi Biotechnology's Self-Developed Nanosecond Pulsed Tumor Ablation System (NanoKnife), it has not only developed multiple clinical applications such as lesion ablation, neuromodulation, and brain-computer interface control, but also broken through the limitations of traditional thermal ablation, enabling the treatment of tumors in high-risk areas, such as those adjacent to critical structures like major blood vessels, nerves, and bile ducts.Filling a Domestic Gap, and was therefore approved to enter the Special Approval Channel for Innovative Medical Devices.

February 2024, Nanosecond Pulsed Tumor Ablation System (Nanosecond Knife)Once again granted the U.S. FDA “Breakthrough Device” designation, it has become the first pulsed field ablation product in China to receive this recognition, and is also the only tumor pulsed field ablation system globally to have secured dual innovation certifications in both China and the United States.

On Wednesday, April 17, at 19:30, the 55th session of VCBeat Select New Product Review invitesZhang Jizhuang, CTO and R&D Director of Hangzhou Ruidi Biotechnology Co., Ltd.; Xu Yingrui, CFO and Financial Director of Hangzhou Ruidi Biotechnology Co., Ltd.; Ren Zhigang, Director of the Infectious Diseases Ward, Department of Infectious Diseases, The First Affiliated Hospital of Zhengzhou University; Chen Wei, Chief Physician, Department of Urology, The First Affiliated Hospital of Wenzhou Medical University，Product Promotion of the Original Innovative Product—Nanosecond Pulsed Tumor Ablation System (NanoKnife)。

Figure: Ruidi Biotechnology Nanosecond Pulsed Tumor Ablation System (Nanosecond Knife)

Existing clinical data have confirmed that nanosecond pulsed technology can break through the contraindications of traditional thermal ablation, achieving non-thermal pulsed electric field ablation of tumors and providing a breakthrough innovative therapy for solid tumors in surgically high-risk areas. Compared with irreversible electroporation using microsecond pulsed electric fields, Ruidi Biotechnology’s Nanosecond Knife featuresMore Precise、Higher Energy、Sharpertechnological iteration advantages.

Under the guidance of imaging equipment, insert the electrode needle into the tumor margin and emit within the nanosecond range.Tens of thousands of volts high-voltage pulse. The high-intensity electric field generated by ultra-high voltage and ultrashort pulses induces superelectroporation of tumor cell membranes, utilizing high-voltage, ultrashort, steep pulses"Transmembrane Nuclear Entry", inducing rapid apoptosis of cancer cells. Due to differences in electrical conductivity, surrounding tissues such as blood vessels and bile ducts are safely preserved.

A global breakthrough in high-power pulsed technology, achieving for the first time kilovolt-level high-voltage electric fields and nanosecond-scale ultrashort pulses. This technology enables super-electroporation of cell membranes, facilitating "transmembrane nuclear entry" to directly act on the nucleus and organelles, thereby inducing complete tumor destruction and activating systemic immunity. The nanosecond-scale ultrashort pulses avoid muscle twitching and electrocardiographic risks associated with long-pulse stimulation.

Scan the QR code on the poster to add the assistant and reserve a spot for the live broadcast.

Zhang Jizhuang

R&D Director, CTO of Ruidi Biotechnology

Chief Technology Officer of Ruidi Biotechnology, Ph.D. from Tsinghua University, responsible for the research and development of software and hardware products for pulsed field ablation as well as team management. Previously held product R&D roles at multiple Fortune 500 medical device companies, with extensive experience in the development of medical imaging and minimally invasive ablation equipment.

Member of the Subcommittee on Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment (SAC/TC10/SC3) under the National Technical Committee for Standardization of Medical Electrical Appliances; Member of the IEC TC62C WG1 Expert Working Group of the International Electrotechnical Commission; Drafted one medical device industry standard; Holds more than 30 authorized invention patents.

Xu Yingrui

CFO, Hangzhou Ruidi Biotechnology Co., Ltd.

Chief Financial Officer of Ruidi Biotechnology, responsible for financing, investment, and the implementation of the company’s IPO plan. Certified Public Accountant (CPA), Certified Tax Agent (CTA), and Certified Internal Auditor (CIA).

Served as an audit manager for listed companies and IPOs at a leading domestic accounting firm for over ten years; previously held positions including Director of Investment Banking at a securities firm, Managing Director of the department, and CFO of a pre-IPO company.

Ren Zhigang

Director of the Infectious Diseases Ward, The First Affiliated Hospital of Zhengzhou University

Associate Professor, Associate Chief Physician, M.D., Ph.D., Postdoctoral Fellow, Doctoral Supervisor, Postdoctoral Co-Supervisor

Chairman of the First Youth Committee, Branch of Infectious Diseases, Henan Medical Association

Zhongyuan Talents Program - Zhongyuan Young Top-notch Talents

Henan Provincial Science and Technology Innovation Talent in Higher Education Institutions

Leading Academic Figure in Mid-career and Young Professionals, Henan Provincial Health Commission

The Second “Top Ten Outstanding Young Professionals” of the Henan Provincial Health Commission

Committee Member of the 6th Committee of the Microecology Branch, Chinese Preventive Medicine Association

Vice Chairman, Microecology Branch, Henan Preventive Medicine Association

Standing Committee Member of the First Specialist Branch of the Liver Disease Rehabilitation Society, Henan Medical Association for Rehabilitation Medicine

Editorial Board Member, *Military Medical Research* and *Hepatobiliary & Pancreatic Diseases International*

Principal investigator of 7 national-level research projects, including projects under the National Key R&D Program, the National Science and Technology Major Project on Prevention and Control of Infectious Diseases, the National Natural Science Foundation of China, and the Special Funding of the China Postdoctoral Science Foundation;

Over the past five years, I have published 76 SCI-indexed papers as first or corresponding author (including co-first/co-corresponding authors) in journals such as *Gut* (IF: 31.80), *Signal Transduction and Targeted Therapy* (IF: 39.30), *Advanced Materials* (IF: 30.85), *Military Medical Research* (IF: 34.92), and *Advanced Science* (IF: 17.52). Among these, five papers have an impact factor greater than 30, 17 are ranked in Zone 1 of the Chinese Academy of Sciences journal classification, and three are ESI Highly Cited Papers. I hold four authorized national invention patents as the primary inventor. My awards include two Henan Provincial Technical Invention Awards (First Prize in 2022, ranking 7/10; Third Prize in 2020, ranking 2/7), one First Prize of the Provincial Natural Science Academic Award (2021, ranking 1/5), two First Prizes of the Provincial Medical Science and Technology Award (2022, ranking 3/12; 2019, ranking 2/11), and the “Young Investigator Award” at the 21st International Liver Transplantation Congress. I was invited to deliver one plenary lecture at an international conference.

Chen Wei

Chief Physician, Department of Urology, The First Affiliated Hospital of Wenzhou Medical University

M.D., Chief Physician, Associate Professor, Master's Supervisor

Committee Member of the Prostate Cancer Expert Committee, Chinese Society of Clinical Oncology (CSCO)

Standing Committee Member, Professional Committee on New Drug Research for Tumor Control through Integrated Traditional Chinese and Western Medicine, China Anti-Cancer Association

Member of the Committee on Integrated Traditional Chinese and Western Medicine Oncology, China Anti-Cancer Association

Member of the Precision Medicine Group, Committee on Urologic and Male Genital Tumors, China Anti-Cancer Association

Standing Committee Member, Urologic and Male Reproductive Oncology Professional Committee, Zhejiang Medical Doctor Association

Committee Member, Committee on Urological and Male Genital Tumors, Zhejiang Anti-Cancer Association

Committee Member, Andrology Branch of Zhejiang Medical Association

Committee Member, Minimally Invasive Urology Group, Urology Branch of Zhejiang Medical Association

Committee Member of the Urology Branch, Wenzhou Medical Association

Committee Member, Urology Group of the Minimally Invasive Surgery Branch, Wenzhou Medical Association

Zhejiang Province Rising Star in Medicine

Founded in 2014, Hangzhou Ruidi Biotechnology Co., Ltd. is a high-tech platform enterprise dedicated to the research and development, manufacturing, and sales of high-end innovative medical devices based on pulsed electric field (PEF) technology. Established by returnee scientists from the UK and the US, the company leverages its internationally leading third-generation nanosecond pulsed electric field platform technology to develop an innovative product pipeline spanning oncology, atrial fibrillation, chronic diseases, and brain-computer interfaces. The company’s flagship product, the Nanosecond Pulsed Electric Field Ablation System (NPA), was selected as a recommended achievement by the Ministry of Science and Technology and the National Health Commission for exhibition at the National “13th Five-Year Plan” Scientific and Technological Innovation Achievements Exhibition. It has received the First Prize for Provincial Scientific and Technological Progress, and obtained dual innovative designations through the NMPA’s Innovative Medical Device Channel and the U.S. FDA’s Breakthrough Device Program, making it the only PEF ablation product worldwide to secure such innovation certifications in both China and the United States.

The company boasts an interdisciplinary R&D team integrating medicine, engineering, and information technology. It is led by distinguished talents including the Chair of the International Society on High Voltage, specially appointed high-voltage experts in China and Hangzhou, and recipients of the Hangzhou 521 Talent Program. R&D personnel account for 60% of the workforce, with nearly 70% holding bachelor’s degrees or higher. Professor Chen Xinhua, the founder, previously served as Chair of the International Society on Electroporation-Based Technologies and Treatments (ISEBT) and pioneered global research into the mechanisms and clinical applications of nanosecond ultra-short pulses. Hangzhou Ruidi Biotechnology Co., Ltd. has established municipal-level R&D centers, expert workstations, and doctoral innovation stations. The company holds over 200 patents, has filed multiple PCT patent applications targeting European and American markets, and has initiated FDA and CE certifications for its products. Additionally, it has formulated and released group standards for the China Instrument and Control Society. Its facilities include Class 10,000 clean workshops designed according to GMP standards, high-standard assembly workshops, and comprehensive testing laboratories, all of which have passed ISO 13485 quality management system certification.

Hangzhou Ruidi Biotechnology Co., Ltd. has deeply cultivated the field of pulsed electric fields, continuously exploring technical principles and overcoming technological bottlenecks. The company has successively received support from more than ten major national science and technology special projects and the National Natural Science Foundation of China. Guided by extensive and robust foundational mechanistic research, it drives disruptive R&D design, aggregates original technological resources from top international universities, and actively engages domestic and foreign large enterprises and research institutions in collaborative development. This has established an original brand poised for global expansion and innovative capabilities ready for the international stage. Upon market launch, its products will break the monopoly held by expensive imported equipment, reduce the cost of tumor ablation surgeries, and thereby alleviate the financial burden on patients. By benefiting a broader population with original scientific and clinical translation achievements, the company contributes to the Healthy China initiative.

“Artery Select New Product Launch” is a live-streaming program under the “Artery Select” brand, dedicated to supporting medical enterprises in launching innovative products. The program’s mission is to empower every milestone launch of innovative medical products.

Scan the QR code below to contact the assistant and schedule a live stream.

(If already added, please proactively contact the assistant)