Recently, the broad-spectrum synergistic “Steep Pulse Therapy Device” and disposable Steep Pulse Therapy Device ablation electrode needle (trade name: Wknife) independently developed by Hangzhou winonco Medical were officially granted the Class III medical device registration certificate by the National Medical Products Administration (NMPA), and can be used for the treatment of liver tumors and pancreatic tumors. (Registration certificate number: Guoxiezhun 20263090885).
Wknife is the world’s first NanoKnife device to achieve “single-needle ablation + local anesthesia” and to simultaneously possess dual indications for liver and pancreatic cancer, marking that NanoKnife tumor ablation technology has since entered a new era of local anesthesia and establishing the leading position of Chinese technology in this field.

IRE Offers Outstanding Clinical Advantages, yet General Anesthesia and Multi-Needle Use Remain Clinical Pain Points
Irreversible electroporation (IRE) technology, also known as the “NanoKnife”, is a non-thermal ablation technique that acts on the cell membrane through a high-voltage pulsed electric field to induce irreversible electroporation, leading to cell death and thereby achieving ablation of tumor tissue.
Compared with traditional thermal ablation techniques, it offers two major advantages—non-thermal and selective: it is not affected by the “heat-sink effect”, and it can ablate tumor tissue while preserving important structures such as blood vessels, bile ducts, pancreatic ducts, and nerves, giving it important clinical value in the treatment of tumors in complex anatomical sites such as the liver and pancreas.
However, traditional IRE technology also faces obvious limitations in clinical adoption. On the one hand, pulse delivery during treatment may trigger severe muscle contraction, and the procedure usually needs to be completed under general anesthesia with the injection of a large amount of muscle relaxant; on the other hand, traditional IRE mostly relies on multi-needle arrays, which is complex to operate and imposes high demands on the physician’s experience, the puncture path, the tumor location, and the supporting equipment conditions.
“Mandatory general anesthesia and muscle relaxation” and “multi-needle placement” have long been the key bottleneck restricting the widespread adoption of IRE technology.
Proprietary Broad-Spectrum Synergistic Technology Truly Achieves “Local Anesthesia + Single Needle”
Wknife adopts the latest-generation IRE technology (S-IRE): an ultra-fine disposable pulse ablation electrode is punctured into the target area and releases a broad-spectrum synergistic high-voltage pulsed electric field to induce multi-site poration of both the inner and outer cell membranes, causing cell death and achieving non-thermal (no heat-sink effect), selective (preserving important ductal and neural structures) ablation of the lesion tissue. Its core breakthrough lies in truly achieving no need for muscle relaxant, tolerance under local anesthesia, and effective single-needle ablation.
The so-called “true local anesthesia” means not only that ablation can be performed without muscle relaxant and under local anesthesia, but also that the effective ablation zone reaches or exceeds the same effective ablation zone achieved by traditional IRE ablation under conditions requiring muscle relaxant plus general anesthesia.
The pioneering IRE bipolar single needle ablation can greatly improve the convenience of the physician’s operation and shorten the learning curve, reduce the number of electrodes used, lower treatment costs, and enable more precise ablation of tumors at special sites such as the hepatic hilar region, pancreas, perivascular areas, and periductal areas.
The “Wknife” product had previously also been granted national innovative medical device recognition for its original breakthrough and clinical value of “local anesthesia + single needle”.
Six Major Technical Features Comprehensively Enhance the Accessibility of Clinical Treatment
lThe first broad-spectrum synergistic pulse energy — multi-site non-thermal killing that improves ablation efficacy
lNo muscle relaxant required — low cardiac and muscle stimulation, tolerated by patients under local anesthesia, avoiding the risks of general anesthesia
lNo ECG synchronization required — low cardiac stimulation, no need for ECG-synchronized delivery
lEffective single-needle ablation — the first effective single-needle ablation, also compatible with traditional multi-needle arrays for flexible clinical choice
lNeedle tract management design — reducing the risk of needle tract bleeding and needle tract seeding
lOutstanding immunological response — can be combined with chemotherapy and immunotherapy for synergistic enhancement


More Than Two Decades of Research Translation, Proprietary Technology Leading the Frontier
Wknife technology originates from more than two decades of sustained research by Professor Yao Chenguo’s team at Chongqing University in the field of pulsed electric field tumor therapy. Since 2000, Professor Yao’s team has applied traditional high-voltage technology in an interdisciplinary manner to the biomedical field, taking the lead in conducting research on pulsed electric field irreversible electroporation medical technology, and in 2004 published the first international academic research paper in this field, advancing the development of research on pulsed electric field tumor therapy.
Over more than two decades, with the support of national-level projects such as the National Natural Science Foundation of China (NSFC) and the National Key R&D Program, Professor Yao’s team has continuously advanced the R&D of pulsed electric field tumor treatment systems. During long-term research and clinical translation, the team further focused on the pain points of traditional IRE treatment—high anesthesia requirements, strong muscle contraction, difficult multi-needle arrays, and limited ablation zone—and proposed a novel microsecond–nanosecond synergistic pulsed electric field waveform and developed single-needle pulsed electric field delivery technology, forming the latest generation of IRE technology — Wknife (broad-spectrum synergistic steep pulse).
Hangzhou winonco Medical Technology Co., Ltd. focuses on the field of minimally invasive tumor ablation and is a National High-Tech Enterprise oriented to clinical needs and driving the R&D of innovative medical technologies. With its entirely self-developed high-voltage pulsed electric field irreversible electroporation technology at its core and covering a multi-physics, multi-modality technology platform, the company develops internationally leading minimally invasive tumor ablation solutions. Its core product Wknife enjoys fully independent intellectual property rights and has to date filed a total of 151 invention patents in China and abroad (including PCT 18), and has twice been granted national innovative medical device recognition. The company will continue to advance technological innovation and clinical translation, providing safer, more minimally invasive, and more accessible Chinese solutions for patients worldwide.
Mobile: 18969972963
Email: hanyanhui@winonco.com
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