WinOnco's VinaBlade Receives NMPA Approval for Dual Indications in Liver and Pancreatic Cancer, Ushering in a New Era of Local Anesthesia-Based Nanoknife Ablation

Recently, Hangzhou Weinai Anke Medical independently developed the broadband collaborative "steep pulse therapy device" and disposable steep pulse ablation electrode needles (Product Name: VenaKnife) has officially obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA), and can be used forLiver Tumors and Pancreatic Tumorsfor treatment. (Registration Certificate No.: National Medical Device Registration 20263090885).

Vienna Knife isThe World's FirstImplementation“Single-Needle Ablation + Local Anesthesia Procedure”andSimultaneously indicated for both liver and pancreatic conditionsthe NanoKnife device, marking the entry of NanoKnife tumor ablation technology into a new era of local anesthesia and establishing China's leading position in this field.

Irreversible Electroporation (IRE) technology, also known as "NanoKnife," is a non-thermal ablation technique that induces irreversible electroporation of the cell membrane through high-voltage pulsed electric fields, leading to cell death and thereby achieving tumor tissue ablation. Compared with traditional thermal ablation techniques, it offers two major advantages: being non-thermal and selective. It is not affected by the "heat-sink effect" and can preserve critical structures such as blood vessels, bile ducts, pancreatic ducts, and nerves while ablating tumor tissue. This makes it of significant clinical value in the treatment of tumors in anatomically complex regions such as the liver and pancreas.

However, the clinical adoption of conventional irreversible electroporation (IRE) technology faces significant limitations. On one hand, pulse delivery during treatment can induce severe muscle contractions, typically necessitating general anesthesia and the administration of high-dose neuromuscular blocking agents. On the other hand, conventional IRE largely relies on multi-needle electrode arrays, resulting in complex procedures that impose stringent requirements on physician expertise, needle trajectory planning, tumor location, and supporting equipment infrastructure.“General anesthesia with muscle relaxation is mandatory” and “multi-needleSetup”YesLong-standing limitations of IRE technologyKey Bottlenecks to Widespread Adoption。

The ViNAD knife employs the latest generation of IRE technology (S-IRE). By puncturing ultra-fine, single-use pulsed ablation electrodes into the target area, it releases a broad-spectrum, synergistic high-voltage pulsed electric field. This induces multi-site electroporation effects on both intracellular and extracellular membranes, leading to cell death. Consequently, it achieves non-thermal (without heat sink effect) and selective ablation of lesion tissues, preserving critical vascular structures and nerves.Its core breakthrough lies in truly achievingNo muscle relaxation required, well-tolerated under local anesthesia, effective ablation with a single needle。

The so-called "true local anesthesia" not only enables ablation to be performed without muscle relaxation and under local anesthesia, but also achieves an effective ablation zone that is equal to or exceeds that of traditional irreversible electroporation (IRE) ablation performed under the conditions of muscle relaxation combined with general anesthesia.

The pioneering bipolar single-needle IRE ablation significantly enhances procedural convenience for physicians and reduces the learning curve. By decreasing the number of electrodes required, it lowers treatment costs and enables more precise ablation of tumors in critical locations, such as the hepatic hilum, pancreas, and areas adjacent to blood vessels or bile ducts.

The “VenaKnife” product had previously received designation as an Innovative Medical Device in China due to its original breakthrough of “local anesthesia + single-needle” technique and its clinical value.

● First broadband synergistic pulse energy—— Multi-point non-thermal ablation to enhance therapeutic efficacy

● No neuromuscular blockade required——Low cardiac electrical and muscle stimulation, tolerable by patients under local anesthesia, avoiding the risks of general anesthesia

● No ECG synchronization required—Low electrical stimulation, no ECG synchronization required

● Single-needle effective ablation— Pioneering single-needle effective ablation, while also compatible with traditional multi-needle array deployment, offering flexible clinical options

● Pin Tract Management Design—Reducing the risk of needle tract bleeding and needle tract metastasis

● Excellent Immunological Response—Can be combined with chemotherapy and immunotherapy to achieve synergistic effects

Wien Knife technology stems from over 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 pioneered the cross-disciplinary application of traditional high-voltage technology to biomedicine, leading the way in researching irreversible electroporation using pulsed electric fields for medical purposes. In 2004, they published the first international academic paper in this field, thereby advancing the development of pulsed electric field-based tumor therapy.

For over two decades, Professor Yao’s team has been advancing the research and development of pulsed electric field tumor treatment systems, supported by national-level projects such as the National Natural Science Foundation of China and the National Key R&D Program. Through long-term research and clinical translation, the team has further focused on addressing key challenges in conventional irreversible electroporation (IRE) therapy, including stringent anesthesia requirements, intense muscle contractions, difficulties in multi-needle array placement, and limited ablation zones. They have proposed a novel waveform featuring microsecond-nanosecond synergistic pulsed electric fields and developed a single-needle delivery technology for pulsed electric fields, thereby establishing the latest generation of IRE technology—VenaSeal™(Broadband Synergistic Steep Pulse)。

Hangzhou Weinacare Medical Technology Co., Ltd. is a national high-tech enterprise dedicated to the field of minimally invasive tumor ablation, driven by clinical needs and committed to the research and development of innovative medical technologies. Centered on its fully self-developed high-voltage pulsed electric field irreversible electroporation (IRE) technology, the company leverages a multi-physics, multi-modal technology platform to develop internationally leading solutions for minimally invasive tumor ablation. Its core product, the Weina Knife, possesses fully independent intellectual property rights and has accumulated more than 200 domestic and international invention patents (including 18 PCT patents). It has twice been recognized as an Innovative Medical Device by China’s National Medical Products Administration. The company will continue to promote technological innovation and clinical translation, providing safer, less invasive, and more accessible Chinese solutions for patients worldwide.

Marketing Department, Hangzhou Vena Anchor Medical Technology Co., Ltd.

Mobile Number: 18969972963 Email: hanyanhui@winonco.com