Winonco Medical's Wknife Receives NMPA Innovation Designation for Groundbreaking Lung Cancer Ablation System

In April 2026, the “Irreversible Electroporation Therapy System” (trade name: Vknife / Wknife), independently developed by Hangzhou V-Onco Medical Technology Co., Ltd., officially passed the special review procedure for innovative medical devices conducted by the National Medical Products Administration (NMPA) and received certification as an innovative medical device, owing to its innovations such as non-thermal ablation with full-lung reachability (including the hilar region). This follows August 2025First Product “Irreversible Electroporation Ablation System” Innovatively Approved with the Advantage of “Single-Needle + Local Anesthesia”Subsequently, the company once again secured a national-level innovation certification, marking a significant step toward resolving the global challenge of ablating hilar lung cancer and benefiting more patients. This achievement further underscores our company’s innovative leadership in the field of precise non-thermal interventional oncology therapy.

The V-Onco technology originated from the Key Program of the National Natural Science Foundation of China, undertaken by Professor Yao Chenguo’s team at Chongqing University since 2000. In 2002, the team pioneered a novel method for tumor ablation using high-voltage, ultra-short pulsed electric field irreversible electroporation (IRE) on an international scale (published in *Acta Biophysica Sinica* 2002, 18(4): 474-77; *IEEE Transactions on Plasma Science*, 2004, 32(4)).Established China’s Position in Original Innovation in This FieldOver the subsequent two decades, the team has continued to deepen its expertise, evolving from the first two generations of products—microsecond pulsed electric field electroporation technology (conventional IRE) and high-frequency composite pulsed electric field electroporation technology (HF-IRE)—to the latest generation of wideband synergistic pulsed electric field technology (S-IRE),V-Onco has achieved fundamental changes in principle and performance.: Significantly reduces muscle contraction, avoiding the use of general anesthesia and muscle relaxants; employs a broadband multi-parameter synergistic waveform to generate a uniform electric field in complex media; enhances cytotoxic efficacy and expands the ablation zone.

● Pioneering Mechanism: Introduces the world’s exclusive technology of wideband synergistic pulsed multi-site ablation, first applied to lung tumors. This approach effectively mitigates the “heat-sink/cold-sink effect” risks associated with conventional thermal ablation near major blood vessels and main bronchi, thereby providing a novel local ablation treatment option for patients with lung cancer in all lung regions—particularly those with hilar lung cancer adjacent to major vessels, which have traditionally been contraindications for ablation therapy.

● Product Innovation: The first steep pulse therapy device for non-thermal ablation of lung cancer, pioneering a dual-pathway treatment approach combining percutaneous and natural orifice (bronchoscopic) access. This allows physicians to select less invasive interventional methods based on tumor location, reducing the risk of complications such as pneumothorax and hemorrhage, while enabling access to more distal or occult lesions, thereby advancing precision and personalized therapy for lung cancer.

Leveraging the V-Onco system, a multi-center collaboration led by the Department of Respiratory and Critical Care Medicine at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and the Department of Interventional Medicine at Shanghai Zhongshan Hospital, successfully completed the first batch of domestic and international clinical trials of V-Onco ablation for malignant pulmonary nodules in humans (including percutaneous approach validation). The trials covered complex scenarios such as one-stop synchronous diagnosis and treatment, bilateral multiple lesions, and large-angle access to the apical segment of the right upper lobe, involving lesions in special locations adjacent to blood vessels, the trachea, and the apical segment of the right upper lobe with large-angle access. Clinical results showed:

● 100% surgical success rate;

● 100% complete lesion ablation rate;

● No serious complications, such as bleeding or pneumothorax, occurred during or after the surgery;

● The average postoperative length of stay was only 3 days, with rapid recovery;

● Immediate postoperative and 6-month follow-up imaging confirmed well-defined ablation margins, complete tumor coverage with significant shrinkage and absorption, demonstrating remarkable therapeutic efficacy.

Percutaneous-Natural Orifice Clinical Trial

This clinical practice marks the first successful application in humans of an innovative protocol combining percutaneous interventional therapy for lung cancer, fusion robot-based precision navigation technology, and V-Onco’s core non-thermal ablation technology. It achieved precise, minimally invasive, and selective ablation of pulmonary lesions with coverage across the entire lung. This represents not only a breakthrough in the field of minimally invasive pulmonary interventional therapy but also validates our company’s R&D strength and technological leadership in the precise interventional treatment of early-stage malignant lung tumors.

The renewed approval as an innovative medical device marks another key milestone in the industrialization of the Vena Blade. Taking this recognition as a new starting point, V-Onco will collaborate with leading clinical institutions to accelerate product registration and market access, facilitate the implementation of a one-stop platform integrating “navigation + synchronous biopsy + Vena Blade precise ablation,” and build a minimally invasive tumor treatment ecosystem covering the entire process of “screening, diagnosis, navigation, ablation, and follow-up.”

Hangzhou V-Onco Medical Technology Co., Ltd. is a national high-tech enterprise dedicated to the field of minimally invasive tumor ablation, driving innovation in minimally invasive oncology solutions through technological R&D. Building on its fully self-developed high-voltage pulsed electric field irreversible electroporation (IRE) technology as its foundational core, the company leverages a multi-physics, multi-modal technology platform to develop internationally leading minimally invasive tumor ablation solutions. Its flagship product, the V-Onco Knife, possesses fully independent intellectual property rights and has accumulated 151 domestic and international invention patents (including 18 PCT patents), while repeatedly receiving national certification as an innovative medical device. The company remains committed to advancing technological innovation and clinical translation, providing safer, more effective, and more accessible Chinese minimally invasive oncology solutions to patients worldwide.

Hangzhou V-Onco Medical Technology Co., Ltd. Marketing Department Email:lanqi@winonco.com